DETAILED ACTION
Claims 1-3, 5-8, 10-15, 25-27, and 29 are pending.
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 .
Priority
The instant application filed 9/18/2024 is a National Stage entry of PCT/US2023/065200, International Filing Date: 3/31/2023. PCT/US2023/065200 Claims Priority from Provisional Application 63325680, filed 3/31/2022.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 9/18/2024, 11/6/2024, and 3/11/2026, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statements are being considered by the Examiner.
Claim Rejections - 35 USC § 102(a)(1)
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)(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.
Claims 1, 3, 5, 6, 8, 10, 11, 13, 15, 25, 27, 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Singh US20120289588A1 published 11/15/2015.
Instant claim 1 is directed to a method for reducing adhesion in a pancreas and/or peritoneal cavity of a mammal, said method comprising administering a lipase inhibitor to said mammal.
This claim is extremely broad, as the patient population is any mammal being administered a lipase inhibitor, as the claim is directed to the intended use (for reducing adhesion in a pancreas) of the compound and not to a well-defined patient population. The claim is also not a treatment, and the patient is not in need of the treatment. Therefore, the claim is directed to administering a lipase inhibitor, which due to its chemical properties would be capable of reducing adhesion in a pancreas.
Singh teaches in claim 1, a method of reducing the risk of organ failure in a subject suffering from acute pancreatitis comprising administering, non-orally, to a subject in need of such treatment, an effective amount of an inhibitor of pancreatic lipase. Singh’s invention is directed towards treating human disease, a mammal, meeting the limitations of instant claims 1, 3, 6, 8, 11, 13, 25, and 27.
Instant claim 6 states a method for reducing fibrosis in a pancreas and/or peritoneal cavity of a mammal, said method comprising administering a lipase inhibitor to said mammal. This claim is also broad and without a clear patient population, the claim is also not directed to treating. Instant claim 11 is directed to a method for reducing inflammation in a pancreas of a mammal, said method comprising administering a lipase inhibitor to said mammal. This claim is also broad and without a clear patient population, the claim is also not directed to treating. Therefore these claims, not requiring treatment of a patient with a specific disease, are also anticipated by the administration of a lipase inhibitor.
Instant claims 5, 10, and 29 state:
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This language stating the structure “comprises” the chemical structure is met by orlistat, the compound used by Singh in testing.
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One can see from the structure of orlistat, that orlistat comprises the instantly claimed compound. If Applicant was trying to claim, wherein said inhibitor “is: the structure, a 103 on simple substitution would be used to reject these claims with Anandan WO2019014434A1 published 1/17/2019.
Claim Rejections - 35 USC § 102(a)(1)
Claims 1-3, 6-8, 11-13, 25-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lotersztain WO2016046130A1 published 3/31/2016.
Instant claim 1 is directed to a method for reducing adhesion in a pancreas and/or peritoneal cavity of a mammal, said method comprising administering a lipase inhibitor to said mammal.
This claim is extremely broad, as the patient population is any mammal being administered a lipase inhibitor, as the claim is directed to the intended use (for reducing adhesion in a pancreas) of the compound and not to a well-defined patient population. The claim is also not a treatment, and the patient is not in need of the treatment. Therefore, the claim is directed to administering a lipase inhibitor, which due to its chemical properties would be capable of reducing adhesion in a pancreas.
Lotersztain teaches a method of treating fibrosis in a subject in need thereof comprising administering the subject with a therapeutically effective amount of at least one monoacylglycerol lipase (MGL) inhibitor. Lotersztain teaches treating cystic fibrosis of the pancreas. Lotersztain teaches, pancreatic fibrosis occurs in chronic pancreatitis. This condition is characterized by duct calcification and fibrosis of the pancreatic parenchyma. Like liver cirrhosis, chronic pancreatitis is associated with alcohol abuse.
Lotersztain anticipates all the claims except the claims requiring a specific structure for the lipase.
Claim Rejections - 35 USC § 102(a)(2)
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.
(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 1-3, 5-8, 10-13, 15, 25-27, 29 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Uchida EP4101467A1 published 12/14/2022 with priority to 2/10/2020.
Instant claim 1 is directed to a method for reducing adhesion in a pancreas and/or peritoneal cavity of a mammal, said method comprising administering a lipase inhibitor to said mammal. Instant claims 2, 7, and 26 require pancreatic fistula.
This claim is extremely broad, as the patient population is any mammal being administered a lipase inhibitor, as the claim is directed to the intended use (for reducing adhesion in a pancreas) of the compound and not to a well-defined patient population. The claim is also not a treatment, and the patient is not in need of the treatment. Therefore, the claim is directed to administering a lipase inhibitor, which due to its chemical properties would be capable of reducing adhesion in a pancreas.
Uchida teaches using orlistat to treat pancreatic fistula after abdominal surgery. This treatment and patient meet the limitations to all the “patients” instantly claimed, and orlistat meets the limitations to the instantly claimed compound. Moreover, the compound properties will result in the outcomes (the intended use) of administration. As such claims 1-3, 5-8, 10-13, 15, 25-27, 29 are anticipated.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J SCHMITT whose telephone number is (571)270-7047. The examiner can normally be reached M-F 8-6 MidDay Flex.
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/MICHAEL J SCHMITT/ Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629
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