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 .
DETAILED ACTION
Applicant’s Request for Reconsideration dated August 26, 2025 is acknowledged.
Claims 1, 3, 4, 6-8, 10, 11, 14-17 and 27-30 are pending.
Claims 2, 5, 9, 12, 13 and 18-26 are cancelled.
Claims 1, 3, 7, 8, 10, 11, 14 and 17 are currently amended.
Claims 1, 3, 4, 6-8, 10, 11, 14-17 and 27-30 as filed on August 26, 2025 are pending and under consideration to the extent of the elected species, e.g., the species of D1 and D2 is dexamethasone and the species of system or article is a co-implant.
This action is made FINAL.
Withdrawn Objections / Rejections
In view of the amendment of the abstract, some previous objections to the specification are withdrawn.
In view of the amendment of the claims, all previous claim objections are withdrawn, all previous claim rejections under 35 USC 112(b) are withdraw, and all previous claim rejections under 35 USC 112(d) are withdrawn.
In view of the AIA exceptions as set forth at page 10 of the Remarks, all previous claim rejections under 35 USC 103 further in view of Parrag are withdrawn.
Applicant’s arguments have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Maintained Objections: Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
The abstract of the disclosure is objected to because it employs phases which can be implied. Correction is required. See MPEP § 608.01(b).
Maintained Grounds of Rejection / New Grounds of Rejection Necessitated by Amendment
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1, 3, 4, 6-8, 10, 11 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sinha et al. (US 2014/0256696, published September 11, 2014, IDS reference filed April 11, 2022) in view of McKay (US 2013/0018320, published January 17, 2013, of record).
Sinha teaches steroid conjugates formed by connecting two or more steroids via a linker (title; abstract; claims; paragraph [0010]):
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The steroid is selected from the group inclusive of dexamethasone (claim 2), as required by instant claim 17 and the elected embodiment. The linker may comprise a carbonate:
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or a polyethylene glycol:
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(claim 3; paragraphs [0016], [0023]). Alternative linkers include (Table 1, page 3):
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The compositions may be administered subcutaneously or via an implant (“configured” to be implanted) (paragraph [0095]), as required by instant claim 6. The pharmaceutical compositions may further comprise excipient components (paragraphs [0084]-[0093]). Regarding the exclusion of controlled release excipients as required by instant claims 7, 8, the compositions of Sinha do not require such.
Sinha does not teach an article body and a second body that is a co-implant comprising at least 90 wt% of the compound of formula A-VIII as required by claims 1, 11 and the elected embodiment.
Sinha does not teach the second body is affixed to the article body with inter alia an adhesive as required by claims 3, 4.
Sinha does not teach the second body comprises 0.01 to 10 wt% plasticizer as required by claim 10.
Sinha does not teach the co-implant is shaped, separate or affixed as required by claims 14-16.
These deficiencies are made up for in the teachings of McKay.
McKay teaches implantable medical devices (article body) comprising an adhesive material having a region configured to receive a solid or semi-solid drug depot (co-implant, second body); the medical devices comprise an effective amount of at least one anti-inflammatory such as dexamethasone (title; abstract; claims; Figures; paragraphs [0025], [0037], [0039], [0048], [0093]), as required by instant claims 3, 4, 6, 11, 15, 16. The drug depot can be any shape (paragraphs [0010], [0111], [0113]), as required by instant claim 14. The loading of the drug in the depot can vary over a wide range and may encompass a high loading such as at least 90 wt% (paragraphs [0083]-[0084]). The drug may be administered with non-active ingredients such as plasticizers; the excipients comprise from about 0.001 to 50 wt% of the formulation (paragraphs [0098], [0100]), as required by instant claim 10. While the depot may optionally contain drug release adjusting agents (paragraph [0110]), optional inclusion of a particular component teaches compositions that both do and do not contain that component, as required by instant claims 7, 8. See MPEP 2123. The devices improve drug efficacy, reduce unwanted migration, and prevent or treat post-operative inflammation by providing consistent anti-inflammatory efficacy at the target tissue site (paragraph [0008]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the steroid conjugates as taught by Sinha within the solid or semi-solid drug depot of the implantable medical devices of McKay in order to provide local anti-inflammatory efficacy at the target tissue site. There would be a reasonable expectation of success because Sinha expressly contemplate subcutaneous administration as an implant and because the depot of the devices of McKay may comprise dexamethasone.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the steroid conjugates of Sinha within the depot of McKay in amounts of at least 90 wt% as taught by McKay because such high loading is expressly contemplated.
