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 .
Response to Arguments
The nonstatutory double patenting rejection will be held in abeyance until the Applicant has submitted persuasive arguments, an acceptable terminal disclaimer, evidence, and/or amendments to overcome the rejection.
Applicant's arguments filed 2/4/2026 have been fully considered but they are not persuasive. The Applicant contends that Figures 12 and 13 of Datta do not recite an inner core that spans the inner width/diameter of the outer element along at least a portion of the length of the outer element. However, alternate embodiments of Datta, such as those shown in Figures 3-4 and 10-11, disclose that the inner core spans the inner width of the outer element. For example, as shown in annotated Figure A, below, the inner core (110) spans the inner width (Figure A) of the outer element along at least a portion of the length of the outer element (Figs. 3-4). Likewise, regarding claim 47, the outer element has a length that is greater than the diameter of the outer element (e.g., Fig. 3-4); and the inner core (e.g., 110) spans the diameter (e.g., Figure A) of the outer element along at least a portion of the length of the outer element (e.g., Fig. 3-4). In view of these disclosures by Datta, it is maintained that this reference reads on the amended claims, as described below.
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 34-38, 40, 41, 43-46, and 55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 and 26 of U.S. Patent No. 10,905,795. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the structural elements and characteristics are disclosed by both sets of claims. Claim 34 of the present application recites an outer element whose length is controlled by a degradable inner core; these features correspond to the outer element, and the degradation of the inner core controlling the elongation of the outer element, as recited in claim 1 of the patent. Claim 35 of the application corresponds to claim 2 of the patent. Claim 36 of the application corresponds to claim 4 of the patent. Claims 37, 38, and 40 of the application correspond to claims 7 and 8 of the patent. Claim 41 of the application corresponds to claim 9 of the patent. Claim 43 of the application corresponds to claim 16 of the patent. Claim 44 of the application corresponds to claims 14 and 15 of the patent. Claims 45 and 55 of the application corresponds to claim 6 of the patent. Claim 46 of the application corresponds to claims 22 and 24 of the patent.
Claim 39 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,905,795 in view of Bashiri et al. (Pub. No.: US 2011/0054589 A1). Bashiri teaches that it is well known in the art that stent elements are constructed with a triaxial braid (para. 0041), for the purpose of providing the stent with the desired mechanical properties needed for its implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the braided elements of the patent to have a biaxial braid, as taught by Bashiri in order to provide the stent with the desired mechanical properties needed for its implantation site. Such a modification would be made with a reasonable expectation of success.
Claim 42 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,905,795 in view of Datta et al. (Pub. No.: US 2007/0106371 A1). Datta teaches that it is well known in the art that stent elements comprise mechanical fasteners (paras. 0044, 0047), for the purpose of securely anchoring the device at its desired implantation site. It would have been obvious to one having ordinary skill in the art to modify the device of the patent to have a fasteners, as taught by Datta in order to securely anchor the device at its desired implantation site. Such a modification would be made with a reasonable expectation of success.
Claim Rejections - 35 USC § 102
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.
Claim(s) 34-36, 42-45, 47-49, and 55-57 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Datta et al. (Pub. No.: US 2007/0106371 A1; hereinafter “Datta”).
Datta discloses the following regarding claim 34: an implantable device, comprising: an outer element (e.g., 130, 715) having a length (e.g., Fig. 3), the outer element being configured to be coupled to tissue located at an implantation site (paras. 0013, 0021, 0044, 0047); and an inner core (e.g., 110, 712) disposed within the outer element (e.g., Fig. 4), wherein the inner core is degradable (paras. 0013, 0021), and wherein presence of the inner core limits the length of the outer element (e.g., Figs. 3-4, 10-11; paras. 0013, 0044, 0058, since the outer element is coated or laid over the inner core, the length of the outer element will be restricted or limited to match that of the inner core), wherein the outer element has an inner width (please see, for example, annotated Figure A below) and the length is greater than the inner width (e.g., Figs. 3-4), and wherein the inner core spans the inner width of the outer element along at least a portion of the length of the outer element (e.g., Figs. 3-4, 11). Please note that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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Figure A.
Datta discloses the following regarding claim 35: the implantable device of claim 34, wherein the inner core comprises a polymer (para. 0013).
Datta discloses the following regarding claim 36: the implantable device of claim 34, wherein the outer element is water permeable (para. 0017).
Datta discloses the following regarding claim 42: the implantable device of claim 55, wherein the outer sleeve is configured to be coupled to the implantation site through use of at least one of sutures, mechanical fasteners (e.g., 30), and adhesive (paras. 0044, 0047).
Datta discloses the following regarding claim 43: the implantable device of claim 34, wherein the inner core is formed as a single piece (e.g., Fig. 4).
Datta discloses the following regarding claim 44: the implantable device of claim 34, wherein the inner core comprises a plurality of separate pieces (paras. 0017, 0050, during degradation).
