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 .
Election/Restrictions
In response to the restriction requirement dated 26th June, 2026, Applicant elects, without traverse Group I, directed towards a method of treating kidney disease or disorder in a subject. In response to the species requirement, Applicant elects without traverse, (A) Ac-aaEGKASFTTFTVTKGSaa-NH2 (SEQ ID NO: 8); (B) L- and D-amino acid stereoisomers; (C) a peptide not comprising an internalization sequence, which reads on the elected species Ac-aaEGKASFTTFTVTKGSaa-NH2 (SEQ ID NO: 8) identified in (A) above; however, if an election is still required, Applicant provisionally elects a peptide comprising an N-terminal internalization sequence; and (D) Alport Syndrome.
Applicant's election in the reply filed on 26th August 2026 is acknowledged.
Claims 1, 2, 6, 7, 8, 11, 13, 18, 24, 28, 31, 32, 34, 35, 36, 37, 38, 39, 40 are hereby examined on the merits. Claims 14, 21, 22 and 41 are withdrawn from further consideration pursuant to 37 CFR l.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Priority
This application filed 04/18/2024 is a National Stage entry of PCT/US2022/078482, International Filing Date: 10/21/2022 PCT/US2022/078482 Claims Priority from Provisional Application 63270852, filed 10/22/2021.
Information Disclosure Statement
The information disclosure statements (IDS)s submitted on 08/26/2026, 04/13/2026, 07/18/2025, 02/14/2025, 08/02/2024, comply 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 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 1, 2, 6, 7, 8, 11, 13, 18, 24, 28, 31, 32, 34, 35, 36, 37, 38, 39, 40 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 1 (b) and (c) are directed to a method of treating or preventing kidney disease comprising administering any one of the amino acid sequences comprising SEQ ID NOs: 2-111 with one or more amino acid substitutions, insertions, deletions or chemical modifications as recited in (c) or comprising SEQ ID NO: 2-111 as recited in (b). Examiner interprets ‘comprising’ as open-ended with any N/C terminal addition, and therefore of varying lengths and amino acid composition.
Claim 6 is directed to the method wherein the modified Cav-1 peptide comprises at least one non-standard amino acid. Examiner interprets at least one non-standard amino acid to comprise one or more than one non-standard amino acid as disclosed in the specification [0118].
The specification reduces to practice, experiments to teach SEQ ID NO: 8 (Api2355) ([0279]. Applicant does not reduce to practice a method of treating or prevention, as claimed, with a representative peptide structure that would encompass one or more substitutions, insertions, deletions, N/C terminal extensions or comprising one or more non-standard amino acids. 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: 8, described in the specification is not representative of the full variation of peptides with the recited amino acid variations or incorporating all possibilities of non-standard amino acids. A skilled artisan is unable to predict the peptides that would collectively present a core structure sufficient for the method of treatment or prevention. Thus, the specification fails to satisfy the written description requirement of 35 USC 112 (a) with respect to claims 1 and 6. A claim directed to peptide of SEQ ID NO: 8 would be fully supported by the disclosure.
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 1, 2, 6, 7, 8, 11, 13, 18, 24, 28, 31, 32, 34, 35, 36, 37, 38, 39, 40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating, comprising administering sequence consisting of SEQ ID NO: 8, does not reasonably provide enablement for preventing. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. This is a scope of enablement rejection.
Claim 1 is directed to a method of treating or preventing kidney disease comprising any one of amino acid sequences of SEQ ID NO 2-111 with one or more amino acid substitutions, insertions, deletions or chemical modifications.
Claim 34 is directed to kidney disease -consisting of chronic kidney disease, end-stage renal disease, glomerulonephritis, focal segmental glomerulosclerosis, kidney fibrosis, polycystic kidney disease, IgA nephropathy, lupus nephritis, nephrotic syndrome, Alport syndrome, amyloidosis, Goodpasture syndrome, granulomatosis with polyangiitis, or acute kidney injury.
