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 .
Election/Restrictions and Claim Status
Applicants’ amendments and arguments filed 8/7/25 are acknowledged. Any objection or rejection from the 5/21/25 office action that is not addressed below is withdrawn based on the amendments.
Previously, Group 2 and the species of SEQ ID NO:1 (LVRYTQKAPQVS) and cancer were elected.
Claims 1, 6-8, 10-11, 16-17, 19-21 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/2/24.
Claims 27-30 do not read on the elected species of SEQ ID NO:1.
Claims 27-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/2/24.
Claims 2-5, 9, 12-14, 18, 22-23 and 25 have been canceled.
Claim 32 has been added as a new claim.
Claims 15, 26 and 31-32 are being examined.
Priority
The priority information is provided in the filing receipt of 9/13/21.
Claim Rejections - 35 USC § 112
This rejection is a new rejection necessitated by amendment.
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 31 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 15 has been amended to recite that the condition is ‘cancer of the liver, pancreas, prostate, or breast’. Claim 31 recites the same information and therefore is not further limiting. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
Claims were previously rejected under 103. Since the claims have been amended, the rejection is updated to correspond to the instant claims.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 15, 26 and 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forssmann et al. (U.S. Patent No. 9,045,563 (563); first cited 4/12/24) in view of Zirafi et al. (as cited with IDS 5/7/21; ‘Zirafi’) in view of Plumridge et al. (US 2013/0028930; first cited 12/8/23; ‘Plumridge’).
563 teach a peptide that is SEQ ID NO:12 (LVRYTKKVPQVS ) (claims 1-3) and compositions (claim 8) and methods of administering (claim 9). 563 teach for inhibiting HIV-1 and blocking tumor cell migration mediated by binding to CXCR4 (column 1 lines 11-15).
563 does not recite administration of a peptide as claimed.
Zirafi teach the peptide LVRYTKKVPQVSTPTL which corresponds to residues 408-423 of human serum albumin (HSA) (abstract and page 863 last paragraph). Zirafi teach that the peptide is an antagonist of CXCR4 (title and abstract). Zirafi teach that known CXCR4 antagonists are used to treat certain cancers (Table 1 and page 866 paragraph connecting columns 1-2). Zirafi also teach that the peptide is HIV-1 inhibitory (page 863 last paragraph). Zirafi teach that albumin sequences from various mammalian species were aligned (page 865 first complete paragraph). Zirafi teach little variation in the aligned sequences (page 865 first complete paragraph). Zirafi teach that the peptides were tested in various mouse models (page 864 2nd column first paragraph and page 865 2nd column first complete paragraph).
Plumridge recognizes various albumin sequences including human (SEQ ID NO:1) and mouse (SEQ ID NO:9) (section 0055 and claims 2-3). Plumridge shows the alignment of human and mouse sequences where figure 4 (sheets 3-4 of the figures) shows LVRYTKKVPQVS of human corresponds to LVRYTQKAPQVS of mouse. Plumridge recognizes that albumins have advantages of polypeptide stability and extension of half-life (sections 0003, 0008 and 0054). Plumridge recognizes applications as cancer vaccines (claim 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 563 because 563 recites the specific peptide that is SEQ ID NO:12 (LVRYTKKVPQVS) (claims 1-3). Since Zirafi teach a peptide comprising such sequence one would have been motivated to treat the subjects suggested by Zirafi. Zirafi teach that known CXCR4 antagonists are used to treat certain cancers (Table 1 and page 866 paragraph connecting columns 1-2) and Zirafi teach that the peptides were tested in various mouse models (page 864 2nd column first paragraph and page 865 2nd column first complete paragraph). With respect to the sequence of the peptide, Zirafi teach that albumin sequences from various mammalian species were aligned (page 865 first complete paragraph). Plumridge shows the alignment of human and mouse sequences where figure 4 (sheets 3-4 of the figures) shows LVRYTKKVPQVS of human corresponds to LVRYTQKAPQVS of mouse. Since Zirafi teach little variation in the aligned sequences (page 865 first complete paragraph) and Plumridge recognizes various albumin sequences including human (SEQ ID NO:1) and mouse (SEQ ID NO:9) (section 0055 and claims 2-3) one would have been motivated to substitute LVRYTQKAPQVS for LVRYTKKVPQVS. Further, Zirafi teach that the peptides were tested in various mouse models (page 864 2nd column first paragraph and page 865 2nd column first complete paragraph) so one would have also been motivated to use the corresponding mouse sequence. One would have had a reasonable expectation of success since the sequences and properties were known and methods of administering were known.
