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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/22/2025 has been entered.
Withdrawn Rejections:
Applicant's amendments and arguments filed on 06/23/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claims 1-6, 9-14, 19, 46-52 are pending and under examination.
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6, 9-14, 19, 46-52 are rejected under 35 U.S.C. 103 as being unpatentable over Sannino et al. (US20130089737) in view of Promrat et al. (“Randomized Controlled Trial Testing the Effects of Weight Loss on Nonalcoholic Steatohepatitis (NASH)”, Hepatology. 2010 January; 51(1): 121–129) evidenced by Sannino-2 (US20160222134).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Sannino et al. teaches teaches a pharmaceutical composition comprising hydrogel of carboxymethylcellulose (CMC) crosslinked covalently (elastic modulus (G’) 1004Pa, 1094 Pa, 1100 Pa, 3712Pa) with citric acid for oral administration to treat obesity (page 3, [0036]); page 10, [0101]; page 15-16, [0163]; claims 1 and 10-11). In on example, carboxymethylcellulose NaCMC of grade 7H3SXF is used (page 10, [0105]). Sannino et al. also teaches 10% loss on drying (page 16, [0167]) and particle size 500 um-1000 um with MUR 61.40 (page 17, [0181]).
Promrat et al. teaches treating obesity (weight reduction) will treat NASH of patient with NASH (abstract; page 8, 3rd paragraph).
Sannino-2 teaches carboxymethylcellulose NaCMC of grade 7H3SXF having viscosity 2100-2300 cps at 1% in aqueous (page 17, [0184]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Sannino et al. is that Sannino et al. does not teach expressly treating NASH, and the deficiency of Sannino et al. is cured by Promrat et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Sannino et al., as suggested by Promrat et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to treat NASH in a patient with NASH and obesity by administering a pharmaceutical composition comprising hydrogel of carboxymethylcellulose because a pharmaceutical composition comprising hydrogel of carboxymethylcellulose (CMC) crosslinked covalently (elastic modulus (G’) 1004Pa, 1094 Pa, 1100 Pa, 3712Pa) with citric acid for oral administration will treat obesity under guidance from Sannino et al., and treating obesity will result in treating NASH as suggested by Promrat et al. Therefore, it is obvious to treat NASH in a patient with NASH and obesity by administering a pharmaceutical composition comprising hydrogel of carboxymethylcellulose and produce instant claimed invention with reasonable expectation of success.
Regarding claims 1-6, 9-12, 19, 46, 49, prior art teaches a pharmaceutical composition comprising hydrogel of carboxymethylcellulose (CMC) crosslinked covalently (elastic modulus (G’) 1004Pa, 1094 Pa, 1100 Pa, 3712Pa) with citric acid for oral administration to treat NASH in a patient with NASH and obesity. Oral administration indicates administering to gastrointestinal tract.
Since Sannino et al. teaches hydrogel of carboxymethylcellulose (CMC) crosslinked with citric acid to treat obesity, hydrogel of carboxymethylcellulose (CMC) crosslinked with citric acid is in effective amount to treat obesity and NASH, because treating obesity is an effective way to treat NASH.
Regarding claim 13-14, Sannino et al. taeches carboxymethylcellulose NaCMC of grade 7H3SXF (page 10, [0105]; viscosity 2100-2300 cps at 1% in aqueous solution as evidenced by Sannino-2) which is high viscosity according to applicant’s specification, high viscosity refers to 1% in aqueous solution having at least 1500 cps.
Regarding claims 47-48, Sannino et al. is silent about properties in claims 47-48, which is regarded as inherently properties or results of prior art steps. In summary, although the reference is silent about all the functional properties instantly claimed, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being administered the same active agent by the same mode of administration in the same amount in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Thus, prior art teaches, either expressly or inherently implied, each and every limitation of the instant claims. It remains the Examiner's position that the instantly claimed method is obvious.
Regarding claims 50-52, the limitation is met by Sannino et al. teaches 10% loss on drying (page 16, [0167]) and particle size 500 um-1000 um with MUR 61.40 (page 17, [0181]).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Argument:
Applicants argued that none of cited reference teaches treating NASH by hydrogel.
