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
Applicant's election with traverse of Group I in the reply filed on 11/3/25 was previously acknowledged.
The requirement was deemed proper and made FINAL.
In the reply filed 4/8/26, Applicants amended claims 1-3
Claim 1-6 are pending.
Claims 4-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claim 1-3 are under examination.
Claim Objections-Withdrawn
The objection to claim 1 is withdrawn.
Claim Objections-NEW
Claim 1 is objected to because of the following informalities: “oligopeptide” in the 2nd to last line of claim 1 should be amended to “oligopeptides”.
Appropriate correction is required.
.
Nucleotide and/or Amino Acid Sequence Disclosures-Maintained
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825. This application contains a “Sequence Listing” as a PDF file (37 CFR 1.821(c)(2)) or as physical sheets of paper (37 CFR 1.821(c)(3)). A copy of the "Sequence Listing" in computer readable form (CRF) has been submitted; however, the content of the CRF does not comply with one or more of the requirements of 37 CFR 1.822 through 1.824, as indicated in the "Error Report" that indicates the "Sequence Listing" could not be accepted. Refer to attachment o/r document "Computer Readable Form (CRF) for Sequence Listing – Defective" dated/ .
Required response – Applicant must provide:
A replacement "Sequence Listing" part of the disclosure, as described above in item 1); together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the replacement "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter and
An amendment to the specification to remove the “Sequence Listing previously submitted as a PDF file (37 CFR 1.821(c)(2)) or as physical sheets of paper (37 CFR 1.821(c)(3))
If the replacement "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, Applicant must also provide:
A CRF in accordance with 1.821(e)(1) or 1.821(e)(2) as required by 37 CFR 1.825(b)(6)(ii); and
Statement according to item 2) a) or b) above.
Response to Arguments
Applicant's arguments filed 4/8/26 have been fully considered but they are not persuasive. Applicants state that an amended sequence listing was submitted.
This argument is not persuasive as the sequence listing filed 4/8/26 is defective.
Claim Rejections - Withdrawn
The rejection of claims 1-3 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 is withdrawn due to amendment of the claims to delete “including” and “pathologic melanocytes”.
The rejection of claims 1-3 under 35 U.S.C. 103 as being unpatentable over Hantash (WO2009003037, cited on IDS and provided by Applicants) is withdrawn due to amendment of the claims.
Claim Rejections - 35 USC § 112-NEW
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.
Claims 1-3 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. This is a NEW rejection necessitated by amendment of claim 1.
The limitation “…a composition comprising an effective amount of one or more oligopeptides consists of SEQ ID NO: 1 and SEQ ID NO: 2…” is unclear. The claim is ambiguous whether the claimed “one or more oligopeptides consists of…” requires (1) both SEQ ID NO: 1 and SEQ ID NO: 2. (2) either SEQ ID NO: 1 or SEQ ID NO: 2, or (3) a combination thereof. The use of “one or more” in conjunction with “consists of” and “and” in the context of claim 1 renders the scope unclear. One of ordinary skill in the art would not be apprised of the metes and bounds of the claim.
For purposes of examination, the claim is interpreted as the composition requires both SEQ ID NO: 1 and SEQ ID NO: 2.
Claims 2-3 are rejected for depending on claim 1.
Claim Rejections - 35 USC § 103-NEW
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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Hantash (WO2009003037, cited on IDS and provided by Applicants) in view of Hantash et al. (WO2012/154959, referred to as Hantash 2).
Hantash teaches peptides which inhibit the enzymatic activity of tyrosinase as well as formulations and methods for their use in the reduction of skin pigmentation (Abstract). Hantash teaches the peptide PLG-OH, which is identical to instantly claimed SEQ ID NO: 2 (Abstract, claim 1). Hantash teaches treatment involving lightening of the skin and other conditions including melanoma (p. 28, lines 21-29). Hantash teaches tyrosinase is an attractive target for melanoma treatment (p. 28, lines 21-29). Hantash teaches that PLG was cytotoxic to melanocytes (Table on top of p. 35). Hantash teaches an example of PLG-OH administered in the B16 pigmentation assay. B16 cells is mouse melanoma cell line. PLG-OH was found to be cytotoxic to the mouse melanoma cells (B16 cells) (page 35, table).
