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 1, 3, 5-6, 8, 10-12, 14, 16, 18-20, 22-23, 25, 27, 30, and 33 are pending. Claims 2, 4, 7, 9, 13, 15, 17, 21, 24, 26, 28-29, and 31-32 are cancelled.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3, 5-6, 8, 10-12, 14, 16, 18 and 33 in the reply filed on 5/19/2026 is acknowledged.
Claims 19-20, 22-23, 25, 27, and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/19/2026.
Claims 1-3, 5-6, 8, 10-12, 14, 16, 18 and 33 are examined herein.
After an initial search of Applicant’s elected species of a subject with type 2 diabetes, prior art was found on the non-elected species of overweight and obesity. Therefore, the requirement for an election of species in Genus (C) is withdrawn.
Specification
The disclosure is objected to because of the following informalities:
Bifidobacterium animalis subsp. lactis LMG P-281149 (line 30 on page 19). There is an extra numeral one. Appropriate correction is required.
Drawings
The drawings are objected to because Fig. 1 is not legible. The specification on page 2, lines 27 states: “The relative abundance of A. muciniphila is represented by the bottom segment of each bar.” However, because of the closeness in grayscale gradients, it is too difficult to distinguish the bottom segment of each bar. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Information Disclosure Statement
The information disclosure statement filed 6/10/2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because NPL reference 1 has no date. It has been placed in the application file, but NPL reference 1 has not been considered. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Objections
Claims 1 and 14 are objected to because of the following informalities:
In claim 1, the claim should spell out A. muciniphila as Akkermansia muciniphila since it is the first appearance in the claim set.
In claim 14, there is an extra numeral one: the claim recites “Bifidobacterium animalis subsp. lactis LMG P-281149” rather than Bifidobacterium animalis subsp. lactis LMG P-28149.”
Appropriate correction is required.
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.
Claims 1-3, 5-6, 8, 10-12, 16, 18 and 33 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 a method of increasing the level of A. muciniphila in the gut microbiome of a subject comprising administering (i) a polymer hydrogel having an elastic modulus (G') of at least about 200 Pa and (ii) A. muciniphila, a mixture of probiotics containing A. muciniphila, or a mixture of Lactobacillus rhamnosus LMG S-29148 and Bifidobacterium animalis subsp. lactis LMG P-28149, does not reasonably provide enablement for a method of increasing the level of A. muciniphila in the gut microbiome of a subject comprising administering (i) a polymer hydrogel having an elastic modulus (G') of at least about 200 Pa and (ii) a probiotic other than A. muciniphila, a probiotic mixture not containing A. muciniphila, or a probiotic mixture not containing Lactobacillus rhamnosus LMG S-29148 and Bifidobacterium animalis subsp. lactis LMG P-28149. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Per MPEP 2164.01(a), the following eight factors should be considered when determining whether the person of ordinary skill in the art would face undue experimentation to make and/or use the invention: (1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. While it is not essential that every factor be examined in detail, those factors deemed most relevant should be considered.
Nature of the invention. Independent claim 1 recites a method of increasing the level of A. muciniphila in a subject in need thereof comprising administering to the intestinal tract of the subject (i) a polymer hydrogel having an elastic modulus (G') of at least about 200 Pa and (ii) a probiotic, wherein the polymer hydrogel and the probiotic are administered in amounts which in combination are effective to increase the level of A. muciniphila in the gut microbiome of a subject.
Breadth of the claims. In claim 1, the probiotic is not limited to A. muciniphila or mixtures containing A. muciniphila. Claim 14 requires that the probiotic is selected from the group consisting of viable A. muciniphila, pasteurized A. muciniphila and a mixture of Lactobacillus rhamnosus LMG S-29148 and Bifidobacterium animalis subsp. lactis LMG P-281149.
State of the prior art and unpredictability. Depommier et al. (Nature medicine 25.7 (2019): 1096-1103) teaches administering an oral supplement of 1010 live A. muciniphila bacteria to overweight or obese individuals with insulin resistance (paragraph bridging pages 1101-1102 and page 1104, Methods, left column, paragraph 2). After three months of supplementation, A. muciniphila reduces the levels of the relevant blood markers for liver dysfunction and inflammation (Abstract). Depommier also teaches administering pasteurized A. muciniphila (Abstract).
Alard et al. (Environmental microbiology 18.5 (2016): 1484-1497) teaches orally administering mono-strain or multi-strain probiotic preparations to high-fat diet-induced obese mice (Summary). The multi-strain probiotic preparation restores the abundance of Akkermansia muciniphila (Summary, p. 1490, left column, first complete paragraph). The multi-strain probiotic preparation includes Lactobacillus rhamnosus LMG S-28148 and B. animalis subsp. lactis LMG P-28149 (page 1494, left column, Experimental procedures, Animals, bacterial strains and diets, paragraph 1). Alard teaches that the effects of the probiotics are strain-specific (Summary).
Guidance in the specification and working examples. Examples 3-4 of the specification disclose that administering GelB (citric acid crosslinked carboxymethylcellulose polymer hydrogel) to mice fed a high fat diet results in rapid and sustained increases in A. muciniphila (liens 1-2 and 18-20 on page 38). Example 6 of the specification discloses the growth of A. munciniphila in the presence of hydrogels and fibers in vitro (line 29 on page 38). The specification also discloses administering Akkermansia muciniphila supplemented with GelB results in decreased weight gain compared to controls in a treatment model of high-fat-diet-induced obesity (lines 1-3 on page 42). The specification does not exemplify administering any probiotic other than A. munciniphila in combination with a polymer hydrogel having an elastic modulus of at least 200 Pa.
Amount of experimentation necessary. The person of ordinary skill in the art would have faced undue experimentation to practice the invention as claimed. Since the probiotic is not limited to A. munciniphila or mixtures of A. munciniphila, a vast number of strains of bacteria would need to be tested in combination with the polymer hydrogel for their effect on the level of A. munciniphila. Although Applicant’s specific polymer hydrogel (citric acid crosslinked carboxymethylcellulose or “GelB”) increases the level of A. munciniphila, the person of ordinary skill in the art would have been unable to predict the effect of combinations of the polymer hydrogel with different bacterial strains on the level of A. munciniphila because the effect of the probiotic is strain-specific.
