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 .
Priority
This application filed 07/24/2024 is a National Stage entry of PCT/US2023/061992 , International Filing Date: 02/03/2023, Claims Priority from Provisional Application 63306979 , filed 02/04/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/01/2024 is in compliance with the
provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the
examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3, 28 and 29 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 3, which is dependent on independent claim 2, the instant claim recites a sequence comprising SEQ ID NO: 11. The number of sequences generated ‘comprising’, far exceeds the possible sequences generated in the independent claim 2, that presents defined ‘X’ number of N/C terminal additions.
Regarding claim 28, which is dependent on independent claim 22, the instant claim recites a sequence comprising SEQ ID NO: 2. The sequence possibilities generated, as recited, far exceeds the sequence possibilities generated from the sequence in the independent claim.
Regarding claim 29, which is dependent on independent claim 22, the instant claim recites a sequence comprising SEQ ID NO: 5. The sequence possibilities generated, as recited, far exceeds the sequence possibilities generated from the sequence in the independent claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 2-5, 9-12, 14, 15, 17, 22, 26, 28, 29, 32-37 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. This is a written description rejection.
Claim 2 is directed to a method of inhibiting carcinoma cell proliferation comprising contacting an effective amount of formulation comprising oligopeptide, consisting of sequence Xp(R/D)EESGEPXq (SEQ ID NO: 10). SEQ ID NO: 10, as recited in the instant claim, includes variables ‘X’, ‘p’ and ‘q’ wherein ‘X’ is any amino acid, ‘p’ is an integer ranging from 0-10, ‘q’ is an integer ranging from 0-9. Applicant reduces to practice SEQ ID NO: 1-8 (see page 24, Table 3-1; Example 3). Applicant does not reduce to practice a method, comprising all possibilities of sequence composition and lengths, generated by the variables in SEQ ID NO: 10.
Claim 3 is directed to a method wherein the oligopeptide comprises sequence Xr(R/D)EESGEP (SEQ ID NO: 11). Examiner interprets ‘comprising’ as open-ended and inclusive of any N/C terminal additions. Applicant does not reduce to practice a method, comprising all possible combinations of N/C terminal additions.
Claims 4, 5, 28 and 29 as noted above, are directed to all possible combinations of N/C terminal additions whilst Applicant reduces to practice SEQ ID NO: 1-8 (see Example 3).
Claim 22 is directed to a method of treating prostate cancer comprising administering Xr(R/D)EESGEP (SEQ ID NO: 11) and the oligopeptide is no more than 26 residues in length. As noted above, Applicant reduces to practice SEQ ID NO: 1-8 (see page 24, Table 3-1; Example 3). Applicant does not reduce to practice a method, comprising all possibilities of the sequences generated by the variables in SEQ ID NO: 11 (i.e. no more than 26 residues in length).
The written description requirement for “a peptide” may be satisfied through sufficient
description of a representative number of species of peptide, by actual reduction to practice, reduction
to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that the Applicant
was in possession of the claimed genus of peptides. A “representative number of species” means that
the species that are adequately described are representative of the entire genus. See MPEP 2163. The peptide SEQ ID NO: 1 to SEQ ID NO: 8 described in the specification, is not representative of the full
variation of peptides comprising different sequence lengths, sequence composition, or of alternate residues located in the variable positions. A skilled artisan is unable to predict the peptides that would
collectively present a core structure sufficient for the method of treatment and method of inhibiting cell proliferation, as claimed. Thus, the specification fails to satisfy the written description requirement of 35
USC 112 (a) with respect to claims 2-5, 9-12, 14, 15, 17, 22, 26, 28, 29, 32-37.
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3-5, 9-12, 14-15, 17, 28-29, 32-37 are rejected under 35 U.S.C. 103 as being unpatentable over James M. Olson et al., hereinafter Olsen (James M. Olsen et al., US11548923B2, EFD: Jan 18, 2017) in view of Neal D Shore et al., hereinafter Shore (Neal D Shore et al., Lancet Oncol 2016; 17: 153–63), evidenced by Jordan E. Vellky et al., hereinafter Vellky (Jordan E. Vellky et al., Neoplasia, Vol.22, No.11, 2020).
Regarding claim 3, Examiner interprets ‘comprises the amino acid sequence’ as inclusive or open-ended (MPEP§ 2111.03 (I)), therefore, SEQ ID NO: 11 as recited, is with any N/C terminal additions. Here, Olsen teaches pharmaceutical compositions and uses of peptides, to treat cancer, tumor or uncontrolled cell growth (i.e. inhibiting proliferation) (see Abstract). In Example 14 and 15, Olsen teaches administration of peptides to the subject as a therapeutic for cancer (see Col 94, line 4). In Example 8, Olsen teaches SEQ ID NO: 1 and site saturation mutagenesis, generating a total of 612 variants of SEQ ID NO: 1, wherein all possible single amino acid substitutions of SEQ ID NO: 1 is cloned, except for the cysteine residues. SEQ ID NO: 1 in Olsen is shown below (see Col 109). The boxed region in SEQ ID NO: 1 corresponds to SEQ ID NO: 11 in instant, which can achieve 100 % sequence identity with site saturation mutagenesis.
