Patent Law’s Enablement Requirement and Genus Claims: What Will SCOTUS Have to Say in Amgen v. Sanofi?  

This blog discusses a patent law case which SCOTUS has decided hear on the enablement requirement as it applies to genus claims.  The anticipated decision will have ramifications in particular in the life sciences industry which includes the biotech and pharmaceutical industries.


Even if the invention described in a patent application meets the subject matter eligibility (35 U.S.C § 101), novelty (35 U.S.C. § 102), and non-obviousness requirements (35 U.S.C. § 103) for patentability, the applicant must still describe the invention with enough particularity such that those skilled in the art will be able to make, use, and understand the “parameters” of the invention disclosed and claimed.  Under 35 U.S.C. § 112, this requirement involves 2 major factors: 1) the enablement requirement; and 2) the written description requirement.   The statute states:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.

Granted patent claims can later be invalidated on the basis of non-enablement or an inadequate written prescription in an inter partes proceeding before the Patent Trial & Appeal Board or during patent infringement litigation.  In long-time patent infringement litigation involving the biopharmaceutical firms Amgen and Sanofi, the enablement requirement issue has become intertwined with civil procedure issues:  is the determination of whether the patent description meets the enable requirements a question of law (to be decided by the presiding judge(s)) or fact (to be determined by a jury)?  In 2021, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed the District of Delaware’s invalidation of Amgen’s patent claims asserted against Sanofi as a matter of law in a post-verdict motion.  These very same invalidated claims had previously survived Sanofi’s “lack of enablement” allegations in two separate jury verdicts which the District Court ignored by ruling in favor of Sanofi. Amgen, Inc. v. Sanofi, 987 F.3d 1080 (Fed. Circ. 2021).

In Nov. 2021, Amgen filed a petition for writ of certiorari requesting the Supreme Court to grant the writ for the purpose of addressing two patent enablement questions raised by the CAFC’s opinion.  The first question pertained to whether enablement determinations are a question of law or fact.   The second question pertained to what level of experimentation is required to make Amgen’s invention enabled under 35 U.S.C. § 112(a) for its genus claims.  The Court invited the U.S. Solicitor General to file a brief; the resultant brief counseled against granting the writ.

Amgen filed a reply, arguing that the government’s own brief created a “disagreement with everyone” that further supports SCOTUS’s review. In support of the writ, Amgen emphasized that the Supreme Court’s “a question of fact” standard for enablement extends back to the pre-Civil war era in the 1847 case of Wood v. Underhill.  Amgen also argued that the Solicitor General’s brief failed to respond to arguments that the Seventh Amendment prohibits reexaminations of jury verdicts except under common law standards, which should have precluded the CAFC from reviewing the jury’s enablement finding de novo.   Finally, Amgen argued that the government never explained why a claim should be invalidated based on the cumulative effort to make all embodiments where, as with Amgen’s invention, such efforts would not require undue experimentation for those skilled in the art.  Indeed, the CAFC, in finding non-enablement, had opined that the the enablement standard for a genus claim may be raised if “substantial time and effort would be required to reach the full scope of the claimed embodiments.”

On Nov. 4, 2022, SCOTUS granted Amgen’s writ on Question 2 only: Whether enablement is governed by the statutory requirement [35 U.S.C. § 112(a)] that the specification teach those skilled in the art to “make and use” the claimed invention or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation – i.e., to cumulative identify and make [the invention] or nearly all [of its] embodiments.”

The Public Policy Behind the Enablement Requirement 

Patent protection lasts for about 20 years from the application’s filing date.  Through the government’s grant of this limited monopoly, the patentee has the right to exclusively use and exploit the invention.  After a patent expires, anyone can use, or sell, or import the invention covered by the patent. As such, the enablement requirement is intended to ensure that the public can actually derive benefit after the granted monopoly period is finished by making and using the invention.  Accordingly, the patent disclosure must provide sufficient information for allowing such persons to make the invention after the patent has expired.

Another aspect of the enablement requirement is to prevent the introduction of new matter during prosecution of the patent application.   MPEP 2164.05(a). Accordingly, the patent application is not to be “adjusted” to include new matter during prosecution.  This requirement is intended to help ensure that the patent application is thorough and complete at the time of filing.

What Does It Mean for an Invention to Enabled?