Taking these factors into account, undue experimentation would be required by one of ordinary skill in the art to practice the full scope of the claimed invention. The specification does not enable a method of increasing the level of A. muciniphila in the gut microbiome of a subject by administering (i) a polymer hydrogel having an elastic modulus of at least 200 Pa and (ii) a probiotic other than A. muciniphila, a probiotic mixture not containing A. muciniphila, or a probiotic mixture not containing Lactobacillus rhamnosus LMG S-29148 and Bifidobacterium animalis subsp. lactis LMG P-281149. Thus, the claims are not fully enabled by the disclosure.
Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is apparent that Lactobacillus rhamnosus LMG S-29148 and Bifidobacterium animalis subsp. lactis LMG P-28149 are required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the Lactobacillus rhamnosus LMG S-29148 and Bifidobacterium animalis subsp. lactis LMG P-28149.
It is not apparent if the biological materials considered necessary to make and use the invention are both known and readily available to the public. There is no repeatable method set forth in the specification by which the public could obtain the strains. Therefore, a deposit at a recognized depositary may be made to obviate the rejection.
If the deposit is made under the terms of the Budapest Treaty, this rejection will be withdrawn if a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, is made that clearly indicates that all restrictions imposed by the depositor on the availability to the public of the deposited material (Lactobacillus rhamnosus LMG S-29148 and Bifidobacterium animalis subsp. lactis LMG P-28149) will be irrevocably removed upon the granting of the patent. See 37 C.F.R. 1.808; MPEP 2404.01. In the alternative, Applicant may convincingly show that there indeed exists a repeatable method to obtain the strains.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the application, access to the invention will be
afforded to the Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed
upon granting of the patent;
(c) The deposit will be maintained in a public depository for a period of 30 years,
or 5 years after the last request or for the enforceable life of the patent,
whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the
time of deposit (see 37 CFR 1.807).
Claim Rejections - 35 USC § 103
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 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 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, 5-6, 8, 10-12, 14, 16, 18 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Depommier et al. (Nature medicine 25.7 (2019): 1096-1103) in view of Sannino et al. (US 2016/0222134 A1).
Regarding claims 1, 14, and 33, Depommier teaches administering an oral supplement of 1010 live A. muciniphila bacteria to overweight or obese individuals with insulin resistance (paragraph bridging pages 1101-1102 and page 1104, Methods, left column, paragraph 2). After three months of supplementation, A. muciniphila reduces the levels of the relevant blood markers for liver dysfunction and inflammation (Abstract). Administering A. muciniphila necessarily increases the level of A. muciniphila in the gut microbiome for at least a transient period of time.
Depommier does not teach administering a polymer hydrogel having an elastic modulus of at least about 200 Pa.
Regarding claims 5-6, 8, and 10-12, Sannino teaches a method of treating overweight obesity in a subject in need thereof comprising orally administering to the subject a satiety-inducing amount of the pharmaceutical composition comprising a crosslinked carboxymethylcellulose (Sannino claim 29). The citric acid crosslinked carboxymethylcellulose has a viscosity as a 1% aqueous solution at 25 °C of greater than 6000 cps (Sannino claim 1) and a G’ of about 1200 to about 2000 Pa (Sannino claim 3, part (a), which is overlaps with the claimed range of at least about 200 Pa.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the step of administering the citric acid crosslinked carboxymethylcellulose polymer hydrogel of Sannino with the step of administering A. muciniphila of Depommier in order to treat obesity and overweight. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the two treatments since each is effective in treating obesity and overweight.
Regarding claim 3, Sannino’s range of about 1200 to about 2000 Pa (Sannino claim 3, part (a)) overlaps with the claimed range of about 200 Pa to about 8,000 Pa.
Regarding claim 16, Depommier does not teach administering the polymer hydrogel and the A. muciniphila as separate compositions.
Sannino teaches a pharmaceutical composition comprising the citric acid crosslinked carboxymethylcellulose in a satchet, tablet, or capsule (Sannino claim 28).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the A. muciniphila and the polymer hydrogel as separate capsules in order to reduce the size of the capsule taken by the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in administering the A. muciniphila and the polymer hydrogel separately.
Regarding claim 18, Depommier does not teach administering the polymer hydrogel in a single dosage form with the A. muciniphila.
Sannino teaches a pharmaceutical composition comprising the citric acid crosslinked carboxymethylcellulose in a satchet, tablet, or capsule (Sannino claim 28).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the A. muciniphila together with the polymer hydrogel in a single capsule, which is a single dosage form, in order to minimize the number of capsules taken by the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
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, 3, 5-6, 8, 10-12, 14, 16, 18, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 26-27 of U.S. Patent No. 10,179,824 (hereafter ‘824) in view of Depommier et al. (Nature medicine 25.7 (2019): 1096-1103).
Claim 27 of ‘824 recites a method of treating overweight or obesity in a subject in need thereof, comprising the step of orally administering to the subject a satiety-inducing amount of the pharmaceutical composition comprising a cross-linked carboxymethylcellulose of claim 1. Claim 1 of ‘824 recites a citric acid crosslinked carboxymethylcellulose, which is produced by a method comprising crosslinking carboxymethylcellulose having a viscosity as a 1% (wt/wt) aqueous solution at 25° C. of greater than 6000 cps and a polydispersity index less than 8 with citric acid.
Claim 27 of ‘824 does not recite the elastic modulus of the polymer hydrogel. However, claim 3 of ‘824, part (a), recites that the citric acid crosslinked carboxymethylcellulose is characterized by G’ of about 1200 to about 2000 Pa and a media uptake ratio of at least about 90.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the citric acid crosslinked carboxymethylcellulose polymer hydrogel of claim 3 of ‘824 to a subject to treat overweight or obesity given that the polymer hydrogel of claim 3 of ‘824 is also a citric acid crosslinked carboxymethylcellulose polymer hydrogel, just like the citric acid crosslinked carboxymethylcellulose polymer hydrogel administered in the method of claim 27 of ‘824. The person of ordinary skill in the art would have had a reasonable expectation of success.
Claims 3 and 27 of ‘824 do not recite administering A. muciniphila to the subject.
