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 is acknowledged. The traversal is on the ground(s) of a lack of serious search burden on the Examiner. Applicants argue that the MPEP states that the inventions must be independent and distinct and there would be a serious search burden on the Examiner if the restriction was not required (see MPEP 802.02 and 803). Applicants argue that a search of all the claims can be completed without a serious search burden. Applicants argue that the claimed oligopeptides are common to all the claims. Accordingly, a search and examination relating to the subject matter would necessarily result in a search of claims 4-6. Applicants traverse the Examiner’s finding that the claims lack unity. Applicants argue that the claims relate to a single inventive entity, i.e. SEQ ID NO: 1 or 2. Applicants argue that the peptide exhibit selective cytotoxity toward pathogenic melanocytes through inhibition of MAPK signaling pathway. Applicants argue that the peptide are linked by a common design principle, common biological mechanism and common therapeutic utility.
This is not found persuasive. Although applicants argue the claims share common structure, biological mechanism and therapeutic utility, such features are disclosed in the prior art and therefore do not constitute a “special technical feature” as required by PCT Rule 13.2. Since the claims do not share a special technical feature defining a contribution over the art, they do not relate to a single inventive concept under PCT Rule 13.1. Applicants arguments regarding MPEP 802 and 803 are not persuasive as those sections of the MPEP pertain to U.S. restriction practice and are not applicable to lack of unity determinations in a 371 application. Accordingly, the lack of unity determination is maintained.
The requirement is still deemed proper and is therefore made FINAL.
Claims 4-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.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
Claim 1 is objected to because of the following informalities:
“wherein SEQ ID NO: 1 and SEQ ID NO: 2 is..” should be amended to : “wherein SEQ ID NO: 1 and SEQ ID NO: 2 are...”;
“[SEQ ID NO: 1]” should be amended to “(SEQ ID NO: 1)”;
“[SEQ ID NO: 2]” should be amended to “(SEQ ID NO: 2)”;
Appropriate correction is required.
.
Nucleotide and/or Amino Acid Sequence Disclosures
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 or document "Computer Readable Form (CRF) for Sequence Listing – Defective" dated 11/3/25.
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.
Claim Rejections - 35 USC § 112
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.
Claim 1 recites a method of treating a subject by inducing selective cytotoxicity in pathologic melanocytes including melanoma cells…”. The limitation “including” is interpreted as exemplary language (like such as or for example) in the context of the claim. Thus, the language renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Furthermore, the limitation “pathologic melanocytes” is indefinite because the specification does not define the limitation and it is not a term of the art. Furthermore, the specification uses the terms “pathologic melanocytes” and “pathogenic melanocytes” interchangeably, without an explanation as to whether the terms refer to the same or different cell populations. The metes and bounds of the claims are unclear.
Claims 2-3 are rejected for depending on rejected claim 1.
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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Hantash (WO2009003037, cited on IDS and provided by Applicants).
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). PLG-OH was explicitly claimed as a tyrosinase inhibitor (claim 25). 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 an example of administration of PLG-OH to a subject in need of treatment, such as a subject with melanoma. However, the teachings of Hantash are suggestive of the limitation.
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 to a subject with melanoma because Hantash teach the peptide was cytotoxic to melanoma cells. A person of ordinary skill in the art would look to the teachings of Hantash and have a motivation to administer PLG-OH because it is tyrosinase inhibitor and tyrosinase inhibitors are attractive targets for melanoma treatment. There is a reasonable expectation of success given that the peptide was effective in melanoma cells.
With respect to the limitation “inducing selective cytotoxity”, “wherein the oligopeptide inhibits MAPK signaling, thereby inducing apoptosis of the pathologic melanocytes”, the PLG-OH peptide from Hantash 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 makes obvious administering the same peptide 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).
Conclusion
No claims are allowed.
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