DETAILED ACTION
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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The present application is drawn from PCT/US2022/011906, filed 1/11/2022; and claims benefit under 35 U.S.C. 119(e) to U.S. Provisional applications 63/135913, filed 1/11/2021 and 63/234776, filed 8/19/2021.
Election/Restrictions
Applicant’s election without traverse of Group I, encompassing claims 2-3, 5, 7, 9, 12, 15, 32 and 45, in the reply filed on 6/5/2026 is acknowledged. Claims 40-41, 43-44, 47, 52, 56, 63, 68, 72 and 73 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II-V, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/5/2026.
Applicant’s election of species of the antibody CDRs and VH/VL sequences, in the reply filed 6/5/2026, is acknowledged.
Status of Claims
Claims 2-3, 5, 7, 9, 12, 15, 32, 40-41, 43-45, 47, 52, 56, 63, 68 and 72-73 are pending; claims 40-41, 43-44, 47, 52, 56, 63, 68 and 72-73 are withdrawn; claims 2-3, 5, 7, 9, 12, 15, 32 and 45 are being examined on the merits.
Claim Objections
Claims 3, 5 and 9 are objected to for reciting “Tables 1-3,” “Tables 4, 6 and 7,” and “Tables 6 or 7,” respectively, in the claims. MPEP 2173.05(s) states:
“Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table ‘is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.’ Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).”
In the instant case the corresponding VH and VL CDR sequences, and the full VH and VL sequences, of the claim limitations could easily be incorporated into the claims to define the invention. For example, the corresponding SEQ ID NOs which define the CDR sequences of Tables 1-3 could be recited in claim 3. Similarly the SEQ ID NOs which define the corresponding VH and VL of Tables 4, 6 and/or 7 could be recited in claims 5 and/or 9. 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.
Claims 2-3, 5, 7, 9, 12, 15, 32 and 45 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.
Independent claim 2 recite a monoclonal antibody, whereby the claimed structure is limited by the VH CDRs 1-3 and the VL CDRs 1-3 as “derived” from the various embodiments of full length VH and VL sequences listed in the claims. However, the claims do not explicitly define the residues of the VH and/or VL full length sequences which correspond to the claimed CDRs. It is known in the art that various numbering schemes define the CDRs of an antigen binding domain differently. The specifications describe this scenario (specs., pg. 41, para. 00107; embodied in Tables 1-3, pg. 33); whereby it states that individual CDRs of an antibody are each independently determined according to one of the Kabat, Chothia, IMGT or AHo numbering schemes, or by a combination of approaches or by other desirable approaches. As numerous numbering systems exist, and more schemes may be introduced or modified in the future, whereby each scheme defines the CDR residues differently, it is indefinite to describe the CDRs by “any definition known in the art,” (see para. 0074); as the types of numbering schemes known in the art is open-ended and subject to change. Claim 2 does not claim the antibody by the full VH and VL sequences; if this were the case, the necessary residues of the CDRs are present regardless of which number scheme is applied. Instead, claim 2 attempts to limit the claimed antibody solely by the CDRs of the full VH and VL sequences; therefore the CDR residues must be explicitly defined. The skilled artisan, attempting to determine the limitations of the claim, must know what residues of the full VH or VL constitute the necessary and required CDRs that meet the limitations of the claims. As different numbering schemes are known in the art, and the different numbering schemes, applied to the various VH and VL sequences listed in the claims, would result in different amino acid sequences for the claimed CDRs, it is unclear what the necessary structural limitations of the antibody of the claims are. The metes and bounds of the claimed structures are unclear, therefore claim 2 is rejected for indefiniteness. Further, as claims 3, 5, 7, 9, 12, 15, 32 and 45 depend from claim 2, but fail to rectify the indefiniteness issue by defining the claimed structures, claims 3, 5, 7, 9, 12, 15, 32 and 45 are also rejected for indefiniteness. Specifically, claim 3 is objected to for reciting “Tables 1-3”, as described above, but the rejection under USC 35 112(a) might be overcome if the explicit CDR sequences were recited in the claim (or in claim 2, from which claim 3 depends). Similarly, claim 5 depends from claim 2 and recites a VH and VL having at least 95% sequence identity to the sequences of Tables 4, 6 and 7; however this rejection might be overcome if the “at least 95% identity” sequences of the variant VH and VL domains necessarily required the explicitly defined CDRs of claim 2, wherein the CDRs are free of the art.
Claim Rejections - 35 USC § 112(a)
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.
Claim 32 is 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 claim(s) contains 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.
