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 .
Status of the Claims
Claims 1-32 are pending and currently under examination.
Information Disclosure Statement
Initialed and dated copies of Applicants’ information disclosure statement (IDS) filed on 12/12/2024 and 12/18/2025 are attached to the instant Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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 person shall be entitled to a patent unless –
(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 1-4, 7-9, 11-15, 17-20, 22-23, and 25-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Celiker (US20180147167A1, Published 05/31/2018).
The claims are drawn to a composition for oral administration comprising a percarbonate.
Regarding claims 1-2, 7-9, Celiker teaches a composition comprising at least 10 mg, at least 25 mg, at least 50 mg, at least 75 mg, or at least 100 mg of at least one peroxide selected from carbamide peroxide and sodium percarbonate; wherein the composition is formulated for oral administration; wherein the composition is formulated with enteric coating; and wherein the composition is formulated for sustained release (claim 50).
Regarding claims 3-4, 11-15, and 17-18, Celiker discloses wherein the at least one agent increases pH and is selected from buffers (i.e., pharmaceutically acceptable additive, carrier) (claim 35).
Regarding claims 19, and 23, Celiker discloses a method of weight management for a subject, comprising: administering an effective amount to the small intestine and/or large intestine of the subject of at least one agent that increases oxygen tension and/or redox potential and/or pH in the colon of the subject to thereby manage the weight of the subject (claim 1). Celiker also discloses wherein the at least one agent is selected from sodium percarbonate (claim 12).
Regarding claims 20 and 22, Celiker discloses wherein the sodium percarbonate is each administered three times per day at a dose of at least 100 mg (claim 17).
Regarding claims 25-26, Celiker discloses wherein the at least one agent increases pH and is selected from buffers (i.e., acceptable carrier) (claim 21).
Regarding claim 27, Celiker discloses wherein sodium percarbonate and catalase are administered orally to the subject, and wherein the subject is a human (claim 16).
Regarding claims 28-29, Celiker discloses use of at least one agent that increases oxygen tension and/or redox potential and/or pH in the colon of a subject for manufacturing a medicament intended to manage the weight of the subject (claim 58).
Accordingly, Celiker anticipated 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.
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 1-32 are rejected under 35 U.S.C. 103 as being unpatentable over Celiker (US20180147167A1, Published 05/31/2018).
Applicant’s invention
The Applicants claims are drawn to a composition for oral administration comprising a percarbonate.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1-2, 7-8, 13, 15, 19, 23, and 27 Celiker teaches in a first aspect this invention provides methods of modifying the gut microbiome of a subject, wherein the methods comprise administering at least one agent that increases oxygen tension and/or redox potential and/or pH in the colon of a subject. In some embodiments the at least one agent increases oxygen tension and is a peroxide, wherein in some embodiments the peroxide is selected from sodium percarbonate (paragraph [0004]). Celiker further teaches in some embodiments the at least one agent is administered as an oral dosage form (paragraph [0005]). Celiker also teaches in some embodiments the weight management comprises at least one of weight loss, maintenance of weight, controlling weight gain, body mass index (BMI) reduction, maintenance of BMI, and controlling BMI gain (dietary supplements)(paragraph [0004]).
Regarding claims 3-4, Celiker teaches liquid carriers may be used in preparing liquid dosage forms, wherein the liquid carrier can contain other suitable pharmaceutical additives such as solubilizers, emulsifiers, buffers, preservatives, sweeteners, flavoring agents, suspending agents, thickening agents, colors, viscosity regulators, stabilizers or osmo-regulators (paragraph [0098]).
Regarding claim 5, Celiker teaches suitable examples of liquid carriers for oral and parenteral administration include water (partially containing additives as above, e.g., cellulose derivatives (paragraph 0098]). Celiker also teaches excipients such as a lubricant such as magnesium stearate (paragraph [0097]).
Regarding claim 6, Celiker teaches the compositions may be provided in the form of capsules (paragraph [0097]).
Regarding claims 9, 14, and 20-22, Celiker teaches the dose is administered 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times per day. In a preferred embodiment the dose is administered 3 times per day (paragraph [0156]). in some embodiments sodium percarbonate is used at a dose of at least 25 mg three times per day. In some embodiments sodium percarbonate is used at a dose of at least 50 mg three times per day. In some embodiments sodium percarbonate is used at a dose of at least 75 mg three times per day. In some embodiments sodium percarbonate is used at a dose of at least 100 mg three times per day (paragraph [0157]).
