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 1-20 are 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.
In claims 1 and 15 the recitations of “a second portion of the covering is devoid of any granular particles such that a second thickness of the covering in the second portion is defined only by the covering” and “the polymeric covering including a second region devoid of any microbeads” respectively are ambiguous because it impossible to discern where this second portion or region is meant to encompass. Since claims 1 and 15 recite “a plurality of granular particles encapsulated within the covering” and “a plurality of microbeads encapsulated within the covering” respectively, how can one know where there is a portion or region devoid of the particles or microbeads? It must be noted that encapsulating the granular particles or microbeads can be understood to result in the covering and either the granular particles or microbeads to be technically together. Thus, in what way can one consider a second portion or region to be devoid of either the granular particles or microbeads since one can actually say all areas in which the covering does not have the granular particles or microbeads in the surrounding of these elements is technically devoid of them by the encapsulation process. Since no parameters set forth a distance from the surface of a granular particle or microbead to define a second portion or region it cannot be understood how one can define this area. It must be understood that there is covering material dispersed about these granular particles or microbeads that encapsulate these elements but they do not mix or become a homogenous mixture of materials, thus there is covering that one might consider devoid of the granular particles or microbeads about the entire surface in which the scaffold is covered. Thus, how can one know where the second portion or region is not existing for the encapsulated covering with these granular particles or microbeads?
The term “granular” in claims 1-4,6,8-10 is a relative term which renders the claim indefinite. The term “granular” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is noted that claim 7, has further limitations to define the vague adjective of “granular” that possibly could provide some clarity in the meaning of dimensions.
Additionally, the term “microbead” in claims 15,19,20 is a relative term which renders the claim indefinite. The term “microbead” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is noted that claim 17, has further limitations to define the vague adjective of “micro-” that possibly could provide some clarity in the meaning of dimensions or what scale of measurement is intended within the scope of the claims.
Claim 18 recites the limitation "additional granular particles" in lines 1,2 of the claim. There is insufficient antecedent basis for this limitation in the claim since no first type of granular particle were recited in claim 15 from which it depends.
Dependent claims are also indefinite for depending from indefinite independent claims.
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, 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(s) 1,2,8-16 are rejected under 35 U.S.C. 103 as being unpatentable over Clerc et al. (2009/0187240) in view of Alt (2004/0039438). Fig. 3 depicts a medical device for treating a body lumen. Fig. 4 shows there is an expandable (paragraph 11) scaffold defined by struts 12,14 including a first end region, a second end region opposite the first end region and an outer surface. It can also be seen (Fig. 4) there is a covering 22 disposed along the outer surface of the expandable scaffold, the covering having an outer surface. It is noted that Clerc et al. disclose (paragraph 29) there can be and a plurality of granular particles (beads) on the outer surface of the expandable structure. As best understood, these particles or beads could be considered within the scope of “granular” or on the “micro” scale since no parameters are set forth. Note Fig. 5 showing the elements 42,44 are encapsulated within covering 40 and Clerc et al. disclose (see claim 4) the elements are embedded (encapsulated) in the covering. Fig. 5 shows portion of the covering on the expandable scaffold devoid of antimigration structure and since antimigration structures are spaced along with encapsulated, the surrounding portion of the material defines a portion devoid of the antimigration structure. Thus, it would have been obvious to one of ordinary skill in the art to substitute alternative anti-migration means or structure and use “granular” particles or “micro”-beads as disclosed by Clerc et al. with an expandable scaffold structure having the covering disposed thereon with encapsulated antimigration structures since substituting one structure for the other only involves routine skill in the art and is a result dependent variable. Finding the optimal antimigration structure would be patient dependent on the condition of the site of treatment. Per the modification it could be said that a second portion of the covering is devoid of any granular particles such that a second thickness of the covering in the second portion is defined only by the covering. Clerc et al. disclose (paragraph 38) the expandable scaffold is configured to shift from a collapsed state to an expanded state; wherein the covering is configured to contact an inner surface of the body lumen in the expanded state. Clerc et al. also disclose (paragraph 33) the antimigration structure used such as alternatively substituting the granular particles are designed to prevent migration of the expandable scaffold upon implantation in the body lumen. However, Clerc et al. did not disclose a first portion of the covering includes at least two granular particles stacked radially outward from the outer surface of the expandable scaffold one on top of another to define this first portion with a first thickness. Alt teaches (Fig. 2) at least two stacked granular particles 33 radially outward from the outer surface 30 of an expandable scaffold one on top of another. Alt additionally discloses (paragraph 37) that there is area or portions devoid of granular particles that include a covering. Alt additionally discloses (paragraph 46) that the volume defined by the “devoid” area or portion between stacked granular particles could provide a loading channel for drugs. Clerc et al. also disclose (paragraph 57) the covering could include that encapsulate the antimigration structure can be loaded with drugs. Thus, it would have been obvious to one of ordinary skill in the art to have a first portion of the covering includes at least two granular particles stacked radially outward from the outer surface of the expandable scaffold one on top of another to define this first portion with a first thickness per the teaching of Alt since stacking can provide a greater loading capacity in the stent of Clerc et al. and also provide the necessary ability to engage vessel lumen wall with engagement with the antimigration structure having the covering and drugs loaded therein. Regarding claim 15, the