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 .
This Office action is responsive to Applicant’s amendment and remarks, filed 12 Sep 2025, in which withdrawn claims 48-49, 51, and 57 are amended to change the scope and breadth of the claim.
This application is a domestic application, filed 27 April 2023; claims benefit as a CON of 17/875,831, filed 28 July 2022, issued as PAT 11,666,597; claims benefit as a CON of 17/227,484, filed 12 April 2021, issued as PAT 11,433,094; and claims benefit as a CON of 15/763,018, which is a 371 of PCT/US2016/053781 filed 26 Sep 2016, issued as PAT 10,973,846; which claims benefit of provisional application 62/232,283, filed 24 Sep 2015.
Claims 48-67 are pending in the current application. Claims 48-59, drawn to non-elected inventions, are withdrawn. Claims 60-67 are examined on the merits herein.
Rejections Withdrawn
Applicant’s amendment, filed 12 Sep 2025, with respect that claims 60-67 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karp et al. (WO 2014/151565 A1, published 25 Sep 2014, provided by Applicant in IDS filed 28 April 2023) has been fully considered and is persuasive, as the amended claims find support in parent provisional application 62/232,28, therefore Karp et al. falls under an exception under 35 U.S.C. 102(b)(1).
This rejection has been withdrawn.
Applicant’s amendment, filed 12 Sep 2025, with respect that claims 63-65 and 67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-8, and 13-19 of U.S. Patent No. 11,666,597 (reference patent) in view of Karp et al. (WO 2014/151565 A1, published 25 Sep 2014, provided by Applicant in IDS filed 28 April 2023) has been fully considered and is persuasive, as the amended claims find support in parent provisional application 62/232,28, therefore Karp et al. falls under an exception under 35 U.S.C. 102(b)(1).
This rejection has been withdrawn.
Applicant’s amendment, filed 12 Sep 2025, with respect that claims 60-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11-17, and 19-20 of U.S. Patent No. 11,524,024 (reference patent) in view of Karp et al. (WO 2014/151565 A1, published 25 Sep 2014, provided by Applicant in IDS filed 28 April 2023) has been fully considered and is persuasive, as the amended claims find support in parent provisional application 62/232,28, therefore Karp et al. falls under an exception under 35 U.S.C. 102(b)(1).
This rejection has been withdrawn.
The following are new grounds of rejection necessitated by Applicant’s amendment, filed 12 Sep 2025, in which withdrawn claim 48 is amended to change the scope and breadth of the claim and which is incorporated into dependent claims.
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 (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 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.
Amended Claims 60-62, 64, and 66-67 are rejected under 35 U.S.C. 103 as being unpatentable over McGrath (US 6,391,860, issued 21 May 2002, provided by Applicant in IDS filed 28 April 2023) in view of Kashimura et al. (US 5,968,906, issued 19 Oct 1999, provided by Applicant in IDS filed 28 April 2023).
McGrath teaches a sucralfate composition which is employed in the treatment of lesions. The composition is formed by the reaction between sucralfate and hydrochloric acid prior to dosing under controlled conditions which limit the reaction to an incomplete stage (abstract). Although oral lesions are specified, the compound of the invention can also be used for the treatment of lesions of the skin, esophagus, rectum, or any other like tissues (column 2, lines 35-40). McGrath teaches in the background of the invention that sucralfate is known for the treatment of ulcers including peptic ulcers (column 1, lines 15-35). The composition can include an active agent such as antibiotics (column 3, lines 5-10). McGrath teaches working examples in which the composition was applied to a sore at bedtime leading to complete resolution of the sore overnight (example 1 at column 3, lines 40-45; example 3 at column 4, lines 30-35). McGrath teaches the paste of the invention is prepared by the incomplete reaction of sucralfate with acid, such a hydrochloric or sulfuric acid. By virtue of the incomplete reaction, no further pharmaceutical processing steps are needed. (column 2, lines 40-45; example 4 at column 4, lines 35-50). Further, this paste is formed with water, implying the composition is a water-based, mucoadhesive composition.
