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 the Claims
Claims 1-18 were originally filed November 12, 2021.
The amendment received May 25, 2022 amended claims 1-14 and 17.
The amendment received February 28, 2025 amended claims 1, 2, 10-12, and 17 and canceled claims 3-9, 13, and 14.
The amendment received November 13, 2025 amended claims 1 and 17 and canceled claim 2.
The amendment received July 20, 2026 changed the status identifiers only.
Claims 1, 10-12, and 15-18 are currently pending.
Claims 1, 10-12, and 17 are currently under consideration.
Election/Restrictions
Applicants elected, without traverse, Group I (claims 1-14 and 17) in the reply filed on August 23, 2024. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 15, 16, and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected products and methods, there being no allowable generic or linking claim.
Applicants elected, without traverse, SEQ ID NO: 11, N-terminal acetylation, neurotrophic keratitis, and human as the species in the reply filed on August 23, 2024. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 13 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 23, 2024.
Priority
The present application is a 371 (National Stage) of PCT/JP2020/019347 filed May 14, 2020 which claims foreign priority to Japan 2019-091700 filed May 14, 2019.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome any rejection of record because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3.
Present SEQ ID NO: 1 (PACAP38) is HSDGIFTDSYSRYRKQMAVKKYLAAVLGKRYKQRVKNK.
SEQ ID NO: 3 wherein X1, X2, and X3 are S/Ser/serine; X4 is K/Lys/lysine; X5 is Q/Gln/glutamine; X6 is M/Met/methionine; X7 is V/Val/valine; X8 and X9 are K/Lys/lysine; and X10 is L/Leu/leucine.
Present SEQ ID NO: 2 (PACAP27) is HSDGIFTDSYSRYRKQMAVKKYLAAVL.
SEQ ID NO: 3 wherein X1, X2, and X3 are S/Ser/serine; X4 is K/Lys/lysine; X5 is Q/Gln/glutamine; X6 is M/Met/methionine; X7 is V/Val/valine; X8 and X9 are K/Lys/lysine; and X10 is L/Leu/leucine.
Please note: due to the closed consisting of language in claims 1 and 17, only PACAP27 now reads on present SEQ ID NO: 3.
Maintained Rejections
Claim Rejections - 35 USC § 103
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.
Claims 1, 10-12, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Takayama et al. U.S. Patent Application Publication 2011/0212899 published September 1, 2011 and Popova et al., 2015, Synthesis and biological properties of amino acids and peptides containing a tetrazolyl moiety, Russian Chemical Reviews, 84(9): 891-916.
For present claims 1, 10-12, and 17, Takayama et al. teach methods of treating keratitis, keratopathy, and/or corneal neutritogenesis via administering PACAP38 (i.e. present SEQ ID NO: 1), PACAP27 (i.e. present SEQ ID NOs: 2 and 3), or a derivative thereof which may also have deletions (i.e. modified sequence) and/or N-terminal acetylation (please refer to the entire specification particularly the abstract; paragraphs 4, 6, 8-23, 35, 57, 66, 71).
For present claims 1, 10-12, and 17, Popova et al. teach replacing aspartic acid with tetrazole to enhance peptide stability (please refer to the entire reference particularly the abstract; Introduction; pages 904, 908, 910, 912, and 913).
The claims would have been obvious because a particular known technique (i.e. replacing aspartic acid with tetrazole to enhance peptide stability) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Takayama et al. and Popova et al. for claims 1, 10-12, and 17 were considered but are not persuasive for the following reasons.
Applicants contend that hindsight reasoning was utilized. Applicants contend that one of skill in the art would have no motivation to combine the prior art. Applicants contend that page 912 of Popova et al. teach that tetrazole substitution resulted in reduced biological activity. Applicants also refer to page 3381 of Herr (Appendix 1 of the response received February 28, 2025) which although tetrazole substitution may stabilize peptides against enzymatic or other metabolic degradation in vivo, lack of activity is often observed as well. Applicants contend that Takayama et al. do not teach PACAP27 wherein the D/Asp/aspartic acid at positions 3 and/or 8 is(are) substituted with tetrazole which retain activity while having enhanced stability. Applicants contend that Popava et al. do not teach PACAP27 wherein the D/Asp/aspartic acid at positions 3 and/or 8 is(are) substituted with tetrazole.
Applicants’ arguments are not convincing since the teachings of Takayama et al. and Popova et al. render the methods of the instant claims prima facie obvious.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper 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).
The claims would have been obvious because a particular known technique (i.e. replacing aspartic acid with tetrazole to enhance peptide stability) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
No where in page 912 of Popova et al. is it taught that tetrazole modifications decrease activity. In addition, applicants should point to specific column and line numbers to support their position (i.e. not just a page number). Page 912 of Popova et al. teach that Shoen et al. taught that compound 213 (i.e. peptidomimetic) substantially enhances the secretion of growth hormone, peptidomimetic 214 has activity, peptidomimetic 215 inhibits protein tyrosine phosphate 1B, a tetrazolyl derivative of amino acids is a nitric oxide synthetase inhibitor, tetrazolediyl modified kinin peptides can interact with kinin receptors, tetrazoldiyl modified peptides that act on CCK-A and CCK-B cholecystokinin receptors had activity as receptor antagonists, and analogues of natural peptides (i.e. tetrazole) had immunosuppressive activity.