The following quotation from section 2163 of the Manual of Patent Examination Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirements for a generic claim covering several distinct inventions:
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... reduction to drawings...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... See BU Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
Claim 32 is rejected as lacking adequate descriptive support for possession of a genus of alternative antibodies or antigen-binding fragments that “competes for binding to the same epitope of a coronavirus spike protein as the monoclonal antibody according to claim 2.” In support of the claimed genus, the specifications disclose the antibodies of instant claim 2, such as 3A3, AM3A3-3, AM3A3-5, 4H2 and 4A5 (pg. 33, Tables 1-3), as well as humanized 3A3 embodiments (pg. 37, Table 6) and affinity matured variants (pg. 38, Table 7). No structure is disclosed for alternative antibodies which compete for binding to the same epitope of coronavirus spike protein. Specifically the amino acid sequences of the 6 CDRs of the antigen binding domain, and the necessary structural features that impart functionality in terms of specificity and affinity, of each of the antibodies is not disclosed. Thus, instant claim 32 encompasses a genus of alternative antibodies directed against the same epitope of the coronavirus spike protein which comprise unidentified CDR, variable heavy and light chain, or full heavy and light chain sequences; thereby providing no structural properties of the claimed alternative antibodies.
It is known in the art that the complementary determining regions (CDR) of an antibody constitute critical aspects of the antibody paratope and ultimately impart the paratope-epitope binding functionality with regard to specificity and affinity (for review see MacCallum et al., 1996). However, the amino acid structure-to-function correlation continues to be highly unpredictable. Further, it is known that even a single substitution of an amino acid within the CDR motifs may significantly alter reactivity. For example, a single point mutation in the heavy chain CDR3 region of the high affinity anti-VEGF antibody, G6.31, could in some cases enhance, or otherwise completely ablate binding to the target antigen, and this occurred in an unpredictable manner (Koenig et al., 2017). That is, only screening each mutation individually provided insight as to the resulting changes in functionality of the antibody variant.
The specifications disclose five example species of antibodies which bind the same epitope of coronavirus spike protein, with full structure provided. Applicants do not identify the shared structural properties that would define the genus of alternative antibodies beyond the desired functionality. Currently, the essential property of the antibodies is recognition and binding of the same epitope of coronavirus spike protein, which is imparted by the specific set of CDR sequences that have been reduced to practice and identified in antibodies 3A3, AM3A3-3, AM3A3-5, 4H2 and 4A5. However the set of CDR sequences for the alternative antibodies, which bind the same epitope, and which may be wholly different, are not described.
Moreover, the decision arrived at in Amgen v. Sanofi, 872, F.3d 1367 (Fed. Cir. 2017) supports expanded analysis of whether a claim drawn to an antibody being specific for an epitope, even a specific epitope, permits an applicant to pursue all possible antibodies that are capable of being produced against such an epitope. Specifically, “disclosure of an antigen fully characterized by its structure, formula or physical properties does not, without more, provide adequate written description of an antibody claimed by its binding affinity to that antigen,” (Amgen v Sanofi, 872, F.3d 1367 (Fed. Cir. 2017)). Presently, the claimed genus of alternative antibodies are only defined by functional properties, but no specific structure is recited. Specifically, the physical features (or amino acid residues presenting said features) which impart the property of binding the same epitope of coronavirus spike protein should be disclosed. Further, a description of the type and number of amino acid residue substitutions that may be made at such identified positions within the sequence would be essential in determining the degree of variability that may be allotted in CDR sequence identity across variant species of the antibodies. This lack of definition complicates the determination of the boundaries of the claimed genus with regard to which, as of yet unidentified, species variants would be anticipated by one skilled in the art to fall within the scope of the claims. Without identification of the necessary shared structural properties of all species variants that fall within the scope of the genus, it is difficult to determine that the applicants have possession of an adequate representative number of species to support the scope of the claimed genus. Instead, applicants seem to be claiming conceptual antibodies, that have yet to be invented, based solely on desired functionality, without providing any guidance as to the basic shared structural features that are necessary for one of skill in the art to produce variants which maintain said functionality.
“The purpose of the written description requirement is to ‘ensure that the scope of the
right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s
contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli
Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D.
Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description
requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed
invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir.
1991). See also MPEP 2163.04. Otherwise, the “claims merely recite a description of the
problem to be solved while claiming all solutions to it and … cover any compound later actually
invented and determined to fall within the claim’s functional boundaries- leaving it to the
pharmaceutical industry to complete an unfinished invention.” Ariad Pharmaceuticals, Inc. v. Eli
Lilly and Co., 598 F.3d 1336, 1353 (Fed. Cir. 2010).
In view of this uncertainty, and the lack of a representative number of examples of the claimed genus of any alternative antibody which competes for binding to the same epitope of coronavirus spike protein with the instantly claimed antibodies, claim 32 is rejected for lack of adequate written description support.
Allowable Subject Matter
The examiner has extended the search beyond that of the elected species. Each of the CDR sets of Tables 1-3, as well as each of the VH and VL pairs of Tables 4, 6 and 7, have been searched and are free of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES R. MELCHIOR whose telephone number is (703)756-4761. The examiner can normally be reached M-F 8:00-5:00 CST.
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/JAMES RYLAND MELCHIOR/Examiner, Art Unit 1644
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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