McGrath does not specifically teach the embodiment of administering the composition to the subject wherein the composition provides a protective coating of the gastrointestinal tract of the subject to thereby modulate nutritional absorption by the subject (claim 60).
Kashimura et al. teaches sucralfate containing preparations which contain both an organic acid and sucralfate, which have enhanced sucralfate adhesion to the mucosal ulcer site even under a nonacidic condition and can be extensively applied not only to ulcers in the upper digestive tract such as esophagitis and duodenal ulcer but also to ulcers in the lower digestive tract (abstract). Kashimura et al. teaches working examples in which the sucralfate containing preparations are administered to rabbits and forms a coating on the large intestine (example 2 at column 4, lines 40-65; example 3 at column 5, lines 5-30; and example 6 at column 5, line 65 to column 6, line 20). In example 6, rabbits were sacrificed at 1h, 3h, and 6h to quantify the aluminum adhering to the ulcer site.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine McGrath in view of Kashimura et al. in order to treat ulcers in the digestive tract such that the coating formed results in modulating nutritional absorption by the subject. One of ordinary skill in the art would have been motivated to combine McGrath in view of Kashimura et al. with a reasonable expectation of success because McGrath teaches the composition can also be used for the treatment of lesions of the esophagus, rectum, or any other like tissues, and that sucralfate is known for the treatment of ulcers including peptic ulcers, and Kashimura et al. teaches sucralfate containing preparations for treatment of ulcers in the upper or lower digestive tract such as the large intestine, suggesting it would have been obvious to modify the method of McGrath to treat ulcers in the digestive tract at a site where nutritional absorption normally occurs such as the large intestine. Regarding claim 62, McGrath teaches the composition can include an active agent such as antibiotics, making obvious treatment of a subject having a microbial infection related to the ulcer being treated. Regarding claim 64, McGrath teaches working examples in which the composition was applied to a sore at bedtime leading to complete resolution of the sore overnight and Kashimura et al. teaches the example of quantifying the aluminum adhering to the ulcer site at 1h, 3h, and 6h, suggesting it would have been routine optimization to select the duration at which the coating remains adhering to the digestive tract such as about 6 hours. Regarding claim 67, McGrath teaches for the paste produces no further pharmaceutical processing steps are needed, suggesting that the composition does not swell after administration.
Regarding claims 60-61 and 66, McGrath in view of Kashimura et al. does not specifically teach the method results in modulating nutritional absorption by the subject. However, MPEP 2111.04 at I. provides “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.” and citing Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005) “a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’”” In this case the claimed method are drawn positively recites the process step of “A method of treating a subject, the method comprising administering to the subject the composition of claim 48, wherein the composition provides a protective coating of the gastrointestinal tract of the subject to thereby modulate nutritional absorption by the subject.” (emphasis added), and the method of administering the same composition to the same subject is taught by McGrath in view of Kashimura et al. The clause “wherein the composition provides a protective coating of the gastrointestinal tract of the subject to thereby modulate nutritional absorption by the subject” is interpreted as expressing the intended result of the positively recited process step, but does not require a particular step to be performed or limit the claim to a particular structure or patient population treated. Further, McGrath in view of Kashimura et al. teaches the composition administered forms a protective coating of the gastrointestinal tract of the subject treated, therefore there is reason to believe the same intended result would result from the method made obvious by McGrath in view of Kashimura et al. even if not described using the same terminology.
Claim 63 is rejected under 35 U.S.C. 103 as being unpatentable over McGrath (US 6,391,860, issued 21 May 2002, provided by Applicant in IDS filed 28 April 2023) in view of Kashimura et al. (US 5,968,906, issued 19 Oct 1999, provided by Applicant in IDS filed 28 April 2023) as applied to claims 60-62, 64, and 66-67 above, and further in view of Aslan et al. (World J. Gastroenterol., 2006, 12(42), p6865-6868, cited in PTO-892).