Applicants should point to specific column and line numbers to support their position (i.e. not just a page number). The highlighted portion of page 3381 of Herr reads “As in these cases, it is often seen that the resistance of tetrazolic drug substances to metabolism may result in a longer duration of action verses carboxylic acids, although just as often a corresponding lack of potency is also observed”. However, Herr (page 3381, left column, first full paragraph) also teaches that tetrazole modified compounds can actually have increased activity. Also see “Three Medicinal Chemistry Case Histories” for additional tetrazole modified compounds taught by Herr which have activity.
Conclusive proof of efficacy is not required to show a reasonable expectation of success. See OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")).
In response to applicant's arguments against 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).
Takayama et al. teach PACAP27 (present SEQ ID NOs: 2 and 3) wherein the only D/Asp/aspartic acids are at residues 3 and 8 (see above – Sequence Interpretation section).
Popova et al. teach of tetrazole substitutions providing stability and high activity (please refer to the entire reference particularly the abstract; Introduction, sections IV.1, V; page 910, left column). Popova et al. teach replacing aspartic acid with tetrazole to enhance peptide stability (please refer to the entire reference particularly the abstract; Introduction; pages 904, 908, 910, 912, and 913).
Claims 1, 10-12, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Ousler III et al. U.S. Patent Application Publication 2006/0270592 published November 30, 2006; Takayama et al. U.S. Patent Application Publication 2011/0212899 published September 1, 2011; and Popova et al., 2015, Synthesis and biological properties of amino acids and peptides containing a tetrazolyl moiety, Russian Chemical Reviews, 84(9): 891-916.
For present claims 1, 10-12, and 17, Ousler III et al. teach methods of treating neurotrophic keratitis via administering PACAP38 (present SEQ ID NO: 3) or PACAP27 (present SEQ ID NOs: 2 and 3) (please refer to the entire specification particularly 4, 6, 19, 25, 36, 37).
For present claims 1, 10-12, and 17, Takayama et al. teach methods of treating keratitis, keratopathy, and/or corneal neutritogenesis via administering PACAP38 (present SEQ ID NO: 1), PACAP27 (present SEQ ID NOs: 2 and 4), or a derivative thereof which may also have deletions (i.e. modified sequence) and/or N-terminal acetylation (please refer to the entire specification particularly the abstract; paragraphs 4, 6, 8-23, 35, 57, 66, 71).
For present claims 1, 10-12, and 17, Popova et al. teach replacing aspartic acid with tetrazole to enhance peptide stability (please refer to the entire reference particularly the abstract; Introduction; pages 904, 908, 910, 912, and 913).
The claims would have been obvious because a particular known technique (i.e. N-terminal acetylation to increase stability; replacing aspartic acid with tetrazole to enhance peptide stability) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Ousler III et al., Takayama et al., and Popova et al. for claims 1, 10-12, and 17 were considered but are not persuasive for the following reasons.
Applicants contend that hindsight reasoning was utilized. Applicants contend that one of skill in the art would have no motivation to combine the prior art. Applicants contend that page 912 of Popova et al. teach that tetrazole substitution resulted in reduced biological activity. Applicants also refer to page 3381 of Herr (Appendix 1 of the response received February 28, 2025) which although tetrazole substitution may stabilize peptides against enzymatic or other metabolic degradation in vivo, lack of activity is often observed as well. Applicants contend that Takayama et al. do not teach PACAP27 wherein the D/Asp/aspartic acid at positions 3 and/or 8 is(are) substituted with tetrazole which retain activity while having enhanced stability. Applicants contend that Popava et al. do not teach PACAP27 wherein the D/Asp/aspartic acid at positions 3 and/or 8 is(are) substituted with tetrazole.
Applicants’ arguments are not convincing since the teachings of Ousler III et al., Takayama et al., and Popova et al. render the methods of the instant claims prima facie obvious.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper 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).
The claims would have been obvious because a particular known technique (i.e. replacing aspartic acid with tetrazole to enhance peptide stability) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
No where in page 912 of Popova et al. is it taught that tetrazole modifications decrease activity. In addition, applicants should point to specific column and line numbers to support their position (i.e. not just a page number). Page 912 of Popova et al. teach that Shoen et al. taught that compound 213 (i.e. peptidomimetic) substantially enhances the secretion of growth hormone, peptidomimetic 214 has activity, peptidomimetic 215 inhibits protein tyrosine phosphate 1B, a tetrazolyl derivative of amino acids is a nitric oxide synthetase inhibitor, tetrazolediyl modified kinin peptides can interact with kinin receptors, tetrazoldiyl modified peptides that act on CCK-A and CCK-B cholecystokinin receptors had activity as receptor antagonists, and analogues of natural peptides (i.e. tetrazole) had immunosuppressive activity.