In response to this argument: this is not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As discussed in the above 103 rejection, One of ordinary skill in the art would have been motivated to treat NASH in a patient with NASH and obesity by administering a pharmaceutical composition comprising hydrogel of carboxymethylcellulose because a pharmaceutical composition comprising hydrogel of carboxymethylcellulose (CMC) crosslinked covalently (elastic modulus (G’) 1004Pa, 1094 Pa, 1100 Pa, 3712Pa) with citric acid for oral administration will treat obesity under guidance from Sannino et al., and treating obesity will result in treating NASH as suggested by Promrat et al. Therefore, it is obvious to treat NASH in a patient with NASH and obesity by administering a pharmaceutical composition comprising hydrogel of carboxymethylcellulose and produce instant claimed invention with reasonable expectation of success.
Applicants argue that about unexpected benefit from specification and intestinal permeability relationship with NASH from reports. All arguments are incorporate herein by reference.
In response to this argument: this is not persuasive. Firstly, the new ground of 103 rejection teaches each limitation of claimed invention, those benefits can only be regarded as results of prior art process. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Thus, prior arts teach, either expressly or inherently implied, each and every limitation of the instant claims. Secondly, In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., intestinal permeability relationship with NASH) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, the 103 rejection is still proper.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after weighing all the evidence, the Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts which is more convincing than the evidence which has been offered in opposition to it.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-6, 9-14, 19, 46-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9353191 in view of Sannino et al. (US20130089737) and Promrat et al. (“Randomized Controlled Trial Testing the Effects of Weight Loss on Nonalcoholic Steatohepatitis (NASH)”, Hepatology. 2010 January; 51(1): 121–129). The reference patent teaches polymer hydrogel of carboxymethylcellulose crosslinked with citric acid, in view of Sannino et al. teaching this hydrogel to treat obesity, Promrat et al. teaches treating obesity will resulting in treating NASH, it is obvious for one of ordinary skill in the art to treat NASH with hydrogel produce instant claimed invention with reasonable expectation of success.
Claims 1-6, 9-14, 19, 46-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10179824 in view of Promrat et al. (“Randomized Controlled Trial Testing the Effects of Weight Loss on Nonalcoholic Steatohepatitis (NASH)”, Hepatology. 2010 January; 51(1): 121–129). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches this hydrogel to treat obesity, Promrat et al. teaches treating obesity will resulting in treating NASH, one artisan in the art would immediately recognize the obvious variant of instant claimed invention over patented subject matter, and treat NASH with hydrogel to produce applicant’s claimed invention with reasonable expectation of success.
Claims 1-6, 9-14, 19, 46-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11130824 in view of Promrat et al. (“Randomized Controlled Trial Testing the Effects of Weight Loss on Nonalcoholic Steatohepatitis (NASH)”, Hepatology. 2010 January; 51(1): 121–129). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches this hydrogel to treat obesity, Promrat et al. teaches treating obesity will resulting in treating NASH, and one artisan in the art would immediately recognize the obvious variant of instant claimed invention over patented subject matter, and treat NASH with hydrogel to produce applicant’s claimed invention with reasonable expectation of success.
Claims 1-6, 9-14, 19, 46-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9855294 in view of Promrat et al. (“Randomized Controlled Trial Testing the Effects of Weight Loss on Nonalcoholic Steatohepatitis (NASH)”, Hepatology. 2010 January; 51(1): 121–129). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches this hydrogel to treat obesity, Promrat et al. teaches treating obesity will resulting in treating NASH, and one artisan in the art would immediately recognize the obvious variant of instant claimed invention over patented subject matter, and treat NASH with hydrogel to produce applicant’s claimed invention with reasonable expectation of success.
Response to Argument:
Applicants argue that no teaching of treating NASH.
In response to this argument: this is not persuasive. As discussed in the above 1023 rejection and double patent rejections, treating obesity will result in treating NASH. Therefore, the double patenting rejections are still proper. rejection is proper.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613