Embodiments of the specification disclose ‘treating’ as obtaining beneficial or desired clinical results, not limited to reduction or alleviation of symptoms [0092]. ‘Preventing’, as disclosed, prevent the development of disease, are prophylactic or preventive measures, and may in certain contexts refer to reducing the risk of developing the condition and associated symptoms [0093]. The instant specification is enabling for treating Alport syndrome by administering SEQ ID NO: 8 (Api2355) (see [0279] to [0298]). The specification is not enabling for the treatment of the genus of kidney disease as recited in claim 1 or the disease list as claimed in claim 34. As noted, SEQ ID NOs 2-111 range in lengths from 7 amino acids to 19 amino acids. The specification is not enabling for treatment, by administering SEQ ID NOs: 2-7, SEQ ID NOs: 9-111 or one or more amino acid substitutions, insertions, deletions of SEQ ID NO: 8, with the outcome of obtaining beneficial or desired clinical results. The specification is not enabling for prevention of disease.
As stated in § MPEP 2164.01(a), “there are many factors to consider when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any experimentation is ‘undue’. These factors include, but are not limited to:
1. The breadth of the claims;
2. The nature of the invention;
3. The state of the prior art;
4. The level of skill in the art;
5. The level of predictability in the art;
6. The amount of direction provided by the inventor;
7. The presence or absence of working examples;
8. The quantity of experimentation needed to make or use the invention based on the
disclosure.
See in re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The eight Wands
factors are applied to claims 1, 2, 6-8, 11, 13, 18, 24, 28, 31, 32, 34-40 as follows:
The breadth of the claims and the nature of the invention
Claims 1, 2, 6, 7, 8, 11, 13, 18, 24, 28, 31, 32, 34, 35, 36, 37, 38, 39, 40 are directed to a method of treating or preventing kidney disease, comprising administering to the subject a therapeutically effective amount of peptide. In Figs 1-11, for example, the specification discloses a method of treatment, comprising administering the peptide of SEQ ID NO: 8, and reduction in glomerular fibrosis and collagen deposition in a Col4a3-/- mouse model of Alport syndrome [0298]. The specification does not provide evidence of a method of treatment, of the genus of kidney disease, comprising administering peptides of SEQ ID NO: 2-7 and SEQ ID NO: 9-111 or variations in the sequences as recited in claim 1 (b) and (c). The specification is not enabling for prevention of kidney disease. Therefore, the claims are unduly broad with respect to treating or preventing kidney disease.
The State of the Prior Art
It is noted that there is no prior art that teaches a method of preventing kidney disease, wherein the disease consists of chronic kidney disease, end-stage renal disease, glomerulonephritis, focal segmental glomerulosclerosis, kidney fibrosis, polycystic kidney disease, IgA nephropathy, lupus nephritis, nephrotic syndrome, Alport syndrome, amyloidosis, Goodpasture syndrome, granulomatosis with polyangiitis, or acute kidney injury. There is no prior art for a method of treatment, with all the recited variations of the peptide sequences as recited in the claims.
The Level of Skill in the Art
Practitioners in this art (physicians) would presumably be highly skilled in the art for providing a method of prevention or treatment for the disorders as claimed.
The Level of Predictability in the Art
It is noted that the therapeutic art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. The amount of guidance or direction needed to enable
the invention is inversely related to the amount of knowledge in the state of the art as well as the
predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). This is because, it
is not obvious from the disclosure, of a specific method of preventing a kidney disease, or treating the genus of kidney diseases as claimed. In the instant case, the specification discloses clinical benefit with SEQ ID NO: 8 in the treatment of Alport syndrome (Fig 1-11). The specification does not demonstrate preventing or treating generally, by administering all the recited peptides. Without any experimentation demonstrating the claimed method, the level of unpredictability in achieving clinical benefit, remains high. Therefore, it is unpredictable that all the peptides (except SEQ ID NO: 8 in Alport syndrome) will function in the treatment method as claimed.
The amount of Direction Provided by the Inventor and The Presence or Absence of
Working Examples
The instant specification does not provide adequate guidance with regard to preventing kidney disease in a subject or treatment with the desired result of clinical benefit with peptides of SEQ ID NO: 2-7 and SEQ ID NO: 9-111 (including insertions, deletions, substitutions, etc.) as claimed. Applicant’s limited disclosure is noted but is not sufficient to justify claiming the method broadly. Absent a reasonable a priori expectation of success for preventing, or treating, one skilled in the art would have to extensively test the peptide composition, determine an effective dose on a subject, ascertain prevention and treatment of kidney disease, etc. Since each prospective embodiment, and indeed future embodiments as the art progresses, would have to be empirically tested, and those which initially failed tested further, an undue amount of experimentation would be required to practice the invention as it is claimed in its current scope, because the specification provides inadequate guidance to do otherwise. The amount of direction or guidance presented in the specification is very limited. As discussed in “[t]he Level of Predictability in the Art” section supra, the specification teaches working examples of treatment of Alport syndrome with peptide of SEQ ID NO: 8.