Hantash does not teach PLG-OH in combination with RRFVLL (SEQ ID NO: 1) or an example of administration of the peptides to a subject in need of treatment, such as a subject with melanoma. However, the teachings of Hantash and Hantash 2 are suggestive of the limitations.
Hantash 2 teaches the peptide RRFVLL which is identical to instantly claimed SEQ ID NO: 1 (p. 13, “P14 peptide” SEQ ID NO: 5). Hantash 2 teaches the peptides may be used for other treatments such melanoma (top of p. 33).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to administer the peptide PLG-OH (instantly claimed SEQ ID NO: 2) and RRFVLL (instantly claimed SEQ ID NO: 1) to a subject with melanoma because Hantash teaches the peptide was cytotoxic to melanoma cells. A person of ordinary skill in the art would look to the teachings of Hantash and Hantash 2 and have a motivation to administer PLG-OH and RRFVLL because they are tyrosinase inhibitors and tyrosinase inhibitors are attractive targets for melanoma treatment according to Hantash and Hantash 2. There is a reasonable expectation of success given that the PLG-OH was effective in melanoma cells. Furthermore, MPEP 2144.06
states: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In the instant case, Hantash teaches SEQ ID NO: 2 for melanoma and Hantash 2 teaches SEQ ID NO: 1 for treatment of melanoma. Therefore the prior art teaches the compositions useful for the same purpose. A reasonable expectation of success is expected given that each components are potential treatments for melanoma.
With respect to the limitation “inducing selective cytotoxicity”, “wherein the oligopeptide inhibits MAPK signaling, thereby inducing apoptosis of the melanoma cells”, the oligopeptides from Hantash and Hantash 2 would inherently have all of the activities and properties of the claim 1. 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 Fitzqerald, 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)).” In other words, Hantash and Hantash 2 makes obvious administering the same peptides to the same patient population (subject with melanoma), therefore the composition would necessarily have the same properties. Moreover, MPEP 2112.01 states: “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Importantly, MPEP 2112 states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer” and “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.”
With respect to claims 2 and 3, Hantash teaches administration of the peptide to mouse melanoma cells (p. 34, lines 16-17 and Table on p. 35). Hantash also teaches the formulation for administration to humans (p. 14, lines 12-13).
Response to Arguments
Applicant's arguments filed 4/8/26 have been fully considered but they are not persuasive. Applicants argue that instant claims are an effective treatment for melanoma by using a composition comprising both p5 and p14 oligopeptides (SEQ ID NO: 1 and 2). Applicants argue that the prior art is focused on a purified peptide having an IC50 of tyrosinase of less than about 10mM selected from the group consisting of PLG-OH and RADSRADC. Applicants argue that nowhere does Hantash disclose the P14 oligopeptide (instant SEQ ID NO: 1). Applicants argue that the present invention discloses a composition comprising the therapeutic oligopeptides P5 and P14 for treating melanoma and aims to selectively induce cytotoxicity in melanoma cells while sparing healthy cells. Applicants argue that the reference fails to disclose the composition comprising the therapeutic oligopeptides (p5 and P14) that selectively kill melanoma cells by targeting different enzymes. Applicants argue that PLG-OH and RADSRADC are tyrosinase inhibitors that work by blocking the enzyme activity of tyrosinase, an enzyme essential for melanin production. This mechanism aims to reduce pigmentation rather than target cancer cells. In contrast, the oligopeptides discloses in the present invention are cytotoxic agents that selectively attack melanoma cells by binding to and inhibiting mutated B-RAF and wild-type C-RAF kinases in the MAPK pathway. This inhibition halts the proliferation of melanoma cells causing their apoptosis while sparing healthy cells.
These arguments were considered but are not persuasive in view of Hantash 2 and the new 103 rejection above. As indicated above, it would have been obvious to combine both peptides because the art teaches them for the same purpose (see MPEP 2144.06). The argument that the instant peptides induce cytotoxicity in melanoma cells while sparing healthy cells and that the peptides of the prior art are tyrosinase inhibitors essential for melanin synthesis, is not persuasive because the peptides are the same. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Importantly, MPEP 2112 states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer” and “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.”
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TARA L MARTINEZ whose telephone number is (571)270-1470. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TARA L MARTINEZ/ Examiner, Art Unit 1654
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