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 .
DETAILED ACTION
Election/Restriction
Applicant’s election of Group I (claims 1-11) in the reply filed on 04/27/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 12-17, 19, and 22-23 are withdrawn. Claims 18, 20-21, and 24-29 are cancelled.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 10/07/2024 has been considered here.
Claim Rejections - 35 USC § 112: Scope of Enablement
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 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating a subject suffering from a pancreatic disease or disorder, does not reasonably provide enablement for reducing the likelihood of developing any and all types of pancreatic disease or disorder by any and all forms of administering any and all Piezo1 antagonists, PLA2 antagonists, TRPV4 antagonists, or combinations thereof. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The enablement requirement is considered based on the following eight Wands factors (MPEP 21.64.01(a)): (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The breadth of the claims: The scope of the instant claims are broad and read on all types of Piezo1 antagonists, PLA2 antagonists, TRPV4 antagonists, or combinations thereof and all routes of administration. Instant claim 1 claims “a method for treating a subject suffering from or reducing the likelihood of developing a pancreatic disease or disorder”, which is not supported by the instant specification.
The nature of the invention: The claim invention is directed to a method for treating a subject suffering from or reducing the likelihood of developing a pancreatic disease or disorder.
The state of the prior art and The level of predictability in the art: The prior art teaches that Piezo1 antagonists, PLA2 antagonists, and TRPV4 antagonists are known to be used to treat pancreatic diseases (see Miller, paragraph 0006-0009; see Thomas, claim 1; claim 3; paragraphs 0056, 0086, and 0140; see Mesquita, page 7, 10. TRPV4). However, there is no support in the instant specification that all types of Piezo1 antagonists, PLA2 antagonists, and TRPV4 antagonists will result in the same functions/outcomes with absolute predictability, as a result one of ordinary skill in the art would have to result to trial and error experimentation in order to practice the invention commensurate in scope with the claims. Regarding types/routes of administration, there is no support in the instant specification that all delivery routes/types will result in the same outcome with absolute predictability, as a result one of ordinary skill in the art would have to result to trial and error experimentation in order to practice the invention commensurate in scope with the claims. Based on all the data presented in the references above, the Examiner deems the art as highly unpredictable since it is unknown if any and all Piezo1 antagonists, PLA2 antagonists, TRPV4 antagonists, or combinations thereof will reduce the likelihood of developing any and all types of pancreatic diseases or disorders via any and all types/routes of administration.
The amount of direction provided and The existence of working examples: There is no evidence in the specification that the instant invention is capable of working or used with any and all of types of administration with any and all types of Piezo1 antagonists, PLA2 antagonists, and TRPV4 antagonists to reduce the likelihood of any and all pancreatic diseases or disorders. There are various examples using specific Piezo1 antagonists, PLA2 antagonists, and TRPV4 antagonists in mice (in vivo) and cells (in vitro), but it is not enough to establish that any all Piezo1 antagonists, PLA2 antagonists, TRPV4 antagonists, or combinations thereof are able to reduce the likelihood of developing any and all pancreatic diseases and disorders via any and all routes of administration.
The quantity of experimentation needed to make or use the invention: Given the breadth of the claims and the data presented above, one of ordinary skill would have to undertake a burdensome amount of research to show how each and every Piezo1 antagonists, PLA2 antagonists, TRPV4 antagonists, or combinations thereof would achieve the same functions when administered via each and every route of administration to reduce the likelihood of developing any and all pancreatic diseases or disorders. It is not clear what specific embodiments would be required in order for one of ordinary skill in the art to practice the instant invention commensurate in scope with the claims.
The level of one of ordinary skill: The level of one of ordinary skill is high, i.e. advanced education and training.
Claim Rejections - 35 USC § 102
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.
Claims 1-2 and 5-6 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO 2020028686 A1 (New York University, 2020; as submitted on IDS of 10/07/2024, referred to as Miller herein).
Miller teaches a composition comprising a Piezo1 inhibitor (see Miller, abstract), such as GsMTx-4, which down regulates or blocks Piezo1 channels (see Miller, paragraph 0007-0009), for inhibiting the growth of cancer cells (see Miller, paragraph 0006). Further, Miller specifically teaches a method for enhancing immune system function comprising administering an agent which inhibits Piezo1 channel activity (see Miller, claim 1), such as GsMTx4 (see Miller, claim 8) and wherein the individual is afflicted with pancreatic duct adenocarcinoma (see Miller, claims 2-3).
Claim Rejections - 35 USC § 103
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 and 4-11 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20190142835 A1 (Thomas, 2019).
In regards to claims 1, 4, and 7-8, Thomas teaches a method of inhibiting cancer cell survival in a human comprising administering a therapeutically effective amount of a phospholipase A2 inhibitor (see Thomas, claim 1), wherein the phospholipase A2 inhibitor is 2-oxo-1,1,1-trifluoro-6,9-12, 15-heneicosatetraene (AACOCF3) (see Thomas, claim 3; paragraph 0056). Thomas also teaches that the method comprises additional therapeutic anticancer agents such as mTOR inhibitors, JAK inhibitors, and VEGF/VEGFR receptor tyrosine kinase inhibitors in therapeutically effective amounts (see Thomas, claims 6-18).
In regards to claims 5-6, the claims of Thomas are silent on the cancer being a pancreatic cancer, however Thomas teaches that the method is used to treat pancreatic ductal adenocarcinoma (see Thomas, paragraphs 0086 and 0140).
In regards to claims 9-11, it is taught that the therapeutically effective will vary depending upon the subject and disease condition being treated, the weight and age of the subject, the severity of the disease condition, the manner of administration and the like, which can readily be determined by one of ordinary skill in the art (see Thomas, paragraph 0238). It is also taught that the various additional therapeutic agents are administered once, twice, or three times daily (see Thomas, paragraphs 0063-0065, 0113-0114, 0130). It would be within the purview of one with ordinary skill in the art to be able to optimize the administration of the additional therapeutic agent to achieve the required administration of the additional therapeutic agents before, concurrently, or after administration of the phospholipase A2 inhibitor using the teachings of Thomas.
Thomas does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Thomas with a reasonable expectation of success to obtain the method of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the method of the instant claims with predictable results.
Claims 1, 3, and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Yu (2019) in view of Mesquita (2021).
Yu teaches that the TRPV4 antagonists are known to treat malignant tumors (i.e., cancer) (see Yu, page 13, conclusion), specifically teaching that RN-1734, ruthenium red, HC-067047, and GSK2193874 are known TRPV4 antagonists (see Yu, Table 2).
Yu is silent on using a TRPV4 antagonist to treat a pancreatic disease or disorder.
Mesquita teaches that TRPV4 antagonists inhibit sustained Ca2+ elevation, which plays an important role in reducing the development of pancreatitis to pancreatic duct adenocarcinoma (PDAC) (see Mesquita, page 7, 10. TRPV4).
In regards to claims 1, 3, and 5-6, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to formulate a method of treating a pancreatic disease or disorder using the specific antagonists taught in Yu by combining the teachings of Yu and Mesquita as both teach that TRPV4 antagonists are known to treat cancer. "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 re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). One with ordinary skill in the art would be motivated to combine the teachings of Yu with the teachings of Mesquita according to the known method of treating cancer using TRPV4 antagonists (see Mesquita, page 9, 19. Targeting TRP channels in PDAC) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYAAN A ALAM whose telephone number is (571)270-1213. The examiner can normally be reached M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611
Prosecution Insights