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 .
The examiner acknowledges receipt of IDS filed 09/06/2024.
Original claims 1-17 are pending.
Priority
This application is a Continuation of 17/338,505 filed 06/03/2021, now US 12121608 B2 and which claims benefit of 63/034,096 filed 06/03/2020.
Information Disclosure Statement
The IDS filed 09/06/2024 has been considered by the examiner.
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.
Claim(s) 1, 3-12 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by MUNI et al., (WO 2007111636 A2) as evidenced by Marchionni (US 20150274795 A1) for claim 6 that olfactory bulb is part of the olfactory system.
MUNI teaches an implant (abstract) for trans-nasal delivery (page 52, lines 15-27, claims 84-86, 162) of one or more therapeutic agents (abstract); the implant comprises a support body or stent comprising a first biodegradable polymer (claim 185) such as PLLA and PGA (page 68, lines 20-30) with the PLLA and PGA meeting the limitation of the first biodegradable polymer or biodegradable polymer of claim 1. The implant comprises a core which comprises therapeutic substance combined with a polymer (claims 151, 187-188) and the core is a reservoir containing the therapeutic agents (claims 84, 87, 145; page 75, lines 8-10). The polymer in the reservoir with the therapeutic agent is hyaluronic acid and absorbs water to form a gel (page 7 5, lines 1-4) meeting the limitation of the second biodegradable polymer or osmotic polymer of claim 1; the therapeutic substance in the matrix layer is a steroid (page 66, lines 20, 23-24). The stent is porous with the pores controlling the rate of delivery of the therapeutic substance and the pores can have sizes that range from 0.2 microns to 200 microns (page 75, lines 27-28, page 55, lines 6-10; claim 124) and pore sizes can also range from 20-100 microns (page 71, lines 23-24). In another embodiment, the size of the pore is 60 microns (page 29, lines 10-11).
For claim 1, MUNI implants the implant comprising biodegradable first and second biodegradable polymer into nasal cavities that provides unique access to the olfactory system and thus the brain (page 23, lines 1-22) and thus the brain/CNS. The therapeutic agent is released and inherently enters the CNS after bypassing the blood brain barrier of the subject. The substance/therapeutic agent is contemplated to be released gradually (page 52, lines 27-28) over a period of time (page 58, lines 12-13).
For claims 3 and 4 and 5, therapeutic agent and biodegradable polymer are generic in claim 1. The as filed specification defines therapeutic agents as small molecule drugs, growth factors, mRNA and others (see at least page 4, item 12, lines 8-11). In MUNI, the therapeutic agent includes mRNA, antitumor agents (cancer therapeutic agents) and other therapeutics such as antimicrobial agents and anti-inflammatory agents (page 17; page 20, line 28; page 22 line 6; claims 48-51) and these therapeutic agents meets the limitation of therapeutic agent of claim 1. Therefore, the therapeutic agent of MUNI would inherently be partially soluble in cerebrospinal fluid (claim 4) and the release of the therapeutic agent would inherently diffuse out of the polymer matrix into the submucosal space (claim 3) and the olfactory system having olfactory epithelium indicates that the therapeutic agent would inherently enter the CNS by diffusion through the olfactory epithelium (claim 5).
For claim 6, the therapeutic agent inherently diffuses to the olfactory bulb of the brain region since the olfactory bulb is part of the olfactory system (see paragraph [0141] of Marchionni).
For claim 7, the implant in MUNI is introduced by surgical procedure (see at least page 15, lines 9-11; page 44, lines 20-25; page 68, lines 15-18; page 71, lines 9-12).
For claim 8, the implant is implanted nasally by means of a catheter (see the abstract; page 9, lines 17-18 and 27-28; page 24, lines 18, 20; paragraph bridging pages 25 and 26).
For claim 9, MUNI contemplates treating Parkinson’s disease, Alzheimer’s disease, Huntington’s disease and other dementias (see page 23, lines 14, 18-20).
For claims 10 and 12, MUNI does not teach that the therapeutic agent gets in contact with peripheral circulatory system of the subject (claim 10) and that the composition administered by MUNI is not taught to elicit immune response (claim 12).
Therefore, MUNI as evidenced by Marchionni teaches all the elements of claims 1 and 3-12.
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.
Claim(s) 1, 2 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over MUNI et al., (WO 2007111636 A2).
