DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments and Arguments
2. Claims 1-5, 9, 11-13, 15-17 and 21-28 are pending.
Claims 6-8, 10, 14, 18-20 and 29-74 have been cancelled.
Claims 1 and 12 have been amended.
Claims 1-5, 9, 11-13, 15-17 and 21-28 are examined on the merits with species, (vaccine’s nucleic acid): a. prostatic acid phosphatase (PAP) gene; and (vaccine composition number): c. comprising a first vaccine to PAP and second vaccine to androgen receptor (AR).
3. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Specification
4. The title of the invention is now descriptive, see Amendments to the Specification submitted November 10, 2025.
Withdrawn Grounds of Rejection
Claim Rejections - 35 USC § 112
5. The rejection of claim 12 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of Applicant’s amendment to the claim on page 4 of the Amendments to the Claims.
Maintained Grounds of Rejection
Claim Rejections - 35 USC § 103
6. 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.
7. 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.
8. The rejection of claim(s) 1-5, 9, 11-13, 15-17 and 21-28 under 35 U.S.C. 103 as being unpatentable over McNeel et al., WO 2017/139628 (published 17 August 2017/ IDS reference #2 submitted April 5, 2024), and further in view of Olson et al. (Cancer Immunol. Immunother. 62:585-596, 2013/ IDS reference #20 submitted February 2, 2023) and Ardiani et al., (Clin. Cancer Res.: 18(22): 6205-6218, 2013/ IDS reference #14, Non-Patent Literature document submitted February 2, 2023) is maintained.
Applicant argues “…the Examiner has failed to identify any teaching in the three combined references that indicates that a PAP vaccine can or should be combined with any other vaccine targeting other gene products in prostate tumors, much less the AR vaccine that is specifically claimed. Instead, the Examiner apparently relies on a "common-sense" rationale that "therapies in combination can be administered with the frequency dictated by the needs of the individual being treated and established to promote an anti-tumor immune response and improve clinical outcome." However, it is known in the art that co-immunization with DNA vaccines to different genes can result in inhibition of specific immune responses as compared to single gene immunization. See, e.g., Ex. 1, [Kjerrström et al. Virology 284: 46-61, 2001] attached hereto. Given this accepted knowledge in the art, there is no reasonable expectation of success for co-immunization using [both] AR and PAP vaccines. This evidence also strongly supports a lack of motivation to combine the cited references as a person of ordinary skill in the art would readily recognize the issues associated with vaccination against multiple genes in a target and the limitations associated therewith. In other words, there is no indication in the cited references or in the prior art in general for the Examiner's assertion that vaccinations against AR and PAP would be consistent with an improved antitumor response or improved clinical outcome as compared to single gene immunization.”, see Remarks submitted November 10, 2025, page 8.
The Examiner has reviewed Exhibit 1 attached to the Remarks submitted November 10, 2025. The Kjerrström paper reads on a distinct disease, human immunodeficiency virus type 1 (HIV-1). At the time of its publication, 2001 it may have been the state of the art at that time. This scientific evidence does not dissuade one of ordinary skill in the art that the claimed combination would not be operable or render the same effect(s) as that claimed given the difference in the disorders and what was known in the technology at the disparate times.
Prior to the time of filing of the instant application, 2020 it was art known to treat prostate cancer with vaccines comprising a nucleic acid comprising a nucleotide sequence from a PAP gene and a nucleic acid comprising a nucleotide sequence of the AR LBD, PD-1 inhibitor and enzalutamide, see all references. McNeel provides motivation to combine compound for the purpose of treating prostate cancer, as “…it is contemplated that the technology comprises vaccines to other antigens for the treatment of prostate cancer”, see paragraph bridging pages 4 and 5; page 28, line 15-page 29, line 11; page 29, lines 28-34; Pharmaceutical formulations spanning pages 43-48; and entire document. And both, Olson and Ardiani read on combination therapy, see both references in their entirety.
It is within the purview of one skilled in the art to combine different components that have similar end results. See MPEP § 2144.06, where it is stated that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from there having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850,205 USPQ 1069, 1072 (CCPA 1980).