McGrath in view of Kashimura et al. teaches as above.
McGrath in view of Kashimura et al. does not specifically teach the method wherein the subject has hyperlipidemia, hypertension, or insulin resistance. (claim 63).
Aslan et al. teaches insulin resistance seems to be associated with increased oxidative stress in H pylori infection (page 6865, abstract). Aslan et al. teaches H pylori is associated with severe gastric pathologies, including peptic ulcer (page 6865, right column, paragraph 1). The association of H pylori infection with insulin resistance has been reported (page 6865, right column, paragraph 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine McGrath in view of Kashimura et al. further in view of Aslan et al. in order to select the subject treated to have insulin resistance associated with H pylori-caused peptic ulcer. One of ordinary skill in the art would have been motivated to combine McGrath in view of Kashimura et al. further in view of Aslan et al. with a reasonable expectation of success because McGrath in view of Kashimura et al. teach treatment of subjects for ulcers of the digestive tract such as peptic ulcer, and Aslan et al. teaches a patient population known to be in need of treatment of peptic ulcer are those with H pylori infection that also cause insulin resistance, suggesting it would have been obvious to select this subject for treatment of peptic ulcer according to the method of McGrath in view of Kashimura et al.
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over McGrath (US 6,391,860, issued 21 May 2002, provided by Applicant in IDS filed 28 April 2023) in view of Kashimura et al. (US 5,968,906, issued 19 Oct 1999, provided by Applicant in IDS filed 28 April 2023) as applied to claims 60-62, 64, and 66-67 above, and further in view of Petersen et al. (Nucl. Med. Biol., 1989, 16(4), p389-395, cited in PTO-892).
McGrath in view of Kashimura et al. teaches as above.
McGrath in view of Kashimura et al. does not specifically teach the composition is administered to the subject about 2 hours to about 1 minute before the subject eats food (claim 65).
Petersen et al. teaches gastric emptying studies were performed on nine healthy volunteers and ten duodenal ulcer (DU) patients utilizing a dual radionuclide technique to assess simultaneously emptying rates of liquid and solid components of a meal. One gram of sucralfate was compared to placebo in separate days in a randomized double-blind crossover fashion. Subjects ingested the radiolabeled test meal 1 h after receiving medication, and gastric emptying was monitored. Slowing of gastric emptying, possibly mediated through aluminum ions, occurs in DU patients on sucralfate. This may be one mechanism by which sucralfate enhances healing and decreases recurrence of duodenal ulcer (page 389, abstract; page 390, left column, paragraphs 3-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine McGrath in view of Kashimura et al. further in view of Petersen et al. in order to select administering the composition 1h before the subject eats food. One of ordinary skill in the art would have been motivated to combine McGrath in view of Kashimura et al. further in view of Petersen et al. with a reasonable expectation of success because both McGrath in view of Kashimura et al. and Petersen et al. are drawn to a method of treating an ulcer of the digestive tract by administering sucralfate, and Petersen et al. suggests administering the medication 1 h before eating the meal to provide enhanced healing.
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.
Amended Claims 60-62 and 66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-8, and 13-19 of U.S. Patent No. 11,666,597 (reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because Reference claims 13-19 of the reference patent are drawn to a method of treating a subject, the method comprising administering to the subject the composition of claim 1. Reference claim 14 recites the composition provides a protective coating of the intestine to modulate nutritional absorption by the subject, addressing limitations of claim 60. Reference claim 15 recites the protective coating modulates absorption of glucose, addressing limitations of claim 66. Reference claims 16-18 recite the subject has pre-diabetes, type II diabetes, obesity, mucositis, or a microbial infection, addressing limitations of claim 62. Reference claim 19 recites the composition forms a coating on healthy mucosa of the intestine of the subject. Reference claim 1 recites the composition comprising an aluminum cross-linked sulfated agent. Reference claim 7-8 recites the composition is formulated into a liquid dosage form including an aqueous suspension, or a water-based composition addressing limitations of the claimed composition administered.