MUNI teaches an implant (abstract) for trans-nasal delivery (page 52, lines 15-27, claims 84-86, 162) of one or more therapeutic agents (abstract); the implant comprises a support body or stent comprising a first biodegradable polymer (claim 185) such as PLLA and PGA (page 68, lines 20-30) with the PLLA and PGA meeting the limitation of the first biodegradable polymer or biodegradable polymer of claim 1. The implant comprises a core which comprises therapeutic substance combined with a polymer (claims 151, 187-188) and the core is a reservoir containing the therapeutic agents (claims 84, 87, 145; page 75, lines 8-10). The polymer in the reservoir with the therapeutic agent is hyaluronic acid and absorbs water to form a gel (page 75, lines 1-4) meeting the limitation of the second biodegradable polymer or osmotic polymer hydrogel of claim 13; the therapeutic substance in the matrix layer is a steroid (page 66, lines 20, 23-24). The stent is porous with the pores controlling the rate of delivery of the therapeutic substance and the pores can have sizes that range from 0.2 microns to 200 microns (page 75, lines 27-28, page 55, lines 6-10; claim 124) and pore sizes can also range from 20-100 microns (page 71, lines 23-24). In another embodiment, the size of the pore is 60 microns (page 29, lines 10-11). The implant is implanted in the nasally by means of a catheter (see the abstract; page 9, lines 17-18 and 27-28; page 24, lines 18, 20; paragraph bridging pages 25 and 26).
Thus, for claim 13, MUNI teaches an osmotic core-shell implant that comprises biodegradable polymer shell surrounding a reservoir, the reservoir containing an osmotic core comprising osmotic hydrogel and therapeutic agent as described above and the implant is implanted by means of a catheter. The method of claim 13 forms the biodegradable polymer in a shape of the support body. MUNI does not specifically say that the biodegradable polymer is shaped in the form of the support body. “The support body encloses or contains a reservoir, i.e. and open space that can be filled with a polymer matrix, such as a hydrogel,” (using the specification to understand support body, page 16 of the specification, lines 6-8). Thus, the reservoir is the support body. The osmotic hydrogel contained in the reservoir has acquired the shape of the reservoir. Hence, before the effective date of the invention, the artisan would reasonably expect that the hydrogel composition contained within the reservoir would predictably conform to the shape of the reservoir, rendering the method of claim 13 prima facie obvious.
For claim 14 and 15, the reservoir of the implant is filled with second biodegradable polymer and therapeutic agent as described above (claim 14) and because the biodegradable polymer and the therapeutic agent are present in the reservoir, it will be reasonable to expect that they are mixed (claim 15), there being no teaching that the therapeutic agent is layered on the biodegradable polymer.
Claim 2 depends on claim 1. MUNI has been described above to teach claim 1. MUNI does not specifically state that a period of time greater than 30 minutes up to about greater than a year as required by claim 2. However, the release of the substances/therapeutic agents is not immediate but controlled/sustained and that the substance/therapeutic agent is released over a period of time including duration of treatment (page 51, lines 5-12); the substance is contemplated to be release gradually (page 52, lines 27-28) over a period of time (page 58, lines 12-13). Therefore, before the effective date of the invention the artisan would reasonably expect the release of the substance/therapeutic to be over a period of time including greater that 30 minutes that is not instantaneous.
Thus, MUNI renders claims 2 and 13-15 prima facie obvious.
Claim(s) 13, 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over MUNI et al., (WO 2007111636 A2), as applied to claim 13, in view of Zheng et al., (US 20160213499 A1).
Claim 16 depends on claim 13. Claim 17 depends on claim 16. MUNI has been described above to render claim 13 prima facie obvious.
MUNI differs from claim 16 and 17 by not teaching 3D printing. MUNI teaches that the implant can be extruded, dip coated or spray coated (page 66, lines 18 and 19). It is also known in the art that stent implant comprising caprolactone can be dip coated, molded or 3D printed.
Therefore, before the effective date of the invention, the ordinary skilled artisan would reasonably expect that dip coating or spray coating or 3D printing the caprolactone composition of MUNI would predictably form the implant of MUNI.
Thus, MUNI in view of Zheng renders claims 16 and 17 prima facie obvious.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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 1-15 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12121608 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the issued osmotic core shell implant of issued claims 1-12 and the composition in the kit of issued claim 17 teaches all the elements of composition in examined method claims 1-15, though not verbatim; the issued method of claims 13-16 teaches the method of examined claims 1-12.
Therefore, issued claims 1-17 renders examined claims 1-15 prima facie obvious.
Claims 16-17 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-17 of US Patent No. 12121608 B2 in view of Zheng et al., (US 20160213499 A1).
For examined claims 16 and 17, the issued claims do not teach molding or 3D printing the composition to form the implant. However, it is also known in the art that stent implant comprising caprolactone can be dip coated, molded or 3D printed (paragraph [0705] of Zheng). Therefore, before the effective date of the invention, the ordinary skilled artisan would reasonably expect that dip coating or spray coating or 3D printing the caprolactone composition of the issued claims would predictably form the issued implant.
Therefore, issued claims 1-17 in view of Zheng renders claims 16-17 prima facie obvious.
No claim is allowed.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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, Brian Yong Kwon can be reached at 5712720581. 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.
/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
Prosecution Insights