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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/19/2026 was filed after the mailing date of the non-final rejection on 2/10/2026. The submission is in compliance with the provisions of 37 CFR 1.97. All of the references cited therein appear to originated from an International search report and/or examination of a related application. Accordingly, the information disclosure statement is being considered by the examiner.
The listing of references in the remarks filed 7/10/206 is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." These references were not provided with a proper IDS. Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Response to Amendment
Applicant’s remarks and amendments filed 7/10/2026, in response to the non-final rejection mailed 2/10/2026, are acknowledged and have been fully considered.
Any previous rejection or objection not expressly mentioned herein is withdrawn or is moot in view of Applicant’s cancelation of claims 1-12.
Election/Restrictions
Applicant’s amendment to the claims is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Claims 1-12 have been canceled. Claims 13-16 remain withdrawn as being drawn to a drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/25/2025. Claims 17-26 are newly added.
Newly submitted claim 26 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons. In the response filed 11/25/2025, applicant elected Invention I, corresponding to claims 1-12, drawn to a bioactive synthetic peptide and a pharmaceutical composition comprising the bioactive peptide (e.g. a product).
New claims 17-25 correspond to the original elected invention. Claim 26 recites a method comprising administering the pharmaceutical composition. This amounts to a process of using the product, and is thus appropriately grouped with Invention III of the restriction described in the communication mailed 9/25/2025. The inventions are distinct because the product as claimed can be used in a materially different process of using the product. The claimed product can be used as a tool for research, which is materially different that administering the product for treatment of a cancer, as previously set forth (see the description in the communication mailed 9/25/2025. New claim 26 recites “administering the pharmaceutical composition... in vivo or in vitro.” These are broad methods with no specific patient group and no specific recited outcome.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 26 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 17-25 are thus pending and have been examined on the merits.
Claim Objections
Claims 17, 18, 21, and 23 are objected to because of the following informalities:
As a matter of form, the phrases “SEQ ID X”, in claims 17 and 18, should instead be in the form of “SEQ ID NO:X”. Example: “SEQ ID 1” should say “SEQ ID NO:1”.
The phrase “the cycle of progression” in claim 21 is not a common phrase in the art, however it is clearly used to mean “cell cycle progression”, as in [063]-[065] of the specification. Correction is recommended.
In claim 23, the term “claim17” is missing a space and should say “claim 17”.
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.
Claims 17-25 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 17 recites the limitation “having no statistically significant reduction in viability of benign cells (p > 10) relative to untreated controls”. One cannot determine if the recitation of “(p > 10)” in parenthesis means that such a statistical test result is required of the claim, or if this is merely exemplary because it is in parenthesis. Additionally, there is no recitation of a particular statistical test, meaning that any and all statistical tests could be encompassed by the claim language. Therefore, the metes and bounds of the claim cannot be determined. Because this is a purely functional limitation it is presumed that any peptide having a structure that exactly matches that of the amino acid sequence possesses this characteristic. As one suggestion to overcome this issue of indefiniteness, it is recommended to remove the language of “statistically significant reduction in viability of benign cells (p > 10)” from the claim.
Claim 18 also recites “having no statistically significant reduction in viability of benign cells (p > 10) relative to untreated controls” and is found indefinite for all of the reasons described above for claim 17.
Claim 18 also recites the limitation: “A bioactive synthetic peptide consisting of one selected from the group consisting of SEQ ID 2, SEQ ID 3, SEQ ID 4, SEQ ID 5, SEQ ID 6, SEQ ID 7, SEQ ID 8, SEQ ID 9, SEQ ID 10”. This amounts to an incorrect Markush grouping because there is no recitation of “and” before the last alternative of the list and it is unclear if the list is open or closed. Further, the term “one” lacks antecedent basis and instead should recite: “consisting of an amino acid sequence selected from the group...” or language similar thereto.
Claims 23, 24, and 25 each recite the limitation "the bioactive protein”. There is insufficient antecedent basis for these limitations in the claims. Claim 17 recites “A bioactive synthetic peptide”. Thus, the references to “the bioactive protein” and “the bioactive peptide” lack antecedent basis because it is unclear if these are the same as the “bioactive synthetic peptide” as recited in claim 1. This indefiniteness may be addressed by amending all the indicated limitations to recite: “bioactive synthetic peptide”.
Claim 23 also recites “wherein the bioactive peptide has a purity of between 70% to greater than 95%”. This range is considered indefinite because the limitation does not clearly set forth the metes and bounds of the patent protection desired. The claim recites “between 70% to greater than 95%”. Under the plain meaning of the terms, the claim means that the purity is at least 70%, or greater than 95%. It is noted that this is not the same as “between 70% to 95%”. Under one interpretation, the recitation of “greater than 95%” is a narrower statement of the range (i.e. that of 95% to 100%). The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
Claim Rejections - 35 USC § 112(a) - Written Description (New Matter)
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 17-25 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 claims 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 new matter rejection.
Claims 17 and 18 each recite: “having no statistically significant reduction in viability of benign cells (p > 0.10) relative to untreated controls.”. There is no support for the limitation in the disclosure as filed. There is no recitation of determining whether the peptides have no statistically significant effect on reduction in viability of all benign cells. Further, if “p > 0.10” is meant to be part of the limitation, e.g. as the cut-off used for determining whether or not there is a statistically significance effect, this is not recited anywhere in the disclosure. The specification describes a statistical test to determine if there is an effect from the peptides on MDAMB231 and HDFa cells, and states that the following was performed “Analysis of Variance (ANOVA) with Bonferroni post- hoc test was applied to the significance of 5%”. However, this appears to be a test for determine if there is an effect, with a cut-off of p < 0.05. Mere recitation of this statistical test is not adequate for determining whether there is “no statistically significant reduction”, as instantly claimed. Failing to have a p-value less than the predetermined cut-off does not mean that there is no effect, because there are a multitude of factors that influence the power of the statistical test, including sample size, effect size, and variance. Further, the claimed requirement of p > 0.10 is not recited or suggested in the disclosure as filed.
Although the specification generally proclaims that these peptides do not affect the proliferation of benign cells, only two types of benign cells are tested herein: MCF10A cells (mammary benign cells, [029]) and skin fibroblasts (HDFa) (see [057]). The claim language used herein encompasses that the peptides have no statistically significant effect on any type of benign cell which is not limited to only the tested cells (in fact this is not limited to only human cells).
Therefore, there is no written support for these newly added limitations regarding statistical significance. Additionally, the Applicant has not specifically pointed to support in the accompanying remarks. See MPEP §§ 2163.05 and 2163.06. “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981)”.
Claims 17 and 18 are thus rejected under 35 U.S.C. § 112(a) because the claimed subject matter is not described in the specification as filed in such a way as to reasonably convey to a skilled artisan that the inventor, or a joint inventor, had possession of the claimed invention.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new grounds 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 ANDREW TERRY MOEHLMAN whose telephone number is (571)270-0990. The examiner can normally be reached M-F 9am-5pm EST.
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/A.T.M./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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