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
Claims 94, 96-100, 102-104 and 109-110 are pending
Claim 98 is withdrawn from examination as being drawn to a nonelected specie.
Claims 94, 96-97, 99-100, 102-104 and 109-110 are under consideration in the instant office action.
Election/Restrictions
Applicant’s election with traverse of the following species in their response dated 08/29/2025 is acknowledged.
Specie 1: Compound: Applicants elected guanidinoethansulfonate.
Applicants traverse the election, with an argument that the species recited in the instant claims are basically the same and the search for one would applicable to others recited and as such there is no serious burden,
Applicant’s argument in the traversal of this election requirement is considered but has been found to be partially persuasive. Examiner would first like to remind the applicant that this requirement is election of species requirement and not a restriction requirement. As such this is only for examination purposes. Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141. Examiner would secondly, point out that the distinctness between the species is provided in paragraph 2 on page 3 of the restriction requirement dated 05/19/2010 and as described in that paragraph the species are distinct and possess mutually exclusive characteristics. For example a composition drug, or a compound is different from a molecule which is an anti-sense oligonucleotide. Examiner agrees that the compounds recited are related being a chemical entity and all having effect on GABA signaling. As such the examination of the species is extended to include the other compounds which inhibit GABA signaling, But the claim drawn to the molecule antisense oligonucleotide is withdrawn
As per MPEP FP 8.01,Should applicant traverse on the ground that the species are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the species 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 species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other species. In the instant case, applicants have not provided evidence on record that these species are obvious variants of each other.
Claims 94, 96-97, 99-100, 102-104 and 109-110 are under consideration in the instant action. The claims will be examined to the extent that they read on the elected species above.
The requirement is still deemed proper and is therefore made FINAL.
Claim 98 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected specie, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/29/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/04/2023 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application is a Continuation-In-Part and claims benefit of PCT/US2021/025629 filed April 2, 2021, which claims benefit of PCT/US2020/052571 filed September 24, 2020 and U.S. Provisional Application No. 63/004,373 filed April 2, 2020.
This application is also a Continuation-In-Part and claims benefit of U.S. Application No. 16/617,108 filed November 26, 2019, which is a 371 and claims benefit of PCT/US2018/034680 filed May 25, 2018, which claims benefit of U.S. Provisional Application No. 62/647,468 filed March 23, 2018 and U.S. Provisional Application No. 62/511,753 filed May 26, 2017
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 94, 96-97, 99-100, 102-104 and 109-110 are rejected under 35 U.S.C. 103(a) as being unpatentable over by Robbins et al. (US 2009/0325906, Cited in IDS) (WO 2018/218161), Cooper et al.(Life Sciences, volume 26 (23) 1980, abstract) and Najarian et al. (WO 2008/153632 A2, Cited in IDS )
Instant claims are drawn to a method of reducing food intake in a monogastric animal or a human, said method comprising: administering to the monogastric animal or the human an effective amount of a composition which is a drug or a compound that effectively depresses hepatic gamma-aminobutyric acid (GABA) production or release, wherein depressing hepatic GABA production or release causes the monogastric animal or human to reduce its food intake as compared to its food intake prior to being administered the composition.
Robbins et al. discloses a method of treating obesity or an obesity-related condition in a subject in need thereof (method of eliminating hyperglycemia (an obesity-related condition) in a subject; paragraph [0048]), the method comprising administering to the subject a therapeutic amount of a composition that modulates the activity of gamma-aminobutyric acid, GABA, transporters (administration of a therapeutic amount of a composition that modulates a blood-CSF barrier transporter including GABA; paragraphs [0021], [0050], {0061]);
Cooper et al. discloses that administration of ethanolamine-O-Sulfate (EOS), an irreversible inhibitor of GABA-transaminase (GABA-T) resulted in relatively long lasting dose dependent decrease in food consumption and body weight of rats. The anorexic effects of EOS corresponded in both time course and magnitude to the elevation of GABA levels and associated decrease in GABA-T activity. They disclose that chronic treatment with very high intraperitoneal doses of EOS which were able to cross the blood brain barrier elevated GABA levels and resulted in weight loss. Further they disclose that Muscimol a GABA receptor agonist also produced anorexia (see abstract).
Najarian et al. discloses the treatment of obesity related indications such as insulin-resistance and diabetes comprising administering anti-epileptic drugs such as vigabatrin (a well known GABA transaminase inhibitor).
The references above fails to disclose that the composition that effectively depresses hepatic gamma-aminobutyric acid (GABA) production or release, wherein depressing hepatic GABA production or release causes the monogastric animal or human to reduce its food intake as compared to its food intake prior to being administered the composition, nor do they disclose the composition increases mRNA or protein expression of the Solute Carrier Family 6 Member 12 (SLC6A12) gene or the Solute Carrier Family 6 Member 13 (SLC6A13) gene
These are functional limitation of the composition and the subject, since the subject (obese patients) and the compositions (GABA transporter inhibitors) are the same in the references as instantly claimed, the functional limitations set forth in the instant application will be inherently achieved. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is also noted that, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430,433 (CCPA 1977). See also MPEP § 2112.01 with regard to inherency and product-by-process claims.
In addition,. It is also noted that “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). As such the instantly claimed mechanistic functions of the adapalene to modulate expression of IL-1ra would be present in the GABA =T inhibitors taught by references above and would therefore elicit these effects whenever it is administered . Accordingly, the combined teachings of the references above renders instant claims prima facia obvious as the method of decreasing weight or treating obesity with compound that inhibit GABA-T was well known in the art. As such a person of ordinary skill in the art would be imbued with a reasonable expectation of success in treatment of obesity by inhibiting GABA transporters, motivated by the references above, absence of evidence to the contrary.
Conclusion
Claims 94, 96-97, 99-100, 102-104 and 109-110 are rejected. No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7 am to 4 pm..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dierdre (Renee) Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVITHA M RAO/Primary Examiner, Art Unit 1691