There is no prior art that teaches prevention or treatment of all kidney disease using all the claimed peptide compositions, in a subject. Also, as noted in the “Breadth of the Claims and Nature of Invention” section, the specification does not provide evidence that a subject is administered a therapeutically effective amount for prevention or treatment. As such, the examples used in the specification are not indicative broadly of the method, with the desired result of prophylaxis or treatment of kidney disease. It is further noted that Applicant provides no data, examples, figures, etc. demonstrating a subject or an effective amount of peptide for prevention or treatment of the kidney diseases recited in claim 34. In the absence of such information, a person of ordinary skill in the art would reasonably require undue quantity of experimentation.
Conclusion of Enablement Analysis 35 USC § 112(a)
MPEP § 2164.01(a), 4th paragraph states that “A conclusion of lack of enablement means that,
based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the
claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d
1510,1513 (Fed. Cir. 1993).
After applying the Wands factors and analysis to claims 1, 2, 6, 7, 8, 11, 13, 18, 24, 28, 31, 32, 34, 35, 36, 37, 38, 39, 40 in view of the Applicant’s entire disclosure, it is concluded that the practice of the invention as claimed, would not be enabled by the written disclosure for treatment or prevention of a disorder. Therefore claims 1, 2, 6, 7, 8, 11, 13, 18, 24, 28, 31, 32, 34, 35, 36, 37, 38, 39, 40 are rejected under 35 U.S.C. §112(a) for failing to disclose sufficient information to enable a person of skill in the art to treat or prevent kidney disease in a subject as claimed.
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) 1, 2, 6, 7, 8, 11, 13, 18, 24, 28, 31, 32, 34, 35, 36, 37, 38, 39, 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dale Christensen et al., hereinafter Christensen (Dale Christensen et al., WO2020055812A1; EFD 2019-09-10).
Regarding claim 1, Christensen teaches Ac-aaEGKASFTTFTVTKGSaa-NH2 (SEQ ID NO: 8), i.e., SEQ ID NO: 8 in Christensen ([0009] line 7). Examiner notes that Applicant elected species SEQ ID NO: 8. Christensen teaches administering the peptide composition in a method of treating fibrotic or inflammatory disease, for example kidney fibrosis [0015] (i.e. kidney disease).
Regarding claim 2, Christensen teaches both the L or D optical isomers ([0029] line 5) (i.e. (a)(b) or (c)).
Regarding claim 6, Christensen teaches non-standard amino acid (see [0046] line 17).
Regarding claim 7, Christensen teaches Ornithine (see [0046] line 17).
Regarding claim 8, Christensen teaches that the peptide composition comprises N- or C-terminal modifications [0008] (i.e. (a) and (b)) and in some aspects teaches an N- and C-terminal modification (i.e., (c)).
Regarding claim 11, Christensen teaches N-terminal modification is acylation or C-terminal modification is amidation ([0008], lines 28-29).
Regarding claim 13, Christensen teaches SEQ ID NO: 3, which comprises the amino acid sequence of FTTFTVT (ASFTTFTVT; SEQ ID NO: 3 in Christensen).
Regarding claim 18, as noted in the rejection under claim 1, Christensen teaches SEQ ID NO: 8.
Regarding claim 24, Christensen teaches either the N-terminal or the C-terminal capping function of the peptide [0059].
Regarding claim 28, Christensen teaches a peptide multimer comprising at least two peptides [0011].
Regarding claim 31, Christensen teaches intramuscular, subcutaneous, intraperitoneal, intravenous and oral administration [0013].
Regarding claim 32, Christensen teaches subcutaneous [0013].
Regarding claim 34, Christensen teaches kidney fibrosis [0015].
Regarding claim 37, Christensen teaches additional therapeutic agent [0098].
Regarding claim 40, Christensen teaches carrier [0098] [00102].