In relation to the polypeptide of claims 15, 26 and 32, LVRYTQKAPQVS as discussed above is instant SEQ ID NO:1.
In relation to the carrier of claim 15, Plumridge recognizes pharmaceutical compositions (section 0025). 563 recites a carrier (claim 6)
In relation to the administration of claim 15, Zirafi expressly recognizes injection (page 864 2nd column first paragraph). 563 recites administering (claim 9)
In relation to the treatment of claims 15 and 31, Zirafi teach that known CXCR4 antagonists are used to treat certain cancers including pancreatic (Table 1 and page 866 paragraph connecting columns 1-2). 563 teach blocking tumor cell migration mediated by binding to CXCR4 (column 1 lines 11-15).
Response to Arguments - 103
Applicant's arguments filed 8/7/25 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants argue that Forssman does not teach the specific therapeutic application, the instant rejection is a multiple reference 103 rejection. 563 teach blocking tumor cell migration mediated by binding to CXCR4 (column 1 lines 11-15). Zirafi teach that known CXCR4 antagonists are used to treat certain cancers including pancreatic (Table 1 and page 866 paragraph connecting columns 1-2).
Although applicants argue that one would not consult certain references,
563 recites the specific peptide that is SEQ ID NO:12 (LVRYTKKVPQVS) (claims 1-3). Since Zirafi (abstract and page 863 last paragraph specifically the peptide LVRYTKKVPQVSTPTL which corresponds to residues 408-423 of human serum albumin) teach a peptide comprising such sequence one would have been motivated to treat the subjects suggested by Zirafi.
Although applicants argue that Forssmann teach a broad disclosure, MPEP 2123 II recognizes that disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure.
Although applicants argue about the teachings of the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Although applicants that there is no reason to select a mouse sequence, Zirafi teach little variation in the aligned sequences (page 865 first complete paragraph) and Plumridge recognizes various albumin sequences including human (SEQ ID NO:1) and mouse (SEQ ID NO:9) (section 0055 and claims 2-3) so one would have been motivated to substitute LVRYTQKAPQVS for LVRYTKKVPQVS. Further, Zirafi teach that the peptides were tested in various mouse models (page 864 2nd column first paragraph and page 865 2nd column first complete paragraph) so one would have also been motivated to use the corresponding mouse sequence. Zirafi expressly refers to mouse models of pancreatic cancer (page 865 2nd column first complete paragraph).
Although applicants argue about hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Although applicants argue that the claims have been amended to remove references to HIV, the amended claims are addressed above. 563 teach blocking tumor cell migration mediated by binding to CXCR4 (column 1 lines 11-15). Zirafi teach that known CXCR4 antagonists are used to treat certain cancers including pancreatic (Table 1 and page 866 paragraph connecting columns 1-2).
Although applicants argue about patentability of EP 3877396, such document does not appear to be of record. Further, the instant claims are in front of the United States Patent and Trademark Office.
Double Patenting
Claims were previously rejected under double patenting based on the references cited below. Since the claims have been amended, the rejection is updated to correspond to the instant claims.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 15, 26 and 31-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,045,563 (563) in view of Zirafi et al. (as cited with IDS 5/7/21; ‘Zirafi’) in view of Plumridge et al. (US 2013/0028930; first cited 12/8/23; ‘Plumridge’).
