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
Claim Rejections - 35 USC § 112
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.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a credible asserted utility or a well-established utility.
The claimed invention, encompassing treatment of a wide range of disorders including treatment of drug addiction (claims 1-14), gambling addiction (claim 15), or obsessive-compulsive disorder (claim 16) by restricting blood flow to the stomach by embolizing an artery perfusing the stomach, lacks a credible or well established utility as evidenced by the Summary Statement (citation 3 in IDS filed 2/4/2022). The scientific review comments at page 2 (“premise is weak, science to back up a supposed idea is not fully developed”), page 4 (comments on secondary mechanism for ghrelin production), page 6 (lines 1-8 and Weaknesses bullets regarding rats vs humans and a paper by Leggio describing increased alcohol abuse), page 8 (Overall Impact and Weaknesses suggest lack of data and AUD likely is more complex with several molecules at play).
Furthermore, the Summary Statement is merely related to scientific review of alcohol disorders, not the full extent of the claimed range of disorders: various drug addictions, gambling addiction, or obsessive-compulsive disorder.
Claims 1-16 also rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Specifically, because the claimed invention is not supported by either a credible asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention.
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.
Claims 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kipshidze et al. USPN 9572700 (Kipshidze) in view of Panagopoulos et al., “The role of ghrelin in addition: a review”, published 20 June 2014, Psychopharmacology (2014) 231:2725-2740, hereafter “Panagopoulos”, with evidentiary support from Baron et al. USPUB 20120094942, hereafter “Baron” and Jerlhag et al. “Requirement of central ghrelin signaling for alcohol reward”, published July 7, 2009, PNAS, hereafter “Jerlhag”.
Regarding claims 1,6,10,14-16 Kipshidze discloses a method of treating an addiction of a human which is mediated by ghrelin levels, the addiction or dependency comprising over-eating food (noted in Applicant’s specification paragraphs [0003]-[0006] as a well known reward-based behavior related to other substance or pathological abuse/addiction disorders that are all mediated by ghrelin levels and treatable by reducing blood flow to the stomach to thereby reduce ghrelin levels). An artery perfusing the stomach is embolized to reduce ghrelin production (abstract, columns 1-3).
As to claims 2-5,7-9,11-13, Kipshidze discloses at c1:26-35, c2:9-c3:50, c6:31-c7:36 steps of occluding, partially or completely, a left gastric artery (or a celiac artery branch artery) by catheter injection of blood flow blocking materials including particles to embolize the vessel. Blood flow and serum ghrelin levels are significantly reduced due to the occluded arteries to reduce appetite (abstract).
As described supra, with regard to claims 1,6,10,14-16, Kipshidze discloses a method of treating a dependency or addiction of a human which is mediated by ghrelin levels, the dependency or addiction comprising over-eating food (noted in Applicant’s specification at paragraphs [0003-0005] as a well known reward-based behavior related to other substance or pathological abuse/addiction disorders). Kipshidze lacks the express disclosure of the method including treatment of an addiction to drugs (such as drugs, tobacco, alcohol), OCD, or gambling.
Panagopoulos teaches it was well known in the art that human dependencies or addictions (reward-based behaviors such as rewarding properties of food and drugs of abuse) are directly affected by ghrelin levels and the mesolimbic dopaminergic reward system, and suggests ghrelin signaling is involved with addictions in general, particularly for food, alcohol, nicotine and stimulants (See Abstract). Panagopoulos further teaches treatment of these types of addictions by reducing ghrelin signaling to reduce cravings for addictive food/substances/behaviors. See Abstract, pages 2726-2727,2736.
As to claim 15, Jerlhag et al. is cited as evidentiary support that it was well known in the art that many forms of addictive behaviors such as gambling, compulsive overeating, alcoholism, nicotine and other chemical addictions share common neurobiological mechanisms, and ghrelin signaling or levels in the mesolimbic dopaminergic reward circuit appears to be a common underlying mechanism.
As to claim 16, Baron et al. is cited as evidentiary support that it was well known in the art that many forms of addictive behaviors including food addiction, binge eating, drug addition, alcoholism, impulse control and obsessive-compulsive disorder were known addictions treatable by modulating ghlerin signaling or levels in the mesolimbic dopaminergic reward circuit (see claims 47-48, abstract, paragraphs 0163,0169,0190-0193,0209-0210].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Kipshidze to include treatments for addictions beyond eating food and known to be related to the mesolimbic dopaminergic reward system and ghrelin levels or signaling, such as addictions to alcohol, nicotine, stimulants and drugs as well as addictive behaviors such as OCD and gambling, as taught in Panagopoulos, Jerlhag, and Baron in order to mediate ghrelin signaling levels in the mesolimbic reward system to treat a range of addictions affected by the mesolimbic reward circuit in a manner known and suggested in the art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11278290. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of the pending claims are anticipated by the issued ‘290 claims as follows:
Pending claim Issued Claim
1
2
3
4
5
1
6
1,5,6
2
1
5,6
1
3,4
1,5,6
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H MATTHEWS whose telephone number is (571)272-4753. The examiner can normally be reached Monday-Friday (9-5).
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/WILLIAM H MATTHEWS/Primary Examiner, Art Unit 3774