Claim(s) 1, 2, 6, 7, 8, 11, 13, 18, 24, 28, 31, 32, 34, 35, 36, 37, 38, 39, 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dale Christensen et al., hereinafter Christensen (Dale Christensen et al., WO2020055812A1; EFD 2019-09-10) in view of Oliver Gross et al., hereinafter Gross (Oliver Gross et al., Kidney International (2009) 76, 599–603) further in view of Michelle N. Rheault, hereinafter Rheault (Michelle N. Rheault, Kidney International (2020) 98, 1400–1402).
The teachings in Christensen has been set forth above.
Regarding claim 35, Christensen does not teach Alport syndrome.
Gross teaches that in Alport syndrome (AS), angiotensin inhibition suppresses collagen production and tubulointerstitial fibrogenesis and inflammation (Abstract). Gross specifically teaches in Figure 2, a synopsis of 8 possible therapeutic targets in AS, one of them being antifibrotic (page 601).
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 method of treatment of kidney fibrosis using SEQ ID NO: 8 [0015], as suggested in Christensen, and administer the peptide composition of SEQ ID NO: 8, to treat Alport syndrome, wherein one of the eight possible therapeutic targets is an antifibrotic as specifically suggested in Gross. One motivated to do so would have a reasonable expectation of success as Christensen teaches the peptide composition of SEQ ID NO: 8 which is 100 % identical to the instantly claimed sequence, and the method of treatment for kidney fibrosis. Thus, one would have recognized that applying the teaching of Christensen to the method of Gross, would have yielded predictable results as Gross discloses that animal studies of Alport kidney disease suggest that the suppression of cytokine and collagen production by podocytes and the antifibrotic and anti-inflammatory effects in the tubulointerstitial compartment may be more important than the antiproteinuric and antihypertensive effects for therapy (see page 600, Pharmacological Therapy-Angiotensin Antagonism, last paragraph) (See MPEP § 2143 l(A)(D)).
Regarding claim 36, Christensen teaches kidney fibrosis [0015].
Regarding claim 38, the obviousness rationale has been set forth above in the rejection under claim 35. Additionally, Gross teaches ACE inhibitors (see page 600, Pharmacological Therapy-Angiotensin Antagonism, last paragraph)
Regarding claim 39, Christensen and Gross do not teach dialysis.
Rheault teaches that before the early 2000s, making a firm diagnosis of Alport syndrome by biopsy or genetic testing was not a priority for nephrologists because no treatments were available to slow or halt the onset of end-stage kidney disease (ESKD) (see 1st paragraph). Specifically, Rheault teaches that patients with ESKD in Alport syndrome go through the grueling process of dialysis or kidney transplantation (see page 1401, 3rd paragraph).
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 method of treatment of kidney fibrosis and Alport syndrome, as suggested in Christensen and Gross, and perform dialysis on patients with ESKD. One motivated to do so would have a reasonable expectation of success as Rheault discloses that ESKD patients with Alport syndrome go through the grueling process of dialysis. Thus, one would have recognized that applying the teaching of Christensen and Gross, to the method of Rheault, would have yielded predictable results and addressed the therapeutic need of the patient (See MPEP § 2143 l(A)(D)).
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.
1. Claims 1, 2, 6, 7, 8, 11, 13, 18, 24, 28, 31, 32, 34, 35, 36, 37, 38, 39, 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 82, 83, 86, 92, 94, 95, 96, 98, 99, 102, 104, 106, 108, 110, 111, 128, 130, 131, 145 of copending Application No. 18/547,931(reference application) in view of Dale Christensen et al., hereinafter Christensen (Dale Christensen et al., WO2020055812A1; EFD 2019-09-10) in view of Oliver Gross et al., hereinafter Gross (Oliver Gross et al., Kidney International (2009) 76, 599–603) further in view of Michelle N. Rheault, hereinafter Rheault (Michelle N. Rheault, Kidney International (2020) 98, 1400–1402).
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 Christensen, Gross and Rheault have been set forth above. Additionally,
regarding claim 1, reference application ‘931 teaches a method of treatment of a subject suffering from fibrosis, comprising treating with a caveolin peptide. Embodiments of the specification in the reference application ‘931 disclose caveolin peptide of SEQ ID NO: 4 [0014] which is 100 % identical to the instantly claimed SEQ ID NO: 8.
Regarding claim 2, reference application ‘931 does not teach L or D isomers.