“[O]bviousness cannot be avoided simply by a showing of some degree of unpredictability in the art so long as there was a reasonable probability of success.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Here, a reasonable probability of success has been established and Applicant’s contentions regarding no reasonable expectation of success for co-immunization using the said vaccines are found to be unpersuasive.
Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art at the time of the claimed invention was made, absent unexpected results. Hence, the rejection maintained.
McNeel teaches “…a method for treating prostate cancer in a subject, the method comprising administering to a subject a vaccine comprising a nucleic acid comprising a nucleotide sequence from a [human] prostatic acid phosphatase (PAP) gene; and administering to the subject a human programmed death receptor-1 (PD- l) inhibitor… In some embodiments, …, the nucleic acid further comprises a transcriptional regulatory element, e.g., in some embodiments the nucleotide sequence from a PAP gene is operatively linked to a transcriptional regulatory element (e.g., a nucleic acid comprising a transcriptional regulatory element, e.g., a nucleic acid comprising a nucleotide sequence encoding a transcriptional regulatory element (e.g., a core promoter, a proximal promoter, an enhancer, a locus control region, a transcription factor binding site, an activator, a coactivator, etc.)).”, see page 5, lines 11-26; and claim 56 on page 98. “[T]he nucleic acid is pTVG4-HP…”, see page 5, line 30; and claim 60 on page 98.
The PD-1 inhibitor is either, pembrolizumab or nivolumab, see page 4, lines 25-30; page 6, lines 6-9. The PD-1 inhibitor may be administered concurrently with the vaccine, wherein the vaccine is followed by the administration of the PD-1 inhibitor; or the PD-1 inhibitor is administered every 10 to 28 days for a period of from 91 days to 365 days; or every 17 to 24 for a period up to 90 days or concurrently every 10 to 28 days for a period of up to 90 days, see page 6, lines 22-25; paragraph (para.) bridging pages 7 and 8; claim 29 on page 94; claims 1 and 2 on page 92; claims 48 and 54 on page 97; claims 76 and 77 on page 99; claim 98 on page 101. “In some embodiments, patients that exhibit a decrease in PSA or tumor regression after 365 days are selected for the administration of the vaccine every 10 to 20 or 21 days and the PD-1 inhibitor every 17 to 24 days for a period of from 366 days to 730 days.”, see page 7, lines 31-34.
“[I]n some embodiments the PD-1 inhibitor is administered at a dose of from 1 to 5 mg/kg. And, in some embodiments, the vaccine is administered in an amount of approximately 100 μg.”, see para. bridging pages 6 and 7; page 58, lines 23-25; claim 12 on page 93; and claim 64 on page 98.
“[C]ompositions of the present technology are administered with one or more adjuvants.”, see page 31, lines 12-27. The taught vaccine can also be administered in combination with another active agent, see page 28, line 15-page 29, line 32.
With the teaching of the method of administration of the vaccine alone or the vaccine in combination with the PD-1 inhibitor, there is an anti-tumor response, see page 3, lines 27-34; page 4, lines 9-11; page 7, lines 31-34; and page 9, lines 19-22.
McNeel does not teach the method comprising administering a ligand-binding domain of an androgen receptor (AR) gene, nor the optional administration of an androgen receptor antagonist that is enzalutamide at a dose of 160 mg and administered daily for 90 days followed by a period of not administering said androgen receptor antagonist, as well as wherein administration of said androgen receptor antagonist is repeated every 90 days. McNeel also does not teach the method, wherein the vaccine, enzalutamide and the PD-1 inhibitor are administered a plurality of times, and wherein after the first concurrent administration of the vaccine and the PD-1 inhibitor, the vaccine is administered every 10 to 21 days, the PD-1 inhibitor is administered every 17 to 28 days for a period of up to 90 days, and the androgen receptor antagonist is administered daily for a period of up to 90 days beginning about 8 to 12 weeks after the first administration of the vaccine. And lastly, McNeel does not teach a second vaccine to AR and the first vaccine to PAP and said second vaccine are administered concurrently.