An enabled invention is one which is sufficiently instructive such that who is skilled in the art could make and use the invention without undue experimentation.  This requirement is not as straight forward as it may seem because all inventions are not equal with respect to their complexity or subject matter.   Storer v. Clark, 860 F.3d, 1340, 1350 (Fed. Circ. 2017).   New and more complex inventions may require more description and “directions” to meet the enablement requirement.   Also, for all claims to be approved under the enable requirement, the disclosure must sufficiently enable all of the claims.  In re Borkowski, 422 F.2d 904, 909 (CCPA 1970).

On the other hand, the enablement requirements does not require that the patent disclosure explain how to make a perfected, commercially viable embodiment of the invention.  See Christianson v. Colt Indus. Operating Corp., 822 F.2d 1544, 1562 (Fed. Cir. 1987).  Also, any invention may be associated with know-how and trade secrets (e.g., a raw material with desirable purity specifications to improve invented-product yields) which need not be revealed providing the trade secrets are not critical to the patentability of the invention.

The relevant factors courts have used in determining if the enablement requirement is met may “include (1) the quantity of experimentation necessary; (2) the amount of direction or guidance presented; (3) the presence or absence of working examples; (4) the nature of the invention; (5) the state of the prior art; (6) the relative skill of those in the art; (6) the unpredictability of the art; and (8) the breadth of the claims.”   In re Wands, 858 F.2d 731, 738 (Fed. Cir. 1988) (reversing the USPTO’s refusal to approve the patent applicant’s claims on non-enablement grounds and stating “[c]onsidering all of the factors, we conclude that it would not require undue experimentation to obtain antibodies needed to practice the claimed invention.”).  The commentator notes that this decision was at a time when biotechnology patents were in favor thanks to SCOTUS’s 1980 decision in Diamond v. Chakrabarty, 447 U.S. 303 (1980).  That decision is credited with paving the way for the rapid growth of the then-new biotechnology industry.  And now 40 years later SCOTUS is widely viewed as stifling innovation in today’s related technologies.

The subject patents the CAFC invalidated in Amgen v. Sanofi are directed to a genus of antibodies defined not by their structure (e.g., their amino acid sequence) but by their function, i.e., the ability of the monoclonal antibodies to bind a certain part of the PCSK9 antigen.  PCSK9 is a target for treating levels of LDL (the particularly “dangerous” form of cholesterol).   Accordingly, monoclonal antibodies directed against PCSK9 may still work with various sequence changes.   Patentees in the life sciences have had a difficult time defending claims directed to discovery of a novel biological therapeutic which often involve a functional genus claim.  Narrowly drawn claims to only the patent’s disclosed variations of the invention do not always “appreciate” the full scope of the invention, giving potential infringers wiggle room.

Amgen’s petition for writ emphasized that the CAFC wrongly applied a “special test” for its genus claims after gutting the juries’ findings.  “This approach will have devastating ramifications for biotech and pharmaceutical innovations because “significant breakthroughs [in these industries] often involve the mechanism for producing a desired effect and making a working embodiment . . . [where] the mechanism . . .may have the same effect when implemented in any number of structurally similar compounds.”  Amgen Pet. at 3, 29-30.  Hence a functional genus claim is one where structurally similar biochemical structures may be able to achieve at least some of level of the claimed function or mechanism.  The CAFC’s opinion indicated that the enablement standard for a genus claim could be raised if “substantial time and effort would be required to reach the full scope of the claimed embodiments.”

In its reply to the Solicitor General’s brief, Amgen argued that the Solicitor General had also wrongly extended the scope of Section 112’s enablement requirement to require a skilled artisan to “reach the full scope of claimed embodiments” without “substantial time and effort.”  Amgen’s position is that  “[o]nce inventors teach skilled artisans how to make and use the individual embodiments across the scope of the claim, there is no reason why they should lose their patent because it would take a lot of work to make them all [consecutively].”  Amgen countered that this standard does not comport with the statutory language of Section 112 which has no language connecting enablement with the amount of time and effort required to practice all embodiments of the claimed invention.  Nor did the government explain “why a claim should be invalidated based on the cumulative effort to make all claimed embodiments where as here, it would not require undue experimentation to make and use any individual embodiment.”  Substantial time and effort is not necessarily undue experimentation.


