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
Claim Status
Claims 6-15 are pending. Claims 6-9 and 12-15 have been amended. Claims 6-9 and 12-15 are being examined in this application. In the response to the restriction requirement, Applicants elected Group II and hypertension. Claim 11 is withdrawn as being drawn to a nonelected species.
Response to Amendment
The declaration under 37 CFR 1.132 filed on 5/1/2026 is insufficient to overcome the rejection of claims 6-10 and 12-15 based upon 35 U.S.C. 103 as set forth in the last Office action because:
Applicant argues that the PI3Kg inhibitors used by Carnevale target the catalytic activity of PI3Kg, whereas the fusion peptide described by Hirsch selectively targets the kinase-independent, or scaffolding, activity of PI3Kg. Specifically, it disrupts the interaction between PI3Kg and PKA, thereby impairing PKA-mediated activation of PDEs and ultimately reducing cAMP degradation.
Applicant’s arguments are not persuasive because Carnevale et al. clearly teach that “[o]ur findings strongly indicate that PI3Kg inhibitors could be further studied as a potential tool to treat hypertension”, and Hirsch et al. teach a method for treating respiratory diseases comprising administering the instantly claimed fusion peptide, which inhibits the kinase-independent function of PI3Kg.
The mechanism by which the function of PI3Kg is inhibited is irrelevant. The references cited clearly teach that inhibitors of PI3Kg (e.g. the fusion peptide of Hirsch) should be further studied as a potential tool to treat hypertension.
Furthermore, the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham, including the exemplary rationales: (A) Combining prior art elements according to known methods to yield predictable results;
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(B) Simple substitution of one known element for another to obtain predictable results;
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(C) Use of known technique to improve similar devices (methods, or products) in the same way;
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(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
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(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
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(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
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(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention (MPEP 2143).
In the instant case, (A), (B), (E) and (G) are satisfied.
Therefore, the presently claimed invention would have been obvious to one of ordinary skill in the art at the time of the invention.
The skilled artisan would have had a reasonable expectation of success in treating hypertension with the PI3Kg inhibitor of Hirsch et al. because Carnevale et al. teach PI3Kg inhibition to treat hypertension.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
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.
This rejection is maintained.
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) the 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 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.
Response to Arguments
Applicant’s arguments filed on 5/1/2026 have been fully considered but they are not persuasive.
Applicant argues that in Teva Pharmaceuticals International GmbH v. Eli Lilly and Company, the Court held that the disclosure of a single humanized anti-CORP antagonist was sufficient to provide adequate written description because the claims were directed to the use of the antibodies not such antibodies themselves, and the antibodies themselves and methods of making them were well known in the prior art.
Applicant also argues that “[t]he peptides recited in claim 6 having at least 85% identity with SEQ ID NO: 1 and having an ability of the SEQ ID NO: 1 to inhibit a kinase-independent function of PI3Kg were well known in the art at the time of filing the subject application”.
Applicant’s arguments are not persuasive.
Teva related to antibodies against CGRP. Making antibodies is completely different than making peptides with a specific function.
Making antibodies involves immunizing animals (polyclonal) or using cell fusion techniques (monoclonal) to prompt B cells to produce antibodies against a specific antigen. Thus, any antibody recovered after purification would necessarily be an antibody against for e.g. CGRP.
This is completely different than claiming a peptide variant (i.e. having at least 85% identity) of a peptide known to have a specific function (i.e. SEQ ID NO: 1).
One of ordinary skill in the art would have to make each and every peptide encompassed by the instant claims and test it for function.
As discussed in the rejection above, even when considering only natural amino acids, one would have 276,000 possible peptides having 85 % identity with SEQ ID NO: 1. If considering also non-natural amino acids, one would end up with million possible sequences.
The amino acid sequence necessary for the claimed function is SEQ ID NO: 1, NOT each and every sequence having at least 85% identity with SEQ ID NO: 1.
This is clearly taught by Perino (cited by the Applicant in the declaration).
Perino teaches that a peptide comprising residues 126-150 of p110g (i.e. SEQ ID NO: 1) can competitively inhibition the kinase-independent function of PI3Kg by disrupting the interaction between p110g and RIIa PKA (pages 85-86 and Fig. 3).
Perino also teaches 6 peptides comprising 2 or 3 amino acid substitutions within SEQ ID NO: 1 (i.e. E145A and E146A; P142A and P143A; P132A, P142A and P143A; L137A and V138A; S144A and S147A; S131A and P132A) which retain the ability of inhibiting the kinase-independent function of PI3Kg, and further teach another peptide comprising a double mutation (i.e. K126A and R130A) which result in the loss of inhibitory activity.
This disclosure is not representative of the enormous number of peptides encompassed by the claimed peptide having at least 85% identity to SEQ ID NO: 1.
Therefore, the claimed invention lacks written description.
For the reasons stated above the rejection is maintained.
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.
This rejection is maintained.
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.
Response to Arguments
Applicant’s arguments filed on 5/1/2026 have been fully considered but they are not persuasive.
Applicant’s arguments have been addressed above under “Response to Amendments” on pages 2-4.
For the reasons stated above the rejection is maintained.
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.
This rejection is maintained.
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).
Response to Arguments
Applicant’s arguments filed on 5/1/2026 have been fully considered but they are not persuasive.
Applicant’s arguments have been addressed above under “Response to Amendments” on pages 2-4.
For the reasons stated above the rejection is maintained.
This rejection is maintained.
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).
Response to Arguments
Applicant’s arguments filed on 5/1/2026 have been fully considered but they are not persuasive.
Applicant’s arguments have been addressed above under “Response to Amendments” on pages 2-4.
For the reasons stated above the rejection is maintained.
Conclusion
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.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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