Datta discloses the following regarding claim 45: the implantable device of claim 55, wherein the outer sleeve comprises a tubular sleeve (e.g., Fig. 4).
Datta discloses the following regarding claim 47: an implantable device, comprising: an outer element (e.g., 130, 715) configured to be coupled to tissue located at an implantation site (e.g., Fig. 3; paras. 0013, 0021, 0044, 0047); and an inner core (e.g., 110, 712) disposed within the outer element (e.g., Fig. 4), wherein the inner core is degradable (paras. 0013, 0021), wherein presence of the inner core sets a diameter of the outer element (e.g., Figure A, above; e.g., Fig. 3; paras. 0013, 0044, 0058, since the outer element is coated or laid over the inner core, the diameter of the outer element will be set or determined by the size the inner core), wherein the outer element has a length that is greater than the diameter of the outer element (e.g., Fig. 3, 11), and wherein the inner core spans the diameter of the outer element along at least a portion of the length of the outer element (e.g., Fig. 3-4, 11).
Datta discloses the following regarding claim 48: the implantable device of claim 47, wherein the inner core comprises a polymer (para. 0013).
Datta discloses the following regarding claim 49: the implantable device of claim 47, wherein the outer element is water permeable (para. 0017).
Datta discloses the following regarding claim 55: the implantable device of claim 34, wherein the outer element is an outer sleeve (e.g., Fig. 4).
Datta discloses the following regarding claim 56: the implantable device of claim 47, wherein the outer element is an outer sleeve (e.g., Fig. 4).
Datta discloses the following regarding claim 57: the implantable device of claim 34, wherein the outer element comprises a first end portion (top end portion) and a second end portion (bottom end portion), and wherein the first and second end portions are closed such that the inner core is held within the outer element (e.g., Figs. 3-4, 11; paras. 0013, 0044, 0058).
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) 37, 40, 46, and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Datta.
Regarding claims 37, 40, and 50, the cited embodiments of Datta disclose the limitations of the claimed invention, as described above. However, these embodiments do not explicitly recite the outer sleeve comprising a braided element. Datta teaches in an alternate embodiment that it is well known in the art that the outer sleeve comprises a braided element (para. 0048); and the braided element comprises a plurality of individual strands, and wherein each of the plurality of individual strands are braided (para. 0048). This type of construction provides the stent with the desired mechanical properties needed for its implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the cited embodiments of Datta to comprise braided elements, in order to provide the stent with the desired mechanical properties needed for its implantation site. Such a modification would be made with a reasonable expectation of success.
Regarding claim 46, Datta discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the values of the Young’s modulus and the crosslinking density of the inner core polymer. It has been held that the optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal Young’s modulus and crosslinking density needed to achieve the desired results and properly suit the implantation site. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the Young’s modulus and crosslinking density of the polymer, would have been obvious at the time of applicant's invention in view of the teachings of Datta. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. Please note that method limitations in apparatus claims are considered to the extent that they further define the structure of the claimed apparatus. As presently worded, the method language fails to structurally distinguish the claimed apparatus from the prior art.
Claim(s) 38 and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Datta in view of Degen (Pub. No.: US 2009/0157168 A1).
Datta discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the outer sleeve comprising a biaxially braided element. Degen teaches that it is well known in the art that stent elements are constructed with a biaxial braid (para. 0030), for the purpose of providing the stent with the desired mechanical properties needed for its implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the braided elements of Datta to have a biaxial braid, as taught by Degen in order to provide the stent with the desired mechanical properties needed for its implantation site. Such a modification would be made with a reasonable expectation of success.
Claim(s) 39 and 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Datta in view of Bashiri et al. (Pub. No.: US 2011/0054589 A1; hereinafter “Bashiri”).
Datta discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the outer sleeve comprising a triaxially braided element. Bashiri teaches that it is well known in the art that stent elements are constructed with a triaxial braid (para. 0041), for the purpose of providing the stent with the desired mechanical properties needed for its implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the braided elements of Datta to have a biaxial braid, as taught by Bashiri in order to provide the stent with the desired mechanical properties needed for its implantation site. Such a modification would be made with a reasonable expectation of success.
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Datta in view of Vong et al. (Pub. No.: US 2013/0245745 A1; hereinafter “Vong”).
Datta discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the outer sleeve having a pitch of 20 to 70 picks per inch. Vong teaches that it is well known in the art that stent elements are constructed with a pitch of 20 to 70 picks per inch (paras. 0150-0152), for the purpose of providing the stent with the structural properties needed implant the device and to suit its implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the braided elements of Datta to comprise the claimed pitch, as taught by Vong, in order to provide the stent with the structural properties needed implant the device and to suit its implantation site. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that the optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal pitch needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the pitch, would have been obvious at the time of applicant's invention in view of the teachings of Datta and Vong. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
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 Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
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