Christensen teaches both the L or D optical isomers ([0029] line 5) (i.e. (a)(b) or (c)).
Regarding claim 6, reference application ‘931 does not teach non-standard amino acid. Christensen teaches non-standard amino acid (see [0046] line 17).
Regarding claim 7, Christensen teaches Ornithine (see [0046] line 17).
Regarding claim 8, Christensen teaches that the peptide composition comprises N- or C-terminal modifications [0008] (i.e. (a) and (b)) and in some aspects teaches an N- and C-terminal modification (i.e., (c)).
Regarding claim 11, reference application ‘931 teaches N and C terminal modification. See SEQ ID NO: 4. Additionally, Christensen teaches N-terminal modification is acylation or C-terminal modification is amidation ([0008], lines 28-29).
Regarding claim 13, reference application ‘931 teaches SEQ ID NO: 3 [0014]. See claim 92.
Regarding claim 18, as noted in the rejection under claim 1, reference application ‘931 teaches SEQ ID NO: 8.
Regarding claim 24, Christensen teaches either the N-terminal or the C-terminal capping function of the peptide [0059].
Regarding claim 28, reference application ‘931 does not teach multimers. Christensen teaches a peptide multimer comprising at least two peptides [0011].
Regarding claim 31, reference application ‘931 teaches intramuscular, subcutaneous, intraperitoneal, intravenous and oral administration [0047]. See claim 1 (b) and claim 130.
Regarding claim 32, reference application ‘931 teaches subcutaneous [0047]. See claim 1 (b) and claim 130.
Regarding claim 34, reference application ‘931 teaches kidney fibrosis. See claim 95.
Regarding claim 35, reference application ‘931 teaches Alport syndrome. See claim 95.
Regarding claim 36, reference application ‘931 teaches kidney fibrosis. See claim 95.
Regarding claim 37, reference application ‘931 does not teach an additional therapeutic agent. Christensen teaches additional therapeutic agent [0098].
Regarding claim 38, reference application ‘931 does not teach ACE inhibitors. Gross teaches ACE inhibitors (see page 600, Pharmacological Therapy-Angiotensin Antagonism, last paragraph). One motivated to do so would have a reasonable expectation of success as reference application ‘931 teaches the peptide composition of SEQ ID NO: 4 which is 100 % identical to the instantly claimed sequence of SEQ ID NO: 8, and the method of treatment for kidney fibrosis. Thus, one would have recognized that applying the teaching of the reference application ‘931 to the method of Gross, would have yielded predictable results as Gross discloses that animal studies of Alport kidney disease suggest that angiotensin inhibition (i.e. ACEI)-led suppression of cytokine and collagen production by podocytes and the antifibrotic and anti-inflammatory effects in the tubulointerstitial compartment may be more important than the antiproteinuric and antihypertensive effects for therapy (see page 600, Pharmacological Therapy-Angiotensin Antagonism, last paragraph). Thus, one would have recognized that applying the teaching of Gross, i.e. treating with ACEI, to the method of the reference application ‘931, would have yielded predictable results for treating kidney fibrosis (See MPEP § 2143 l(A)(D)).
Regarding claim 39, reference application ‘931 does not teach dialysis.
Rheault teaches that before the early 2000s, making a firm diagnosis of Alport syndrome by biopsy or genetic testing was not a priority for nephrologists because no treatments were available to slow or halt the onset of end-stage kidney disease (ESKD) (see 1st paragraph). Specifically, Rheault teaches that patients with ESKD in Alport syndrome go through the grueling process of dialysis or kidney transplantation (see page 1401, 3rd paragraph).
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 method of treatment of Alport syndrome, as suggested in the reference application ‘931, and perform dialysis on patients with ESKD. One motivated to do so would have a reasonable expectation of success as Rheault discloses that ESKD patients with Alport syndrome go through the grueling process of dialysis. Thus, one would have recognized that applying the teaching of the reference application ‘931, to the method of Rheault, would have yielded predictable results and addressed the therapeutic need of the patient (See MPEP § 2143 l(A)(D)).
Regarding claim 40, reference application ‘931 does not teach carrier. Christensen teaches carrier [0098] [00102].
