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 .
Status of Application, Amendments and/or Claims
The amendment of 18 September 2025 has been entered in full. Claims 4-15 are amended.
Claims 1-16 are pending.
Election/Restrictions
Applicant's election with traverse of Group II, claims 4-15, drawn to a method of cell remodeling, in the reply filed on 18 September 2025 is acknowledged. Applicant’s election of (k) Cambly (SEQ ID NO: 11) as the species of synthetic peptide amino acid sequence in the reply filed on 18 September 2025 is also acknowledged. The traversal is on the ground(s) that pursuant to 37 CFR 1.143, Applicant requests reconsideration of the restriction requirement because the claimed subject matter of the unelected groups and species are sufficiently related such that an undue burden would not be presented to the Examiner by maintaining all of the claims in this application.
This is not found persuasive because the instant application is a national stage application filed under 35 U.S.C. 371 and the analysis used to determine whether the Office may require restriction differs in national stage applications submitted under 35 U.S.C. 371 (unity of invention analysis) as compared to national applications filed under 35 U.S.C. 111(a) (independent and distinct analysis). As discussed in-depth in the Restriction requirement of 18 June 2025, Groups I-II lack unity of invention because the technical feature of a synthetic peptide sequence is not a special technical feature as it does not make a contribution over the prior art. Specifically, Tavassi et al. (WO 2020/102874; published 28 May 2020 and priority to 22 November 2018) teach the synthetic peptide sequence of SEQ ID NO: 11 (as now recited in amended claim 4). Please also see the rejections under 35 U.S.C. 102(a)(1) and 102(a)(2) set forth below.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-3, 5-8, and 11-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 18 September 2025.
Claims 4, 9, and 10 are under consideration in the instant application as they read upon the elected species of synthetic peptide amino acid sequence of SEQ ID NO: 11.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 21 May 2025 and 21 April 2022 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
1. The drawings are objected to because in Figures 1A-1C, 8, 9A, and 9B, the text and numbers are blurry and/or too small, making the information illegible (see 37 CFR 1.84(p)).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
2. The disclosure is objected to because of the following informalities:
2a. At page 4, [0013], the Brief Description of the Drawings does not refer to Figure 3D.
Appropriate correction is required.
Claim Objections
3. Claims 9 and 10 are objected to because of the following informalities:
3a. In claim 9, line 1, the word “peptides” should be singular, “peptide” (because only one peptide is administered in claim 4). Furthermore, if Applicant amends the claim to “peptide”, in line 2, the word “decrease” should be amended to recite “decreases”.
3b. In claim 10, line 2, the phrase “Cambly peptides inhibit” should recite “Cambly peptide inhibits”.
3c. In claim 10, line 2, the word “the” in the phrase “the positive” should recite “a” (i.e., “a positive”).
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
4. Claims 4, 9, and 10 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.
4a. Regarding claims 4, 9, and 10, the recitations of the term “including” in claim 4, lines 1 and 2, renders the claims indefinite because it is unclear whether the limitations following the term are part of the claimed invention. See MPEP § 2173.05(d). For example, the preamble recites a method of cell remodeling “including reducing inflammation and degenerative diseases of an inflammatory nature including rheumatoid arthritis and osteoarthritis”. It is not clear what is encompassed by the preamble and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
4b. Regarding claims 4, 9, and 10, the phrase “(SEQ ID No: 11)” in claim 4, line 4 renders the claims indefinite because it is unclear whether the limitation in the parentheses is part of the claimed invention. See MPEP § 2173.05(d). Additionally, recitation of just “Cambly” as the sole means of identifying the administered peptide renders the claims vague and indefinite. The use of laboratory designations to identify a particular molecule renders the claims indefinite because different laboratories may use the same laboratory designations to define completely distinct molecules. Hence, one of ordinary skill in the art would not be unable to discern the metes and bounds of the claimed invention.
Please note that these issues could be overcome by amending claim 4 to recite, for example, “…the method comprising administering a synthetic Cambly peptide comprising the amino acid sequence of SEQ ID NO: 11”.
Claim Rejections - 35 USC § 112(d)
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.
5. Claims 9 and 10 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.
Claim 9 recites the method of claim 4, wherein the peptides decrease pain markers in a neuron model. Claim 10 recites the method of claim 4, wherein the Cambly peptides inhibit the production of a substance P when added before the positive stimulus in a neuron model.
Claim 4, from which claims 9 and 10 depend, is directed to a method of cell remodeling, including reducing inflammation and degenerative diseases of an inflammatory nature including rheumatoid arthritis and osteoarthritis, the method comprising administering a synthetic peptide including Cambly (SEQ ID NO: 11).
Claims 9 and 10 recite characteristics of the peptide and do not recite any limitations that further limit the method or method step(s) of claim 4. Additionally, claims 9 and 10 recite limitations regarding the peptide in a neuron model, which also fail to further limit the subject matter of claim 4 (which is directed to cell remodeling and reducing inflammation reducing inflammation and degenerative diseases of an inflammatory nature including rheumatoid arthritis and osteoarthritis).
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 § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
6. Claims 4, 9, and 10 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Tavassi et al. (WO 2020/102874, cited on the IDS of 21 April 2022; published 28 May 2020 and priority to 22 November 2018; please see the attached English translation provided by WIPO). The citations below refer to the English translation document.
