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 .
DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group II and hypertension in the reply filed on 11/12/2025 is acknowledged. The traversal is on the ground(s) that “[c]laim 6 is generic (and allowable) over Hirsch et al. In particular, the peptide was disclosed in the cited reference as an inhibitor of the kinase-independent (scaffold) activity of PI3Ky enzyme for the treatment of respiratory diseases. The inhibition of the kinase- independent function of PI3Ky in airway smooth muscles with the Applicant's fusion peptide promotes bronchorelaxation”. This is not found persuasive because the claimed groups lack the same or corresponding special technical feature (i.e. the fusion peptide of original claim 1). Therefore, the requirement for restriction/election is proper under 35 U.S.C. 121 and 372.
The requirement is still deemed proper and is therefore made FINAL.
Claim 11 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.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 11/12/2025.
Status of the Claims
Claims 6-15 are pending in this application.
Claim 11 is withdrawn as being drawn to a non-elected elected species.
Claims 6-15 are presently under consideration as being drawn to the elected species/invention.
Claim Objections
Claims 6-9 and 12-15 are objected to because of the following informalities:
Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995); See also MPEP § 608.01(m). The claims should be amended to remove the period between “SEQ ID NO” and “:”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6-8, 10 and 12-15 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a therapeutic method for treating, preventing and/or delaying onset of a fibroproliferative vascular disease; the method comprising administering to a patient in need thereof a fusion peptide in an amount sufficient to carry out the method, wherein the fusion peptide comprises:(a) an amino acid sequence as defined in SEQ ID No.: 1 or a related homolog having at least 85% identity with SEQ ID No.: 1 and having an ability of the sequence SEQ ID No.: 1 to inhibit a kinase-independent function of PI3Kg, and(b) a peptide having the ability able to penetrate a cell.
When referring to the peptide, the specification does not provide any structural attributes.
Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“A definition by function alone “does not suffice” to sufficiently describe a coding sequence because it is only an indication of what the gene does, rather than what it is”).”
Here, the specification fails to describe what part of the sequence correlates with the required activity (i.e. treating, preventing and/or delaying onset of a fibroproliferative vascular disease).
The MPEP states that a broad genus can be described by a showing of representative number of examples. The claims in the instant application are broad.
Based on the teachings of the specification, the peptide can be: 1) any peptide comprising an amino acid sequence (i.e. any two or more consecutive amino acids) as defined in SEQ ID NO: 1 (note the open language “an amino acid sequence”); and 2) a homolog having at least 85% identity with SEQ ID NO: 1.
However, the specification fails to provide a representative number of examples for the claimed peptide.
The specification provides only one exemplary peptide (i.e. SEQ ID NO: 1). It is noted that SEQ ID NO: 1 is 25 amino acids long. Therefore, even considering only natural amino acids, one would have 276,000 (25x24x23x20) possible peptides having 85 % identity with SEQ ID NO: 1.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does “little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”).
Therefore, since the specification fails to identify any relevant structural characteristics that can be attributed to the claimed function and activity, the claimed invention lacks written description.
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 6-10 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Hirsch et al. (WO 2016/103176) in view of Carnevale et al. (Cardiovasc Res. 2012 Jan 1;93(1):200-9).
With respect to claims 6, 10 and 12-13, Hirsch et al. teach a method for treating respiratory diseases comprising the administration to a patient in need thereof of at least one fusion peptide comprising: i) an amino acid sequence as defined in SEQ ID No: 1 or a related homolog having at least 90% identity with SEQ ID No: 1 and having the ability of the sequence SEQ ID No: 1 to inhibit the kinase-independent function of PI3Kg, and ii) a peptide having the ability to penetrate a cell (claim 11). It is noted that SEQ ID NO: 1 corresponds to instantly claimed SEQ ID NO: 1.
Hirsch et al. do not teach the claimed fibroproliferative vascular disease.
Carnevale et al. teach that inhibition of PI3Kg reduced blood pressure in normotensive and hypertensive mice in a concentration-dependent fashion (abstract).
Carnevale et al. also teach that “[o]ur findings strongly indicate that PI3Kg inhibitors could be further studied as a potential tool to treat hypertension (page 209, left column, 2nd para).
It would have been obvious, with a reasonable expectation of success, to one of ordinary skill in the art to treat hypertension with the fusion peptide of Hirsch et al. because Carnevale et al. teach that PI3Kg inhibition to treat hypertension.