Put another way, the question SCOTUS will be addressing in 2023 is the following:  under the enablement requirement, must an invention like Amgen’s disclose every single potential embodiment of the claimed functional invention and how to make it to meet the enablement requirement and thereby minimize time required for making the embodiments by future users who are skilled in the art?  The commentator adds that the question is related to the actual disclosure’s quality.  Is there sufficient disclosure to meet the enablement requirement for the disclosed embodiments which will allow future users having the requisite skill in the art to proceed in making the disclosed and additional embodiments of a genus claim even if considerable time is involved? Under the enablement requirement, future users should not have to reinvent the wheel to make the patented invention and its various embodiments.  But time and effort are not necessarily undue experimentation.  Even the seminal Wands case’s “enablement” factors do not refer to time and effort but the quantity of experimentation.   Experimentation is itself subjective – and could range from optimization experiments (e.g., to maximize the yield of a claimed process’s product) to experimentation directed to filling in a critical missing or vague step not disclosed in the original application.

In sum, the issue in Amgen v. Sanofi is whether a precise roadmap for making all embodiments of a genus claim must be disclosed to meet the enablement requirement.  Does “time and effort” refer to the “time and effort” for making a limited number of the patent’s discussed embodiments or the “time and effort” for cumulatively making all possible embodiments which of course will result require more time and effort.   Amgen Pet. at 2 (quoting Amgen, 987, F.3d at 1088).  The commentator notes that the methodology for making and growing monoclonal antibodies was first developed last century and is routinely used by biotech companies who rely on the quicker technologies which have been developed over the years to support the biotech and pharmaceutical industries.

In Jan. 2021, SCOTUS denied a cert petition filed by Idenix Pharmaceuticals for nearly identical issues of enablement of functionally defined genus claims after it lost its appeal.  Idenix Pharmaceuticals, LLC v. Gilead Sciences, Inc., 941 F.3d 1149 (Fed. Cir. 2019).  The Amgen case will be closely watched by the patent bar and the life sciences industries now that SCOTUS is finally involved. After many decisions which have invalidated patent claims and negatively impacted patent portfolios in the life sciences industry, there is optimism that patent owners will see a shift in the pendulum in favor of genus claims which are common in this industry given the nature of the beast.  Of interest is the fact that three amicus briefs have been filed in favor in Amgen, including one by highly respected Professor Mark Lemley of Stanford Law School on behalf of a group of intellectual property professors.  This commentator is rooting for Amgen.

Stay tuned for a blog on SCOTUS’s opinion.


© 2022 by Troy & Schwartz, LLC


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Posted in Intellectual Property Law, Patent Law - Current Issues on November 15,2022 12:11 PM



Watch the Ps & Qs When Representing a Client Before the Trademark Trial & Appeal Board

The Sept. 2, 2022 decision by the Trademark Trial & Appeal Board (TTAB) in Shanghai Zhenglang Technology Co. (SZT), Ltd. v. Superbox is a good reminder than an opposition or cancellation proceeding could be dismissed on procedural technicalities.  The SZT case involved an opposition proceeding commenced by Shanghai Zhenglang Technology to oppose registration of the mark JEWEL HUNTER.

Entitlement to a statutory cause of action, known as standing, must be established in every inter partes case before the TTAB.  The bar is low for establishing standing.  As long as the opposer has a reasonable belief that it would be proximately damaged by registration of the mark and therefore has a real interest in the proceedings, standing will be established.  Indeed, the TTAB infrequently dismisses an opposition or cancellation proceeding on lack of standing grounds.  Plaintiff has the burden of establishing standing.

SZT opposed the registration of the Applicant’s mark on the ground of likelihood of confusion based on its alleged prior common law rights in the mark JEWEL HUNTER for an online “game app.”  In its notice of opposition, SZT alleged use of the mark in the United States since January 2015 and that its mark is “very famous” in the United States and China.

During the testimony period, SZT filed three different testimony declarations by its president.  Two of them were untimely as they were filed after the close of SZT’s trial period and also did include proof of service.  The second one was made of the record and considered by the TTAB while the third was not.  And this is where things get interesting.

Under its rules of procedure, witness testimony may be submitted in the form of a sworn affidavit or an unsworn declaration under Trademark Rule 2.20.  Rule 2.20 provides that “[i]nstead of an oath, affidavit, or sworn statement, the language of 28 U.S.C. § 1746, or the following declaration language may be used:

The signatory being warned that willful false statements and the like are punishable by fine or imprisonment, or both, under 18 U.S.C. § 1001 and that such willful false statements and like may jeopardize the validity of the application submission or any registration resulting therefrom, declares that all statements made of his/her own knowledge are true and all statements made on information and belief are believed to be true.

