DETAILED ACTION
This Office action details a final action on the merits for the above referenced application No. Claims 24-28, 30-39, and 41-45 are pending in this application.
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 Claims
Claims 1-23, 29, and 40 are cancelled. Claims 24, 35, and 41-43 are amended.
Response to Amendment
The amendments filed on 22 Jun. 2026 have been entered.
Response to Arguments
In view of Applicants amendments, the rejection of claims 35-39 under 35 USC 112(a) for not reasonably providing enable for the prevention of cancer is withdrawn.
In view of Applicants amendments, the rejection of claims 44-45 under 35 USC 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends is withdrawn.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 24-28, 30-39, and 41-45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rubenfield et al. (US 6,551,795 B1; issued 22 Apr. 2023), in view of Fialho et al. (AIMS Microbiology; published 2016) and Ingber et al. (WO 2013/185032 A1; published 12 Dec. 2013) for the reasons cited in the Office action filed on 10 Apr. 2026.
Applicants Arguments
Applicants assert that Rubenfield is not a proper starting point. Rubenfield would not have been a logical or natural starting point for PHOSITA in connection with the methods of claims 24 and 25 directed to diagnosing and treating cancer expressing LGR5. Rubenfield provides not teaching or suggestion towards use of any sequences within SEQ ID NO 20369 and Rubenfield provides not functional, structural or biological characterization of SEQ ID NO 20369. The application of Rubenfield is impermissible hindsight. The cited references fail to disclose all the elements. Rubenfield does not mention PGR5 or any cancer receptor. A PHOSITA could not have reasonably predicted that an arbitrarily selected 7 mer peptide from would bind LGR5 with specificity required for the recited diagnostic and therapeutic application. Fialho’s findings are not generalizable and Fialho does not describe a sequence containing STCTRSR. The mere common origin in P. aeruginosa cannot serve as a predictor of biological activity. Ingber is directed to a fundamentally different problem. Ingber does not describe STCTRSR. A person of ordinary skill would lack motivation to explore Ingber.
Applicant's arguments filed 10 Apr. 2026 have been fully considered but they are not persuasive. Rubenfield is a proper starting point and analogous art to the claimed invention since Rubenfield teaches and motivates all of methods for diagnosing and treating a pathological condition wherein the methods comprising administering a composition comprising a polypeptide having an amino acid sequence of SEQ ID NO: 1 to a subject in need thereof. Regarding Applicants arguments that a person of ordinary skill in the art would not have selected the cited SEQ ID NO: 20369 out the sequences in Rubenfield, it is noted that the SEQ ID NO: 20369 is an identified predictable solution in Rubenfield. A person of ordinary skill in the art has good reason to pursue the known options withing his or her technical grasp. See KSR, 550 U.S. at 421, 82 USPQ2d at 1397. Rubenfield teaches peptide sequences derived from P. aeruginosa and at col. 12, Rubenfield teaches probes associated with a label. Fialho teaches that bacterial proteins and their derivative peptides in particular proteins and derivative peptide derived from P. aeruginosa have emerged as promising anticancer agents. Fialho teaches that proteins or bacterial origin have a unique ability to enter cancer cells and enable treatment of cancer cells in addition to antibacterial activity. Numerous applications in oncology and diagnostics have been reported for non-Ig scaffolds. The proteins can be easily produced and purified in a bacterial host. After expression and purification of the proteins of interest, studies on the anticancer activity can be carried out. Fialho teaches breast cancer, melanoma, colon, prostate and pancreatic cancers. Fialho teaches that the microbial world represents an extraordinary reservoir of molecules and may hold the key for finding lead compounds for cancer treatment. A recognized advantage is the strongest reason to combine. It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the methods of diagnosing and/or treating a pathological condition in Rubenfield that administers to a subject a polypeptide having an amino acid sequence of instant SEQ ID NO 1 so that the pathological condition is a cancer including breast cancer, melanoma, colon, prostate and pancreatic cancers as taught by Fialho because it would have been expected to advantageously enable diagnosis and treatment of those pathological conditions using a peptide derived of P. aeruginosa known to produce peptides that are selectively taken up by cancer cells advantageously wherein the peptide can be easily produced and purified in a bacterial host. Ingber teaches P. aeruginosa and diagnosis and treatment of cancer. Fialho and Ingber are analogous art to the claimed invention. A person of ordinary skill in the art would have reasonably considered Rubenfield, Fialho, and Ingber in combination without the benefit of hindsight analysis as they all relate to P. aeruginosa, pathological conditions, and pharmaceutical applications. Regarding the recitation of wherein the cancer expresses leucine-rich repeat containing G-protein coupled receptor (LGR5) protein in amended claims 24 and 35, Rubenfield, Fialho, and Ingber provide adequate reason and motivation to administer a polypeptide having an amino acid sequence of instant SEQ ID NO 1 to a subject having gastric, colon, and pancreatic cancer. As noted in the specification, those cancer express the LGR5 protein. Therefore, the administration of a polypeptide having an amino acid sequence of instant SEQ ID NO 1 to a subject having gastric, colon, and pancreatic cancer includes the diagnosing and treating of cancers wherein the cancer expresses LGR5 protein. Rubenfield, Fialho, and Ingber in combination teach and motivate all of the claim limitations.
Conclusion
THIS ACTION IS MADE FINAL. 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 SEAN R DONOHUE whose telephone number is (571)270-7441. The examiner can normally be reached on Monday - Friday, 8:00 - 5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on (571)272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618
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