Regarding claims 10, 16 and 24, Celiker teaches the compositions may be provided in the form of tablets, troches, pills, capsules, powders, liquids, and the like (paragraph [0097]), wherein liquid carriers may be used in preparing liquid dosage forms such as solutions, suspensions, dispersions, emulsions, syrups, elixirs and pressurized compositions (paragraph [0098]).
Regrading claims 11, 17 and 25, Celiker teaches liquid carriers may be used in preparing liquid dosage forms, wherein the liquid carrier can contain other suitable pharmaceutical additives such as solubilizers, emulsifiers, buffers, preservatives, sweeteners, flavoring agents, suspending agents, thickening agents, colors, viscosity regulators, stabilizers or osmo-regulators (paragraph [0098]).
Regarding claims 12, 18, and 26, Celiker teaches excipients such as lubricant, solid carrier binder, disintegrating agents, (paragraph [0097]), buffers, and suspending agents (paragraph [0098]).
Regarding claim 28, Celiker teaches methods of weight management for a subject. In some embodiments the methods comprise administering an effective amount to the small intestine and/or large intestine of the subject of at least one agent that increases oxygen tension and/or redox potential and/or pH in the colon of the subject to thereby manage the weight of the subject (i.e., dietary supplement) (paragraph [0017]).
Regarding claim 29, Celiker teaches in some embodiments the medicament (i.e., pharmaceutical composition) is formulated for delivery of an effective amount of the at least one agent to the small intestine and/or large intestine of a subject following oral administration of the composition to the subject (paragraph [0040]).
Regarding claims 30-31, in some embodiments weight management of the pre-obese, obese, or morbidly obese subject results in at least one of inducing weight loss in a pre-obese, obese, or morbidly obese subject; reducing BMI in a pre-obese, obese, or morbidly obese subject; reducing food intake in a pre-obese, obese, or morbidly obese subject; improving glucose homeostasis in a pre-obese, obese, or morbidly obese subject; preventing weight gain and preventing an increase in BMI in a normal, pre-obese, obese, or morbidly obese subject (paragraph [0190]). Celiker also teaches the at least one active agent is administered to a subject suffering from obesity (e.g., a pro-obese, obese, or morbidly obese patient), an obesity-related disease or disorder, diabetes (i.e., treating a percarbonate-improvable condition of the subject that fatigue and/or malaise) (paragraph [0191]).
Regarding claim 32, Celiker teaches weight loss can occur, for example, from dieting, exercising, illness, drug treatment, surgery or any combination of these methods, but often an individual that has lost weight will regain some or all of the lost weight. Therefore, weight maintenance in an individual who has lost weight can include preventing weight gain after weight loss, reducing the amount of weigh gained after weight loss, controlling weight gain after weight loss or slowing the rate of weight gain after weight loss (paragraph [0074]). Celiker also teaches the dose is administered 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times per day (paragraph [0156]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Celiker does not disclose a single embodiment or example where every limitation recited in the instant claims are taught.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The claims are considered prima facie obvious to one of ordinary skill in the art because
Celiker teaches all of the claimed elements. It would have been prima facie obvious at the time
of filing to have a composition for oral administration comprising a percarbonate because
Celiker teaches these elements as components of their invention.
With regards to claim 32, wherein the percarbonate is administered to the subject before, during, and/or after physical work or exercise, it would have been obvious to one of ordinary skill to administer Celiker’s composition to the subject before, during, and/or after physical work or exercise. One would have understood in view of Celiker that weight loss can occur, for example, from dieting, exercising, but often an individual that has lost weight will regain some or all of the lost weight. Therefore, weight maintenance in an individual who has lost weight can include preventing weight gain after weight loss, reducing the amount of weigh gained after weight loss, controlling weight gain after weight loss or slowing the rate of weight gain after weight loss (paragraph [0074]). Weight maintenance is achieved wherein the at least one active agent is administered to a subject suffering from obesity (e.g., a pro-obese, obese, or morbidly obese patient), an obesity-related disease or disorder (paragraph [0191]). Celiker also teaches the dose is administered 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times per day (paragraph [0156]). It would have been obvious to administer Celiker’s composition to the subject before, during, and/or after physical work or exercise because Celiker teaches administering an oral composition comprising sodium percarbonate for weight maintenance, wherein this weight maintenance is done after weight loss from exercising, wherein the dose can be administered multiple times a day (i.e., before, during, or after).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AFUA BAMFOAA BOATENG whose telephone number is (703)756-1358. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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AFUA BAMFOAA BOATENGExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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