Neither of the “of record” declarations by SZT’s president included the above language.  Accordingly, the following language of 28 U.S.C. § 1746 was the language that should have been included in the shown statement:

I declare (or certify, verify, or state) under penalty of perjury under the laws of the United States of America that the foregoing is true and correct.  Executed on (date).

Instead, the purported declarations, executed in Shanghai, China, stated, “I…declare under penalty of perjury the following to be true” and concluded with the following: “The above statements were translated to me in my primary language, Mandarin.  I fully understand and under penalty of perjury, the above statements are true and correct.”

The purported declarations thus missed the essential reference to the United States.  As the TTAB has explained, “[w]hen a person executes a document outside the United States, a reference to which country’s perjury laws will be applied provides no assurance of truthfulness because the penalty of perjury may be nonexistent or trivial in the place where the person signed the document.”   As such, the First and Second declarations did not comply with the requirements for declaration testimony under U.S. law and were not considered by the TTAB.

As a result of their faultiness, the declarations could not be used to determine if the opposer had standing. Standing cannot be established on mere allegations in its complaint or arguments in its proof to prove entitlement to maintain an opposition proceeding.  Additionally, the TTAB noted that even if they had considered the Internet printouts which were attached to the first two declarations, website printouts are hearsay and have little probative value when it comes to establishing an Opposer’s entitlement.  Without authentication, such printouts can only be used to demonstrate what the documents show on their face, not the truth of what has been printed.  Accordingly, the Plaintiff could not prove that it was entitled to bring the opposition proceeding and the opposition was dismissed.


The decision is a good example of how failure to pay attention to the rules of the agency or court in which a proceeding is filed can have detrimental consequences.   It appears that the Plaintiff’s attorney did not read the rules – proof of service was not provided and the declarations were faulty.  Also, filing deadlines were missed.   Although the proceeding was dismissed on lack of standing grounds, the decision also suggests that plaintiff’s evidence was insufficient for establishing the requisite harm required for preventing registration of applicant’s mark.

Take Home Points

  • It’s important to hire an attorney who has experience in opposition and other proceedings before the TTAB and is well-versed in administrative rules and the law.
  • Where a declaration is to be executed outside of the United States for presentation before the TTAB, be sure that it includes the proper language for subjecting the declarant or affiant to the perjury laws of the United States.  Also for any court proceeding.  We recently represented a defendant from Greece in a lawsuit filed in a Florida court where an  affidavit was executed in Athens with the language of 28 U.S.C. § 1746.
  • Where a declaration is to be signed in the U.S. for presentation to a foreign IP office or court, be sure that it is executed in compliance with the foreign country’s laws.



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Troy & Schwartz, LLC

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Last week’s blog provided information on the Supplemental Register as part of its discussion on the Trademark Trial & Appeal’s Board’s refusal to register the generic mark FELATI on even the Supplemental Register.  That blog briefly referred to the fact that merely descriptive marks may be registered on the Principal Register if: 1) they are found to be suggestive rather than merely descriptive; or 2) have become distinctive.  Otherwise, merely descriptive marks may be registered on the Supplemental Register.  For registration on either register, the examiner must have concluded that there is no likelihood of confusion with an existing registered mark.

This blog goes into depth as to what constitutes a merely descriptive mark by discussing the Board’s affirmance of the examining attorney’s Section 2(e)(1) refusal to register the proposed word mark SMART BEZEL.  In re Zuma Array Limited, 2020 USPQ2d 736 (TTAB 2022) [precedential]. The opinion is instructive because it is a reminder that a proposed mark that describes the intended use or purpose of the goods may be a merely descriptive mark.  In other words, the definition of a merely descriptive mark is not confined to those marks which merely describe a characteristic of the specified goods or services, e.g., CHUNKY CHOCOLATE for ice cream.


 Section 2(e)(1) of the Trademark Act, 15 U.S.C. § 1052(e)(1), prohibits registration on the Principal Register of “a mark which, (1) when used on or in connection with the goods of the applicant is merely descriptive . . . of them,” unless the mark has acquired distinctiveness under Section 2(f) of the Lanham Act, 15 U.S.C. § 1052(f).  A merely descriptive mark which has acquired distinctiveness according to the USPTO’s requirements may file for registration of the mark on the Principal Register under Section 2(f).  If the mark is instead registered on the Supplemental Register, the registrant may later seek registration on the Principal Register if and when the merely descriptive mark acquires the required level of distinctiveness for such registration.