Tavassi et al. teach a synthetic peptide compound, termed “C-ter”, comprising the amino acid sequence of SEQ ID NO: 1 (page 3, [0008]; page 4, [0027, 0030]; page 5, [0046]; Figures 11, 13; see also SEQ ID NOs: 3, 5 of Tavassi et al.). It is noted the amino acid sequence of SEQ ID NO: 1 of Tavassi et al. is 100% identical to the amino acid sequence of SEQID NO: 11 of the instant application, meeting the limitations of instant claim 4 (see Figures 11, 13 of Tavassi et al.; see sequence alignment, below).
Qy=instant SEQ ID NO: 11
Db= SEQ ID NO: 1 of Tavassi et al.
ID BHV13733 standard; protein; 50 AA.
DT 23-JUL-2020 (first entry)
DE Tick amblyomin-X protein derived peptide, SEQ ID 1.
KW Amblyomin-X protein; cancer; cytostatic; diagnostic test;
KW protein therapy; therapeutic.
OS Amblyomma sp.
CC PN WO2020102874-A1.
CC PD 28-MAY-2020.
CC PF 22-NOV-2019; 2019WO-BR050501.
PR 22-NOV-2018; 2018BR-10074037.
CC PA (BUTA-) INST BUTANTAN.
CC PI Tavassi AMC, Flores MPA, Morais KLP, Mourier G, Servent D;
DR WPI; 2020-476593/048.
CC PT New compound, specifically peptide derived from C-terminal portion of tick amblyomin-X protein, for preparing medicament for treating cancer or diseases related to cancer, and for in vitro diagnosis of cellular and/or biochemical changes.
CC PS Claim 1; SEQ ID NO 1; 57pp; Portuguese.
CC The present invention relates to a novel peptide derived from C-terminal portion of tick amblyomin-X protein useful for preparing a medicament for
CC treating cancer or diseases related to cancer, and for in vitro diagnosis
CC of cellular and/or biochemical changes. The invention also provides: an
CC in vitro diagnosis of cellular and/or biochemical changes; and a method
CC for carrying and/or internalizing a compound into eukaryotic cells.
SQ Sequence 50 AA;
Query Match 100.0%; Score 262; Length 50;
Best Local Similarity 100.0%;
Matches 50; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EEQTHFHFESPKLISFKVQDYWILNDIMKKNLTGISLKSEEEDADSGEID 50
||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EEQTHFHFESPKLISFKVQDYWILNDIMKKNLTGISLKSEEEDADSGEID 50
Furthermore, Tavassi et al. disclose a pharmaceutical composition comprising the peptide compound and a method for treatment of cancer or other altered cellular states (pages 4-5, [0031-0032, 0038]). Tavassi et al. teach that the C-ter peptide is bound with an amine reactive dye and named “488-Amblyomin-X” (page 5, [0050-0052]). Tavassi et al. disclose contacting tumor cells with Amblyomin-X and state that Amblyomin-X decreases cell viability of the tumor cells, meeting the limitations of instant claim 4 (pages 6-7, [0061-0062]). Tavassi et al. teach that the C-ter peptide is responsible for uptake of Amblyomin-X in the cells (page 7, [0063-0065]; Figures 3A-3C). Tavassi et al. indicate that C-ter cellular uptake occurs by caveolin-mediated endocytosis and then co-localization with late endosomal markers, LysoTracker and LAMP-2, meeting the limitations of instant claim 4 (page 7, [0066]).
Applicant cannot rely upon the certified copy of the foreign priority application to overcome the rejection 102(a)(1) rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Additionally, the applied reference has a common Applicant and two common inventors with the instant application. Based upon the earlier effectively filed date of the reference, it also constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Conclusion
No claims are allowable.
The art made of record and not relied upon is considered pertinent to applicant's disclosure:
NHAC-Kn primary human chondrocytes utilized in the examples of the instant specification are well-known in the art to be an appropriate in vitro model for rheumatoid arthritis and osteoarthritis (Zhao et al., Biosci Report 40: BSR20200417, 28 May 2020; page 2, 1st paragraph under “Materials and methods”;; Cao et al., Cell Cycle 19(12): 1443-1453, 2020;; Accegen website for NHAC-Kn cells product description, www.accegen.com/product/human-articular-chondrocytes-abc-tc3968/; downloaded 31 October 2025; see pages 2 and 3).
SH-SY5Y neuronal cells utilized in the examples of the instant specification are well-known in the art to be an appropriate in vitro model for neurodegenerative disease (Agholme et al. J Alzheim Dis 20: 1069-1082, 2010 (cited on the IDS of 21 April 2022);; Braz-De-Melo et al. Sci Reports 9: 20119, 2019;; Kaya et al. Sci Reports 14: 4775, 2024; Xicoy et al. Mol Neurodeg 12: 10, 2017)
Ko et al. Int J Mol Sci 23: 2583, 2022 (review of Substance P in musculoskeletal disorders)
Post-filing date references that disclose the Cambly peptide of instant SEQ ID NO: 11
Buri et al. PLoS One 20(3): e0318119, 2025
Maia Lobba et al. FEBS Open Bio 12(Suppl S1): 40, ShT-03.3-4, 2022
Oliveira et al. Osteoarthrit Cartukage 33: 820, #839, 2025
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BEB
Art Unit 1647
31 October 2025
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647