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 .
Applicant’s amendment and response filed on 11/3/2025 have been received and entered into the case. Claims 1-32, 34, 38, 40-43, 46-47, and 56-67 have been canceled. Claims 33, 35-37, 39, 44-45, and 48-55 are pending, Claims 36-37, 39, 44-45, and 54 have been withdrawn, and Claims 33, 35, 48-53, and 55 have been considered on the merits, insofar as they read on the elected species of P. goldsteinii and an enteric coating.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.
Withdrawn Objections
Objections are withdrawn in view of applicant’s amendments.
Withdrawn Rejections
Rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of applicant’s amendments.
Rejections under nonstatutory double patenting are withdrawn in light of applicant’s filling of Terminal Disclaimer.
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 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.
Claims 33, 48, 50-53, and 55 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grant et al (WO 2016/203220 A1; 12/22/2016. 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.
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).
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)
Therefore the reference anticipates the claimed subject matter.
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.
Claim 35 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) as applied to claims 33, 48, 50-53, and 55 above, further in view of Sanz Herranz et al (US 8,501,169 B2, 8/6/2013. Cited on IDS).
Grant does not teach heat-inactivated bacterial strain (claim 35).
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 bacterial strains such as 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. 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 bacterial strains such as Parabacteroides goldsteinii, with a reasonable expectation for successfully obtaining a composition.
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) 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.).
Grant does 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 Grant relates to use of live bacteria to treat inflammatory or autoimmune disease, in contrast, the instant pending claims relate to pharmaceutical or probiotic compositions comprising inactivated (i.e., killed) bacteria for delivery to the gastrointestinal system, that Grant focuses on different species of bacteria than P. goldsteinii as instantly claimed, that one of skill would not have had any reason based on Grant to believe that a different species, selected from all the species of Parabacteroides would be useful for any particular purpose, and that one of skill would further not have had any reason to believe that an inactivated (i.e., killed) bacteria selected from all the species of Parabacteroides would be useful for any particular purpose.
These arguments are not found persuasive because the limitation of “for delivery to the gastrointestinal system” is an intended use limitation. 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. (MPEP 2112) Therefore, rejected claims are directed to a pharmaceutical or probiotic composition comprising a therapeutically effective amount of inactivated Parabacteriodes goldsteinii and an excipient. Grant does teach a pharmaceutical product (p.24 line 23) or a probiotic composition (p.24 line 24) 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), wherein the Parabacteroides species includes Parabacteroides goldsteinii (p.8 line 31), and the bacterial strain may be inactivated (p.28 line 12). It is noted that a vaccine composition is a pharmaceutical composition.
Applicant argues that Herranz does not cure the deficiencies of Grant, that Herranz teaches away from the idea that the microorganisms in the list would necessarily be therapeutic, that examiner uses improper hindsight, and that Figs. 7A-B in the instant specification show unexpected results.
These arguments are not found persuasive because Grant does teach a pharmaceutical product (p.24 line 23) or a probiotic composition (p.24 line 24) comprising a therapeutically effective amount (p.24 line 25) of a bacterial strain of the genus Parabacteroides (Title, p.8 line 26) including Parabacteroides goldsteinii (p.8 line 31). Herranz is relied upon to demonstrate heat-inactivated bacterial strain. In addition, “disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or non-preferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).” (MPEP 2123) Further, “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).” (MPEP 2141.02) In the instant case, applicants have not pointed to the specific teachings of the Herranz reference to show that the said reference actually “criticize, discredit or otherwise discourage” obtaining a pharmaceutical or probiotic composition comprising a therapeutically effective amount of inactivated Parabacteroides goldsteinii. Furthermore, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, Grant does teach a pharmaceutical or probiotic composition comprising a therapeutically effective amount of a bacterial strain of the genus Parabacteroides including Parabacteroides goldsteinii, wherein the bacterial strain may be inactivated. And Herranz does teach heat-inactivated microorganisms continue to be useful for therapeutic or preventive purposes, wherein said microorganisms include Parabacteroides spp.. Finally, unexpected results do not apply to 102 rejections. In the instant case, there was no comparison of the claimed invention with the closest prior art, since the closest prior art does teach a pharmaceutical or probiotic composition comprising a therapeutically effective amount of a bacterial strain of the genus Parabacteroides including Parabacteroides goldsteinii, wherein the bacterial strain may be inactivated. Therefore, lack of basis for judging the practical significance of data with regard to the disclosed unexpected results.
Applicant argues that Gyorgy does not describe or relate to P. goldsteinii, that Gyorgy does not relate to or describe inactivated P. goldsteinii, and that Gyorgy does not relate to or describe pharmaceutical or probiotic compositions comprising inactivated P. goldsteinii.
These arguments are not found persuasive because Grant does teach a pharmaceutical product (p.24 line 23) or a probiotic composition (p.24 line 24) comprising a therapeutically effective amount (p.24 line 25) of a bacterial strain of the genus Parabacteroides (Title, p.8 line 26) including Parabacteroides goldsteinii (p.8 line 31). Gyorgy is relied upon to demonstrate extracellular vesicles from Parabacteroides goldsteinii.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 extension fee 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.
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.
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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.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759