563 recites a peptide that is SEQ ID NO:12 (LVRYTKKVPQVS ) (claims 1-3) and compositions (claim 8) and methods of administering (claim 9).
563 does not recite administration of a peptide as claimed.
Zirafi teach the peptide LVRYTKKVPQVSTPTL which corresponds to residues 408-423 of human serum albumin (HSA) (abstract and page 863 last paragraph). Zirafi teach that the peptide is an antagonist of CXCR4 (title and abstract). Zirafi teach that known CXCR4 antagonists are used to treat certain cancers (Table 1 and page 866 paragraph connecting columns 1-2). Zirafi also teach that the peptide is HIV-1 inhibitory (page 863 last paragraph). Zirafi teach that albumin sequences from various mammalian species were aligned (page 865 first complete paragraph). Zirafi teach little variation in the aligned sequences (page 865 first complete paragraph). Zirafi teach that the peptides were tested in various mouse models (page 864 2nd column first paragraph and page 865 2nd column first complete paragraph).
Plumridge recognizes various albumin sequences including human (SEQ ID NO:1) and mouse (SEQ ID NO:9) (section 0055 and claims 2-3). Plumridge shows the alignment of human and mouse sequences where figure 4 (sheets 3-4 of the figures) shows LVRYTKKVPQVS of human corresponds to LVRYTQKAPQVS of mouse. Plumridge recognizes that albumins have advantages of polypeptide stability and extension of half-life (sections 0003, 0008 and 0054). Plumridge recognizes applications as cancer vaccines (claim 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 563 because 563 recites the specific peptide that is SEQ ID NO:12 (LVRYTKKVPQVS) (claims 1-3). Since Zirafi teach a peptide comprising such sequence one would have been motivated to treat the subjects suggested by Zirafi. Zirafi teach that known CXCR4 antagonists are used to treat certain cancers (Table 1 and page 866 paragraph connecting columns 1-2) and Zirafi teach that the peptides were tested in various mouse models (page 864 2nd column first paragraph and page 865 2nd column first complete paragraph). With respect to the sequence of the peptide, Zirafi teach that albumin sequences from various mammalian species were aligned (page 865 first complete paragraph). Plumridge shows the alignment of human and mouse sequences where figure 4 (sheets 3-4 of the figures) shows LVRYTKKVPQVS of human corresponds to LVRYTQKAPQVS of mouse. Since Zirafi teach little variation in the aligned sequences (page 865 first complete paragraph) and Plumridge recognizes various albumin sequences including human (SEQ ID NO:1) and mouse (SEQ ID NO:9) (section 0055 and claims 2-3) one would have been motivated to substitute LVRYTQKAPQVS for LVRYTKKVPQVS. Further, Zirafi teach that the peptides were tested in various mouse models (page 864 2nd column first paragraph and page 865 2nd column first complete paragraph) so one would have also been motivated to use the corresponding mouse sequence. One would have had a reasonable expectation of success since the sequences and properties were known and methods of administering were known.
In relation to the polypeptide of claims 15, 26 and 32, LVRYTQKAPQVS as discussed above is instant SEQ ID NO:1.
In relation to the carrier of claim 15, Plumridge recognizes pharmaceutical compositions (section 0025). 563 recites a carrier (claim 6)
In relation to the administration of claim 15, Zirafi expressly recognizes injection (page 864 2nd column first paragraph). 563 recites administering (claim 9)
In relation to the treatment of claims 15 and 31, Zirafi teach that known CXCR4 antagonists are used to treat certain cancers including pancreatic (Table 1 and page 866 paragraph connecting columns 1-2).
Response to Arguments – double patenting
Applicant's arguments filed 8/7/25 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants argue about reasons set forth above, the arguments are addressed above and are not found persuasive as set forth above.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658