However, Olson teaches a DNA vaccine targeting the androgen receptor (AR) ligand-binding domain (LBD), see Abstract. The cDNA sequence of the AR LBD was cloned into the pTVG4 plasmid DNA immunization construct (pTVG-AR), see page 588, 1st column, Immunization…segment.
Additionally, Ardiani teaches administering enzalutamide, an androgen antagonist at dose of 100 mg in combination with a metastasis vaccine, see title; page 6205, Results; and page 6207, 1st column, 1st paragraph.
It would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to combine the teachings of all three references to effectively treat prostate cancer. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings well known in the art and the references, therapies in combination can be administered with the frequency dictated by the needs of the individual being treated and established to promote an anti-tumor immune response and improve clinical outcome, see all references in their entireties.
Further, one of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings well known in the art, that dosages of any pharmaceutical composition must be adjusted and optimized. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235(CCPA 1955).
Double Patenting
9. 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.
10. Claims 1, 3-5, 9, 11, 21-26 and 28 continue to be rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,00,578 B2 (issued May 11, 2021).
Applicant did not traverse the instant rejection in the Remarks submitted November 10, 2025, hence the rejection is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims read on a method of treating prostate with the administration of a nucleic acid with a nucleotide sequence of prostatic acid phosphatase (PAP) gene, pTVG4-HP with a human programmed death receptor-1 (PD-1) inhibitor, wherein the vaccine is administered within the range of every 10-21 days and the PD-1 inhibitor is administered within the range of every 17 to 28 days; or
wherein after the first administration of the vaccine and the PD-1 inhibitor, the vaccine is administered every 14 days and the PD-1 inhibitor is administered every 28 days for a period of up to 90 days; or
wherein administering the vaccine every 10 to 21 days and the PD-1 inhibitor every 17 to 28 days for a period of from 91 days to 365 days; or
wherein patients that exhibit a decrease in PSA or tumor regression after 90 days are selected for the administration of the vaccine every 10 to 21 days and the PD-1 inhibitor every 17 to 28 days for a period of from 91 days to 365 days; or
wherein administering the vaccine every 10 to 20 days and the PD-1 inhibitor every 17 to 28 days for a period of from 366 days to 730 days. The PAP nucleotide sequences, SEQ ID NO: 1 and SEQ ID NO: 2 are the same in both, the instant application and the patent, absent evidence to the contrary. The PD-1 inhibitor may be pembrolizumab or nivolumab.
1 2036 100.0 381 US-10-669-474-2 2003-09-25 2 METHODS AND COMPOSITIONS FOR TREATING PROSTATE CANCER USING DNA VACCINES
US-15-430-012-2 2017-02-10 CANCER THERAPY
US-17-313-335-2 2021-05-06 CANCER THERAPY
1 2028 100.0 381 US-10-669-474-3 2003-09-25 2 METHODS AND COMPOSITIONS FOR TREATING PROSTATE CANCER USING DNA VACCINES
US-15-430-012-3 2017-02-10 CANCER THERAPY
US-17-313-335-3 2021-05-06 CANCER THERAPY
11. Claims 1, 3-5, 9, 11, 21-26 and 28 continue to be rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,806,391 B2 (issued November 7, 2023, 2021).
Applicant did not traverse the instant rejection in the Remarks submitted November 10, 2025, hence the rejection is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims read on a method of treating prostate with the administration of a nucleic acid with a nucleotide sequence of prostatic acid phosphatase (PAP) gene with a human programmed death receptor-1 (PD-1) inhibitor, wherein the vaccine is administered within the range of every 10 to 21 days and the PD-1 inhibitor is administered within the range of every 17 to 28 days; or
wherein after the first administration of the vaccine and the PD-1 inhibitor, the vaccine is administered every 14 days and the PD-1 inhibitor is administered every 28 days for a period of up to 90 days; or
wherein administering the vaccine every 10 to 21 days and the PD-1 inhibitor every 17 to 28 days for a period of from 91 days to 365 days; or
wherein patients that exhibit a decrease in PSA or tumor regression after 90 days are selected for the administration of the vaccine every 10 to 21 days and the PD-1 inhibitor every 17 to 28 days for a period of from 91 days to 365 days; or
wherein administering the vaccine every 10 to 20 days and the PD-1 inhibitor every 17 to 28 days for a period of from 366 days to 730 days.