With respect to claims 7 and 14-15, Hirsch et al. teach that the peptide having the ability to penetrate a cell is selected from the sequences specified in SEQ ID No: 3 to 12 (claim 2), which corresponds to instant SEQ ID NOs: 2-4 and 6-12.
With respect to claim 8, Hirsch et al. teach that the peptide having the ability to penetrate a cell is conjugated to the C-terminal or the N-terminal of SEQ ID No.: 1 or its homologs (claim 3).
With respect to claim 9, Hirsch et al. teach that the fusion peptide has the sequence shown in SEQ ID NO: 2 (page 17, lines 9-16; page 22, lines 1-8), which corresponds to instant SEQ ID NO: 14.
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 6-8, 10 and 12-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10421794 in view of Carnevale et al. (Cardiovasc Res. 2012 Jan 1;93(1):200-9).
With respect to claims 6, 10 and 12-13, ‘794 teaches a method for treating respiratory diseases comprising administering to a patient in need thereof at least one fusion peptide in an amount sufficient to carry out said treatment, wherein the fusion peptide comprises: i) an amino acid sequence as defined in SEQ ID No: 1 or a related homolog having at least 90% identity with SEQ ID No: 1 and having the ability of the sequence SEQ ID No: 1 to inhibit the kinase-independent function of PI3Kg, and ii) a peptide having the ability to penetrate a cell (claim 1). It is noted that SEQ ID NO: 1 corresponds to instantly claimed SEQ ID NO: 1.
‘794 does not teach the claimed fibroproliferative vascular disease.
Carnevale et al. teach that inhibition of PI3Kg reduced blood pressure in normotensive and hypertensive mice in a concentration-dependent fashion (abstract).
Carnevale et al. also teach that “[o]ur findings strongly indicate that PI3Kg inhibitors could be further studied as a potential tool to treat hypertension (page 209, left column, 2nd para).
It would have been obvious, with a reasonable expectation of success, to one of ordinary skill in the art to treat hypertension with the fusion peptide of ‘794 because Carnevale et al. teach that PI3Kg inhibition to treat hypertension.
With respect to claims 7 and 14-15, ‘794 teaches that the peptide having the ability to penetrate a cell is selected from the sequences specified in SEQ ID No: 3 to 12 (claim 2), which corresponds to instant SEQ ID NOs: 2-4 and 6-12.
With respect to claim 8, ‘794 teaches that the peptide having the ability to penetrate a cell is conjugated to the C-terminal or the N-terminal of SEQ ID No.: 1 or its homologs (claim 4).
Claims 6-8, 10 and 12-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10730921 in view of Carnevale et al. (Cardiovasc Res. 2012 Jan 1;93(1):200-9).
With respect to claims 6, 10 and 12-13, ‘921 teaches a method for treating respiratory diseases comprising administering to a patient in need thereof (a) at least one fusion peptide and (b) at least one potentiator of the cystic fibrosis transmembrane conductance regulator (CFTR) and/or at least one corrector of the cystic fibrosis transmembrane conductance regulator (CFTR) in an amount sufficient to carry out said treatment, wherein the fusion peptide comprises: i) the amino acid sequence as defined in SEQ ID No.: 1 or a related homolog having at least 90% identity with SEQ I D No.: 1 and having the ability of the sequence SEQ ID No.: 1 to inhibit the kinase-independent function of PI3Kg, and ii) a peptide having the ability to penetrate a cell (claim 1). It is noted that SEQ ID NO: 1 corresponds to instantly claimed SEQ ID NO: 1.
‘921 does not teach the claimed fibroproliferative vascular disease.
Carnevale et al. teach that inhibition of PI3Kg reduced blood pressure in normotensive and hypertensive mice in a concentration-dependent fashion (abstract).
Carnevale et al. also teach that “[o]ur findings strongly indicate that PI3Kg inhibitors could be further studied as a potential tool to treat hypertension (page 209, left column, 2nd para).
It would have been obvious, with a reasonable expectation of success, to one of ordinary skill in the art to treat hypertension with the fusion peptide of ‘921 because Carnevale et al. teach that PI3Kg inhibition to treat hypertension.
With respect to claims 7 and 14-15, ‘921 teaches that the peptide having the ability to penetrate a cell is selected from the sequences specified in SEQ ID No: 3 to 12 (claim 2), which corresponds to instant SEQ ID NOs: 2-4 and 6-12.
With respect to claim 8, ‘921 teaches that the peptide having the ability to penetrate a cell is conjugated to the C-terminal or the N-terminal of SEQ ID No.: 1 or its homologs (claim 3).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658