Here the Applicant’s identified goods under IC class 009 were for “electronic sensor modules for controlling and integrating home automation systems, including lighting and thermal control apparatus, energy control devices and household appliances, smart plugs, smart sockets for electric lights, electronic appliances and smart switches, audio and loudspeakers, alarms, and other security control apparatus and home monitoring equipment; electronic sensor modules for controlling and integrating smart lighting systems and smart heating systems; component parts and fittings for the aforesaid goods.”

In rejecting the mark SMART BEZEL on merely descriptive grounds, the examining attorney relied on: 1) the dictionary definition of the adjective “smart” in this context as using a built-in microprocessor for automatic operation, for processing of data, or for achieving greater versatility;” a dictionary definition of the word “bezel” as the “outer frame of a computer screen, mobile phone, or other electronic device;” and an article about a patent held by Apple where the article states the invention enabled Apple to create a “smart bezel.”  Slip opinion @ 2.  The Applicant acknowledged that “smart” is defined as “using a built-in microprocessor” and the word “bezel” refers to “the outer frame of a computer screen, mobile phone or other electronic device.” However, it also asserted, “none of the applied for goods … feature a ‘bezel’ at all.”     The Examining Attorney, on the other hand, maintained that the proposed mark immediately conveys information about the goods because Zuma’s sensors are designed to be incorporated into the bezels of various electronic appliances and lighting and heating systems, “to render the bezels … capable of performing automatic operations for processing data or achieving greater versatility.”

The Board discounted the Applicant’s argument, finding the mark to be descriptive of a use or purpose of the goods’ modules, and thus ineligible for registration without proof of acquired distinctiveness.  In reaching its conclusion, the Board took a somewhat different tack by focusing on the nature of the Applicant’s “electronic sensor modules.”  First, the Board took judicial notice that a “module”  is “a usually packaged functional assembly of electronic components for use with … other assemblies.”  Second, the Board then relied on the wording in the Applicant’s own website to conclude that the proposed mark, by describing the intended use or purpose of the goods with which it is used, is merely descriptive.  For example, the Applicant’s website states that “swap[ping] out a standard bezel for a Smart Bezel (TM)” enables homeowners to access a wide range of built-in sensors to support environmental, presence and life safety operations.”  Slip opinion at 15.  Citing precedent, the Board emphasized that “[P]roof of mere descriptiveness may originate from [the] applicant’s own descriptive use of its proposed mark,  or portions thereof” in its materials and “an applicant’s own website and marketing materials may be  . . . ‘the most damaging evidence’ in indicating how the relevant purchasing public perceives a term.’”  Slip opinion at 14.

Accordingly, the Board concluded that the word BEZEL refers to the type of device on which Zuma’s sensors will be used.  The commercial context of Applicant’s use of its proposed mark on its website “demonstrates that a consumer would immediately understand the intended meaning of” SMART BEZEL for electronic sensor modules, namely, that the modules are used to create a “smart bezel.”

The commentator notes that the Applicant should now have the option of seeking registration on the Supplemental Register.

Take Home Points

  1. Trademark law is complex. As this decision demonstrates, a merely descriptive analysis involves an evaluation of whether the proposed mark describes a particular characteristic of the specified goods/services and/or the intended usage of the proposed mark.  Many applicants are focused on a likelihood of analysis rejection and not familiar with other types of registration rejections.  Accordingly, a proposed mark that is not rejected on likelihood of confusion grounds may still be rejected on merely descriptive or generic grounds as the Zuma Array decision demonstrates.
  2. The USPTO may look beyond the Principal Register other registered marks to ascertain whether a mark is merely descriptive. Here, the examining attorney and the Board used dictionary definitions, a patent document, and the Applicant’s own website to find that the mark was merely descriptive.
  3. Interestingly there was no evidence that third parties were descriptively using “smart bezel” for the application’s specified goods. Although such proof can be highly relevant to a merely descriptive analysis, such lack of proof was of no consequence in the Zuma Array decision.  “The fact that Applicant may be the first or only user of a term does not render the term distinctive if, as here, it has been shown to be merely descriptive of the goods identified in the application.”  Slip opinion at 12.  The commentator notes that Applicant may be able to establish distinctiveness in the future by, e.g., by providing satisfactory evidence that the consumer has come to associate the mark with the Applicant as the provider of the goods.

In Need of Legal Counsel on Trademark Matters and Other Intellectual Property Matters?

