DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 9, 2026 has been entered.
Claims 1-32, 34-36, 38, 40-43, 46-47, and 56-67 have been canceled. Claims 33, 37, 39, 44-45, and 48-55 are pending, Claims 37, 39, 44-45, and 54 have been withdrawn, and Claims 33, 48-53, and 55 have been considered on the merits, insofar as they read on the elected species of P. goldsteinii and an enteric coating. All arguments have been fully considered.
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 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.
Claims 33, 48, 50-53, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Grant et al (WO 2016/203220 A1; 12/22/2016. Cited on IDS) in view of Sanz Herranz et al (US 8,501,169 B2, 8/6/2013. Cited on IDS).
The instant claims recite a pharmaceutical or probiotic composition for delivery to the gastrointestinal system comprising a therapeutically effective amount of inactivated Parabacteroides goldsteinii and an excipient, wherein the composition comprises Lactobacillus gasseri, Lactobacillus reuteri, or heat-inactivated Parabacteroides goldsteinii.
Grant teaches a composition comprising a therapeutically effective amount (p.24 line 25) of a bacterial strain of the genus Parabacteroides (Title, p.8 line 26) and one or more excipients (p.4 line 26-27) for delivery to the gastrointestinal system (p.22 line 30, p.24 line 10), wherein the Parabacteroides species includes Parabacteroides goldsteinii (p.8 line 31), the bacterial strain may be inactivated (p.28 line 12), and said composition is a pharmaceutical product (p.24 line 23) or a probiotic composition (p.24 line 24). The composition is formulated in freeze-dried form (p.24 line 3). The composition is administered orally and in the form of a tablet or capsule (p.24 line 18). The composition comprises citrus fibers (a plant fiber, an enteric coating) (p.25 line 12).
Grant does not teach heat-inactivated Parabacteroides goldsteinii (claim 33).
However, Grant does teach the composition comprises Parabacteroides strains that may be useful for modulating a patient’s immune system (p.16 line 18), wherein said Parabacteroides strains include Parabacteroides goldsteinii that may be inactivated (p.28 line 12). Sanz Herranz teaches non-viable microorganisms inactivated by different procedures including heat continue to be useful for therapeutic or preventive purposes such as immunomodulatory purposes (col.11 line 22-26), wherein said microorganisms include Parabacteroides spp. (col.7 line 50).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate heat-inactivated Parabacteroides goldsteinii, since Grant discloses compositions comprise inactivated bacterial strains including Parabacteroides goldsteinii may be useful for modulating a patient’s immune system, and Sanz Herranz discloses that heat-inactivated microorganisms continue to be useful for therapeutic or preventive purposes such as immunomodulatory purposes, wherein said microorganisms include Parabacteroides spp.. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to incorporate heat-inactivated Parabacteroides goldsteinii, with a reasonable expectation for successfully obtaining a composition.
The limitation of “wherein the pharmaceutical or probiotic composition is resistant to degradation in the stomach but releases bacteria in the small intestine and/or large intestine of the subject” in claim 51 is regarded as intended use. The claiming of a new use, function or unknown property does not necessarily make the composition patentable. The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103. (MPEP 2112)
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Grant et al (WO 2016/203220 A1; 12/22/2016. Cited on IDS) in view of Sanz Herranz et al (US 8,501,169 B2, 8/6/2013. Cited on IDS) as applied to claims 33, 48, 50-53, and 55 above, further in view of György et al (Rev Pharmacol Toxicol. 2015;55:439-464.).
References cited above do not teach extracellular vesicles from Parabacteroides goldsteinii (claim 49).
However, Grant does teach compositions comprise Parabacteroides strains including Parabacteroides goldsteinii (p.8 line 31) for therapeutic uses (p.11 line 32). György teaches that the therapeutic potential of extracellular vesicles (EVs) presents exciting new avenues for intervention in many diseases. Promising aspects of EVs include the ability of EVs to transport genetic information, as well as drugs and proteins, to target specific cell types and to increase the stability of therapeutic cargoes in vivo (p.17 last para).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate extracellular vesicles from Parabacteroides goldsteinii, since Grant discloses compositions comprise Parabacteroides strains including Parabacteroides goldsteinii for therapeutic uses, and György discloses that extracellular vesicles have beneficial effects and therapeutic potential. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to incorporate extracellular vesicles from Parabacteroides goldsteinii, with a reasonable expectation for successfully obtaining a composition.
Response to Arguments
Applicant argues that cited references do not teach the instant amendments. However, these arguments are moot in light of the new rejections above in view of applicant’s amendments.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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, Curtis Mayes can be reached on (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Lynn Y Fan/
Primary Examiner, Art Unit 1759
Prosecution Insights