Applicants should point to specific column and line numbers to support their position (i.e. not just a page number). The highlighted portion of page 3381 of Herr reads “As in these cases, it is often seen that the resistance of tetrazolic drug substances to metabolism may result in a longer duration of action verses carboxylic acids, although just as often a corresponding lack of potency is also observed”. However, Herr (page 3381, left column, first full paragraph) also teaches that tetrazole modified compounds can actually have increased activity. Also see “Three Medicinal Chemistry Case Histories” for additional tetrazole modified compounds taught by Herr which have activity.
Conclusive proof of efficacy is not required to show a reasonable expectation of success. See OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")).
In response to applicant's arguments against 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).
Takayama et al. teach PACAP27 (present SEQ ID NOs: 2 and 3) wherein the only D/Asp/aspartic acids are at residues 3 and 8 (see above – Sequence Interpretation section).
Popova et al. teach of tetrazole substitutions providing stability and high activity (please refer to the entire reference particularly the abstract; Introduction, sections IV.1, V; page 910, left column). Popova et al. teach replacing aspartic acid with tetrazole to enhance peptide stability (please refer to the entire reference particularly the abstract; Introduction; pages 904, 908, 910, 912, and 913).
Double Patenting
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 1, 10-12, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent 12,304,932 (application 16/763,732) in view of Takayama et al. U.S. Patent Application Publication 2011/0212899 published September 1, 2011.
U.S. Patent 12,304,932 claims SEQ ID NO: 3 wherein the aspartic acids at residues 3 and/or 8 are substituted with tetrazole, amino acids can be deleted or added, and N-terminal acetylation.
Takayama et al. teach methods of treating keratitis, keratopathy, and/or corneal neutritogenesis via administering PACAP38 (present SEQ ID NO: 1), PACAP27 (present SEQ ID NOs: 2 and 3), or a derivative thereof which may also have deletions (i.e. modified sequence) and/or N-terminal acetylation (please refer to the entire specification particularly the abstract; paragraphs 4, 6, 8-23, 35, 57, 66, 71).
The claims would have been obvious because a particular known technique (i.e. treating keratitis or keratopathy and/or corneal neutritogenesis via utilizing PACAP27) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent 12,304,932 and Takayama et al. for claims 1, 10-12, and 17 were considered but are not persuasive for the following reasons.
Applicants contend that since U.S. Patent 12,304,932 does not claim methods of treatment, the patent cannot be utilized in a Double Patenting rejection. Applicants also contend that Takayama et al. do not teach present SEQ ID NO: 3.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent 12,304,932 and Takayama et al. renders obvious the method of the instant claims. U.S. Patent 12,304,932 claims present SEQ ID NO: 3 wherein the aspartic acids at residues 3 and/or 8 are substituted with tetrazole, amino acids can be deleted or added, and N-terminal acetylation. Takayama et al. teach methods of treating keratitis, keratopathy, and/or corneal neutritogenesis via administering PACAP38 (present SEQ ID NO: 1), PACAP27 (present SEQ ID NOs: 2 and 3), or a derivative thereof which may also have deletions (i.e. modified sequence) and/or N-terminal acetylation (please refer to the entire specification particularly the abstract; paragraphs 4, 6, 8-23, 35, 57, 66, 71).
Applicants should point to specific column and line numbers to support their position (i.e. not just a page number). The highlighted portion of page 3381 of Herr reads “As in these cases, it is often seen that the resistance of tetrazolic drug substances to metabolism may result in a longer duration of action verses carboxylic acids, although just as often a corresponding lack of potency is also observed”. However, Herr (page 3381, left column, first full paragraph) also teaches that tetrazole modified compounds can actually have increased activity. Also see “Three Medicinal Chemistry Case Histories” for additional tetrazole modified compounds taught by Herr which have activity.
Conclusive proof of efficacy is not required to show a reasonable expectation of success. See OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")).
In response to applicant's arguments against 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).
In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent 5,198,542 (SEQ ID NOs: 7 and 15 have 100% identity and the same length as present SEQ ID NOs: 1 and 2 wherein SEQ ID NO: 1 is a fusion of SEQ ID NO: 3-SEQ ID NO: 37).
JP 2001151799 (SEQ ID NOs: 3 and 4 have 100% identity and the same length as present SEQ ID NOs: 1 and 2 wherein SEQ ID NO: 1 is a fusion of SEQ ID NO: 3-SEQ ID NO: 37).
U.S. Patent Application Publication 20020155533 wherein SEQ ID NO: 47 has 100% identity and the same length as present SEQ ID NO: 2.
WO 2010/036936 wherein SEQ ID NO: 56 has 100% identity and the same length as present SEQ ID NO: 3.
U.S. Patent Application Publication 20040132648 wherein SEQ ID NO: 17 has 100% identity and the same length as present SEQ ID NO: 3.
THIS ACTION IS MADE FINAL. 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.
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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, Melissa Fisher can be reached on 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMBER D STEELE/Primary Examiner, Art Unit 1658
Prosecution Insights