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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 25, 2025 has been entered.
Claims 3, 11 and 14-16 have been cancelled.
Claims 1-2 and 4-9 are pending in this application and are examined on the merits in this office action.
Withdrawn Rejection
Rejection of claims 1-9 under 35 U.S.C. 101, is hereby withdrawn in view of Applicant’s amendment to the claims.
Rejections of claims 1-9 and 11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are hereby withdrawn in view of Applicant’s amendment to the claims. However, a new rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is set forth below.
Rejection of claim 11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is hereby withdrawn in view of Applicant’s cancellation of the claim.
Rejection of claims 1-9 and 11 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is hereby withdrawn in view of Applicant’s amendment to the claims.
Rejection of claims 1-9 under 35 U.S.C. 103 as being unpatentable over Russo et al (US 2012/0294802, cited in the previous office action) as evidenced by SigmaAldrich (https://www.sigmaaldrich.com/US/en/Product/mm/05232404, pp. 1-7, enclosed in the previous office action) in view of Liik et al (US 2008/0306001, cited in the previous office action), is hereby withdrawn in view of Applicant’s amendment to the claims.
Maintained Objection
10. The abstract is objected to for the following minor informality:
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
In the instant case, the abstract recites, “Vasodilators for treating retinal ischemic disorder in a mammal...” at line 1 of the abstract. The first line of the abstract appears to be an incomplete sentence. Applicant should correct this informality. See MPEP 608.01(b). For example, line 1 of the abstract is advised to be amended to recite, “Vasodilators for treating…are described.”
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Response to Applicant’s Arguments
11. Applicant argues that “…the Abstract of the Disclosure is rewritten to correct the noted informalities…”
12. Applicant’s arguments have been fully considered but are not found persuasive. The amended abstract still has informalities, e.g., an incomplete sentence. Applicant is required to correct this error.
New Objection
13. Claim 1 is objected to for the following: Claim 1 recites, “…a carrier selecting from the group consisting of…” Applicant is advised to amend claim 1 to recite, “…a carrier selected from the group consisting of…”
New Rejections
U.S.C. 112(b)
14. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
15. Claims 4 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
16. Claim 4 recites the limitation "has at least 25% amino acid sequence identity with a sequence selected from the group consisting of SEQ ID NO: 1-8" in the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 4 depends from claim 1. Claim 1 recites, “…the vasodilator comprises a peptide motif of SEQ ID NO: 9 (XCXTATCXT)…wherein position 1 of SEQ ID NO: 9 is Ala (A)…wherein positions 1, 3 and 8 of SEQ ID NO: 9 are not Ala (A), Asp (D), and Val (V), respectively, at the same time.” Instant SEQ ID NOs: 1-8 are fully defined peptide sequences with varying residues. For example, SEQ ID NO: 1 is a 128 residue protein. A sequence having at least 25% sequence identity to SEQ ID NO: 1 would imply that 96 of the 128 residues may be different from SEQ ID NO: 1. Because the sequences are fully defined and a peptide having at least 25% sequence identity of SEQ ID NO: 1, for example, would be different and would not necessarily have the sequence of SEQ ID NO: 9, there is lack of antecedent basis.
17. Claim 9 recites, “…has at least 75% amino acid sequence similarity with SEQ ID NO: 2.” Claim 9 depends from claim 1. Claim 1 recites, “…the vasodilator comprises a peptide motif of SEQ ID NO: 9 (XCXTATCXT)…wherein position 1 of SEQ ID NO: 9 is Ala (A)…wherein positions 1, 3 and 8 of SEQ ID NO: 9 are not Ala (A), Asp (D), and Val (V), respectively, at the same time.” Instant SEQ ID NO: 2 is a fully defined peptide sequence. Instant SEQ ID NO: 2 is a 37 residue peptide. A sequence having at least 75% sequence similarity with SEQ ID NO: 2 would imply that 9 of the 37 residues may be different from SEQ ID NO: 2. Because the sequence is fully defined and a peptide having at least 75% sequence identity of SEQ ID NO: 2, for example, would be different and would not necessarily have the sequence of SEQ ID NO: 9, there is lack of antecedent basis.