Depommier teaches administering an oral supplement of 1010 live A. muciniphila bacteria to overweight or obese individuals with insulin resistance (paragraph bridging pages 1101-1102 and page 1104, Methods, left column, paragraph 2). After three months of supplementation, A. muciniphila reduces the levels of the relevant blood markers for liver dysfunction and inflammation (Abstract). Administering A. muciniphila necessarily increases the level of A. muciniphila in the gut microbiome for at least a transient period of time.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the step of administering the citric acid crosslinked carboxymethylcellulose polymer hydrogel of claims 3 and 27 of ‘824 with Depommier’s step of administering A. muciniphila in order to treat obesity and overweight. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the two treatments since each is effective in treating obesity and overweight.
Instant claim 3 is obvious over claims 3 and 27 of ‘824 because the ranges for elastic modulus recited in claim 3 of ‘824 overlap with the presently claimed range of about 200 Pa to about 8,000 Pa.
Instant claims 5-6 and 8-12 are obvious over claims 3 and 27 of ‘824.
Regarding instant claim 14, Depommier teaches administering an oral supplement of 1010 live A. muciniphila bacteria to overweight or obese individuals with insulin resistance (paragraph bridging pages 1101-1102 and page 1104, Methods, left column, paragraph 2).
Regarding instant claim 16, claims 3 and 27 of ‘824 do not recite administering the polymer hydrogel and the A. muciniphila bacteria (probiotic) as separate compositions.
Claim 26 of ‘824 recites the pharmaceutical composition of claim 25 in the form of a satchet, tablet or capsule.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the A. muciniphila and the polymer hydrogel in separate capsules in order to reduce the size of the capsule taken by the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in administering the A. muciniphila and the polymer hydrogel separately.
Regarding instant claim 18, claims 3 and 27 of ‘824 do not recite that the polymer hydrogel and the A. muciniphila probiotic are administered in a single dosage form.
Claim 26 of ‘824 recites the pharmaceutical composition of claim 25 in the form of a satchet, tablet or capsule.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the A. muciniphila of Depommier together with the citric acid crosslinked carboxymethylcellulose polymer hydrogel in the same capsule in the method of claims 3 and 26-27 of ‘824 in order to minimize the number of capsules taken by the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the polymer hydrogel with A. muciniphila into a single dosage form.
Regarding instant claim 33, claim 27 of 824 recites administering the citric acid crosslinked carboxymethylcellulose polymer hydrogel to treat overweight or obesity in a subject in need thereof.
Claims 1, 3, 5-6, 8, 10-12, 14, 16, 18, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,855,294 (hereafter ‘294) in view of Depommier et al. (Nature medicine 25.7 (2019): 1096-1103) and Sannino et al. (US 2016/0222134 A1).
Claim 1 of ‘294 recites a method for treating overweight or obesity in a subject comprising orally administering to the subject crosslinked carboxymethylcellulose, wherein the carboxymethylcellulose is crosslinked with citric acid and is characterized by an elastic modulus of at least about 350 Pa.
Claim 1 of ‘294 does not recite administering the crosslinked carboxymethylcellulose with A. muciniphila.
Regarding claims 1, 14, and 33, Depommier teaches administering an oral supplement of 1010 live (“viable”) A. muciniphila bacteria to overweight or obese individuals with insulin resistance (paragraph bridging pages 1101-1102 and page 1104, Methods, left column, paragraph 2). After three months of supplementation, A. muciniphila reduces the levels of the relevant blood markers for liver dysfunction and inflammation (Abstract). Administering A. muciniphila necessarily increases the level of A. muciniphila in the gut microbiome for at least a transient period of time.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the step of administering the citric acid crosslinked carboxymethylcellulose polymer hydrogel of claim 1 of ‘294 with the step of administering A. muciniphila of Depommier in order to treat obesity and overweight. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the two treatments since each is effective in treating obesity and overweight.
Regarding instant claim 3, the range of at least about 350 Pa recited in claim 1 of ‘294 for the elastic modulus overlaps with the presently claimed range of about 200 Pa to about 8,000 Pa.
Regarding instant claims 5-6 and 8, claim 1 of ‘294 recites that the carboxymethylcellulose is crosslinked with citric acid.
Regarding instant claims 10-12, claim 1 of ‘294 does not recite that the carboxymethylcellulose has a viscosity as a 1% solution in water at 25 °C of at least 6000 cps.
Sannino teaches a method of treating overweight or obesity in a subject in need thereof comprising orally administering to the subject a satiety-inducing amount of the pharmaceutical composition comprising a crosslinked carboxymethylcellulose (Sannino claim 29). The citric acid crosslinked carboxymethylcellulose has a viscosity as a 1% aqueous solution at 25 °C of greater than 6000 cps (Sannino claim 1) and a G’ of about 1200 to about 2000 Pa (Sannino claim 3, part (a), which overlaps with the claimed range of at least about 200 Pa.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to specifically crosslink carboxymethylcellulose with a viscosity of at least 6000 cps at a 1% aqueous solution at 25 °C in the method of claim 1 of ‘294 per the teaching of Sannino. The person of ordinary skill in the art would have had a reasonable expectation of success applying the carboxymethylcellulose of Sannino to the method of claim 1 of ‘294, which requires a citric acid crosslinked carboxymethylcellulose.
Regarding instant claim 16, claim 1 of ‘294 does not recite administering the polymer hydrogel and the A. muciniphila bacteria (probiotic) as separate compositions.
Sannino teaches a pharmaceutical composition comprising citric acid crosslinked carboxymethylcellulose in the form of a satchet, tablet or capsule (Sannino claim 28).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the A. muciniphila and the polymer hydrogel in separate capsules in order to reduce the size of the capsule taken by the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in administering the A. muciniphila and the polymer hydrogel separately.
Regarding instant claim 18, claim 1 of ‘294 does not recite that the polymer hydrogel and the A. muciniphila probiotic are administered in a single dosage form.
Sannino teaches a pharmaceutical composition comprising citric acid crosslinked carboxymethylcellulose in the form of a satchet, tablet or capsule (Sannino claim 28).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the A. muciniphila of Depommier together with the citric acid crosslinked carboxymethylcellulose polymer hydrogel in the same capsule in the method of claim 1 of ‘294 in order to minimize the number of capsules taken by the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the polymer hydrogel with A. muciniphila into a single dosage form.
Claims 1, 3, 5-6, 8, 10-12, 14, 16, 18, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,658,147 (hereafter ‘147) in view of Depommier et al. (Nature medicine 25.7 (2019): 1096-1103) and Sannino et al. (US 2016/0222134 A1).
