DETAILED ACTION
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 .
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.
Election/Restrictions
Applicant's election of species with traverse with respect to disease in the reply filed on 11/11/2025 is acknowledged. The traversal is on the ground(s) that only one species of disease is claimed in the claims. The examiner agrees with applicant assessment therefore election of species requirement for disease is withdrawn.
Applicant’s election of species of agent in the reply filed on 11/11/2025 is acknowledged. Because applicant was silent on the with or without traversal, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant elected a compliant species of agent: N-acetylglycine.
Examiner found prior art for N-acetylglycine. Therefore, Markush search was not extended to other species according to Markush search practices.
Claims 4-5, and 25-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/23/2025.
Claims 1-3, 6-7 and 24 are examined.
Current Status of 18/027,168
This Office Action is in response to the amended claims of 03/20/2023.
Claims 1-2 and 6-7 are original; 3-5 are currently amended; 24-26 are new.
Claims 4-5, and 25-26 are withdrawn.
Claims 1-3, 6-7 and 24 are examined.
Priority
Effected filing date is 09/20/2021 based on PCT/IL2021/051146.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
The term “agent” in claims 1-2 is interpret as any that fulfills the function as claimed, that can treat obesity or reduces the reduce the risk of weight gain after nicotine cessation including fecal transplant of claim 7. Agent is not limited to species in claim 24.
Examiner interprets substance measured in the fecal metabolome same as the agent used for treating obesity or reducing the risk of weight gain. For example, N-acetylglycine is the agent and N-acetylglycine is the metabolite measured in the fecal metabolome.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 05/08/2023, and 07/02/2025. The submissions 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 § 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 1-3, 6 and 24 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 N-acetylglycine for reducing the risk of weight gain after nicotine cessation, specification does not reasonably provide enablement for use of any agent as required by instant claims 1-3, 6 and 24. 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.
Factors to be considered in making the determination as to whether one skilled in the art would recognize that the applicant was in possession of the claimed invention as a whole at the time of filing include:
(a) Breadth of the claims: separate
(b) Nature of the invention;
(c) State of the prior art;
(d) Level of one of ordinary skill;
(e) level of predictability art
(f) amount of direction provided by the inventor;
(g) existence of working examples;
(h) and Quantity of experimentation needed to make or use the invention based on the content of the disclosure
Breadth and nature of the claims and Nature of the Invention
Instant claims 1-3, 6 and 24 are directed to method of treating obesity and risk of weight again by administering plurality of agent including fecal transplant of claim 7. Please note “an agent” could be anything including water, exercise et. Claims 3 and 24 lists numerous agents hexadecadienoate (16:2n6), N-acetylglycine, 1 -palmitoyl-2-gamma- linolenoyl-GPC (16:0/18:3n6) and/or Hexanoylglycine.
State of the prior art:
Method for treating obesity and reducing the risk of obesity with fecal transplant is known in the art (Anonymous, page 1, 1st paragraph). Prior art does not disclose the use of hexadecadienoate (16:2n6), N-acetylglycine, 1 -palmitoyl-2-gamma- linolenoyl-GPC (16:0/18:3n6) and/or Hexanoylglycine, for treating or reducing risk of weight gain. For example, hexadecadienoate is an essential fatty acid (Puder et.al, Essent Fatty Acids. 2009 Aug-Sep;81(2-3):165-70., page 2, last paragraph).
Level of one of ordinary skill
The instant claims are drawn very broadly to plurality of species of agent (claims 1-3, 6 and 24) without providing enablement for this plurality agent. For example, experiments in the disclosure supports N-Acetyl glycine (page 39 of the specification) but do not support vast number of agent that treat or reduce the risk of weight gain. Therefore, a person skill in the art would not be able to conclude all agent will treat obesity or reduce the risk of weight gain without further and undue experimentation/investigation. A person of ordinary skill will have to navigate numerous agents to determine what agent will treat obesity or reduces the risk of weight gain in a subject.
Level of predictability art
A person skilled in the around would not be able to envision using hexadecadienoate (16:2n6), N-acetylglycine, 1 -palmitoyl-2-gamma- linolenoyl-GPC (16:0/18:3n6) and/or Hexanoylglycine (Wands factor (d)) for treating obesity or reduce risk of weight gain after nicotine cessation because specification does not provide guidance(wand factor (e)). Moreover, there are numerous agent that can treat obesity or reduce the risk of weight gain after nicotine cessation (wand factor (e)).
Therefore, method claims 1-3, 6-7 and 24 are rejected for lacking scope of enablement.
Applicant can overcome scope of enablement rejection by narrowing the species of agent to what the Specification actually provides guidance-for example, N-acetylglycine.
Examiner did not issue scope of enablement for fecal transplant, because fecal transplant have support in the specification(see page 5, lines 12-29).
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.
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 1-3, 6 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over
MARDINOGLU et.al. (WO-2018117954-A1)
in view of
Telenti et.al. Cell Metabolism 29, 488–500 February 5, 2019,
and in further view of:
Rogler G et.al . “Smoking cessation induces profound changes in the composition of the intestinal microbiota in humans.” PLoS One. March 2013;8(3):59260.
1. Determining the scope and contents of the prior art.
Claims 1-3 and 24 are drawn to method of treating obesity in a subject in need thereof by administrating an agent, N-acetylglycine. MARDINOGLU et.al disclose administrating agent comprising of N-acetylglycine for treating obesity (page 51, claim 1-13 and 15) partially teaching claims 1-3 and 24.