Contact Susan Troy, the author of this blog and all of the IP law blogs posted at this website, at 305-279-4740.  She will assist you in determining whether your proposed brand is synergistic with the legal requirements for obtaining a registered trademark.


© 2022 by Troy & Schwartz, LLC




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On July 7, 2022, in In re Lana Grossa mode mit Wolle Handels-und Vertriebs GmbH, the Trademark Trial & Appeal Board (the “Board”) held that a mark utilizing the Italian word for yarn, Filati, could not be registered because the mark is generic and thus incapable of registration.

The opinion is instructive because it covers several matters pertinent to trademark registration that often take a backseat to the far more common likelihood-of-confusion registration issues.  This blog summarizes the take home points from Lana Grossa wherein the Applicant sought registration of the mark FILATI on the Supplement Register as a generic mark.

  1.  Some Background on the Supplemental Register.

The Supplemental Register (“SR”) offers legal protections to a lesser extent than the Principal Register.  SR can thus be a viable alternative to registration on the Principal Register if an applied-for mark is rejected on merely descriptive/generic grounds providing the proposed mark passes a likelihood of confusion analysis by the examining attorney.  Indeed, examining attorneys may recommend that the original application be amended to a “Supplemental Registration” application if the applied-for mark is not rejected on likelihood of confusion grounds. One can also initially apply for registration on the Supplemental Register as did the FILATI mark Applicant but such an application will nevertheless be examined to see if it qualifies for such registration.   Additionally, a “Supplemental Registered” mark may later qualify for registration on the Principal Register if the registrant can establish that the mark has become distinctive in the minds of consumers.

2.  A Mark Comprising a Foreign Word Will Not Overcome Potential Registration Issues.

Over the years, the commentator has encountered clients who mistakenly believe that using a foreign word as a mark for service(s) or good(s) provided in the U.S will eliminate registration problems.   This assumption is a fallacy.  First, trademark applications require the applicant to provide a translation of the foreign word.

Second, under the doctrine of equivalents, the foreign equivalent of a registered arbitrary English word mark may result in a finding of likelihood of confusion.  For example, a proposed mark for MANZANA (Spanish for apple) as an arbitrary mark for computers would clearly not be registrable in today’s “Apple Brand” world.

Moreover, a merely descriptive or generic foreign word mark is no more registrable than its English counter-part. As the Lana Grossa opinion states:  “[A] word taken from a well-known foreign modern language, which is, itself, merely descriptive of a product or service will be so considered when it is attempted to be registered as a trademark in the United States for the same product.”   The doctrine is, however, to be applied only when it is likely that the ordinary American purchaser who is knowledgeable in the foreign language would stop and translate the foreign word into its English equivalent.  The FILATI mark applicant had argued that the mark was merely descriptive and eligible for registration on the SR.

As a result of various websites and publications accessible in the U.S. promoting a premier international Italian yarn (as “Filati”) event, the Board concluded that the relevant U.S. consumers, particularly those with knowledge of Italian, will translate the word “Filati” into “yarn.” As such, the word “Filati” is a generic term for yarn and cannot be registered on the Supplemental Register.

As discussed above, a merely descriptive foreign word may be registered on the Supplemental Register.  A merely descriptive mark is one which describes a desirable characteristic of the specified good/service.  For example, In In re Geo. A. Hormel & Co., 227 USPQ 813 (TTAB 1985), the Board held that the applied-for mark SAPORITO, an Italian word meaning “tasty,” was merely descriptive and ineligible for registration on the Principal Register.   Interestingly the SAPORITO mark was originally registered in 1973 on the Supplemental Register by a company other than Hormel.  Reg. no. 952,895.   In 1989, that same company was able to achieve registration on the Principal Registration by showing that the mark had acquired distinctiveness and recognition by the buying public.  Reg. no. 1573637 obtained under Section 2(F) of the Lanham Act.

  1. The Stylized Lettering in FILATI Is Insufficient for Creating a Distinct Commercial Impression Separate and Apart from the Generic Word Itself.

Having found that the mark FILATI is generic, the Board next determined if the Applicant’s stylized drawing of the word mark is so distinctive that it is possible to disclaim the unregistrable components and still have a registrable mark as a whole.  Generic matter within an applied-for mark, whether the mark is to be registered on the Principal Register or the Supplemental Register, must generally be disclaimed. Here, the entire mark itself (i.e. (“Filati”) would need to be disclaimed.  Yet, an entire mark cannot be disclaimed.  TMEP § 1213.06 (2022).   The Board concluded that the FILATI mark does not create a distinct commercial impression separate and apart from the word itself.   As such the mark was not registrable on the Supplemental Register.  To understand the Board’s reasoning, compare the registered mark CONSTRUCT A CLOSET, where the stylistic rendering of the mark was found to be distinctive, with the unregistrable FILATI mark.

