Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) filed 12/01/2023 has been considered and the references therein are of record.
Claim Objections
Claims 12 and 13 are objected to because of the following informalities: contain inconsistent capitalization of BlyS, reciting Blys. Appropriate correction is required.
Claim Rejections - 35 USC § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-14 are rejected for recitation of intended result/effect without conferring some structural or material difference on the scope of the claim. The claims recite, or are dependent upon, the functional language of a BlyS antagonist, an anti-BlyS antibody, a variant of belimumab, a variant of belimumab capable of binding to the same epitope as belimumab, and an anti-BlyS antagonist that’s capable of treating Long Covid and/or post-acute sequelae SARS-CoV-2 infection (PASC) without specifying any specific structures required to perform the functions. The requisite structures are merely implied by the functional language and thus the scope of the claim is undefined. Absent additional structure, it is unclear how these claims further limit the scope of the parent claim. MPEP 2173.05(g) states: “the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim' and thus be indefinite.” It further states: “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim.” The claims are rejected since they fail to meet all (3) criteria set forth in MPEP 2173.05(g).
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 14 recites the limitation of obtaining a sample from the human, yet obtaining a sample is inherent to the method of claim 13, as a sample must be obtained in order to test for levels of serum cytokines, Blys, IFN-3, PTX3, IFN-lambda 2/3, and/or IL-6. As such, claim 14 does not properly limit claim 13. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 112 (a)
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming.
“For use” clauses in product claims do not hold patentable weight unless they impart structure to the product. As such, claims 1-12 will be examined as the product only.
Claim 1-12 recite, or are dependent upon, a BlyS antagonist, an anti-BlyS antibody, a variant of belimumab, and a variant of belimumab capable of binding to the same epitope as belimumab, each of which encompasses a genus of agents. These claims do not require that the genera of the claims possess any particular structure or other distinguishing feature that is characteristic of the genera as a whole. Therefore, the claims are drawn to a genera of antagonists for which there is inadequate written description. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see MPEP 2163(II)(3)(a)(i)(A), reduction to drawings MPEP 2163(II)(3)(a)(i)(B), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus MPEP 2163(II)(3)(a)(i)(C).
It is clear from the Sequence Listing that the Applicant is in possession of belimumab. The claims, however are not limited to that species and the specification fails to provide a representative number of species within the recited genera. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics of the genus as a whole, or representative number of species within the genus, the specification does not provide adequate written description of the claimed genera.
Claim 13-14 recites a method of treating Long Covid and/or post-acute sequelae SARS-CoV-2 infection (PASC) in a human by using a BlyS antagonist. The specification provides no evidence that the Applicant was in possession of a method of treating Long Covid and/or post-acute sequelae SARS-CoV-2 infection (PASC) in a human by using a BlyS antagonist. The specification only provides evidence for a correlation between BlyS levels and PASC.The Applicant provides no evidence of treating any patients suffering from Long Covid and/or post-acute sequelae SARS-CoV-2 infection (PASC) with an anti-BlyS antagonist. As such, the specification does not provide adequate written description of the claimed invention.
Enablement
Claims 13-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure would require undue experimentation include:
A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
The breadth of the claims:
With respect to claim breadth, the standard under 35 U.S.C. §112, first paragraph, entails the determination of what the claims recite and what the claims mean as a whole. As such, the broadest reasonable interpretation of the claimed method is that it covers a method of treating Long Covid and/or post-acute sequelae SARS-CoV-2 infection (PASC) in a human by using a BlyS antagonist. A skilled artisan would not know how to perform the claim method with a reasonable expectation of success based solely on what is disclosed in the specification since the specification provides no evidence that a BlyS antagonist is capable of treating Long Covid and/or post-acute sequelae SARS-CoV-2 infection (PASC) in a human.
The amount of direction provided by the inventor and the level of predictability in the art:
The specification provides no direction as to a BlyS antagonist that is capable of treating Long Covid and/or post-acute sequelae SARS-CoV-2 infection (PASC) in a human. The specification merely provides evidence for a correlation between BlyS levels and PASC. As evidenced by Baptista et al. 2026, numerous failed clinical trials have been conducted on potential treatments of Long Covid and/or post-acute sequelae SARS-CoV-2 based on hypotheses about the potential role of the immune system in the development of the disease/disorder. It is clear from the evidence presented by Baptista that a simple hypothesis on a potential treatment of Long Covid and/or post-acute sequelae SARS-CoV-2 based on correlative proteomic data is not sufficient to predict the outcome of actual clinical application with a reasonable expectation of success. As such, the art at the time of filing does not provide enabling guidance and the specification as filed does not provide guidance that overcomes this unpredictability within the art.
The existence of working examples:
The specification provides no working examples for a BlyS antagonist capable of treating Long Covid and/or post-acute sequelae SARS-CoV-2 infection (PASC) in a human.
The quantity of experimentation needed to make or use the invention:
The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. In the decision of Genentec, Inc., V. Novo Nordisk, 42 USPQ 2d 100, (CAFC 1997), the court held that: "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable" and that "[t]ossing out the mere germ of an idea does not constitute enabling disclosure". The court further stated that "when there is no disclosure of any specific starting material or of any of the conditions under which a process is to be carried out, undue experimentation is required; there is a failure to meet the enablement requirements that cannot be rectified by asserting that all of the disclosure related to the process is within the skill of the art","[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement". The instant specification is not enabling for the full scope of the claimed invention because one cannot follow the guidance presented therein and practice the claimed method without first making a substantial inventive contribution.
Given that the nature of the invention is treatment of Long Covid and/or post-acute sequelae SARS-CoV-2 infection (PASC) using a BlyS antagonist, a person having ordinary skill in the art would have to perform multiple further experiments, in human clinical trials, or in animal models that are predictive of treatment, in order to demonstrate the invention could be used with a reasonable expectation of success. The amount of experimentation required for enabling guidance, commensurate in scope with what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to use the method with a reasonable expectation of success.
Therefore, claims 13-14 lack enablement.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-12 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Blake-Haskins et al., 2015 (WO2015173782A1) (see IDS).
The instant claims are drawn to a BlyS antagonist such as belimumab.
Blake-Haskins teaches the structural features of the anti-BLyS antibody, belimumab (claims; SEQ ID NO: 2, 3, 6, 7, & 11-16).
Therefore, Blake-Haskins anticipates instant claims 1-12.
Conclusion
No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH CESARE whose telephone number is (571)272-6908. The examiner can normally be reached Monday - Friday 10am-4pm.
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/JOSEPH D. CESARE/ Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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