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 .
Claim Amendments
Claim 1 has been amended to omit “the growth medium of Parabacteroides goldsteinii, or vesicles from Parabacteroides goldsteinii”, as well as add “wherein:(i) the Parabacteroides goldsteinii bacteria have been inactivated via exposure to heat, a peroxide, ionizing radiation, air plasma, ultrasound under pressure, an alcohol,high hydrostatic pressure (HHP), or pulsed electric field (PEF); and/or (ii) the pharmaceutical or probiotic composition is resistant to degradation in the stomach of a mammalian subject but releases bacteria in the small intestine and/or large intestine of the subject”.
Claims 44-46 and 48-51 have also been amended to obviate claims objections.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 10/03/2025 is in compliance with the provisions of 37 C.F.R. 1.97 and all references have been fully considered.
Drawings
RE: Objection to the drawings
The substitute drawings for Figures 9-10 and 11A-11B resolved previously identified issues, but Figures 12A and 12B have informalities that were overlooked.
New objection
The drawings are objected to because of the following minor informalities:
(i) “Parabacteroides” is misspelled as “Parabacteriodes” in Figure 12A; and
(ii) the genus names “Parabacteriodes” and “Lactobacillus” in Figures 12A and 12B are not properly written in italics.
Applicant must re-submit Figures 9-10 and 11A-11B along with corrected Figures 12A-12B in reply to this Office action in order 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.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Specification
RE: Objection to the specification
The amendments to the specification are sufficient to overcome the objection, which has been withdrawn.
Claim Objections
RE: Objection to the claims
All minor informalities in claims 44-46 and 49-51 have been corrected. Thus, the claim objections have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
RE: Rejection of claims 48 and 50 under 35 U.S.C. 112(b)
The amendments in claim 48 and 50 have rectified the issue of indefiniteness. The rejections have therefore been withdrawn.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
RE: Rejection of claims 43, 45-47, and 51-56 are rejected under 35 U.S.C. 101
Traverses of rejections is based on the incorporation of limitations of claims that were not rejected in the last office action.
Applicant’s traversal has been fully considered and is found persuasive. Specifying that the bacteria are inactivated via one of the specified processes, and/or the composition is resistant to degradation in a mammalian subject’s stomach but releases bacteria in the small intestine and/or large intestine, leads to the recited natural product having properties (i.e., cells become non-replicating but structurally intact and/or significantly changed bioavailability) that are markedly different from naturally occurring Parabacteroides goldsteinii. These limitations are sufficient to render the claims subject matter eligible.
Hence, the rejections have been withdrawn.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
RE: Rejection of claims 43-47, 51-52, and 57-58 under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Goodman et al.
Applicant traverses the rejections because Goodman et al. does not disclose all elements of the amended claims.
The traversal has been fully considered and is found persuasive. It is conceded that the cited prior art provides a generic disclosure of bacterial extracellular vesicles and whole cells and does not teach the limitations added in claim 43.
Accordingly, the rejections of record have been withdrawn.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
RE: Rejection of claims 43-52 and 57-58 under 35 U.S.C. 103 as being unpatentable over Goodman et al. in view of Hussan et al.; claims 43-47 and 51-58 under 35 U.S.C. 103 as being unpatentable over Goodman et al. in view of Ramos-Molina et al. and Sadasivan et al.
Applicant points out that Goodman et al.’s extracellular vesicles and whole cells are derived from a long list of bacteria. Since some of the listed bacterial species cause diseases, it is argued that said prior art teaches away from using them for therapeutic purposes and formulating them in a pharmaceutical or probiotic composition for gastrointestinal delivery. There is allegedly no reason to select one of the multitude of bacteria to treat a particular disease and any therapeutic response is supposedly unpredictable. Applicant also asserts that Goodman et al. teaches treating a laundry list of different diseases that focuses on cancer. In addition, applicant contends that the other cited references do not cure the deficiencies of Goodman et al..
All arguments have been fully considered and are found unpersuasive. Although Goodman et al. does not provide a reason to specifically choose Parabacteroides goldsteinii from the bacteria listed in Table 1, teachings of other prior art (such as the IDS-cited document WO 2016/203220 A1) provide motivation for use of said species. Accordingly, new grounds of obviousness rejections are set forth below.
