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 .
Status of Claims / Response to Amendments
The Amendments and Remarks filed 08/08/2025 in response to the Office Action of 05/08/2025 are acknowledged and have been entered.
Claims 1-8, 11-20 are currently pending.
Claim 20 has been newly added by Applicant.
Claim 8 has been amended by Applicant.
Claims 1-7 and 14-19 have been withdrawn by Applicant.
Claims 8, 11-13 and 20 are currently under examination in the instant Office Action.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
This Office Action contains New Rejections Necessitated by Amendments.
Objections Withdrawn
Specification
The specification objections are withdrawn.
Claim Rejections Withdrawn
The rejection of claims 8 and 11-13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), second paragraph has been withdrawn.
The written description rejection of claims 8 and 11-13 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph has been withdrawn.
The enablement rejection of claims 8 and 11-13 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph has been withdrawn.
The previous provisional rejection of claims on the ground of nonstatutory double patenting is withdrawn; however, a new provisional rejection of claims on the ground of nonstatutory double patenting addressing amendments is set-forth below.
Claim Objections
Claim 8 is objected to because of the following informalities:
Claim 8 awkwardly recites “…a light chain variable region (VL) that comprises a light chain complementarity determining region (CDRL)3 and a heavy chain variable region (VH) that comprises a heavy chain complementarity determining region (CDRH)3,…”. It is suggested that the claim be amended to recite “…a light chain variable region (VL) that comprises [[a]] light chain complementarity determining regions CDRL1, CDRL2 and CDRL3, and a heavy chain variable region (VH) that comprises [[a]] heavy chain complementarity determining regions CDRH1, CDRH2 and CDRH3,…”
Claim 8 recites in lines 6-8 “…the CDRL1…, CDRL2…., and the CDRL3”. It also recites in lines 9-11 “…the CDRH1…, CDRH2…., and the CDRH3….”. For consistency, it is suggested that the claim be amended to recite “…the CDRL1…, the CDRL2…., and the CDRL3” in lines 6-8 and “…the CDRH1…, the CDRH2…., and the CDRH3….” in lines 9-11 for consistency of the claim language.
Claim 8 awkwardly recites the phrase “comprises at least 60% identical to” in six instances throughout lines 6-12. It is suggested that the claim be amended to recite “comprises at least 60% identity to” or “is at least 60% identical to”.
Claim 8 appears to have a typographical error in line 8 where it is missing a “closed bracket” following SEQ ID NO: 13127. The claim should be amended to recite in lines 7- 8 “ (SEQ ID NO: 13127)…..”.
Appropriate correction is required.
Rejections Necessitated by Amendments
Claim Rejections - 35 USC § 112(a) – Necessitated by Amendments
Claims 8, 11-13 and 20 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 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
In the instant case, the claims are inclusive of a genus of recombinant antibodies that targets an influenza glycoprotein, wherein the recombinant antibody comprises a light chain variable region (VL) that comprises light chain complementarity determining regions CDRL1, CDRL2 and CDRL3, and a heavy chain variable region (VH) that comprises heavy chain complementarity determining regions CDRH1, CDRH2 and CDRH3, wherein the CDRL1 is at least 60% identical to QYIGSF (SEQ ID NO: 13121), the CDRL2 is at least 60% identical to AAS, and the CDRL3 is at least 60 % identical to CQQSYNVPTF (SEQ ID NO: 1884), wherein the CDRH1 is at least 60% identical to GFSISFYA (SEQ ID NO: 13103), the CDRH2 is at least 60% identical to FSGSGDRL (SEQ ID NO: 13109), and the CDRH3 is at least 60% identical to CAKGLTTESRLEFW (SEQ ID NO: 1818). In other words, a multitude of possible variants of the six CDR sequences have been claimed that can have at least 60% sequence identity to the recited CDR sequences in claim 8.