Regarding claim 10, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the steroid conjugate depots of Sinha and McKay to optionally further comprise non-active ingredients such as plasticizers in amounts from about 0.001 to 50 wt% because such are expressly contemplated by McKay. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05.
Claims 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Sinha et al. (US 2014/0256696, published September 11, 2014, IDS reference filed April 11, 2022) in view of McKay (US 2013/0018320, published January 17, 2013, of record) as applied to claims 1, 3, 4, 6-8, 10, 11 and 14-17 above, and further in view of Stache et al. (US 3,663,579, published May 16, 1972, IDS reference filed April 11, 2022).
The teachings of Sinha and McKay have been described supra.
They do not teach the compound is:
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as required by claims 27, 29.
They do not teach the compound is:
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as required by claims 28, 30.
These deficiencies are made up for in the teachings of Stache.
Stache teaches bis steroid alkyl carbonates of the general formula (title; abstract; claims; column 1):
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wherein R1 represents an open-chain alkylene such as (column 2):
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wherein n is an integer from 2 to 18; the alkylene may be interrupted by oxygen atoms.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the linker of the steroid / dexamethasone conjugates of Sinha to comprise a bis alkyl carbonate as taught by Stache inclusive of an open chain alkylene comprising 2 to 18 repeating CH2 groups which may be optionally interrupted by oxygen atoms because Sinha expressly contemplates such carbonate linkers, repeating CH2 groups, which may be optionally interrupted with oxygen atoms in the form of a polyethylene glycol. Thus, the linkers of Stache fall within the genus embraced by Sinha.
Response to Arguments: Claim Rejections - 35 USC § 103
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant at page 8 of the Remarks alleges Sinha fails to provide any guidance regarding the administration of the steroid conjugates disclosed therein, citing to the Field of Invention, the introductory paragraph of the Detailed Description, and paragraphs [0080], [0081], [0095], [0101] and [0102].
This is unpersuasive because steroids, and the utility thereof, are well known. For example, Sinha in paragraph [0007] describes delivery of steroids for the treatment of infection and inflammation.
Applicant at pages 8-9 alleges the disclosure in paragraph [0095] of implants comes in a generic laundry list and fails to provide a conjugate in any implant form.
This is unpersuasive because an implant is broadly and reasonably encompassing anything capable of being implanted and it is understood from paragraph [0095] that Sinha contemplated multiple modes of delivery inclusive of implants.
Applicant at page 9 alleges McKay discloses a laundry list of therapeutic agents and a long list of loadings, precluding motivation for selection.
This is unpersuasive because selection is not required. Disclosure of a species within a so-called “laundry list” is anticipatory. See MPEP 2131.02. “Disclos[ure of] a multitude of effective combinations does not render any particular formulation less obvious.” Merck & Co. Inc. v. Biocraft Laboratories, Inc. 874 F.2d 804, 807 (Fed. Cir. 1989). Stated differently, “[r]eading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put into the last opening in a jig-saw puzzle. It is not invention.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 335 (1945). In the instant case, it is understood that the devices of McKay are suitable for any number of drugs inclusive of anti-inflammatories such as dexamethasone and it is understood that that the devices of McKay are suitable for wide ranges of drug loadings inclusive of higher loadings as instantly claimed.
Applicant at pages 10-11 alleges Stache does not cure the deficiencies of the base rejection.
This is unpersuasive because there are no deficiencies in the base rejection. Therefore, the rejections over Sinha are properly maintained in modified form as necessitated by Applicant’s amendments.
