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
Filing Receipt and Priority
The filing receipt mailed 03/29/2024 states that the instant application is a continuation of 17/678,754, filed 02/23/2022, which is a continuation of 16/493,882 (now U.S. patent 11,278,551), filed 09/13/2019, which is a 371 of PCT/US2018/022617, filed 03/15/2018, which claims benefit of provisional application 62/471,761, filed 03/15/2017.
The instant application finds support in the provisional application. Therefore the effective filing date is 02/23/2022.
Information Disclosure Statement
The information disclosure statements (IDS) filed 10/08/2025 has been considered.
Specification
In view of the corrected sequence listing received 03/06/2026, the objection to the specification made in the prior office action has been withdrawn.
Response to Amendments and Terminal Disclaimer
In view of the amendments made to the claims the 112(b) and 102 rejection made in the prior office action are withdrawn.
In view of the terminal disclaimers, the non-statutory double patenting rejections made in the prior office action are withdrawn.
Maintained Rejections
Claim Rejections - 35 USC § 112(a)
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 1-4 and 6-11 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 claim(s) 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.
Claim 1 now states “A method for treating pancreatic fibrosis in a subject, comprising administering to a subject having pancreatic an effective amount of a CCK receptor inhibitor, wherein the CCK receptor inhibitor inhibits a CCK-B receptor.”
The specification discusses examples of CCK receptor inhibitors but does not limit the term to any specific CCK receptor inhibitor. For example, on p. 4, l. 30-33, the instant specification states “In any of the methods provide herein, the CCK receptor inhibitor or antagonist can be a CCK receptor inhibitor or antagonist that inhibits one or more CCK receptors selected from the group consisting of a CCK-A receptor, a CCK-B receptor and a CCK-C receptor.”
Another example of this exemplary language is found on p. 5 , l. 35-37 where the specification states “Examples of antagonists that preferentially inhibit the CCK-B receptor include, but are not limited to, Spiroglumide, Itriglumide, CI-988, L365,260 and YF476.”
These examples are non-limiting. The broadest reasonable interpretation includes anything that inhibits the CCK receptors discussed above. This includes all inhibitors/antagonists that have not been identified or any inhibitor that has not been made yet.
To overcome this rejection, applicant can amend the claim to specify one functional CCK receptor inhibitor or a grouping of functional CCK receptor inhibitors. Limiting potential inhibitors to CCK inhibitors that inhibit CCK-B receptor as currently amended as noted by Applicant in their remarks, while more narrow, does not sufficiently limit the claim.
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.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shiratori (Pancreas, Vol. 25, No. 1, pp. e1-e5, 2002) and as made evidenced by Walpole (BMC Public Health 2012, 12;439) and Gonzalez-Puga (Journal of Pineal Research, 39: 243-250, 2005).
Shiratori on p. e1, sec. Methodology (summarized) states “A multicenter dose-response controlled trial was conducted at 110 institutions in Japan from June 1993 to December 1994. Chronic pancreatitis was diagnosed for all patients on the basis of the Japanese criteria for chronic pancreatitis. Two-hundred seven patients were randomized to oral treatment with loxiglumide (300, 600, 1200 mg/d) or placebo for 4 weeks.”
Shiratori in the summarized sec. Conclusion (p. e1) states “These results indicate that oral administration of loxiglumide may be useful in the treatment of patients with acute, painful attacks of chronic pancreatitis…”.
Additionally, Shiratori on p.4 connects fibrosis to pancreatitis where it states “Recurrent or continuous abdominal pain in patients with chronic pancreatitis must be treated. Although the mechanism of the pain is incompletely understood, it may be multifactorial and may include inflammation, high-pancreatic duct pressure due to duct obstruction or stenosis, and fibrotic encasement of sensory nerves.”
Regarding claim 5, Shiratori on p. e1, left col. para. 1 states “…CCK-receptor antagonists, such as proglumide, loxiglumide, and lorglumide, have been found to markedly reduce the severity of pancreatitis and improve survival in experimental animal models of acute pancreatitis.”
Regarding claims 8-9, Shiratori in its summarized sec. Methodology teaches administration of 300, 600, and 1,200 mg per day. Walpole on p. 3, Table 3 teaches the average mass of an adult human is 62 kg. The doses-per-day divided by the average kilogram of an adult are then ~5, 10, and 20 mg/kg*d.
Additionally, Gonzalez-Puga, in its abstract, l. 10-11 identifies proglumide as a “CCK-A plus CCK-B antagonist”.
Regarding claims 10 and 11, the claim limitations are drawn to a property of the CCK receptor inhibitor. Because the inhibitor is taught within the art, the claims limitations do not necessarily have to be disclosed within the art as they are an inherent feature of the CCK inhibitor.
Shiratori does not explicitly teach the administration of proglumide. However, one of ordinary skill in the art would find it obvious to use proglumide in place of loxiglumide as Shiratori states proglumide is also another CCK receptor inhibitor that is effective in treating pancreatitis.
Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to have taken the teachings of Shiratori to arrive at the instant claims with a reasonable assumption of success. One of ordinary skill in the art would have been motivated to make the modification as Shiratori teaches proglumide is another CCK receptor inhibitor that is effective in treating pancreatitis.
The addition of Gonzalez-Puga has been necessitated by amendments made to the claims.
Response to Arguments
Applicant argues that a prima facie case of obviousness has not been met because “the cited references fail to disclose or suggest all claim limitations”. Regarding Shiratori, applicant states that “Shiratori does not provide any data or experiments using proglumide or any other CCK-B inhibitor.” Applicant continues stating “Shiratori discloses the treatment of acute, painful attacks of chronic pancreatitis with a CCK-A receptor inhibitor, loxiglumide (citation omitted), not a CCK-B receptor inhibitor.”
This point is addressed by Gonzalez-Puga, cited above, which indicates that proglumide is both a CCK-A and CCK-B receptor inhibitor.
Applicant then states that “pancreatitis relates to inflammation…whereas fibrosis refers to the build-up of scar tissue, which can be caused by chronic pancreatitis.” One of ordinary skill in the art could easily envision that treating even acute instances of pancreatitis would also treat pancreatic fibrosis, at least in the sense that it would prevent further build up of scar tissue caused by inflammation.
Additionally, the connection between pancreatitis and pancreatic fibrosis is further affirmed by Shimizu (J. Gastroenterol 2008, 43:823-832). Shimizu on p. 823, sec. Introduction states “Chronic panreatitis is characterized by destruction of pancreatic parenchyma, inflammatory cell infiltration, and irregular fibrosis…”.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) 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.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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