However, the written description in this case only sets forth two species in the instant specification. The specification does not disclose, and the art does not teach, the genus of recombinant antibodies that targets an influenza glycoprotein as broadly encompassed in the claim such that these antibodies have at least 60% sequence identity to the six recited CDR SEQ ID NOs in claim 8. Specifically, the specification discloses two antibodies with a full set of 6 CDRs that can be used for the treatment of influenza, namely: (1) species one with CDRL1 is SEQ ID NO: 13121, CDRL2 is AAS, CDRL3 is SEQ ID NO: 1884, CDRH1 is SEQ ID NO: 13103, CDRH2 is SEQ ID NO: 13109, and CDRH3 is SEQ ID NO: 1818, and (2) species two with CDRL1 is SEQ ID NO: 13121, CDRL2 is AAS, CDRL3 is SEQ ID NO: 25, CDRH1 is SEQ ID NO: 13103, CDRH2 is SEQ ID NO: 13109, and CDRH3 is SEQ ID NO: 1818 (Pg. 29 Line 17 to Pg. 30 Line 10 and Pg. 33 Line 31 to Pg.34 Line 6). Of these two species, only species one which is named as mAb688 (Table Pg. 70 Table 1) was tested to have the functional ability to recognize and bind to Influenza A HA (see discussion in the first 112(a) scope of enablement rejection above). It is also noted that the CDRL3 of SEQ ID NO: 25 (QQSYNVPT) is fully encompassed within SEQ ID NO: 1884 (CQQSYNVPTF) and fulfills the 60% identity match to SEQ ID NO: 1884 (See alignment below where SEQ ID NO: 1884 is presented at the top). As such, species two would have been expected to recognize and bind to Influenza A HA as well.
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The specification discloses the genus of recombinant antibodies that targets an influenza glycoprotein. However, the written description only reasonably conveys two species. A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or by describing structural features common to that genus that “constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997): “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNA, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.”
The inventions at issue in Lilly were DNA constructs per se, the holdings of that case is also applicable to claims such as those at issue here. Further, disclosure that does not adequately describe a product itself logically cannot adequately describe a method of using that product. See Ariad, 598 F.3d at 1354-55 (“Regardless whether the asserted claims recite a compound, Ariad still must describe some way of performing the claimed methods... the specification must demonstrate that Ariad possessed the claimed methods by sufficiently disclosing molecules capable of reducing NF-kB activity so as to ‘satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed.’”) (internal citation omitted); see also Univ. of Rochester v. G.D. Searle& Co., Inc., 358 F.3d916,918 (Fed.Cir.2004) (applying the same analysis to assess written description for claims to a “method for selectively inhibiting” a particular enzyme by administering a functionally defined compound, i.e., a “non-steroidal compound that selectively inhibits activity” of the gene product for that enzyme).
The instant specification fails to provide sufficient descriptive information, such as definitive structural features that are common to the recombinant antibodies that target an influenza glycoprotein that have 60% identity to the specified CDR amino acid sequences in claim 8. That is, the specification provides neither a representative number of recombinant antibodies that encompass the genus that targets an influenza glycoprotein that have 60% identity to the recited CDR amino acid sequences, nor does it provide a description of structural features that are common to the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus. “[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the 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 to provide a "representative number” of species.
Since the disclosure fails to describe common attributes or characteristics that adequately identify members of the genus, and because the genus is highly variant, the disclosure of two species is insufficient to describe the genus. Thus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, even though Applicant may propose methods of screening for possible members of the genus, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolation. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. See Ariad, 94 USPQ2d at 1161; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Double Patenting –Necessitated by Amendments
Claims 8, 11-13, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 18, 25-27, 34 and 35 of copending Application No. 17/600,893 (Notice of allowance mailed on 10/08/2025).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending Application No. 17/600,893 (herein after referred to as ‘893) is drawn in part in claim 1 to “A recombinant antibody, for binding both Human Immunodeficiency virus (HIV) and Hepatitis C virus (HCV), said antibody comprising a light chain variable region (VL) that comprises a light chain complementarity determining region (CDRL)1, CDRL2, and CDRL3 and a heavy chain variable region (VH) that comprises a heavy chain complementarity determining region (CDRH)1, CDRH2, and CDRH3, wherein: (iv) CDRH1 is SEQ ID NO: 13103, CDRH2 is SEQ ID NO: 13109, CDRH3 is SEQ ID NO: 1818, CDRL1 is SEQ ID NO: 13121, CDRL2 is SEQ ID NO: 13127, and CDRL3 is SEQ ID NO: 25 or 1884.” The sequence of SEQ ID NO: 13127 is AAS.