Claim 1 of ‘147 recites a method of treating obesity in a subject in need thereof comprising orally administering to the subject a therapeutically effective amount of a polymer hydrogel comprising carboxymethylcellulose covalently cross-linked with citric acid.
Claim 1 of ‘147 does not recite that the polymer hydrogel has an elastic modulus of at least about 200 Pa or that the method further comprises administering A. muciniphila.
Regarding claims 1, 14, and 33, Depommier teaches administering an oral supplement of 1010 live A. muciniphila bacteria to overweight or obese individuals with insulin resistance (paragraph bridging pages 1101-1102 and page 1104, Methods, left column, paragraph 2). After three months of supplementation, A. muciniphila reduces the levels of the relevant blood markers for liver dysfunction and inflammation (Abstract). Administering A. muciniphila necessarily increases the level of A. muciniphila in the gut microbiome for at least a transient period of time.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the step of administering the citric acid crosslinked carboxymethylcellulose polymer hydrogel of claim 1 of ‘147 with the step of administering A. muciniphila of Depommier in order to treat obesity and overweight. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the two treatments since each is effective in treating obesity and overweight.
Regarding the elastic modulus of the polymer hydrogel, Sannino teaches administering a citric acid crosslinked carboxymethylcellulose to treat overweight or obesity (Sannino claim 29). Sannino teaches that the citric acid crosslinked carboxymethylcellulose has an elastic modulus G’ of at least 1500 Pa ([0078]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to specifically use a citric acid crosslinked carboxymethylcellulose with an elastic modulus of at least 1500 Pa in the method of claim 1 of ‘147 based on the teaching of Sannino. The person of ordinary skill in the art would have had a reasonable expectation of success given the teaching of Sannino.
Regarding instant claim 3, the presently range of about 200 Pa to about 8,000 Pa overlaps with the range of at least 1500 Pa (Sannino [0078]).
Regarding instant claims 5-6 and 8, claim 1 of ‘147 recites orally administering to the subject a therapeutically effective amount of a polymer hydrogel comprising carboxymethylcellulose covalently cross-linked with citric acid.
Regarding instant claims 10-12, claim 1 of ‘147 does not recite the viscosity of the carboxymethylcellulose.
Sannino teaches a citric acid crosslinked carboxymethylcellulose in which the carboxymethylcellulose has a viscosity as a 1% aqueous solution at 25 °C of greater than 6000 cps (Sannino claim 1). Sannino teaches administering a citric acid crosslinked carboxymethylcellulose to treat overweight or obesity (Sannino claim 29).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the citric acid crosslinked carboxymethylcellulose of Sannino to the method of claim 1 of ‘147 given that Sannino also teaches administering a citric acid crosslinked carboxymethylcellulose to treat obesity or overweight. The person of ordinary skill in the art would have had a reasonable expectation of success in the modification.
Regarding instant claim 16, claim 1 of ‘147 does not recite administering the polymer hydrogel and the probiotic as separate compositions.
Sannino teaches a pharmaceutical composition comprising citric acid crosslinked carboxymethylcellulose in the form of a satchet, tablet or capsule (Sannino claim 28).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the A. muciniphila and the citric acid crosslinked carboxymethylcellulose as separate capsules in order to reduce the size of the capsule taken by the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in administering the A. muciniphila and the citric acid crosslinked carboxymethylcellulose polymer hydrogel separately.
Regarding instant claim 18, claim 1 of ‘147 does not recite that the citric acid crosslinked carboxymethylcellulose and the A. muciniphila are administered in a single dosage form.
Sannino teaches a pharmaceutical composition comprising citric acid crosslinked carboxymethylcellulose in the form of a satchet, tablet or capsule (Sannino claim 28).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the A. muciniphila of Depommier together with the citric acid crosslinked carboxymethylcellulose in the same tablet in the method of claim 1 of ‘147 in order to minimize the capsules taken by the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the citric acid crosslinked carboxymethylcellulose with A. muciniphila into a single dosage form.
Claims 1, 3, 5-6, 8, 10-12, 14, 16, 18, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-11 of U.S. Patent No. 11,130,823 (hereafter ‘823) in view of Depommier et al. (Nature medicine 25.7 (2019): 1096-1103) and Sannino et al. (US 2016/0222134 A1).
Claim 1 of ‘823 recites a method of reducing caloric intake by a subject in need thereof comprising orally administering to the subject an effective amount of a polymer hydrogel consisting essentially of carboxymethylcellulose crosslinked with citric acid.
Claim 10 of ‘823 requires that the polymer hydrogel is characterized by an elastic modulus of at least about 350 Pa.
Claim 11 of ‘823 requires that the polymer hydrogel is formulated as a tablet or a capsule.
Regarding instant claims 1, 14, and 33, claims 10-11 of ‘823 do not recite administering A. muciniphila to the subject.
Depommier teaches administering an oral supplement of 1010 live (“viable”) A. muciniphila bacteria to overweight or obese individuals with insulin resistance (paragraph bridging pages 1101-1102 and page 1104, Methods, left column, paragraph 2). After three months of supplementation, A. muciniphila reduces the levels of the relevant blood markers for liver dysfunction and inflammation (Abstract). Administering A. muciniphila necessarily increases the level of A. muciniphila in the gut microbiome for at least a transient period of time.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the step of administering the citric acid crosslinked carboxymethylcellulose polymer hydrogel of claim 10 of ‘823 with the step of administering A. muciniphila of Depommier in order to treat obesity and overweight. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the two treatments since the method of claim 10 of ‘823 is for reducing caloric intake, which the person of ordinary skill in the art would have recognized as also beneficial for treating obesity and overweight.
Instant claim 3 is obvious over claim 10 of ‘823 because the range of at least 350 Pa overlaps with the presently claimed range of about 200 Pa to about 8,000 Pa.
Instant claims 5-6 and 8 are obvious over claim 10 of ‘823.
Regarding instant claims 10-12, claim 10 of ‘823 does not recite that the carboxymethylcellulose has a viscosity of at least 6000 cps as a 1% solution in water at 25 °C.
Sannino teaches a citric acid crosslinked carboxymethylcellulose in which the carboxymethylcellulose has a viscosity as a 1% aqueous solution at 25 °C of greater than 6000 cps (Sannino claim 1). Sannino teaches administering a citric acid crosslinked carboxymethylcellulose to treat overweight or obesity (Sannino claim 29).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the citric acid crosslinked carboxymethylcellulose of Sannino to the method of claim 10 of ‘823 given that Sannino also teaches administering a citric acid crosslinked carboxymethylcellulose to treat obesity or overweight. The person of ordinary skill in the art would have had a reasonable expectation of success in the modification.