With regards to applicant’s argument that Goodman et al. “teaches away from the idea that the microorganisms on the list would necessarily be therapeutic” (fourth par. in page 13, Applicant Arguments), it is respectfully submitted that therapeutic properties are not identical for all strains of a given bacterial species as they can vary from one strain to another. For example, Clostridium difficile is known to generally cause gastrointestinal disorders but Gerding et al. (Journal of American Medical Association 2015, Vol. 313, pages 1719-1727) shows that C. difficile strain M3 is nontoxigenic and can significantly reduce C. difficile infection (Abstract). Moreover, Goodman et al. teaches that the bacteria can be modified in order to attain desirable properties such as enhanced immunomodulatory/therapeutic effect and immune activation, as well as to target particular cell types (par. [81]). A person with ordinary skill in the art before the effective filing date of the claimed invention would have thus recognized that Goodman et al. does not teach away from therapeutic applications of bacteria in Table 1 especially since said prior art explicitly teaches that the listed strains are examples of bacteria that can be used for disease treatment.
Furthermore, MPEP § 2123 states that “a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments”. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). Preferred embodiments do not also constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). So even though Goodman et al. appears to focus on treating cancer, it does not negate other embodiments wherein bacterial extracellular vesicles and whole cells can be utilized to treat other diseases/disorders such as autoimmune diseases and inflammatory diseases (par. [194]-[196]).
New grounds of rejection
Claims 43-52 and 57-58 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman et al. (Pub. No. WO 2019/051380A1) in view of Grant et al. (Pub. No. WO 2016/203220 A1; IDS-cited), Wu et al. (Gut 2019, Vol. 68, pages 248-262), and Hussan et al. (IOSR Journal of Pharmacy 2012, Vol. 2, pages 5-11), as evidenced by Sakamoto et al. (International Journal of Systematic and Evolutionary Microbiology 2006, Vol. 56, pages 1599-1605).
Goodman et al. provides pharmaceutical compositions comprising bacterial extracellular vesicles (EVs) that can be used to treat and/or prevent a disease. In some embodiments, the pharmaceutical compositions also comprise whole bacteria (par. [2])
The whole bacteria can be killed/attenuated and comprise one or more of the bacteria listed in Table 1 and/or Table 2 (par. [2] and [100]). The cells of whole bacteria can be killed/attenuated using an antibiotic, irradiation, or heat, and can be administered with the EVs orally, intravenously, intraperitoneally, or nasally (par. [89], [332], [342], [352], [363], [371], [383], [392], [398], [412], and [419]). Examples of applicable bacteria include Parabacteroides goldsteinii, Lactobacillus gasseri, and L. reuteri (Table 1, pages 60-61 and 72).
The pharmaceutical compositions can be added with active and/or inactive materials to form a final product, which may be in single dosage unit or multi-dose format (par. [127]). Suitable product forms include tablets and capsules (par. [139]).
The pharmaceutical compositions of Goodman et al. are comparable to the claimed invention as explained below:
Regarding claim 43: the disclosed pharmaceutical compositions comprising EVs and whole bacteria such as Parabacteroides goldsteinii, P. distasonis, P. gordonii, and P. johnsonii, and P. merdae, is analogous to “A pharmaceutical or probiotic composition comprising a therapeutically effective amount of inactivated Parabacteroides goldsteinii, wherein the composition is formulated for delivery to the gastrointestinal system”.
