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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10, 19, and 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites "wherein the conduit includes a needle that is 18 gauge or smaller". There is an inverse relationship between needle size and gauge value (e.g. a 24 gauge needle is thinner in diameter than an 18 gauge needle). It is unclear whether "or smaller" is meant to apply to gauge (e.g. 18 gauge, 16 gauge, 12 gauge needles, which are all larger in size than an 18 gauge needle) or to conduit size (e.g. 28 gauge, 32 gauge, or 40 gauge, which are all smaller in size than an 18 gauge needle).
Claim 19 pertains to an apparatus, but requires a process step of eluting therapeutic agent over a first period of time and a second elution over a second period of time when located within a patient. Per MPEP 2173.05(p)(II), the inclusion of required process of use limitations within apparatus claims, as opposed to limitations focused on the capabilities of the system (e.g. “configured to…”), renders the intended scope of the claim unclear as it is uncertain when direct infringement occurs.
As claim 20 depends from claim 19, claim 20 is rejected for the same issue discussed above.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. U.S. Pat. No. 12,076,464. Although the claims at issue are not identical, they are not patentably distinct from each other.
Specifically, claims 15 and 21 of ‘464 pertain to a SMP foam consistent with those claimed, including open cells with a strut, a coating on the strut with the same materials, whereby a therapeutic agent of the coating is configured to elute from the SMP foam and into a patient tissue during a first period of time; an interior portion of the strut includes at least one of the therapeutic agent, an additional therapeutic agent, or combinations thereof that is configured to elute from the SMP foam and into the patient tissue during a second period of time; the second period of time occurs at least one day after the first period of time. All remaining limitations are found within the claims of ‘464. Therefore, ‘464 anticipates the present claims.
Allowable Subject Matter
Claims 1-9 and 11-18 would be allowable upon filing of a terminal disclaimer to overcome the above double patenting rejection.
Claim 10 would be allowable upon filing of a terminal disclaimer to overcome the above double patenting rejection and if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Discussion of Closest Prior Art
Stankus (US 2009/0035350 A1) describes shape memory polymer compositions as implantable drug delivery devices (Abstract). The polymer is adhered/coated to an implant device with drugs embedded therein (¶ 212-218). The use of an SMP foam with open cells is not described. The use of therapeutic agent(s) within both the coating and interior portion of a strut is not described.
Roorda (US 2008/0057102 A1) describes porous polymeric bodies with releasable drugs (Abstract). The body can be shape memory material (¶ 77-78). The use of SMP foams with open cells including struts is not described. The use of therapeutic agent(s) within both a coating and interior portion of a strut is not described.
Sutermeister (US 2009/0198321 A1) describe implantable devices with struts, whereby different coating compositions are used to coat the inner and outer surfaces of the struts (Abstract). The differing coatings compositions may posses differing or identical therapeutic agents with different release profiles (Abstract; ¶ 46). The use of SMP foam with open cells is not described. The release of therapeutic agents from an interior portion of a strut, as opposed to a coating, is not described.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN E RIETH whose telephone number is (571)272-6274. The examiner can normally be reached Monday - Friday, 8AM-4PM Mountain Standard Time.
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/STEPHEN E RIETH/Primary Examiner, Art Unit 1759