The PAP nucleotide sequences, SEQ ID NO: 1, SEQ ID NO: 2 are the same in both, the instant application and the patent, absent evidence to the contrary. The PD-1 inhibitor may be pembrolizumab or nivolumab.
1 2036 100.0 381 US-10-669-474-2 2003-09-25 2 METHODS AND COMPOSITIONS FOR TREATING PROSTATE CANCER USING DNA VACCINES
US-15-430-012-2 2017-02-10 CANCER THERAPY
US-17-313-335-2 2021-05-06 CANCER THERAPY
1 2028 100.0 381 US-10-669-474-3 2003-09-25 2 METHODS AND COMPOSITIONS FOR TREATING PROSTATE CANCER USING DNA VACCINES
US-15-430-012-3 2017-02-10 CANCER THERAPY
US-17-313-335-3 2021-05-06 CANCER THERAPY
12. Claims 1, 3, 4, 11, 12, 21 and 28 continue to be provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/492,311 (filed October 23, 2023).
Applicant did not traverse the instant rejection in the Remarks submitted November 10, 2025, hence the rejection is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims read on treating prostate cancer with the administration of a composition comprising a nucleic acid sequence from a prostatic acid phosphatase (PAP) gene with a human programed death receptor-1 (PD-1) inhibitor, wherein the PAP is administered every 10-14 days and the PD-1 inhibitor is administered every 17 to 28 days. Absent evidence to the contrary, the PAP nucleotide sequences are the same within both sets of claims.
13. Claims 1, 3, 4, 11, 12, 21 and 28 continue to be provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/948,989 (filed November 15, 2024).
Applicant did not traverse the instant rejection in the Remarks submitted November 10, 2025, hence the rejection is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims read on treating prostate cancer with the administration of a composition comprising a nucleic acid sequence from a prostatic acid phosphatase (PAP) gene with a human programed death receptor-1 (PD-1) inhibitor, wherein the PAP is administered every 10 to 21 days and the PD-1 inhibitor is administered every 17 to 28 days. The PAP nucleotide sequences, SEQ ID NO: 2 and SEQ ID NO: 3 are the same within both sets of claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
RESULT 1 from 2.rapbn database.
US-18-948-989-2
Sequence 2, US/18948989
Publication No. US20250074987A1
GENERAL INFORMATION
APPLICANT: Madison Vaccines Incorporated (en)
TITLE OF INVENTION: CANCER THERAPY (en)
FILE REFERENCE: MVI_33984_305
CURRENT APPLICATION NUMBER: US/18/948,989
CURRENT FILING DATE: 2024-11-15
NUMBER OF SEQ ID NOS: 4
SEQ ID NO 2
LENGTH: 381
TYPE: PRT
FEATURE:
NAME/KEY: source
LOCATION: 1..381
QUALIFIERS: mol_type = protein
organism = Homo sapiens
Query Match 100.0%; Score 2036; Length 381;
Best Local Similarity 100.0%;
Matches 381; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MRAVPLPLSRTASLSLGFLLLLSLCLDPGQAKELKFVTLVFRHGDRGPIETFPTDPITES 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MRAVPLPLSRTASLSLGFLLLLSLCLDPGQAKELKFVTLVFRHGDRGPIETFPTDPITES 60
Qy 61 SWPQGFGQLTQWGMEQHYELGSYIRKRYGRFLNDTYKHDQIYIRSTDVDRTLMSAMTNLA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 SWPQGFGQLTQWGMEQHYELGSYIRKRYGRFLNDTYKHDQIYIRSTDVDRTLMSAMTNLA 120
Qy 121 ALFPPEGISIWNPRLLWQPIPVHTVSLSEDRLLYLPFRDCPRFEELKSETLESEEFLKRL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 ALFPPEGISIWNPRLLWQPIPVHTVSLSEDRLLYLPFRDCPRFEELKSETLESEEFLKRL 180
Qy 181 HPYKSFLDTLSSLSGFDDQDLFGIWSKVYDPLFCESVHNFTLPSWATEDAMIKLKELSEL 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 HPYKSFLDTLSSLSGFDDQDLFGIWSKVYDPLFCESVHNFTLPSWATEDAMIKLKELSEL 240
Qy 241 SLLSLYGIHKQKEKSRLQGGVLVNEILKNMKLATQPQKYKKLVMYSAHDTTVSGLQMALD 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 SLLSLYGIHKQKEKSRLQGGVLVNEILKNMKLATQPQKYKKLVMYSAHDTTVSGLQMALD 300
Qy 301 VYNGVLPPYASCHMMELYHDKGGHFVEMYYRNETQNEPYPLTLPGCTHSCPLEKFAELLD 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 VYNGVLPPYASCHMMELYHDKGGHFVEMYYRNETQNEPYPLTLPGCTHSCPLEKFAELLD 360
Qy 361 PVISQDWATECMATSSHQGRN 381
|||||||||||||||||||||
Db 361 PVISQDWATECMATSSHQGRN 381
RESULT 1 from 3.rabpn database.