Copending Application ‘893 recites in claim 10: “The recombinant antibody of claim 1, wherein the VL comprises an amino acid sequence selected from SEQ ID NOs: 119, 227, 242, 351, 1399, 1406, and 1899-1904”, and in claim 18: “The recombinant antibody of claim 1, wherein the VH comprises an amino acid sequence selected from the group consisting of SEQ ID NOs: 1895-1898, 1694, and 1718”, and in claim 25: “A method of treating a HIV/HCV co-infection comprising administering to a subject a therapeutically effective amount of the recombinant antibody of any one of claims 1”. Copending Application ‘893 is also drawn to the recombinant antibody of claim 1, wherein CDRH1 is SEQ ID NO: 13103, CDRH2 is SEQ ID NO: 13109, CDRH3 is SEQ ID NO: 1818, CDRL1 is SEQ ID NO: 13121, CDRL2 is AAS (SEQ ID NO: 13127), and CDRL3 is SEQ ID NO: 25 or 1884 (in claim 34), and the recombinant antibody of claim 34, wherein the VH comprises SEQ ID NO: 1896, or an amino acid sequence at least 60% identical thereto, and wherein the VL comprises SEQ ID NO: 1900, or an amino acid sequence at least 60% identical thereto (in claim 35).
With regards to sequences recited by instant claim 8, the Copending Application ‘893 recites a recombinant antibody comprising CDRH1 is SEQ ID NO: 13103, CDRH2 is SEQ ID NO: 13109, CDRH3 is SEQ ID NO: 1818, CDRL1 is SEQ ID NO: 13121, CDRL2 is AAS, and CDRL3 is SEQ ID NO: 1884 that have 100% identity matches to instant recombinant antibody that comprises CDRH1 of SEQ ID NO: 13103, CDRH2 of SEQ ID NO: 13109, CDRH3 of SEQ ID NO: 1818, CDRL1 of SEQ ID NO: 13121, CDRL2 of AAS (SEQ ID NO: 13127), and CDRL3 of SEQ ID NO: 1884. In addition, the CDRL3 of QQSYNVPT (SEQ ID NO: 25) of copending Application ‘893 is entirely encompassed in the instant CDRL3 of CQQSYNVPTF (instant SED ID NO: 1884).
Further, when reviewing the alignments of the sequences of instant CDRLs of SEQ ID NO(s): 13121, AAS and 1884 with SEQ ID NO: 227 or 1900 (VL) of co-pending Application ‘893, it was noted that the three instant CDRLs are fully encompassed within the VL SEQ ID NO: 227 or 1900 of co-pending Application ‘893. It is also noted that co-pending Application ‘893 SEQ ID NO: 227 and SEQ ID NO: 1900 are fully identical to each other. Similarly, the alignment of the sequences of instant CDRHs of SEQ ID NO(s): 13103, 13109 and 1818 with VL SEQ ID NO: 1896 of co-pending Application ‘893 revealed that the three instant CDRHs are fully encompassed within the VH SEQ ID NO: 1896 of co-pending Application ‘893.
With regards to instant claims 8 and 11-13, while the instant invention recites treatment of Influenza A or Influenza B (now recited in instant claim 8 with CDRs and variants thereof previously recited by instant claim 9) in a subject co-infected with HIV or HCV (as recited in instant claim 13), copending Application ‘893 recites treatment using a recombinant antibody with identical CDRs to instant recombinant antibody (comprising the same set of six CDRs) in subjects that are co-infected with HIV and/or HCV (see copending claims 25-27) without reciting the subjects also have Influenza A or Influenza B. In addition, even though instant claim 8 does not specifically recite subjects have HIV and/or HCV, lines 20-24 on page 2 of the instant specification discloses claimed embodiments include embodiments wherein the subject with Influenza A or B is co-infected by a virus selected from the group consisting of MERS-CoV, SARS-CoV, SARS-CoV-2, HIV, and HCV. It would be obvious to administer the recombinant antibody of the copending claims to such subjects who have Influenza A or B and also are coinfected with HIV and/or HCV because the recombinant antibody provides therapeutic benefit to subjects with HIV and/or HCV. In other words, it would be obvious to perform the methods of the copending claims to treat just any subjects that have HIV and/or HCV (including subjects that also have Influenza A or Influenza B) by administering the recited antibody because the copending claims recite the antibody is administered to treat subjects with HIV and/or HCV infection.
Thus, taken together, claims 1, 10, 18, 25-27, 34 and 35 of copending Application ‘893 render instant claims 8, 11-13, and 20 as a whole prima facie obvious.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/YIE-CHIA LEE (TONYA)/Examiner, Art Unit 1642
/SEAN E AEDER/Primary Examiner, Art Unit 1642