18. Claim 9 recites, “…has at least 75% amino acid sequence similarity with SEQ ID NO: 2.” Claim 9 depends from claim 1. Claim 1 recites, “…the vasodilator comprises a peptide motif of SEQ ID NO: 9 (XCXTATCXT)…wherein position 1 of SEQ ID NO: 9 is Ala (A)…wherein positions 1, 3 and 8 of SEQ ID NO: 9 are not Ala (A), Asp (D), and Val (V), respectively, at the same time.” Instant SEQ ID NO: 2 is a fully defined peptide sequence. Instant SEQ ID NO: 2 is a 37 residue peptide. A sequence having at least 75% sequence similarity to SEQ ID NO: 2 is different from a sequence of at least 75% sequence identity with SEQ ID NO: 2. Because the sequence is fully defined and a peptide having at least 75% sequence similarity with SEQ ID NO: 2, for example, would be different and would not necessarily have the sequence of SEQ ID NO: 9, there is lack of antecedent basis.
19. Claim 9 recites, “…has at least 75% amino acid sequence similarity with SEQ ID NO: 2.” It is unclear what is encompassed within a “vasodilator has at least 75% amino acid sequence similarity with SEQ ID NO: 2.” As evidenced by Kanduc reference (Journal of Peptide Science, 2012, 18: 487-494), “similarity is a quantitative property…a pairwise sequence alignment reveals whether corresponding aa positions in two sequences are identical, similar, or different and quantifies the results in terms of number of identical, different, or similar residues. There are two ways to measure sequence similarity: (1) percent identity and (2) percent similarity” (see p. 488, bottom of left column). Kanduc reference teaches that “precent similarity measures the identities and, in addition, includes sequence gaps and aa similarity in the evaluation. For example, residues with similar biochemical properties (e.g., hydrophobicity and polarity) or similar steric conformation (e.g., side chain volume) are given positive score. From this, it follows the definition of identity: only a percent identity equal to 100 defines identity, whereas a percent similarity equal to 100 defines a maximal resemblance but not the identity of two sequences” (see p. 488, right column). The % similarity does not equal to % identity. Therefore, the metes and bounds of the claim is unclear.
U.S.C. 112(d)
20. 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.
21. Claims 4 and 9 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. 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.
22. Claim 4 recites the limitation "has at least 25% amino acid sequence identity with a sequence selected from the group consisting of SEQ ID NO: 1-8" in the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 4 depends from claim 1. Claim 1 recites, “…the vasodilator comprises a peptide motif of SEQ ID NO: 9 (XCXTATCXT)…wherein position 1 of SEQ ID NO: 9 is Ala (A)…wherein positions 1, 3 and 8 of SEQ ID NO: 9 are not Ala (A), Asp (D), and Val (V), respectively, at the same time.” Instant SEQ ID NOs: 1-8 are fully defined peptide sequences with varying residues. For example, SEQ ID NO: 1 is a 128 residue protein. A sequence having at least 25% sequence identity to SEQ ID NO: 1 would imply that 96 of the 128 residues may be different from SEQ ID NO: 1. Because the sequences are fully defined, claim 4 is broader than instant claim 1.
23. Claim 9 recites, “…has at least 75% amino acid sequence similarity with SEQ ID NO: 2.” Claim 9 depends from claim 1. Claim 1 recites, “…the vasodilator comprises a peptide motif of SEQ ID NO: 9 (XCXTATCXT)…wherein position 1 of SEQ ID NO: 9 is Ala (A)…wherein positions 1, 3 and 8 of SEQ ID NO: 9 are not Ala (A), Asp (D), and Val (V), respectively, at the same time.” Instant SEQ ID NO: 2 is a fully defined peptide sequence. Instant SEQ ID NO: 2 is a 37 residue peptide. As evidenced by Kanduc reference (Journal of Peptide Science, 2012, 18: 487-494), “similarity is a quantitative property…a pairwise sequence alignment reveals whether corresponding aa positions in two sequences are identical, similar, or different and quantifies the results in terms of number of identical, different, or similar residues. There are two ways to measure sequence similarity: (1) percent identity and (2) percent similarity” (see p. 488, bottom of left column). Kanduc reference teaches that “precent similarity measures the identities and, in addition, includes sequence gaps and aa similarity in the evaluation. For example, residues with similar biochemical properties (e.g., hydrophobicity and polarity) or similar steric conformation (e.g., side chain volume) are given positive score. From this, it follows the definition of identity: only a percent identity equal to 100 defines identity, whereas a percent similarity equal to 100 defines a maximal resemblance but not the identity of two sequences” (see p. 488, right column). The % similarity does not equal to % identity. Therefore, claim 9 is broader than instant claim 1.