  1. Take Home Points.

Trademark law is not as simple as it may seem as this decision shows.   This is why a trademark attorney should be consulted so that the registration risks can be understood and discussed.  Why spend a lot of money on building brand where legal protection may well not even be available?   Contact Susan Troy at 305-279-4740 for a complimentary consultation on your branding legal requirements.





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Just because a patent is granted does not mean that it will not be subjected to attempts to have one or more of its claims invalidated during the lifetime of the patent.   Such invalidation attempts by the defendants in a patent infringement lawsuit are not uncommon.  Grounds for invalidation include claim indefiniteness.  The public policy behind trying to prevent indefinite patent claims is that the public is entitled to know what the claim is really about. This blog discusses the recent opinion in University of Massachusetts, Carmel Laboratories, LLC  v. L’Oréal S.S., L’Oréal USA, Inc. by the Court of Appeals for the Federal Circuit (CAFC) where the court held that the patent claims were indefinite.  The opinion provides an excellent discussion of the type of analysis that goes into such a determination.

This is a long blog and hopefully instructive in its approach to explaining what went wrong for the patentee so that a similar mistake can be avoided by others during patent prosecution.

Some background information

A patent application examiner may reject a claim on the basis of indefiniteness.  Amendment of the claim by the applicant is an option to try to overcome the indefiniteness conclusion.  If an allegation of indefiniteness is made by the defendant during a patent infringement lawsuit, the court may engage in a process known as Claim Construction to determine what the claim is “really” saying or “not” saying.  In doing so, the court may refer to the patent’s specification to try and ascertain what the inventors were contemplating, how a particular word was defined, etc. and the prosecution history.  For a previous blog on the importance of the patent’s specification to claim construction, click here.   Generally, the court will rely on the plain reading of the claim.

The Questionable Claim in U Mass

A method for enhancing the condition of unbroken skin of a mammal by reducing one more of wrinkling, roughness, dryness, or laxity of the skin, without increasing dermal cell proliferation, the method comprising [1] topically applying to the skin a composition comprising a concentration of adenosine in [2] an amount effective to enhance the condition of the skin without increasing dermal cell proliferation, [3] wherein the adenosine concentration applied to the dermal cells is 10-4 to 10-7 M.

Can you see the problem with this claim?  First it says that a topical solution containing adenosine is applied to the skin but clause [1] does not recite the concentration of adenosine in this topical solution effective for achieving the result stated in clause [2].  Clause [3] with its “wherein” clause can be interpreted to mean that the amount of adenosine which ends up coming into contact with dermal cell falls in the specified range.  What is the actual adenosine concentration in the topical solution?  If clause [3] is intended to mean the resultant adenosine concentration in the dermis, was this concentration actually measured?  Furthermore, there are 2 objects intended for contact with the adenosine: the skin and the dermal cell.

The dermis is the skin layer under the outer epidermis layer.  Common sense would tell us that the topical solution would have to have an adenosine concentration greater than the amount of adenosine which ends up in a dermis cell for a number of physiological and structural skin reasons based on the topical solution’s absorption properties and the skin’s level of hydration and texture.   For example, the epidermis layer protects the dermis layer.  Anything intended for the dermis layer must first get through the epidermis layer. But what exactly is that concentration and why didn’t the claim just state “a topical solution having an adenosine concentration in the range of X-Y?”  Does clause [3] really refer to adenosine’s concentration in the dermis or is the clause the result of inartful drafting which has caused a big problem for the patent owner?

The CAFC’s Conclusion

The district court had relied on subjective determination precedent to conclude that the claim was indefinite because of clause [2] which focused on the topical solution’s effectiveness: “Indeed, the determination of whether the skin is enhanced provides a paradigmatic example of indefiniteness. Beauty after all, is ‘in the eyes of the beholder.’ ”

The Federal Circuit decided claim construction de novo because of the district court’s wrong approach to finding indefiniteness.  Upon appeal to the CAFC, U Mass contended that the “concentration” in the wherein clause is the concentration of adenosine in the dermis after it has entered the dermis.  In other words, to overcome an indefiniteness finding, U Mass would have to establish exactly what the suspect wording actually meant because the wording was ambiguous and not clear on its face.