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 1, 3, 4, 6-8, 10, 11, 14-17 and 27-30 are rejected on the ground of nonstatutory double patenting as being unpatentable (1) over claims 1-16 and 26-41 of U.S. Patent No. 10,588,862; (2) over claims 1-22 of U.S. Patent No. 10,632,075; (3) over claims 8-11 of U.S. Patent No. 10,945,958; and (4) over claims 8-11 of U.S. Patent No. 10,959,954 in view of Sinha et al. (US 2014/0256696, published September 11, 2014, IDS reference filed April 11, 2022), McKay (US 2013/0018320, published January 17, 2013, of record) and Stache et al. (US 3,663,579, published May 16, 1972, IDS reference filed April 11, 2022).
The instant claims are drawn to a system comprising (a) an article body and (b) a second body comprising a steroid of formula D1-L-D2, wherein D1 and D2 are steroid radicals dexamethasone and L is a linker, and wherein the second body comprises at least 90 wt% of the steroid. The second body may be packaged with or affixed with inter alia an adhesive to the article body. The article body may be an implant. The second body may be free of a controlled release excipient. The second body may further comprise 0.01 to 10 wt% plasticizer. The second body may be a co-implant that is shaped, separate or affixed. The steroid material may be:
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or:
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.
The conflicting ‘862 Patent claims (1) are drawn to an article comprising compound 1:
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and to an article of compound 6:
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wherein the articles provide controlled release of dexamethasone at 37 ºC in 100% bovine serum or at 37 ºC in PBS. The articles may comprise at least 90% of the compound. The articles may comprise 0.1 to 10 wt% of one or more plasticizers. The articles may be a pellet, cylinder, hollow tube, microparticle, nanoparticle or shaped. The articles may be free of controlled release excipient.
The conflicting ‘075 Patent claims (2) are drawn to an article comprising a compound of formula D1-L-D2, wherein D1 and D2 are steroids and L is a linker, at least 70% of the article is the compound, the article is free of controlled release polymer, and the article is a fiber, pellet, cylinder, hollow tube, microparticle or nanoparticle. The article may comprise 0.1 to 10 wt% of one or more plasticizers. The article may release D1 and D2 at 37 ºC in 100% bovine serum or at 37 ºC in PBS at a rate such that t10 is greater than or equal to 1/10 of t50.
The conflicting ‘958 Patent claims (3) are drawn to an article comprising compound 6:
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wherein the article provides controlled release of dexamethasone at 37 ºC in PBS. The article may comprise at least 90% of the compound. The article may be a pellet, cylinder, hollow tube, microparticle, nanoparticle or shaped.
The conflicting ‘954 Patent claims (4) are drawn to an article comprising compound 1:
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wherein the article provides controlled release of dexamethasone at 37 ºC in PBS. The article may comprise at least 90% of the compound. The article may be a pellet, cylinder, hollow tube, microparticle, nanoparticle or shaped.
The instantly claimed system comprising an article body and a second body primarily differs from the articles of the conflicting patented claims with respect to the details of the system. However, these differences are prima facie obvious in view of the disclosure of McKay as elaborated supra. It would have been obvious to employ the articles of the conflicting patented claims as part of the drug depot within the implantable medical devices of McKay – comprising an adhesive, the drug depot having any shape, the drug being loaded in amounts of at least 90 wt%, the drug depot optionally further comprising about 0.001 to 50 wt% excipient such as plasticizers, the drug depot not requiring drug release adjusting agents -- in order to provide local anti-inflammatory efficacy at the target tissue site.
The instantly claimed system also differs from the ‘075 Patent claims with respect to the particulars of the steroid dimer and linker. However, these differences are prima facie obvious in view of the disclosure of Sinha and Stache as elaborated supra. It would have been obvious to employ steroids inclusive of dexamethasone as taught by Sinha and to employ linkers comprising a carbonate as taught by Sinha or a bis carbonate as taught by Stache, the bis carbonate comprising repeating CH2 groups optionally interrupted by O inclusive of polyethene glycol as taught by Sinha because such is routine in the art for linking steroids.