Regarding claim 61, Reference claims 1, 7-8, and 13-19 do not specifically recite the composition blocks nutrient sensing. However, MPEP 2112.01 especially at I. citing In re Best, 562 F.2d 1252, 195 USPQ 430 (C.C.P.A. 1977) and In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly recited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to show the products of the applicant and the prior art are not the same or that the prior art products do not necessarily possess the characteristics of the claimed product. In this case the Reference claims 1, 7-8, and 13-19 are drawn to administering the same composition as claimed which produces the same result of providing a protective coating of the intestine to modulate nutritional absorption by the subject, therefore there is reason to believe it also necessarily produces the same claimed result of blocking nutrient sensing.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 12 Sep 2025, have been fully considered and not found to be persuasive.
Regarding the above modified grounds of rejection, as there is no terminal disclaimer recorded it is proper to make this modified grounds of rejection.
Amended Claims 60-62 and 66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10-13 of U.S. Patent No. 11,666,597 (reference patent) in view of McGrath (US 6,391,860, issued 21 May 2002, provided by Applicant in IDS filed 28 April 2023).
Although the claims at issue are not identical, they are not patentably distinct from each other because Reference claims 10-13 of the reference patent are drawn to a method of treating a subject, the method comprising administering to the subject the composition of claim 1. Reference claim 11 recites the composition provides a protective coating of the intestine to modulate nutritional absorption by the subject, addressing limitations of claim 60. Reference claim 12 recites the subject has pre-diabetes, type II diabetes, obesity, mucositis, or a microbial infection, addressing limitations of claim 62. Reference claim 13 recites the composition forms a coating on healthy mucosa of the intestine of the subject. Reference claim 1 recites the composition comprising an aluminum cross-linked sulfated agent wherein the composition forms a paste with an aqueous liquid in the absence of acid. Reference claim 7-8 recites the composition is formulated into a liquid dosage form including an aqueous suspension, or a water-based composition addressing limitations of the claimed composition administered.
Reference claims 1 and 10-13 do not specifically recite the composition administered is a water-based, mucoadhesive composition (claim 60).
McGrath teaches as above. McGrath teaches formulating the paste comprising an aluminum cross-linked sulfated agent as a water-based, mucoadhesive composition.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1 and 10-13 in view of McGrath in order to formulate the composition administered as a water-based, mucoadhesive composition. One of ordinary skill in the art would have been motivated to combine Reference claims 1 and 10-13 in view of McGrath with a reasonable expectation of success because both the Reference claims and McGrath are drawn to composition comprising an aluminum cross-linked sulfated agent wherein the composition forms a paste with an aqueous liquid in the absence of acid that forms a coating on mucosa of the subject, and McGrath teaches formulating a paste comprising an aluminum cross-linked sulfated agent as a water-based, mucoadhesive composition for administration, suggesting it would have been obvious to formulate the composition of the Reference claims in the same manner in order to be administered for a similar purpose.
Regarding claims 61 and 66, Reference claims 1, 7-8, and 13-19 do not specifically recite the composition blocks nutrient sensing or the specific nutrient modulated. However, MPEP 2112.01 especially at I. citing In re Best, 562 F.2d 1252, 195 USPQ 430 (C.C.P.A. 1977) and In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly recited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to show the products of the applicant and the prior art are not the same or that the prior art products do not necessarily possess the characteristics of the claimed product. In this case the Reference claims 1, 7-8, and 13-19 are drawn to administering the same composition as claimed which produces the same result of providing a protective coating of the intestine to modulate nutritional absorption by the subject, therefore there is reason to believe it also necessarily produces the same claimed result of blocking nutrient sensing.
Conclusion
No claim is found to be allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at (571)270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JONATHAN S LAU/ Primary Examiner, Art Unit 1693