Although P. goldsteinii is only one of the many bacterial strains in Goodman et al.’s Table 1, Grant et al. teaches that Parabacteroides strains are useful for treating cancer, inflammatory diseases, and autoimmune diseases (Abstract; lines 1-29, page 2), wherein said strains can be killed, inactivated, or attenuated (line 12, page 28). Examples of suitable Parabacteroides are P. goldsteinii, P. distasonis, P. johnsonii, and P. merdae (lines 30-31, page 8) such as the strains disclosed by reference #16 (line 7, page 9), which include P. goldsteinii strain JCM 13446 according to Sakamoto et al. (Abstract, page 1599). Wu et al. demonstrates that P. goldsteinii JCM 13446 not only decreased inflammation but also lowered insulin resistance and reduced obesity (Abstract; Figure 6, page 257; Figure 7, page 258). Due to the strain’s anti-inflammatory, anti-obesogenic, and anti-diabetic effects, P. goldsteinii JCM 13446 can be used to treat obesity and associated metabolic disorders (last par. in right col., page 260). A person with ordinary skill in the art before the effective filing date of the claimed invention would have therefore been motivated by Wu et al. to choose a P. goldsteinii strain like JCM 13446 as the bacteria in the disclosed pharmaceutical compositions. It can be expected that administering pharmaceutical compositions comprising a P. goldsteinii strain like JCM 13446 would facilitate treatment of inflammation, obesity, and other metabolic disorders. Obviousness is based on the rationale that some teaching, suggestion, or motivation in the prior art would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP § 2143.01 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Goodman et al. teaches that the whole bacteria can be killed/attenuated, which leads to inactivation, and can be administered at a dose sufficient to treat or prevent a disease like a metabolic disease or disorder (par. [185]-[186], [192], and [205]), thereby meeting the requirement that the P. goldsteinii is “inactivated” and present at “a therapeutically effective amount”.
The teaching that whole bacteria like P. goldsteinii are killed or attenuated using heat meets the limitations “wherein the Parabacteroides goldsteinii has been inactivated via exposure to a peroxide, ionizing radiation, heat, air plasma, ultrasound under pressure, an alcohol, high hydrostatic pressure (HHP), or pulsed electric field (PEF)”
The pharmaceutical compositions being formulated as single dosage unit like tablets and capsules (and can be orally administered) satisfies “wherein the composition is formulated for delivery to the gastrointestinal system”.
Goodman et al. is different from the instant claim in that it does not specify that the disclosed pharmaceutical compositions are formulated to be “resistant to degradation in the stomach but releases bacteria in the small intestine and/or large intestine of the subject”.
Nevertheless, formulating compositions containing biological materials like bacteria with an enteric coating is known in the art. Hussan et al., for example, teaches that an enteric coating is a barrier that control the location of oral medication in the digestive system where it is absorbed. An enteric coating remains insoluble at low pH and therefore prevents release of the contents before the small intestine is reached, but becomes soluble as the pH increases when exposed to the intestinal fluid. Typical materials used as enteric coatings include CAP, CAT, PVAP, HPMCP, fatty acids, waxes, shellac, plastics, and plant fibers. Hussan et al. teaches that formulating a tablet or capsule with an enteric coating offers various advantages such as protection of active ingredients from the acidic environment of the stomach, prevention of gastric distress or nausea due to irritation, optimal absorption in the small intestine, provision of a delayed-release component for repeat action, and minimization of first pass metabolism (Abstract; section II, page 6).
A person with ordinary skill in the art before the effective filing date of the claimed invention would have been motivated by Hussan et al.’s teachings to modify the pharmaceutical compositions of Goodman et al. by preparing them with an enteric coating using a material like CAP, CAT, PVAP, HPMCP, fatty acids, waxes, shellac, plastics, or plant fibers because of the various benefits it provides. The presence of an enteric coating would prevent the whole bacteria and EVs from being degraded in the subject’s stomach and would ensure they are delivered to the small intestine. Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. Id.
Hence, claim 43 is obvious over Goodman et al. in view of Grant et al., Wu et al., and Hussan et al., as evidenced by Sakamoto et al..
Regarding claim 44: the whole bacteria like P. goldsteinii being killed/attenuated using heat fulfills “wherein the ccomposition comprises heat-inactivated Parabacteroides goldsteinii”.
Regarding claim 45: the whole bacteria can comprise other bacterial species aside from P. goldsteinii, such as L. gasseri (Table 1, page 60) and L. reuteri (Table 1, page 61), which are the same as “wherein the pharmaceutical or probiotic composition further comprises Lactobacillus gasseri or Lactobacillus reuteri”.