Claims 1, 3, 4, 6-8, 10, 11, 14-17 and 27-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable (a) over claims 1-15 of copending Application No. 18/738,907; (b) over claims 134 and 135 of copending Application No. 18/706,880; and (c) over claims 28-44 and 48-50 of copending Application No. 17/629,733; and are rejected on the ground of nonstatutory double patenting as being unpatentable over (d) over claims 7-12 of U.S. Patent No. 12,473,326 (Application No. 17/426,779) in view of Sinha et al. (US 2014/0256696, published September 11, 2014, IDS reference filed April 11, 2022), McKay (US 2013/0018320, published January 17, 2013, of record) and Stache et al. (US 3,663,579, published May 16, 1972, IDS reference filed April 11, 2022).
The instant claims have been described supra
The copending ’907 claims (a) are drawn to an implant comprising a steroid of formula D1-C(O)-L-C(O)-D2, wherein D1 and D2 are steroid radicals and L is a linker, wherein the implant comprises at least 60 wt% of the steroid. The steroid may be D1-C(O)-O-RA-O-C(O)-D2, wherein RA may be O(CH2CH2O)nCH2CH2O wherein n is an integer from 1-10. The steroid may be D1-C(O)-O(CH2CH2O)n-C(O)-D2 wherein n is an integer from 1-10, from 3-5. D1 and D2 may release at 37 ºC in 100% bovine serum or at 37 ºC in PBS at a rate such that t10 is greater than or equal to 1/10 of t50.
The copending ‘880 claims (b) are drawn to an implant comprising at least 50 wt% of a compound of formula:
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The copending ‘733 claims (c) are drawn to an article comprising a steroid of formula D1-L-D2, wherein D1 and D2 are steroid radicals and L is a linker. The steroid material may be free of controlled release excipient. The article may comprise 45 to 99 wt% of the steroid. D1 and D2 may such that the rate at t10 is greater than or equal to 1/10 of t50. D1 and D2 may be dexamethasone.
The conflicting ‘326 Patent claims (d) (formerly copending ‘779 claims (d)) are drawn to an article comprising at least 70 wt% of
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The instantly claimed system comprising an article body and a second body primarily differs from the articles of the conflicting copending claims and conflicting patent claims with respect to the details of the system. However, these differences are prima facie obvious in view of the disclosure of McKay as elaborated supra. It would have been obvious to employ the articles or/and implants of the conflicting copending claims and conflicting patent claims as part of the drug depot within the implantable medical devices of McKay – comprising an adhesive, the drug depot having any shape, the drug being loaded in amounts of at least 90 wt%, the drug depot optionally further comprising about 0.001 to 50 wt% excipient such as plasticizers, the drug depot not requiring drug release adjusting agents -- in order to provide local anti-inflammatory efficacy at the target tissue site.
The instantly claimed system also differs from the conflicting copending claims and conflicting patent claims with respect to the particulars of the steroid dimer and linker. However, these differences are prima facie obvious in view of the disclosure of Sinha and Stache as elaborated supra. It would have been obvious to employ steroids inclusive of dexamethasone as taught by Sinha and to employ linkers comprising a carbonate as taught by Sinha or a bis carbonate as taught by Stache, the bis carbonate comprising repeating CH2 groups optionally interrupted by O inclusive of polyethene glycol as taught by Sinha because such is routine in the art for linking steroids.
Response to Arguments: Double Patenting
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant pages 11-12 of the Remarks alleges the instantly claimed system differs from the articles of the conflicting patents and conflicting copending claims. Applicant further alleges the applied prior art does not bridge the differences.
This is unpersuasive because the instantly claimed system is an article recited at a very high level of generality, wherein the most limiting claims are drawn to an article per se wherein the (a) article body and (b) the second body are attached (e.g., are one article). Therefore, the double patenting rejections are properly maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID BLANCHARD can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISSA PROSSER/
Examiner, Art Unit 1619
/MARIANNE C SEIDEL/Primary Examiner, Art Unit 1600