Regarding instant claim 16, claim 10 of ‘823 does not recite administering the citric acid crosslinked carboxymethylcellulose polymer hydrogel and the A. muciniphila as separate compositions.
Sannino teaches a pharmaceutical composition comprising citric acid crosslinked carboxymethylcellulose in the form of a satchet, tablet or capsule (Sannino claim 28).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the A. muciniphila and the citric acid crosslinked carboxymethylcellulose as separate capsules in order to reduce the size of the capsule taken by the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in administering the A. muciniphila and the polymer hydrogel separately.
Regarding instant claim 18, claim 10 of ‘823 does not recite that the citric acid crosslinked carboxymethylcellulose polymer hydrogel and the A. muciniphila are administered in a single dosage form.
Claim 11 of ‘823 recites administering the citric acid crosslinked carboxymethylcellulose in the form of a tablet or capsule.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the A. muciniphila of Depommier together with the polymer hydrogel in the same capsule in the method of claim 11 of ‘823 in order to minimize the number of oral dosages for the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the citric acid crosslinked carboxymethylcellulose polymer hydrogel with A. muciniphila into a single dosage form.
Claims 1, 3, 5-6, 8, 10-12, 14, 16, 18, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-9 of U.S. Patent No. 11,130,824 (hereafter ‘’0824) in view of Depommier et al. (Nature medicine 25.7 (2019): 1096-1103) and Sannino et al. (US 2016/0222134 A1).
Claim 9 of ‘0824 recites a method of treating overweight or obesity in a subject in need thereof comprising the step of orally administering to the subject an effective amount of citric acid crosslinked carboxymethylcellulose characterized by a G’ of about 2000 to about 35000 Pa. Claim 8 of ‘0824 recites the pharmaceutical composition comprising citric acid crosslinked carboxymethylcellulose is in the form of a satchet, tablet or capsule.
Claim 9 of ‘0824 does not recite administering A. muciniphila to the subject.
Regarding instant claims 1, 14, and 33, Depommier teaches administering an oral supplement of 1010 live A. muciniphila bacteria to overweight or obese individuals with insulin resistance (paragraph bridging pages 1101-1102 and page 1104, Methods, left column, paragraph 2). After three months of supplementation, A. muciniphila reduces the levels of the relevant blood markers for liver dysfunction and inflammation (Abstract). Administering A. muciniphila necessarily increases the level of A. muciniphila in the gut microbiome for at least a transient period of time.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the step of administering the citric acid crosslinked carboxymethylcellulose polymer hydrogel of claim 9 of ‘0824 with the step of administering A. muciniphila of Depommier in order to treat obesity and overweight. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the two treatments since each is effective in treating obesity and overweight.
Instant claim 3 is obvious over claim 9 of ‘0824 because claim 9 of ‘0824 depends from claim 1, which recites an elastic modulus of about 2000 Pa to about 3500 Pa, which overlaps with the presently claimed range of about 200 Pa to about 8000 Pa.
Instant claims 5-6 and 8 are obvious over claim 9 of ‘0824.
Regarding instant claims 10-12, claim 9 of ‘0824 does not recite that the carboxymethylcellulose as a 1% solution in water at 25 °C has a viscosity of at least 6000 cps.
Sannino teaches a citric acid crosslinked carboxymethylcellulose in which the carboxymethylcellulose has a viscosity as a 1% aqueous solution at 25 °C of greater than 6000 cps (Sannino claim 1). Sannino teaches administering a citric acid crosslinked carboxymethylcellulose to treat overweight or obesity (Sannino claim 29).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the citric acid crosslinked carboxymethylcellulose of Sannino to the method of claim 9 of ‘0824 given that Sannino also teaches administering a citric acid crosslinked carboxymethylcellulose to treat obesity or overweight. The person of ordinary skill in the art would have had a reasonable expectation of success in the modification.
Regarding instant claim 16, claim 9 of 0824 does not recite that the citric acid crosslinked carboxymethylcellulose and A. muciniphila are administered as separate compositions.
Claim 8 of ‘0824 recites the pharmaceutical composition comprising citric acid crosslinked carboxymethylcellulose is in the form of a satchet, tablet or capsule.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the A. muciniphila and the citric acid crosslinked carboxymethylcellulose as separate capsules in order to reduce the size of the capsule taken by the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in administering the A. muciniphila and the polymer hydrogel separately.
Regarding instant claim 18, claim 9 of ‘0824 does not recite that the polymer hydrogel and the A. muciniphila are administered in a single dosage form.
Claim 8 of ‘0824 recites the pharmaceutical composition comprising citric acid crosslinked carboxymethylcellulose is in the form of a satchet, tablet or capsule.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the A. muciniphila of Depommier together with the citric acid crosslinked carboxymethylcellulose in the same capsule in the method of claims 8-9 of ‘0824 in order to minimize the number of capsules taken by the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the polymer hydrogel with A. muciniphila into a single dosage form.
Claims 1, 3, 5-6, 8, 10-12, 14, 16, 18, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10-11 of U.S. Patent No. 10,584,183 (hereafter ‘183) in view of Depommier et al. (Nature medicine 25.7 (2019): 1096-1103) and Sannino et al. (US 2016/0222134 A1).
Claim 1 of ‘183 recites a pharmaceutical composition comprising a crosslinked carboxymethylcellulose, which is produced by a method comprising crosslinking carboxymethylcellulose with citric acid, wherein the carboxymethylcellulose has a viscosity as a 1% aqueous solution at 25°C of greater than 6000 cps.
Claim 10 of ‘183 recites the pharmaceutical composition in the form of a satchet, tablet or capsule.
Claim 11 of ‘183 recites a method of treating overweight or obesity in a subject in need thereof comprising the step of orally administering to the subject an effective amount of the pharmaceutical composition of claim 1.
Claim 11 of ‘183 does not recite the elastic modulus of the citric acid crosslinked carboxymethylcellulose or that the method further comprises administering A. muciniphila.
