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 .
Election/Restrictions
Claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on April 14, 2026. In response to applicant’s assertion that there would be no search and examination burden, the examiner respectfully points out that the claimed can be used for materially different use, and there may be non-prior art issues under 35 U.S.C. §112 (a) and/or §101 present in one set of claims and not present in the other. Searching and examining the both product and process claim groups would impose burden on the examiner.
The requirement is still deemed proper and is therefore made FINAL.
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.
(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 15-17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ratay et al. (“TRI microspheres prevent key signs of dry eye disease in a murine, inflammatory model”, Sci Rep 7:17527, 2017, cited in IDS) (“Ratay” hereunder).
Claim 15 is directed to a composition for use in the treatment of a gastrointestinal condition, wherein the composition comprises at least two of:
a) a controlled release microparticle comprising a transforming growth factor beta (TGF-β) polypeptide;
b) a controlled release microparticle comprising an interleukin polypeptide; or
c) a controlled release microparticle comprising a macrolide.
Ratay discloses an injection composition comprising a combination of microspheres comprising TGF- β polypeptide, Rapamycin and IL-2 (interleukin-2) polypeptide. The microparticles provide “local controlled release system” and “a slow continuous release”. See abstract; p. 3, Characterization of TRI MS: IL-2, TGF-β1 and Rapamycin; instant claims 15 and 19.
The present claim 15 recites “for use in the treatment of a gastrointestinal condition”. The phrase requires no structural limitation and is considered a preamble reciting the intended future use or purpose of the composition. See MPEP 2111.02. As the Ratay composition is suitable for administration in vivo, the prior art composition is capable and suitable for the presently recited intended use. It also follows that the prior art composition is suitable and capable for treating the specifically defined gastrointestinal conditions in claim 16.
Regarding claim 17, the microparticles comprise poly(lactic-co-glycolic) acid (PLGA-50:50: lactide: glycolide, acid terminated) (MW:7k-17k) and PEG-PLGA.
Claims 15-17, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Little et al. (WO 2013112456 A1, published on August 1, 2013, cited in IDS) (“Little” hereunder).
Little discloses a combination of controlled-release microparticles individually comprising IL-2 polypeptide, TGF-β polypeptide and rapamycin. Abstract; Table 2. The composition is useful in treating immunological disorders and/or transplant rejection reactions locally, without systemic immunosuppression. See the present claims 15 and 19.
The present claim 15 recites “for use in the treatment of a gastrointestinal condition”. The phrase requires no structural limitation and is considered a preamble reciting the intended future use or purpose of the composition. As Little teaches an embodiment wherein the target tissue is an intestinal or gut tissue, it is viewed that the prior art composition is capable and suitable for the presently recited intended use. The reference particularly mentions adding a vasoactive intestinal peptide to treat Crohn’s disease. See p. 31, line 27. It also follows that the prior art composition is suitable and capable for treating the specifically defined gastrointestinal conditions in claim 16.
Regarding claim 17, Little discloses that polyethylene glycol and poly(lactide-co-glycolide) polymer are used to make the microparticles. See p. 4, line 19 – p. 5, line 6.
Regarding claim 20, the reference discloses kits for using the composition. See p. 42, lines 17 – 30.
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.
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.
Claims 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ratay as applied to claims 15-17 and 19 as above, and further in view of DeFail et al. (“Controlled release of bioactive TGF-β1 from microspheres embedded within biodegradable hydrogels”, Biomaterials, March 2006, vol. 27, Iss 8, p. 1579-1585) (“DeFail” hereunder).
Ratay fails to teach hydrogel formulations.
DeFail teaches controlled release microspheres comprising TGF-β, the microspheres are embedded within biodegradable hydrogels to prevent initial burst. See abstract. The reference teaches that the hydrogel can act as a scaffold that “permits containment and conformation of the spheres to the defect shape” and provide “controlled release of TGF-β1 to a cartilage wound site.” See Introduction. The reference further teaches that combining microspheres and scaffolds for controlled drug delivery is commonly studied in biomedical and pharmaceutical projects. See pp 1582-1583, bridging paragraph.
Given the teachings of Ratay of the TRI microspheres which slowly release the active ingredients that increase the regulatory T-cells in the eye to stop inflammation, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of Ratay and combine the microspheres with hydrogels to research and study the release behaviors and potential for localized delivery system of the medicaments. As DeFail specifically teaches that such study had been conducted for developing controlled drug delivery, the POSITA would have had a reasonable expectation of success in combining the teachings of the references to conduct further research and study on developing controlled release microparticle formulations.
Regarding claim 20, although the disclosed claims does not specifically mention a kit, it is viewed prima facie obvious for a POSITA to provide materials to conveniently use the disclosed composition.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Little as applied to claims 15-17, 19 and 20 as above, and further in view of DeFail.
Little fails to teach hydrogel formulations.
DeFail teaches controlled release microspheres comprising TGF-β, the microspheres are embedded within biodegradable hydrogels to prevent initial burst. See abstract. The reference teaches that the hydrogel can act as a scaffold that “permits containment and conformation of the spheres to the defect shape” and provide “controlled release of TGF-β1 to a cartilage wound site.” See Introduction. The reference further teaches that combining microspheres and scaffolds for controlled drug delivery is commonly studied in biomedical and pharmaceutical projects. See pp 1582-1583, bridging paragraph.