Regarding claim 46: other bacterial species from which the EVs can be derived include Lactobacillus gasseri and Lactobacillus reuteri, thus satisfying “wherein the pharmaceutical or probiotic composition further comprises extracellular vesicles from Lactobacillus gasseri or extracellular vesicles from Lactobacillus reuteri”.
Regarding claim 47: the modified pharmaceutical compositions being formulated for oral administration meets “wherein the pharmaceutical or probiotic composition is formulated for oral, colonic, enema, orogastric, or nasogastric administration”.
Regarding claim 48: the modified pharmaceutical or probiotic composition being formulated to have an enteric coating corresponds to “resistant to degradation in the stomach but releases bacteria in the small intestine and/or large intestine of the subject”.
Regarding claim 49: the enteric coating in the modified pharmaceutical compositions of Goodman et al. and Hussan et al. satisfies “wherein the pharmaceutical or probiotic composition comprises an enteric coating, chitosan-alginate beads, or a hydrogel”.
Regarding claim 50: the enteric coating being made with CAP, CAT, PVAP, HPMCP, fatty acids, waxes, shellac, plastics, or plant fibers is the same as “the enteric coating is a fatty acid, a wax, a shellac, a plastic such as a phthalate, CAP, CAT, PVAP, HPMCP, or a plant fiber”.
Regarding claim 51: the pharmaceutical compositions can be prepared as liquids, pastes, and jellies, which are product forms that do not comprise an enteric coating. This teaching fulfills “wherein the pharmaceutical or probiotic composition does not comprise an enteric coating”.
Regarding claim 52: the pharmaceutical compositions being formulated as tablets or capsules corresponds to “wherein the pharmaceutical or probiotic composition is a tablet or capsule”.
Regarding claims 57-58: the teaching that whole bacteria like P. goldsteinii are killed or attenuated using heat meets the limitations “wherein the Parabacteroides goldsteinii has been inactivated via exposure to a peroxide, ionizing radiation, heat, air plasma, ultrasound under pressure, an alcohol, high hydrostatic pressure (HHP), or pulsed electric field (PEF)” and “wherein the Parabacteroides goldsteinii has been inactivated via exposure to a peroxide, ionizing radiation, or heat”, respectively.
Claims 43-58 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman et al. (Pub. No. WO 2019/051380A1) in view of Grant et al. (Pub. No. WO 2016/203220 A1; IDS-cited), Wu et al. (Gut 2019, Vol. 68, pages 248-262), Hussan et al. (IOSR Journal of Pharmacy 2012, Vol. 2, pages 5-11), Ramos-Molina et al. (Frontiers in Nutrition 2019, Vol. 6, article 24, pages 1-15), and Sadasivan et al. (European Journal of Pharmacology 2014, Vol. 729, pages 94-99), as evidenced by Sakamoto et al. (International Journal of Systematic and Evolutionary Microbiology 2006, Vol. 56, pages 1599-1605).
The teachings of Goodman et al., Grant et al., Wu et al., Hussan et al., and Sakamoto et al. are described previously and applied herein. These prior art are found to render claims 43-52 and 57-58 obvious.
Goodman et al.’s pharmaceutical compositions are similar to the following claims:
Regarding claim 53: the pharmaceutical or probiotic composition of claim 43 has the additional limitation “further comprises spermine or spermidine”.
What differentiates Goodman et al. from the instant claim is that the disclosed composition does not contain spermine or spermidine.
Despite this, Ramos-Molina et al. teaches that spermidine and spermine are widely distributed polyamines that are essential for cellular functions. For instance, inactivation of genes controlling the biosynthesis of spermidine or its precursor putrescine is embryo-lethal in mice given that they interact with nucleic acids and can therefore affect many processes in which DNA, RNA, or proteins act as substrates (Abstract, page 1; last par., left col. and first par., right col., page 2).