U.S.C. 102
24. 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.
25. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
26. Claim(s) 1 and 5-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bevec reference (US 2010/0204117).
27. Bevec reference teaches a peptide sequence ACNTATCVTHRLAGLLSRSGGMVKSNFVPTNVGSKAF-NH2 (SEQ ID NO: 1). This meets the limitation of instant claim 1 wherein the sequence of Bevec reference comprises instant SEQ ID NO: 9, wherein 1st residue is A, 3rd residue is N and 8th residue is V. The SEQ ID NO: 1 of Bevec do not have A, D and V at residues 1, 3 and 8 at the same time. Bevec reference teaches a pharmaceutical composition comprising the peptide compound ACNTATCVTHRLAGLLSRSGGMVKSNFVPTNVGSKAF-NH2 (SEQ ID NO: 1) as a therapeutic agent…for treatment of…inflammatory diseases…in a form of a lyophilizate or liquid buffer solution, together with at least one pharmaceutically acceptable carrier, cryoprotectant, lyoprotectant, excipient and/or diluent (see abstract), meeting the limitation of instant claims 1, 7 and 8. Bevec reference teaches that the peptide compound ACNTATCVTHRLAGLLSRSGGMVKSNFVPTNVGSKAF-NH2 is a beta Calcitonin Gene-related peptide (beta-CGRP)) (see paragraph [0001]), meeting the limitation of instant claims 5-6. In regards to claims 7-8, the claims recite an inherent property of the composition comprising a vasodilator comprising a peptide motif of SEQ ID NO: 9. Since Bevec reference teaches the peptide motif of SEQ ID NO: 9, the peptide composition of Bevec reference would inherently have the same function and same activity as instant claims. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).”
Bevec reference further teaches that symptoms and signs of inflammation associated with specific conditions include…blurry vision…decreased night vision, loss of peripheral vision…(see paragraphs [0066]-[0071]). Therefore, Bevec reference encompasses pharmaceutical compositions for treatment of ocular conditions. Since the Bevec reference teaches ALL of the active components, the reference anticipates instant claims 1 and 5-8.
28. Claim(s) 1-2 and 4-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Corradini et al (WO 2009/109911).
29. Corradini et al teach a peptide having the sequences
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258
408
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(see Figure 8). The human beta-CGRP, rat alpha-CGRP, rat beta-CGRP, mouse beta-CGRP and rabbit CGRP sequences meet the limitation of instant claims 1 and 4-8. And SEQ ID NOs: 17 and 18 (see page 43) have at least 75% sequence identity to instant SEQ ID NO: 2, meeting the limitation of instant claims 4 and 9. Corradini et al teach a pharmaceutical composition comprising pharmaceutically acceptable carrier including phosphate buffered saline solution, water, emulsions such as oil/water emulsion (see p. 17, lines 4-10). Corradini et al teach that the composition may be administered via a route of…intravitreal, intra-articular…(see p. 17, lines 16-23). Corradini et al further teach that the polypeptide…peptide and proteins…has been modified naturally or by intervention, for example, disulfide bond formation, glycosylation…(see p. 12, lines 8-19), meeting the limitation of instant claim 2.
In regards to claims 7-8, the claims recite an inherent property of the composition comprising a vasodilator comprising a peptide motif of SEQ ID NO: 9. Since Bevec reference teaches the peptide motif of SEQ ID NO: 9, the peptide composition of Bevec reference would inherently have the same function and same activity as instant claims. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).”
Since Corradini et al teach ALL of the active components of instant claims, the reference anticipates instant claims 1-2 and 4-9.
CONCLUSION
No claim is allowed.
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/JULIE HA/Primary Examiner, Art Unit 1654
1/29/2026