DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/3/26.
Applicant’s election without traverse of claims 1-8 and 10-15 in the reply filed on 2/3/26 is acknowledged.
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 1-8 and 10-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 8261423. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of USPN 8261423 fully encompass instant claims 1-8 and 10-15.
Claims 1-8 and 10-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 8752265. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of USPN 8752265 fully encompass instant claims 1-8 and 10-15.
Claims 1-8 and 10-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 8752266. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of USPN 8752266 fully encompass instant claims 1-8 and 10-15.
Claims 1-8 and 10-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9155870. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of USPN 9155780 fully encompass instant claims 1-8 and 10-15.
Claims 1-8 and 10-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 9681971. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of USPN 9681971 fully encompass instant claims 1-8 and 10-15.
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 7,8,10,11,12, and 13 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Van Sciver (USP 2012/0010639). Van Sciver teaches the claimed process as evidenced at paragraph 0082-0085, and fig 11.
The applied reference has a common assignee with the instant application. Based upon the pre-AIA 35 U.S.C. 102(e) date of the reference, it constitutes prior art. This rejection under pre-AIA 35 U.S.C. 102(e) might be overcome either by a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor or joint inventors (i.e., the inventive entity) of this application and is thus not the invention “by another,” or if the same invention is not being claimed, by an appropriate showing under 37 CFR 1.131(a).
Claim 7. (Currently amended) A method for securing a scaffold to a balloon, comprising the steps of:
crimping the scaffold to the balloon while the scaffold has a temperature of between about TG and 15 degrees below TG, the scaffold being made from a polymer comprising PLLA
(a) reducing the scaffold diameter from a starting size to a first size (Van Sciver: paras. 0082-0085; fig 11; crimping stage 2 including a starting size of 0.083in and a first size of 0.068in),
(b) maintaining the first size for a first dwell period to allow for stress relaxation in the polymer (Van Sciver: paras. 0082-0085; fig 11; crimping stage 2 including a hold/dwell time of 15 secs),
(c) reducing the scaffold diameter from the first size to a second size (Van Sciver: paras. 0082-0085; fig 11; crimping stage 3 including a first size of 0.068in and a second size of 0.070in),
(d) maintaining the second size for a second dwell period to allow for stress relaxation in the polymer while the balloon has a first pressure (Van Sciver: paras. 0082-0085; fig 11; crimping stage 3 including a hold/dwell time of 10 secs, and balloon pressure of 17psi), and
(e) reducing the scaffold diameter from the second size to a third size, wherein the balloon has a second pressure while the scaffold diameter is being reduced from the second size to the third size (Van Sciver: paras. 0082-0085; fig 11; crimping stage 4 including a second size of 0.070in and a third size of 0.047in; and balloon pressure of 200psi).
Claim 8. (Currently amended) The method of Claim 7, wherein the polymer consists of comprises PLLA
Claim 10. (Original) The method of Claim 7, wherein the scaffold has a circumferential series of closed cells having a W-shape and linear link struts connecting the W-shape cells (Van Sciver: paras. 0082-0085; figs 5A-7).
Claim 11. (Original) The method of Claim 7, wherein the scaffold diameter is reduced in size by about 30% in step (e) (Van Sciver: paras. 0082-0085; fig 11; reduction is from 0.070 to 0.047in).
Claim 12. (Original) The method of Claim 7, wherein the scaffold diameter is reduced in size by about 50% from steps (a) to (d) (Van Sciver: paras. 0082-0085; fig 11; reduction is from 0.083 to 0.047in).
Claim 13. (Original) The method of Claim 7, wherein the scaffold is crimped in a crimper mechanism, further including removing the scaffold from the crimper mechanism after the scaffold diameter is reduced to the second size, wherein the scaffold is removed from the crimper after its diameter is reduced by 50%, and wherein the scaffold diameter is reduced in diameter by an additional about 30% when it attains the third size (Van Sciver: paras. 0082-0085; fig 11).
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Van Scover (USP2012/0010693) as applied to claim 7 and 13 above. The above teachings of Van Sciver are incorporated hereinafter.
Van Sciver teaches a first pressure of 17psi and a second pressure of during the crimping stage 4 (Van Sciver: para. 0084-0085; fig 11), but does not teach the first pressure being about twice the second pressure. It should be noted that Van Sciver also teaches using several intermediate crimping steps before the final crimping steps with each step including an inflation of the balloon. Since it is well-known in the crimping art to reduce the inflation of a balloon by at least twice from the beginning to the end of the cycle in order to gradually reduce the scaffold size, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to set the inflation pressure of the crimping stage 4 of Van Sciver to be half the inflation pressure of crimping stage 3 in order to ensure the scaffold is reduced in size without compromising its integrity.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following references teach crimping a scaffold onto a balloon: 20120073733, 20110190872, 8539663, 8961848, 10059034, 11806898, 11376762, 8261423, 8752265, 8752266, 9155870, and 9681971.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDMUND H LEE whose telephone number is (571)272-1204. The examiner can normally be reached M-Th 9AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xiao (Sam) Zhao can be reached at 571-270-5343. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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EHL
/EDMUND H LEE/Primary Examiner, Art Unit 1744