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Olsen does not teach non-steroidal antiandrogen.
Shore teaches a comparative study, TERRAIN, comparing efficacies of enzalutamide with bicalutamide (i.e. nonsteroidal antiandrogen) in patients with metastatic castration-resistant prostate cancer (see Summary).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teaching in Olsen, by adding a non-steroidal antiandrogen as disclosed in Shore. Olsen suggests that treatment regimen comprises one or more peptides along with a standard small molecule or chemotherapy (see Col 101, lines 4-6) and Shore specifically teaches that Bicalutamine is approved for clinical use in men with hormone-treatment-naïve prostate cancer, and often used in clinical practice (see page 154, 2nd paragraph).
One motivated to do so would have a reasonable expectation of success as administration of anti-androgen therapy is established in clinical practice and the peptide generated in Olsen is suggested for use as a therapeutic in cancer (see Col 94, line 4). Thus, one would have recognized that applying the teaching of Olsen to the method of Shore, would have yielded predictable results and improved the formulation comprising oligopeptide (See MPEP § 2143 l(A)(D)).
Regarding claims 4 and 5, the obviousness rationale has been noted above in the rejection under claim 3.
Regarding claims 9, 10, 11, Shore teaches bicalutamine and enzalutamide (see Summary, page 153).
Regarding claim 12, Shore teaches patients with histologically confirmed adenocarcinoma (see study design and participants, line 6, page 155).
Regarding claims 14 and 15, Shore teaches patients with metastatic castration-resistant prostate cancer; identified by patients with AR signaling (AR positive) and AR low/negative cases as evidenced by Vellky (see Abstract).
Regarding claim 17, Olsen teaches in Example 19, that peptides are administered to a subject in need thereof, wherein the subject is human or animal (i.e. in vivo).
Regarding claim 28, the obviousness rationale has been set forth in the rejection under claim 3.
Regarding claim 29, the obviousness rationale has been set forth in the rejection under claim 3.
Regarding claim 32, 33 and 34, Shore teaches bicalutamine and enzalutamide (see Summary, page 153).
Regarding claim 35, Shore teaches that patients are stratified by whether bilateral orchiectomy or receipt of luteinizing hormone-releasing hormone agonist or antagonist therapy (see Methods, line 5-7) (i.e. GnRH).
Regarding claim 36-37, the obviousness rationale has been set forth in the rejection under claims 14 and 15.
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 2-5, 9-12, 14-15, 17, 22, 26, 28-29, 32-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 22 of copending Application No. 18/832,869 (reference application) in view of Neal D Shore et al., hereinafter Shore (Neal D Shore et al., Lancet Oncol 2016; 17: 153–63), evidenced by Jordan E. Vellky et al., hereinafter Vellky (Jordan E. Vellky et al., Neoplasia, Vol.22, No.11, 2020).
Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The teachings of Olsen and Shore have been set forth above.
Regarding claim 2, reference application ‘869 teaches SEQ ID NO: 10 in the instant claim and a method of treating (see claims 1 and 22).
Reference application does not teach nonsteroidal antiandrogen.
Shore teaches enzalutamide with bicalutamide (i.e. nonsteroidal antiandrogen) in patients with metastatic castration-resistant prostate cancer (see Summary).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teaching in the reference application ‘869 by adding a non-steroidal antiandrogen as disclosed in Shore. Shore specifically teaches that Bicalutamine is approved for clinical use in men with hormone-treatment-naïve prostate cancer and is often used in clinical practice (see page 154, 2nd paragraph).
One motivated to do so would have a reasonable expectation of success as administration of anti-androgen therapy is established in clinical practice and the peptide generated in the reference application ‘869 is used for the treatment of disease (see claim 22). Thus, one would have recognized that applying the teaching of the reference application ‘869 to the method of Shore, would have yielded predictable results and improved the formulation comprising oligopeptide (See MPEP § 2143 l(A)(D)).
Regarding claims 3, 4, 5, 9, 10, 11, 12, 14, 15, 17, see claim 1 and 22 in the reference application ‘869.
Regarding claim 22, reference application ‘869 teaches SEQ ID NO: 11 in the instant claim and a method of treating or preventing a disease or condition in a mammalian subject in need thereof. See claims 1 and 22.
Reference application does not teach antiandrogen.
Shore teaches treating prostate cancer with antiandrogen (see Summary).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teaching in the reference application ‘869 by adding a non-steroidal antiandrogen as disclosed in Shore. One motivated to do so would have a reasonable expectation of success as administration of anti-androgen therapy is established in clinical practice and the peptide generated in the reference application ‘869 is used for the treatment of disease (see claim 22). Thus, one would have recognized that applying the teaching of the reference application ‘869 to the method of Shore, would have yielded predictable results and improved the formulation comprising oligopeptide (See MPEP § 2143 l(A)(D)).
Regarding claim 26, Shore teaches improvements in objective tumor response and radiographic progression-free survival (see page 154, Added value of this study).
Regarding claims 28, 29, 32-37, the obviousness rationale has been set forth above.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARCHANA VARADARAJ/ Examiner, Art Unit 1658
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
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