The CAFC concluded that the claim was ambiguous about what clause [3] referred to:  “We first conclude that the relevant claim language, especially when viewed in the context of the whole claim, is not plain on its face, much less plain in supporting U Mass’s interpretation of it.”  Slip opinion at 8.  The court went on to emphasize the U Mass’s view of clause [3] is referring to something that has no existence before the application – that it refers to an adenosine concentration of the dermal layer after the adenosine particles per unit of dermal layer, after the adenosine particles have suffused into the dermis and thus already come into contact with the dermal cells.  Slip opinion at 10.   Therefore, the claim cannot be definite.

After the district court’s construction, U Mass had retained an infringement expert to conduct various experiments to assess the concentration as moles of applied adenosine in the dermis over liters of the dermis to “come up” with numbers within the range specified in the claim.  The CAFC emphasized that the expert’s methodology actually revealed an interpretation that would call for a rewrite of the wherein clause to say something like “wherein the adenosine permeating to the dermal layer results in a concentration of adenosine in the dermal layer of 10-4 to 10-7 M.   As such, the need for a departure from the natural meaning confirmed that U Mass’s asserted meaning is not plain.  Slip opinion at 10.

Next the court looked to the specification to see if it supported U Mass’s claim construction.  It did not.  Tellingly, the disclosure never implied that the invention included measuring adenosine concentrations beneath the skin surface after topical application. “U Mass has not shown that, even in this context, the specification makes clear that the inventors contemplated the adenosine concentration after exposure to the cells, rather than in a solution before application in the cells.”  Id. at 12.

The court also looked at the prosecution history, emphasizing that the histories resolve the ambiguity surrounding the meaning of “the adenosine concentration applied to the dermal cells” in the wherein clause. As with most patent applications, the prosecution history involved amendments to the original claims.  To overcome a prior-art rejection, U Mass imported a previous dependent claim which had only referred to an adenosine concentration with no mention of dermal cells into the preceding independent claim to create the problematic claim which now included the wording: formal “wherein the adenosine concentration applied to the dermal cells is …..” Slip opinion at 13.

The accompanying remarks made by the applicant are inconsistent with the “new wording” because they stated: “All [claims] are based on the application of certain concentrations of adenosine to the skin to achieve certain results.”   The applicants also stated that the amendment included no new matter suggesting that the invention was still and always was the topical solution at the specified concentration.  The new wording changed the scope and resulted in an indefinite claim. Interestingly, the examiner made the following comment in writing after accepting the amendment:  “the [i]nstant claims are directed to a method of enhancing the condition of unbroken skin . . . where the method comprises administering adenosine at a concentration of 10-4 M to 10-7 M, to the skin.” Slip opinion at 13.

According to the CAFC, U Mass’s amendments and comments clearly conveyed that U Mass had never veered from its pre-amendment reliance on the adenosine composition in the topical solution which had resulted in its two patents.  During prosecution, no mention had ever been of the materially different, unexplained notion of an adenosine concentration being determined after contact with the object (the dermis) of the topical solution.   Slip opinion at 14.   Even in its response to the examiner’s reasons for allowance, the applicants never communicated a disagreement with the examiner’s clear statement of what the language meant.

The CAFC reversed the district court’s claim construction of the wherein clause and vacated the court’s subsequent summary-judgement determination.  The case has been remanded for further proceedings consistent with the opinion.

Commentator’s Comments

This is a situation which seemingly could have been avoided.  The claims at issue in two related patents were not complicated.  The examiner made very clear that the adenosine was applied to the skin at the concentration range specified but somehow the claims ended up stating that the adenosine was applied to the dermal cells.   It is not clear why U Mass changed the wording in the amendment. Sloppy drafting?  Not carefully reading the new independent claims as whole?  Why didn’t the examiner mention anything about an incongruity between the amended claim and what the concentration range was referring to.  A few simple word changes could have resolved the ambiguity.

Patent prosecution can be a long, tedious process.  This case is a good lesson on how every aspect of the prosecution process must be monitored and the documents read and reread by both the patent attorney and the inventors.  An issued patent is in no way a guarantee that the patent will withstand scrutiny if push comes to shove in a court of law.   And if an amendment is made, make sure that it’s supported by the specification.   Remember, no new matter can be introduced in an amended specification.




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Posted in Uncategorized on July 31,2022 09:07 PM
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