Moreover, dysregulation of polyamine metabolism has been shown to affect regulation of glucose, lipid, and energy homeostasis. Studies suggest that increased levels of polyamines in white adipose tissue, liver, or skeletal muscle stimulate energy expenditure and confer resistance to diet-induced obesity and non-alcoholic fatty liver disease. Obesity animal models also show altered levels of polyamines in adipose tissue, liver, pancreatic islets, and urine (last par., right col., page 7). In diet-induced obesity mouse models, a high-dose daily administration of spermidine or spermine has been shown to be an effective strategy for weight loss and improvement of the glycemic status. Spermidine supplementation, for example, resulted in a significant decrease in body weight, increased glucose tolerance and insulin sensitivity and ameliorated hepatic steatosis in high-fat diet-induced obese mice. Administration of spermidine is also shown to prevent lipid accumulation and necrotic core formation in vascular smooth muscle cells through the induction of cholesterol efflux in an experimental model of atherosclerosis. Similarly, treatment with exogenous spermine led to decreased body weight and fasting glucose, as well as improved glucose tolerance in diet-induced obese mice. Spermine is also found to enhance glucose transport and the conversion of glucose into triacylglycerols in cultured rat adipocytes, and increase the ability of insulin to bind to its own receptor (first two par., left col., page 8).
Furthermore, Sadasivan et al. demonstrates that administering 10 mg of spermine per kg body weight to high fat diet-induced obese mice twice daily for 4 weeks decreased body weight by 24% and fasting glucose level by 18% (Abstract, page 94; section 2.1, page 95). Exogenous administration of spermine is therefore useful for controlling glucose and lipid metabolism in obese subjects (first par., left col., page 95).
One with ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to add spermine and/or spermidine to the modified pharmaceutical compositions comprising P. goldsteneii whole bacteria and EVs. Such addition is expected to help treat a metabolic disease or disorder based on the teachings of Ramos-Molina et al. and Sadasivan et al.. Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art references to arrive at the claimed invention. Id.
Claim 53 is therefore obvious over Goodman et al. in view of Grant et al., Wu et al., Hussan et al., Ramos-Molina et al., and Sadasivan et al., as evidenced by Sakamoto et al..
Regarding claims 54-56: the pharmaceutical or probiotic composition of claim 53 is further limited to comprise “spermine”, “spermidine”, or “both spermine and spermidine”, respectively, which are considered obvious as explained above.
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.
RE: Nonstatutory double patenting rejections
The terminal disclaimers filed on 8/12/2025, disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,541,083 and the full statutory term of any patent granted on co-pending application 18/060134, have been reviewed and accepted, thereby obviating the double patenting rejections over said patent and co-pending application.
With regards to co-pending Application No. 18/619514, applicant argues that it is a later-filed, unrelated application and is thus not subject to a double patenting rejection in view of MPEP § 804(I)(B)(1)(b)(i). Since the instant claims are not allowable, the double patenting rejection over the co-pending application is maintained.
Maintained double patenting rejection
Claims 43-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15, 17-29, 32-40, 45-49, 53, 55, and 59 of co-pending Application No. 18/619514.
Co-pending application 18/619514 is drawn to a method of treating a disease in a mammalian subject comprising administering to the mammalian subject a therapeutically relevant amount of a composition, as well as a pharmaceutical or probiotic composition. Like the instant application’s pharmaceutical or probiotic composition, the co-pending application’s pharmaceutical or probiotic composition comprises: (i) P. goldsteinii, the growth medium of P. goldsteinii, or vesicles from P. goldsteinii, and (ii) a biphosphate; wherein the composition is formulated for delivery to the gastrointestinal system.
The P. goldsteinii can be heat-inactivated and additionally combined with L. gasseri, L. reuteri, Akkermansia muciniphila, or extracellular vesicles from P. goldsteinii. In one embodiment, the composition further comprises spermine and/or spermidine.
The pharmaceutical or probiotic composition can be resistant to degradation in the stomach but releases bacteria in the small intestine and/or large intestine of the subject. It can be provided in the form of a tablet or capsule. In some embodiments, it comprises an enteric coating, chitosan-alginate beads, or a hydrogel, wherein the enteric coating can be a fatty acid, a wax, a shellac, a plastic such as a phthalate, CAP, CAT, PVAP, HPMCP, or a plant fiber. In another embodiment, the pharmaceutical or probiotic composition does not comprise an enteric coating.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 10/03/2025 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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, Adam Weidner can be reached at (571) 272-3045. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651