Regarding instant claims 1, 14, and 33, Depommier teaches administering an oral supplement of 1010 live A. muciniphila bacteria to overweight or obese individuals with insulin resistance (paragraph bridging pages 1101-1102 and page 1104, Methods, left column, paragraph 2). After three months of supplementation, A. muciniphila reduces the levels of the relevant blood markers for liver dysfunction and inflammation (Abstract). Administering A. muciniphila necessarily increases the level of A. muciniphila in the gut microbiome for at least a transient period of time.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the step of administering the citric acid crosslinked carboxymethylcellulose polymer hydrogel of claim 11 of ‘183 with the step of administering A. muciniphila of Depommier in order to treat obesity and overweight. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the two treatments since each is effective in treating obesity and overweight.
Regarding the elastic modulus of the polymer hydrogel, Sannino teaches administering a citric acid crosslinked carboxymethylcellulose to treat overweight or obesity (Sannino claim 29). Sannino teaches that the citric acid crosslinked carboxymethylcellulose has an elastic modulus G’ of at least 1500 Pa ([0078]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to specifically use a citric acid crosslinked carboxymethylcellulose with an elastic modulus of at least 1500 Pa in the method of claim 11 of ‘183 based on the teaching of Sannino. The person of ordinary skill in the art would have had a reasonable expectation of success given the teaching of Sannino.
Regarding instant claim 3, the presently range of about 200 Pa to about 8,000 Pa overlaps with the Sannino’s range of at least 1500 Pa.
Regarding instant claims 5-6 and 8, claim 11 of ‘183 recites orally administering to the subject a therapeutically effective amount of a polymer hydrogel comprising carboxymethylcellulose covalently cross-linked with citric acid.
Regarding instant claims 10-12, claim 11 of ‘183 requires that the carboxymethylcellulose has a viscosity as a 1% aqueous solution at 25°C of greater than 6000 cps.
Regarding instant claim 16, claim 11 of ‘183 does not recite administering the polymer hydrogel and the A. muciniphila as separate compositions.
However, claim 10 of ‘183 recites the pharmaceutical composition in the form of a satchet, tablet or capsule.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the A. muciniphila and the citric acid crosslinked carboxymethylcellulose as separate capsules in order to reduce the size of the capsule taken by the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in administering the A. muciniphila and the polymer hydrogel separately.
Regarding instant claim 18, claim 11 of ‘183 does not recite that the citric acid crosslinked carboxymethylcellulose and the A. muciniphila are administered in a single dosage form.
Claim 10 of ‘183 recites the pharmaceutical composition in the form of a satchet, tablet or capsule.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the A. muciniphila of Depommier together with the citric acid crosslinked carboxymethylcellulose in the same tablet in the method of claim 11 of ‘183 in order to minimize the number of capsules taken by the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the citric acid crosslinked carboxymethylcellulose with A. muciniphila into a single dosage form.
Claims 1, 3, 5-6, 8, 10-12, 14, 16, 18, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,544,233 (hereafter ‘233) in view of Sannino et al. (US 2016/0222134 A1) and Depommier et al. (Nature medicine 25.7 (2019): 1096-1103).
Claim 1 of ‘233 recites a method for producing polymer hydrogel particles comprising granulating a carboxymethylcellulose/citric acid composite to produce particles and heating the carboxymethylcellulose/citric acid composite particles at a temperature of at least 80 °C, thereby cross-linking the carboxymethylcellulose with citric acid to produce a polymer hydrogel.
Claim 1 of ‘233 does not recite the elastic modulus of the polymer hydrogel is at least about 200 Pa.
Claim 1 of ‘233 does not recite administering the hydrogel to the intestinal tract of a subject, administering A. muciniphila to the intestinal tract of a subject, or that the subject is in need of treatment for obesity and overweight (instant claim 33).
Sannino teaches a method of producing a crosslinked carboxymethylcellulose comprising heating a carboxymethylcellulose/citric acid composite at a temperature of at least about 80 °C ([0028]). In one embodiment the crosslinked carboxymethylcellulose is comminuted by grinding or milling and optionally sieved to obtain particles of a desired size range ([0028]).
Regarding the elastic modulus of the polymer hydrogel and the step of administering the polymer hydrogel, Sannino teaches orally administering a citric acid crosslinked carboxymethylcellulose to treat overweight or obesity (Sannino claim 29). Sannino teaches that the citric acid crosslinked carboxymethylcellulose has an elastic modulus G’ of at least 1500 Pa ([0078]), which overlaps with the claimed range..
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to orally administer the citric acid crosslinked carboxymethylcellulose polymer hydrogel of claim 1 of ‘233 to treat obesity or overweight per the teaching of Sannino. The person of ordinary skill in the art would have had a reasonable expectation of success given the teachings of Sannino.
Since the method of Sannino for producing a citric acid crosslinked carboxymethylcellulose has the same method steps as claim 1 of ‘233, then the properties of the resulting polymer hydrogel, including the elastic modulus, are necessarily the same.
Regarding instant claims 1, 14, and 33 and the step of administering A. muciniphila to the intestinal tract of a subject, Depommier teaches administering an oral supplement of 1010 live A. muciniphila bacteria to overweight or obese individuals with insulin resistance (paragraph bridging pages 1101-1102 and page 1104, Methods, left column, paragraph 2). After three months of supplementation, A. muciniphila reduces the levels of the relevant blood markers for liver dysfunction and inflammation (Abstract). Administering A. muciniphila necessarily increases the level of A. muciniphila in the gut microbiome for at least a transient period of time.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the step of administering the citric acid crosslinked carboxymethylcellulose polymer hydrogel in the method of claim 1 of ‘233 modified by Sannino with the step of administering A. muciniphila of Depommier in order to treat obesity and overweight. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the two treatments since each is effective in treating obesity and overweight.
Regarding instant claim 3, Sannino teaches that the citric acid crosslinked carboxymethylcellulose has an elastic modulus G’ of at least 1500 Pa ([0078]). The presently claimed range of about 200 Pa to about 8,000 Pa overlaps with the Sannino’s range of at least 1500 Pa.
Regarding instant claims 5-6 and 8, Sannino teaches orally administering to the subject a therapeutically effective amount of a polymer hydrogel comprising carboxymethylcellulose covalently cross-linked with citric acid (Sannino claim 29).
Regarding instant claims 10-12, claim 1 of ‘233 does not recite that the carboxymethylcellulose has a viscosity as a 1% aqueous solution at 25°C of greater than 6000 cps.