Claims 1-2 are drawn the increases of N-acetylglycine in fecal metabolome correlated with treating obesity. Telenti discloses N-acetylglycine (metabolite associated with in body mass index (BMI)) decreases in the microbiome (examiner interpret this fecal metabolome) as the BMI increases (examiner interpret amount of N-acetylglycine increases in the microbiome with decreasing BMI)(page 489 column 2, 2nd paragraph and page 491 table 1) . Thus, partially teaching claim 1-2.
Claim 2 is drawn to weight gain after smoking cessation Rogler et.al discloses pathogenetic link between weight gain and smoking cessation (abstract, conclusion) caused by an alternation of fecal microbiome partially teaching claim 2.
2. Ascertaining the differences between the prior art and the claims at issue.
Although MARDINOGLU et.al. teaches method of treating obesity with N-acetylglycine. MARDINOGLU et.al, does not teach measuring amount of N-acetylglycine in fecal metabolome or use of N-acetylglycine for reducing risk of obesity after nicotine smoking cessation.
Although Telenti teaches increase in N-acetylglycine in microbiome with increase in BMI, Telenti et.al, does not teach method of administering N-acetylglycine to treat obesity or for reducing risk of obesity after nicotinesmoking cessation.
Although Rogler teaches weight gain after smoking cessation, Rogler does not teach use of fecal microbiome transplants after nicotine smoking cessation reduce the risk of weight gain.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in treading obesity and weight gain.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Regarding claims 1 and 3: A person skilled in the art would be motivate to use prior art of MARDINOGLU et.al which teaches a method of administering N-acetyl glycine (claims 1 and 3) for treating obesity (MARDINOGLU et.al page 51, claims 1-13 and 15) and combine with the prior of Telenti et.al. which teaches N-acetylglycine increases in fecal microbiome with decrease in BMI) (Telenti et.al. page 489 column 2, 2nd paragraph and page 491 table 1) to measure the effect of agent like, N-acetyl glycine. It would be expected by measuring N-acetylglycine in fecal metabolome, a person skilled in the art would be able to evaluated the effectiveness of the agent N-acetylglycine in treating obesity. Therefore, it would be prima facia obvious for a person skilled in the art to combine the teaching of MARDINOGLU et.al with the teaching of Telenti for developing a method of treating obesity with N-acetylglycine(agent), by measuring N-acetylglycine in fecal metabolome thus teaching claims 1 and 3 .
Regarding claims 2,6 and 24: A person skilled in the art would be motivated to develop a method of reducing risk of weight gain after nicotine smoking cessation by combining the prior art of MARDINOGLU et.al which teaches a method of administering N-acetyl glycine (claims 2 and 24) for treating obesity (MARDINOGLU et.al page 51, claim 1-13 and 15), thereby reduce risk of weight gain, with the prior of Telenti et.al. which teaches N-acetylglycine increases in fecal microbiome with decrease in BMI) (Telenti et.al. page 489 column 2, 2nd paragraph and page 491 table 1). It would be expected by measuring N-acetylglycine in fecal metabolome, a person skilled in the art would be able to evaluated the effectiveness of the agent, N-acetylglycine, in reducing the risk of weight gain.
It would be expected administering the agent, N-acetylglycine, immediately after nicotine smoking cessation in a subject would also reduce the risk of weight gain, because nicotine smoking cessation causes weight gain(Roger, abstract, conclusion), Therefore, it would be prima facia obvious for a person skilled in the art to combine the teaching of MARDINOGLU et.al with the teaching of Telenti et.al and Roger for developing a method of reducing risk of weight gain with N-acetylglycine(agent), by measuring N-acetylglycine in fecal metabolome after nicotine smoking cessation, thus teaching claims 2, 6 and 24.
Claims 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Elinav et.al. (WO 2017/138007)
In view of
Rogler G et.al . “Smoking cessation induces profound changes in the composition of the intestinal microbiota in humans.” PLoS One. March 2013;8(3):59260.
1. Determining the scope and contents of the prior art.
Claim 7 is drawn to method for reducing risk of weight gain following nicotine smoking cessation by administrating fecal transplant. Elinav et.al disclose fecal microbiome transplants ameliorate post dieting weight gain, by replenishing the gut microbiome with “healthy microbiome” thereby reducing risk of weight gain, partially teaching claims 7.
Claim 7 is drawn to weight gain after smoking cessation treated by fecal transplant, Rogler et.al discloses pathogenetic link between weight gain and smoking cessation (abstract, conclusion) caused by an alternation of fecal microbiome, partially teaching claim 7.
2. Ascertaining the differences between the prior art and the claims at issue.
Although Elinav et.al. teaches fecal microbiome transplants ameliorate post dieting weight gain Elinav does not teach use of fecal microbiome transplants after nicotine smoking cessation reduce the risk of weight gain.
Although Rogler teaches weight gain after smoking cessation, Rogler et.al. does not teach use of fecal microbiome transplants after nicotine smoking cessation reduce the risk of weight gain.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in treading obesity and weight gain.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to use prior art of Elinav which teaches fecal transplant for ameliorate post dieting weight gain (examiner interpret this as reducing risk of weight gain) by replenishing unhealthy microbiome with healthy microbiome (Elivav, page 55-56 example 5), to reduce the risk of weight gain caused by smoking cessation. It would be expected fecal transplant would also reduce the risk of weight gain after nicotine smoking cessation caused by alteration of microbiome (Roger, abstract, conclusion), since both post dieting and smoking cessation causes weight gain due to alteration of gut microbiome. It is prima facia obvious for a person skilled in the art to use fecal transplant (teaching of Elinav et.al.) with Roger et. al. to reduce the risk of weight gain after smoking cessation with fecal transplant, teaching claim 7.
Conclusion
No claims are allowed as written.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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