Given the teachings of Little of the controlled-release microspheres for treating immunological disorders, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of Little and combine the microspheres with hydrogels as motivated by DeFail as 1) both references teach controlled-release microparticles and immunomodulatory agents; and 2) DeFail specifically teaches that the microparticles embedded in hydrogel exhibit reduced initial burst. As both references teach using the same microparticle materials and TGF-β, the POSITA would have had a reasonable expectation of success in combining the teachings of the references to develop stable composition with reduced initial burst of the microparticles.
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.
Claims 15-17, 19 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12491159 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a composition comprising a first controlled release microparticles comprising a first therapeutic agent, wherein the first therapeutic agent is transforming growth factor beta (TGF-β) and a second controlled release microparticle comprising a second therapeutic agent, wherein the second therapeutic agent is IL-2. See the present claim 15; reference claim 1. The present claim 15 also recites “for use in the treatment of a gastrointestinal condition”. The phrase requires no structural limitation and is considered a preamble reciting the intended future use or purpose of the composition. The “tissue” of the subject in the reference claim is defined to include intestinal tissue, thus the prior art composition is capable and suitable for the presently recited intended use. It also follows that the prior art composition is suitable and capable for treating the specifically defined gastrointestinal conditions in claim 16.
Regarding claim 17, the polymers of the controlled release particles are disclosed in the reference claim 2.
Regarding claim 19, the reference claim 5 requires that the composition comprises a third controlled release microparticle comprising rapamycin.
Regarding claim 20, although the disclosed claims does not specifically mention a kit, it is viewed prima facie obvious for a POSITA to provide materials to conveniently use the disclosed composition.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over claims 1-11 of U.S. Patent No. 12491159 B2 as applied to the present claims 15-17, 19 and 20 as above, and further in view of DeFail.
The ‘159 claims fail to teach hydrogel formulations.
DeFail teaches controlled release microspheres comprising TGF-β, the microspheres are embedded within biodegradable hydrogels to prevent initial burst. See abstract. The reference teaches that the hydrogel can act as a scaffold that “permits containment and conformation of the spheres to the defect shape” and provide “controlled release of TGF-β1 to a cartilage wound site.” See Introduction. The reference further teaches that combining microspheres and scaffolds for controlled drug delivery is commonly studied in biomedical and pharmaceutical projects. See pp 1582-1583, bridging paragraph.
Given the teachings of the ‘159 claims of the controlled-release microspheres for treating immunological disorders, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings and combine the microspheres with hydrogels as motivated by DeFail as 1) both references teach controlled-release microparticles and immunomodulatory agents; and 2) DeFail specifically teaches that the microparticles embedded in hydrogel exhibit reduced initial burst. As both references teach using the same microparticle materials and TGF-β, the POSITA would have had a reasonable expectation of success in combining the teachings of the references to develop stable composition with reduced initial burst of the microparticles.
Claims 15, 16, 19 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10765634 B2.
The reference claim 1 discloses a formulation for administering to a tissue of a subject, the formulation comprising a first sustained release microparticle population comprising TGF-B, a second sustained release microparticle population comprising rapamycin, and a third sustained release microparticle population comprising IL-2. The present claim 15 recites “for use in the treatment of a gastrointestinal condition”. The phrase requires no structural limitation and is considered a preamble reciting the intended future use or purpose of the composition. The “tissue” of the subject in the reference claim is defined to include intestinal tissue, thus the prior art composition is capable and suitable for the presently recited intended use. It also follows that the prior art composition is suitable and capable for treating the specifically defined gastrointestinal conditions in claim 16.
Regarding claim 20, although the disclosed claims does not specifically mention a kit, it is viewed prima facie obvious for a POSITA to provide materials to conveniently use the disclosed composition.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over claims 1-5 of U.S. Patent No. 10765634 B2 as applied to the present claims 15, 16, 19 and 20 as above, and further in view of DeFail.
The ‘634 claims fail to teach hydrogel formulations.
DeFail teaches controlled release microspheres comprising TGF-β, the microspheres are embedded within biodegradable hydrogels to prevent initial burst. See abstract. The reference teaches that the hydrogel can act as a scaffold that “permits containment and conformation of the spheres to the defect shape” and provide “controlled release of TGF-β1 to a cartilage wound site.” See Introduction. The reference further teaches that combining microspheres and scaffolds for controlled drug delivery is commonly studied in biomedical and pharmaceutical projects. See pp 1582-1583, bridging paragraph.
Given the teachings of the ‘634 claims of the controlled-release microspheres for treating immunological disorders, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings and combine the microspheres with hydrogels as motivated by DeFail as 1) both references teach controlled-release microparticles and immunomodulatory agents; and 2) DeFail specifically teaches that the microparticles embedded in hydrogel exhibit reduced initial burst. As both references teach using the same microparticle materials and TGF-β, the POSITA would have had a reasonable expectation of success in combining the teachings of the references to develop stable composition with reduced initial burst of the microparticles.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GINA JUSTICE whose telephone number is (571)272-8605. The examiner can normally be reached M-F 9:00 AM - 5 PM.
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, BETHANY BARHAM can be reached at 571-272-6175. 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.
/GINA C JUSTICE/Primary Examiner, Art Unit 1617
Prosecution Insights