Sannino teaches a method of producing a crosslinked carboxymethylcellulose comprising heating a carboxymethylcellulose/citric acid composite at a temperature of at least about 80 °C ([0028]). In one embodiment the crosslinked carboxymethylcellulose is comminuted by grinding or milling and optionally sieved to obtain particles of a desired size range ([0028]).
Sannino teaches a citric acid crosslinked carboxymethylcellulose in which the carboxymethylcellulose has a viscosity as a 1% aqueous solution at 25 °C of greater than 6000 cps (Sannino claim 1).
Since the method of Sannino for producing a citric acid crosslinked carboxymethylcellulose has the same method steps as claim 1 of ‘233, then the properties of the resulting polymer hydrogel are necessarily the same.
Regarding instant claim 16, claim 1 of ‘233 does not recite administering the polymer hydrogel and the A. muciniphila as separate compositions.
Sannino teaches a pharmaceutical composition comprising citric acid crosslinked carboxymethylcellulose in the form of a satchet, tablet or capsule (Sannino claim 28).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the A. muciniphila and the citric acid crosslinked carboxymethylcellulose of claim 1 of ‘233 as separate capsules in order to reduce the size of the capsule taken by the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in administering the A. muciniphila and the polymer hydrogel separately.
Regarding instant claim 18, claim 1 of ‘233 does not recite that the citric acid crosslinked carboxymethylcellulose and the A. muciniphila are administered in a single dosage form.
Sannino teaches a pharmaceutical composition comprising citric acid crosslinked carboxymethylcellulose in the form of a satchet, tablet or capsule (Sannino claim 28).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the A. muciniphila of Depommier together with the citric acid crosslinked carboxymethylcellulose in the same capsule in the method of claim 1 of ‘233 modified by Sannino in order to minimize the number of capsules taken by the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the citric acid crosslinked carboxymethylcellulose with A. muciniphila into a single dosage form.
Claims 1, 3, 5-6, 8, 10-12, 14, 16, 18, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 14 of U.S. Patent No. 9,353,191 (hereafter ‘191) in view of Depommier et al. (Nature medicine 25.7 (2019): 1096-1103) and Sannino et al. (US 2016/0222134 A1).
Claim 1 of ‘191 recites a polymer hydrogel consisting essentially of carboxymethylcellulose cross-linked with citric acid.
Claim 7 of ‘191 recites that the polymer hydrogel is further characterized by an elastic modulus of at least about 350 Pa.
Claim 14 of ‘191 recites a pharmaceutical composition comprising the hydrogel in the form of a tablet or a capsule.
Claim 7 of ‘191 does not recite administering the polymer hydrogel and administering A. muciniphila to the intestinal tract of a subject, or that the subject is in need of treating obesity and overweight (instant claim 33).
Sannino teaches orally administering a citric acid crosslinked carboxymethylcellulose to treat overweight or obesity (Sannino claim 29).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to orally administer the citric acid crosslinked carboxymethylcellulose polymer hydrogel of claim 7 of ‘191 to treat obesity or overweight per the teaching of Sannino. The person of ordinary skill in the art would have had a reasonable expectation of success given the teachings of Sannino.
Regarding instant claims 1, 14, and 33 and the step of administering A. muciniphila to the intestinal tract of a subject, Depommier teaches administering an oral supplement of 1010 live A. muciniphila bacteria to overweight or obese individuals with insulin resistance (paragraph bridging pages 1101-1102 and page 1104, Methods, left column, paragraph 2). After three months of supplementation, A. muciniphila reduces the levels of the relevant blood markers for liver dysfunction and inflammation (Abstract). Administering A. muciniphila necessarily increases the level of A. muciniphila in the gut microbiome for at least a transient period of time.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the step of administering the citric acid crosslinked carboxymethylcellulose polymer hydrogel in the method of claim 1 of ‘191 modified by Sannino with the step of administering A. muciniphila of Depommier in order to treat obesity and overweight. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the two treatments since each is effective in treating obesity and overweight.
Regarding instant claim 3, claim 7 of ‘191 recites that the polymer hydrogel is further characterized by an elastic modulus of at least about 350 Pa. The presently claimed range of about 200 Pa to about 8,000 Pa overlaps with the range of at least about 350 Pa.
Regarding instant claims 5-6 and 8, Sannino teaches orally administering to the subject a therapeutically effective amount of a polymer hydrogel comprising carboxymethylcellulose covalently cross-linked with citric acid (Sannino claim 29).
Regarding instant claims 10-12, claim 7 of ‘191 does not recite that the carboxymethylcellulose has a viscosity as a 1% aqueous solution at 25°C of greater than 6000 cps.
Sannino teaches a citric acid crosslinked carboxymethylcellulose in which the carboxymethylcellulose has a viscosity as a 1% aqueous solution at 25 °C of greater than 6000 cps (Sannino claim 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the citric acid crosslinked carboxymethylcellulose of Sannino to the method of claim 7 of ‘191 modified by Sannino and Depommier given that Sannino also teaches administering a citric acid crosslinked carboxymethylcellulose to treat obesity or overweight. The person of ordinary skill in the art would have had a reasonable expectation of success in this modification.
Regarding instant claim 16, claim 7 of ‘191 does not recite administering the polymer hydrogel and the A. muciniphila as separate compositions.
Claim 14 of ‘191 recites a pharmaceutical composition comprising the hydrogel in the form of a tablet or a capsule.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the A. muciniphila and the citric acid crosslinked carboxymethylcellulose of claim 7 of ‘191 as separate capsules in order to reduce the size of the capsule taken by the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in administering the A. muciniphila and the polymer hydrogel separately.
Regarding instant claim 18, claim 7 of ‘191 does not recite that the citric acid crosslinked carboxymethylcellulose and the A. muciniphila are administered in a single dosage form.
Claim 14 of ‘191 recites a pharmaceutical composition comprising the hydrogel in the form of a tablet or a capsule.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the A. muciniphila of Depommier together with the citric acid crosslinked carboxymethylcellulose in the same capsule in the method of claim 7 of ‘191 modified by Sannino and Depommier in order to minimize the number of oral dosages for the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the citric acid crosslinked carboxymethylcellulose with A. muciniphila into a single dosage form.