2. Claims 1, 2, 6, 7, 8, 11, 13, 18, 24, 28, 31, 32, 34, 35, 36, 37, 38, 39, 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 7, 11, 14, 17, 19, 20, 21, 25, 28, 31, 38, 39, 40, 42, 53 of copending Application No. 18/571,114 (reference application) in view of Dale Christensen et al., hereinafter Christensen (Dale Christensen et al., WO2020055812A1; EFD 2019-09-10) in view of Oliver Gross et al., hereinafter Gross (Oliver Gross et al., Kidney International (2009) 76, 599–603) further in view of Michelle N. Rheault, hereinafter Rheault (Michelle N. Rheault, Kidney International (2020) 98, 1400–1402).
Regarding claims 1, 2, 5, 7, 11, 14, 17, 19, 20, 21, 25, 28, 31, 38, 39, 40, 42, 53, reference application ‘114 teaches SEQ ID NO: 8.
Reference application ‘114 does not teach kidney disease. Christensen teaches the instant elected peptide SEQ ID NO: 8, that is 100 % identical to the peptide in the reference application ‘114, in a method of treatment of kidney fibrosis (see SEQ ID NO: 8 in reference application ‘114). 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 method of treatment of the reference application ‘114, in the treatment method as suggested in Christensen. Accordingly, claims 2, 5, 7, 11, 14, 17, 19, 20, 21, 25, 28, 31, 38, 39, 40, 42, 53 are rendered obvious in view of the teachings of Christensen, Gross and Rheault.
3. Claims 1, 2, 6, 7, 8, 11, 13, 18, 24, 28, 31, 32, 34, 35, 36, 37, 38, 39, 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 7, 9, 14, 18, 20, 21, 24, 26, 30, 33, 34, 36, 43, 44, 58, 59, 61, 62 of copending Application No. 18/002,420 (reference application) in view of Dale Christensen et al., hereinafter Christensen (Dale Christensen et al., WO2020055812A1; EFD 2019-09-10) in view of Oliver Gross et al., hereinafter Gross (Oliver Gross et al., Kidney International (2009) 76, 599–603) further in view of Michelle N. Rheault, hereinafter Rheault (Michelle N. Rheault, Kidney International (2020) 98, 1400–1402).
Regarding claims 1, 2, 6, 7, 8, 11, 13, 18, 24, 28, 31, 32, 34, 35, 36, 37, 38, 39, 40 reference application ‘420 teaches instant SEQ ID NO: 8. 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 method of treatment of the reference application ‘420, in the treatment method as suggested in Christensen. Accordingly, claims 2, 5, 7, 11, 14, 17, 19, 20, 21, 25, 28, 31, 38, 39, 40, 42, 53 are rendered obvious in view of the teachings of Christensen, Gross and Rheault.
4. Claims 1, 2, 6, 7, 8, 11, 13, 18, 24, 28, 31, 32, 34, 35, 36, 37, 38, 39, 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 19, 20, 21, 26, 27, 29, 31, 33, 34, 36, 37, 40, 43, 44, 45, 48 of copending Application No. 18/993,188 (reference application) in view of Dale Christensen et al., hereinafter Christensen (Dale Christensen et al., WO2020055812A1; EFD 2019-09-10) in view of Oliver Gross et al., hereinafter Gross (Oliver Gross et al., Kidney International (2009) 76, 599–603) further in view of Michelle N. Rheault, hereinafter Rheault (Michelle N. Rheault, Kidney International (2020) 98, 1400–1402).
Regarding claims 1, 2, 6, 7, 8, 11, 13, 18, 24, 28, 31, 32, 34, 35, 36, 37, 38, 39, 40 reference application ‘188 teaches instant SEQ ID NO: 8. The instant claims are rendered obvious in view of the teachings of Christensen, Gross and Rheault.
5. Claims 1, 2, 6, 7, 8, 11, 13, 18, 24, 28, 31, 32, 34, 35, 36, 37, 38, 39, 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-84 of copending Application No. 19/488,474 (reference application) in view of Dale Christensen et al., hereinafter Christensen (Dale Christensen et al., WO2020055812A1; EFD 2019-09-10) in view of Oliver Gross et al., hereinafter Gross (Oliver Gross et al., Kidney International (2009) 76, 599–603) further in view of Michelle N. Rheault, hereinafter Rheault (Michelle N. Rheault, Kidney International (2020) 98, 1400–1402).
Conclusion
No claim is allowed.
Correspondence
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/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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