DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 28 May, 2025 has been entered.
Election/Restrictions
Applicants elected group I (method of treatment), specifically, gastrointestinal inflammation with propionate without traverse in the reply filed on 28 May, 2024.
In the response of 29 April, 2025, applicants amended claim 1 to treating IBD. Applicants have not elected this disorder, so these claims are withdrawn.
Claims Status
Claims 1-4, 7, 14, 15, 18, 24-27, 36, and 53-59 are pending.
Claims 1, 24, and 53 have been amended.
Claims 58 and 59 are new.
Claims 1-4, 7, 14, 18, 36, and 53-59 have been withdrawn due to an election restriction requirement.
Claim Objections
Claims 24-27 are objected to because of the following informalities: All these claims have a limitation that the agent is formulated to restrict delivery of the agent to the gastrointestinal tract of the subject. The plain meaning of this limitation is that the material is not allowed to leave the gastrointestinal tract. However, applicants have defined this phrase to “refer to a formulation that permits or facilitates the delivery of the agent or pharmaceutical composition described herein to the colon, large intestine, or small intestine in viable form” (paragraph 166). This difference between the plain English meaning of the phrase and the way applicants have defined it is confusing. Appropriate correction is required.
Withdrawn Rejections
The rejection of claim(s) 1-4, 7, 14, 15, 18, 24-27, and 53 under 35 U.S.C. 103 as being unpatentable over Tedelind et al (World J. Gastroenterol (2007) 13(20) p2826-2832) in view of Tragardh et al (Front. Bioengin. Biotech. (2017) 5 (24)) is hereby withdrawn as redundant to the rejection under 35 USC 102, below.
The rejection of claims 1-4, 7, 14, 15, and 18 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph due to lack of enablement is hereby withdrawn due to amendment and withdrawal of the rejected claims.
The rejection of claims 1-4, 7, 14, 15, 18 and 53 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, due to the addition of new matter is hereby withdrawn due to amendment and withdrawal of the rejected claims.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 24-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tedelind et al (World J. Gastroenterol (2007) 13(20) p2826-2832) with evidentiary support from Abraham et al (NEJM (2009) 361 p2066-2078).
Tedelind et al discuss the anti-inflammatory properties of short chain fatty acids (title). Experimentally, propionate (applicant’s elected species) reduces inflammation in a number of different experiments (p2828, 1st column, 4th paragraph to p2829, 1st column, 2nd paragraph). Propionate is explicitly suggested as a treatment for inflammatory conditions, such as IBD (p2831, 1st column, 2nd paragraph).
Tedelind et al states that proprionic acid can be used to treat an inflammatory gastrointestinal disorder (applicant’s elected invention) by reducing inflammation. While the reference is silent on binding to Ffar2, and the effects of that binding (other than reduction of inflammation), this is the identical therapy treating the identical disorder, so it will inherently have identical effects. As evidenced by Abraham et al, IBD is a disorder of the intestinal tract (p2066, 2nd paragraph), indicating that the material must reach this point to be effective (i.e. restricted to the intestinal tract by applicant’s definition). Thus, the reference anticipates claims 24-27.
response to applicant’s arguments
Applicants argue that this rejection does not meet the limitation of restricted to the intestinal tract.
Applicant's arguments filed 29 April, 2025 have been fully considered but they are not persuasive.
The rejection has been amended to show how it meets this limitation.
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.
first rejection
Claims 24-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 9,693,977, with evidentiary support from Smith et al (Science (2013) 341(6145)). Although the claims at issue are not identical, they are not patentably distinct from each other because the competing claims anticipate the examined claims.
Competing claim 1 is a method of increasing the quantity of colonic regulatory T-cells in a patient in need thereof, comprising administering one or more short chain fatty acid compounds. Competing claim 7 lists specific compounds, including propionic acid. As evidenced by Smith et al, these regulatory T-cells regulate intestinal inflammation, a subgenus of applicant’s elected disorder, making such patients in need thereof. Note that, as this is a colonic location, the material must have arrived there, so the limitation of restricted to the gastrointestinal tract is met by applicant’s definition of the phrase.
response to applicant’s arguments
Applicants have argued that the competing claims do not meet the limitation of restriction to the gastrointestinal tract.
Applicant's arguments filed 29 April, 2025 have been fully considered but they are not persuasive.
The rejection has been amended to show how it meets this limitation.
second rejection
Claims 24-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 8 of U.S. Patent No. 10,105,329. Although the claims at issue are not identical, they are not patentably distinct from each other because the competing claims anticipate the examined claims.
Competing claim 2 describes a method of treating colonic inflammation, comprising administering one or more short chain fatty acid compounds. Competing claim 8 lists specific compounds, including propionic acid. Note that this is part of the intestinal tract, so the material must have arrived at that location. Thus, the competing claims meet the limitation of restricted to the gastrointestinal tract, by applicant’s definition.
response to applicant’s arguments
Applicants have argued that the competing claims do not meet the limitation of restriction to the gastrointestinal tract.
Applicant's arguments filed 29 April, 2025 have been fully considered but they are not persuasive.
The rejection has been amended to show how it meets this limitation.
New Rejections
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 24-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fisher (Bonappetit, issue of 16 March, 2017) with evidentiary support from Eckelkamp (Levels blog entry of 8 June, 2022) and Abraham et al (NEJM (2009) 361 p2066-2078).
Fisher discusses sauerkraut (title). A chef was diagnosed with Crohn’s disease and inflammatory bowel disease (2nd page, 1st paragraph), which responded to consumption of fermented foods, especially sauerkraut (3d page, 1st paragraph). As evidenced by Eckelkamp, fermented foods, such as sauerkraut contain short chain fatty acids, including propionate (4th page, 2nd paragraph). Note that this is the same drug that applicants are using, so it will inherently bind to the same receptors and have the same effects.
Fisher discusses treating Crohn’s disease and IBD, with sauerkraut, which contains propionate. As evidenced by Abraham et al, IBD and Crohn’s disease are inflammatory disorders of the intestinal tract (p2066, 2nd paragraph), indicating that the material must reach this point to be effective (i.e. restricted to the intestinal tract by applicant’s definition). As this is the same active ingredient as used by applicants, it will inherently hit the same receptors and have the same effects. Thus, this reference anticipates claims 24-27.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658