same explanation is made since claim limitations are similar and the “granular particles” of claim 1 can be analogous to the recited “microbeads” so there is no difference in scope other than a particular material recited for the covering. Clerc et al. disclose the covering (paragraph 51) can be a polymer. Regarding claim 2, Clerc et al. disclose (paragraph 49) the antimigration structures can be metals or polymers. Again as noted Clerc disclosed alternative features such as beads (particles) could be used, which is an obvious alternative as already explained above. Regarding claim 8, Clerc et al. did state (paragraphs 8,46) a surface texture having a variable surface roughness. Alt teaches to use a plurality of granular particles arranged on the surface that can vary the thickness. Thus, per the combined teachings the surface has variable surface roughness. Regarding claim 9, it can be seen (Fig. 5) of Clerc that where there is to be surface antimigration feature (42,44) that is alternatively substituted with granular particles, beads per Clerc alternative embodiment feature and use of a plurality of particle by Alt that the covering 40 is higher and then tapers to a less thicker height when it is devoid of the particle. As a result of the combined teachings there is a first thickness of the covering in the first portion includes a combined thickness of the at least two granular particles plus the covering, the first thickness being greater than a thickness of the covering in the second portion. With respect to claim 10, it is noted that Alt did teach different diameters and dimensions can be applied and the amount, such that it variable. Thus, since the application of the granular particles is a result dependent variable, it is obvious to one of ordinary skill in the art to alternatively use different arrangements for engagement and loading capability within the region or portion devoid of a granular particle per the teaching of Alt and one can provide a covering such that a third portion includes only a single granular particle and the covering, the third portion having a third thickness defined by a diameter of the single granular particle plus the covering, wherein the third thickness is less than the first thickness and greater than the second thickness. Such an arrangement is an embodiment that can be patient dependent due to vessel condition and drug delivery desired for the site of application. Regarding claims 11,12 Clerc et al. disclose (paragraph 67) the covering is disposed along an entirety of the outer surface of the expandable scaffold or can be disposed only along a portion of the outer surface of the expandable scaffold. Regarding claims 13,14, Clerc et al. disclose (paragraph 27) the expandable scaffold can be provided with a plurality of struts with a plurality of interstices located therebetween, and wherein the covering spans at least one of the plurality of interstices and the covering completely surrounds at least some of the plurality of struts. With respect to claim 16, Clerc discloses (paragraphs 49,50,67) the polymeric cover is not biodegradable.
Claim(s) 3,18 are rejected under 35 U.S.C. 103 as being unpatentable over Clerc et al. (2009/0187240) in view of Alt (2004/0039438) as applied to claims 1,15 respectively above, and further in view of Egashira et al. (WO 2011/024831). Clerc et al. as modified with Alt is explained as before. However, Clerc et al. in view of Alt did not disclose additional granular particles disposed along the outer surface of the covering, with an outer surface of the additional granular particles exposed radially outward of the covering. Egashira et al. teach (page 16 of translation, 2nd full paragraph, page 17 of translation, last full paragraph) that additional granular particles disposed along the outer surface of the covering, with an outer surface of the additional granular particles exposed radially outward of the covering. It would have been obvious to one of ordinary skill in the art to additionally provide more rapid delivering drug holding granular particles on the outer surface of the covering as taught by Egashira et al. with the stent of Clerc et al. as modified by Alt such that some drug delivery occurs immediately upon implantation since they are on the outer surface of the covering layer and contact the lumen.
Claim(s) 4,5,19 are rejected under 35 U.S.C. 103 as being unpatentable over Clerc et al. (2009/0187240) in view of Alt (2004/0039438) as applied to claims 1,15 respectively above, and further in view of Dimauro et al. (WO 2004/073563). Clerc et al. in view of Alt is explained supra. However, Clerc et al. as modified by Alt did not disclose at least some of the plurality of granular particles are made of a material configured to harden over time and that the material is configured to harden with moisture absorption over time. Dimauro et al. teach (page 32, lines 26-30) beads used in an implantable structure are configured to harden over time. Dimauro et al. also disclose (page 61, lines 17-20) materials that can be used which absorb fluid to solidify. It would have been obvious to one of ordinary skill in the art to alternatively use hardening materials capable of solidifying after implantation as taught by Dimauro et al. with the stent of Clerc et al. as modified with Alt such that it provides a rigid support for the site of repair, see Dimauro page 5, line 24.
Claim(s) 6,20 are rejected under 35 U.S.C. 103 as being unpatentable over Clerc et al. (2009/0187240) in view of Alt (2004/0039438) as applied to claim 1,15 respectively above, and further in view of Anzai et al. (WO 2011/033957). Clerc et al. as modified with Alt is explained as before. However, Clerc et al. in view of Alt did not disclose at least some of the plurality of granular particles are made of a material configured to swell over time. Anzai et al. teach (Figs. 2A,B) granular particles of a material that swells are disposed on the surface of a stent expandable scaffold, page 4 of translation. It would have been obvious to one of ordinary skill in the art to utilize a swellable material for the granular particles as taught by Anza et al. with the stent of Clerc et al. modified by Alt such that amounts of drug are included in the swellable particles and aided in release to the patient site due to the swelling, pages 10-12 of Anzai translation.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 12,023,265. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claim recites structure as claimed in US ‘265. The claim of the current application overlaps entirely in scope other than the recited “portion devoid of granular particles” which as mentioned above is ambiguous since the covering encapsulates the granular particles. Thus in giving the broadest reasonable interpretation since the particles do not take up or in other words homogenously mix but stay separate, there is covering material with no portions of particles there so it could be construed as a portion devoid of granular particles.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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