US-18-948-989-3
Sequence 3, US/18948989
Publication No. US20250074987A1
GENERAL INFORMATION
APPLICANT: Madison Vaccines Incorporated (en)
TITLE OF INVENTION: CANCER THERAPY (en)
FILE REFERENCE: MVI_33984_305
CURRENT APPLICATION NUMBER: US/18/948,989
CURRENT FILING DATE: 2024-11-15
NUMBER OF SEQ ID NOS: 4
SEQ ID NO 3
LENGTH: 381
TYPE: PRT
FEATURE:
NAME/KEY: source
LOCATION: 1..381
QUALIFIERS: mol_type = protein
organism = Homo sapiens
Query Match 100.0%; Score 2028; Length 381;
Best Local Similarity 100.0%;
Matches 381; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MRAVPLHLVGTASLTLGFLLLLSLRLDPGQAKELKFVTLVFRHGDRGPIETFPNDPIKES 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MRAVPLHLVGTASLTLGFLLLLSLRLDPGQAKELKFVTLVFRHGDRGPIETFPNDPIKES 60
Qy 61 SWPQGFGQLTKWGMGQHYELGSYIRRRYGRFLNNSYKHDQVYIRSTDVDRTLMSAMTNLA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 SWPQGFGQLTKWGMGQHYELGSYIRRRYGRFLNNSYKHDQVYIRSTDVDRTLMSAMTNLA 120
Qy 121 ALFPPEGISIWNPRLLWQPIPVHTVSLSEDRLLYLPFRDCPRFQELKSETLKSEEFLKRL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 ALFPPEGISIWNPRLLWQPIPVHTVSLSEDRLLYLPFRDCPRFQELKSETLKSEEFLKRL 180
Qy 181 QPYKSFIDTLPSLSGFEDQDLFEIWSRLYDPLYCESVHNFTFRTWATEDAMTKLKELSEL 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 QPYKSFIDTLPSLSGFEDQDLFEIWSRLYDPLYCESVHNFTFRTWATEDAMTKLKELSEL 240
Qy 241 SLLSLYGIHKQKEKSRLQGGVLVNEILKNMKLATQPQKARKLIMYSAYDTTVSGLQMALE 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 SLLSLYGIHKQKEKSRLQGGVLVNEILKNMKLATQPQKARKLIMYSAYDTTVSGLQMALE 300
Qy 301 LYNGLLPPYASCHIMELYQDNGGTFVEMYYRNETQNEPYPLTLPGCTHSCPLEKFAELLD 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 LYNGLLPPYASCHIMELYQDNGGTFVEMYYRNETQNEPYPLTLPGCTHSCPLEKFAELLD 360
Qy 361 PVIPQDWATECMGTSNHQASL 381
|||||||||||||||||||||
Db 361 PVIPQDWATECMGTSNHQASL 381
Conclusion
14. 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.
15. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached 8AM-8PM, Monday through Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Julie Wu can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
22 December 2025
/Alana Harris Dent/Primary Examiner, Art Unit 1643