Claims 1, 3, 5-6, 8, 10-12, 14, 16, 18, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/663,301 (‘301) in view of Sannino et al. (US 2016/0222134 A1) and Depommier et al. (Nature medicine 25.7 (2019): 1096-1103).
Claim 1 of ‘301 recites a method for producing a polymer hydrogel comprising (a) preparing an aqueous solution of a water soluble polysaccharide derivative and an amount of polycarboxylic acid less than about 0.5% by weight relative to the weight of the polysaccharide derivative; (b) agitating the solution; (c) isolating a polysaccharide derivative/polycarboxylic acid composite from the solution; and (d) heating the polysaccharide derivative/polycarboxylic acid composite at a temperature of at least about 80°C, thereby cross-linking the polysaccharide with the polycarboxylic acid. Claims 2-16, 18, and 20 of ‘301 depend from claim 1. Claim 10 of ‘301 recites the polysaccharide derivative is carboxymethylcellulose. Claim 11 of ‘301 recites the polycarboxylic acid is citric acid. Claim 17 of ‘301 recites a method for producing a polymer hydrogel, comprising the steps of (a) preparing an aqueous solution of carboxymethylcellulose, wherein the concentration of the carboxymethylcellulose is at least 4% by weight relative to water, and an amount of citric acid less than 0.5% by weight relative to the weight of the polysaccharide derivative, (b) agitating the solution; (c) drying the solution to form a carboxymethylcellulose/citric acid composite; (d) granulating the composite to produce composite particles; (e) heating the composite particles at a temperature of at least about 800, thereby cross-linking the carboxymethylcellulose with the citric acid and forming the polymer hydrogel. Claim 19 of ‘301 depends from claim 17.
Claims 1-20 of ‘301 do not recite the elastic modulus of the polymer hydrogel.
Claims 1-20 of ‘301 do not recite administering the polymer hydrogel and administering A. muciniphila to the intestinal tract of a subject, or that the subject is in need of treatment for obesity and overweight (instant claim 33).
Sannino teaches a method of producing a crosslinked carboxymethylcellulose comprising heating a carboxymethylcellulose/citric acid composite at a temperature of at least about 80 °C ([0028]). In one embodiment the crosslinked carboxymethylcellulose is comminuted by grinding or milling and optionally sieved to obtain particles of a desired size range ([0028]).
Sannino teaches orally administering a citric acid crosslinked carboxymethylcellulose to treat overweight or obesity (Sannino claim 29). Sannino teaches that the citric acid crosslinked carboxymethylcellulose has an elastic modulus G’ of at least 1500 Pa ([0078]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to orally administer the citric acid crosslinked carboxymethylcellulose polymer hydrogel of claims 1-20 of ‘301 to treat obesity or overweight per the teaching of Sannino. The person of ordinary skill in the art would have had a reasonable expectation of success given the teachings of Sannino.
Regarding the elastic modulus of the polymer hydrogel, since the method of Sannino for producing a citric acid crosslinked carboxymethylcellulose has the same method steps as claim 10, 11 and 17 of ‘301, then the properties of the resulting polymer hydrogel, including the elastic modulus, are necessarily the same.
Regarding instant claims 1, 14, and 33 and the step of administering A. muciniphila to the intestinal tract of a subject, Depommier teaches administering an oral supplement of 1010 live A. muciniphila bacteria to overweight or obese individuals with insulin resistance (paragraph bridging pages 1101-1102 and page 1104, Methods, left column, paragraph 2). After three months of supplementation, A. muciniphila reduces the levels of the relevant blood markers for liver dysfunction and inflammation (Abstract). Administering A. muciniphila necessarily increases the level of A. muciniphila in the gut microbiome for at least a transient period of time.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the step of administering the citric acid crosslinked carboxymethylcellulose polymer hydrogel in the method of claims 1-20 of ‘301 modified by Sannino with the step of administering A. muciniphila of Depommier in order to treat obesity and overweight. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the two treatments since each is effective in treating obesity and overweight.
Regarding instant claim 3, Sannino teaches that the citric acid crosslinked carboxymethylcellulose has an elastic modulus G’ of at least 1500 Pa ([0078]). The presently claimed range of about 200 Pa to about 8,000 Pa overlaps with the range of at least 1500 Pa.
Instant claims 5-6 and 8 are obvious over claim 17 of ‘301.
Regarding instant claims 10-12, claims 1-20 of ‘301 do not recite that the carboxymethylcellulose has a viscosity as a 1% aqueous solution at 25°C of greater than 6000 cps.
Sannino teaches a method of producing a crosslinked carboxymethylcellulose comprising heating a carboxymethylcellulose/citric acid composite at a temperature of at least about 80 °C ([0028]). In one embodiment the crosslinked carboxymethylcellulose is comminuted by grinding or milling and optionally sieved to obtain particles of a desired size range ([0028]).
Sannino teaches a citric acid crosslinked carboxymethylcellulose in which the carboxymethylcellulose has a viscosity as a 1% aqueous solution at 25 °C of greater than 6000 cps (Sannino claim 1).
Since the method of Sannino for producing a citric acid crosslinked carboxymethylcellulose has the same method steps as claims 1-20 of ‘301, then the properties of the resulting polymer hydrogel are necessarily the same.
Regarding instant claim 16, claims 1-20 of ‘301 do not recite administering the polymer hydrogel and the A. muciniphila as separate compositions.
Sannino teaches a pharmaceutical composition comprising citric acid crosslinked carboxymethylcellulose in the form of a satchet, tablet or capsule (Sannino claim 28).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the A. muciniphila and the citric acid crosslinked carboxymethylcellulose of claims 1-20 of ‘301 as separate capsules in order to reduce the size of the capsule taken by the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in administering the A. muciniphila and the polymer hydrogel separately.
Regarding instant claim 18, claims 1-20 of ‘301 do not recite that the citric acid crosslinked carboxymethylcellulose and the A. muciniphila are administered in a single dosage form.
Sannino teaches a pharmaceutical composition comprising citric acid crosslinked carboxymethylcellulose in the form of a satchet, tablet or capsule (Sannino claim 28).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the A. muciniphila of Depommier together with the citric acid crosslinked carboxymethylcellulose in the same capsule in the method of claims 1-20 of ‘301 modified by Sannino in order to minimize the number capsules taken by the subject. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the citric acid crosslinked carboxymethylcellulose with A. muciniphila into a single dosage form.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/CANDICE LEE SWIFT/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
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