DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
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Claims 2, 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11, 944, 509 in view of Suokas et al (Pub. No.: US 2007/0141111)
Regarding claim 2, patented claim 1 discloses:
a continuous, bioabsorbable filament forming at least one loop, wherein upon full deployment of the surgical implant within the surgically created cavity, the at least one loop of the filament forms a three-dimensional structure sized and shaped to fill the surgically created cavity and to delineate margins of the surgically created cavity [see column 18 lines 38-55];
a plurality of radiopaque markers secured at various locations along a peripheral surface of the three-dimensional structure [see column 18 lines 38-55].
Patented claim 1 doesn’t disclose at least one loop to forms a three-dimensional structure.
Nonetheless, Suokas et al disclose at least one loop to forms a three-dimensional structure [see 0069].
Therefore, it is obvious to one skilled in the art at the time the invention was to use at least one loop to forms a three-dimensional structure; to mimic structural organs.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 2-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Suokas et al (Pub. No.: US 2007/0141111) in view of Chi Sing et al (Pub. No.: US 2011/0313288).
Regarding claims 2, 12, Suokas et al disclose a surgical implant for placement within a surgically created cavity [see 0096];
the surgical implant comprising:
a continuous, bioabsorbable filament forming at least one loop, wherein upon full deployment of the surgical implant within the surgically created cavity, the at least one loop of the filament forms a three-dimensional structure sized and shaped to fill the surgically created cavity and to delineate margins of the surgically created cavity [see abstract, 0065, 0069, 0077, 0097];
Suokas et al don’t disclose a plurality of radiopaque markers secured at various locations along a peripheral surface of the three-dimensional structure.
Nonetheless, Chi Sing discloses a plurality of radiopaque markers secured at various locations along a peripheral surface of the three-dimensional structure [see 0116, 0151 -0152].
Therefore, it is obvious to one skilled in the art at the time the invention was made and would
have been motivated to combine Suokas et al and Chi Sing by using a plurality of radiopaque markers secured at various locations along a peripheral surface of the three-dimensional structure; to track different regions concurrently and for enhancing visibility of internal structures.
Regarding claim 3, Suokas et al disclose wherein the at least one loop has an open center [see 0011, 0069, claim 1, figs 3-4].
Regarding claim 4, Suokas et al disclose wherein the continuous, bioabsorbable filament forms a plurality of loops [see 0069, 0071, figs 3-4].
Regarding claim 5, Suokas et al disclose wherein the continuous, bioabsorbable filament forms four loops [see 0069, 0071, figs 3-4].
Regarding claim 6, Suokas et al disclose wherein each of the plurality of loops has an open center [see 0069, 0071, figs 3-4].
Regarding claim 7, Suokas et al disclose wherein respective ends of each of the plurality of loops are positioned adjacent to one another in the three-dimensional structure [see 0069, 0071, figs 3-4].
Regarding claim 8, Suokas et al disclose wherein, upon full deployment of the surgical implant within the surgically created cavity, the open centers of the plurality of loops are evenly spaced relative to each other about the three-dimensional structure [see fig 3].
Regarding claim 9, Suokas et al disclose wherein the three-dimensional structure defines a hollow internal cavity (opening 2) [see fig 4].
Regarding claim 10, Suokas et al don’t disclose wherein the three-dimensional structure has a spherical shape.
Nonetheless, Chi Sing discloses wherein the three-dimensional structure has a spherical shape [see 0083, 0145, 0185, 0189].
Therefore, it is obvious to one skilled in the art at the time the invention was made and would have been motivated to combine Suokas et al and Chi Sing by using a three-dimensional structure that has spherical shape; the spherical shape distributes internal and external pressure evenly across its surface, making it highly resistant to rupture under high pressure and the symmetrical structure allows rapid self-assembly using minimal genetic instructions, conserving energy and resources
Regarding claim 11, Suokas et al don’t disclose wherein the plurality of radiopaque markers comprise clips attached to the peripheral surface of the three-dimensional structure via preformed holes in the filament into which the clips can be pressed and attached.
Nonetheless, Chi Sing discloses the plurality of radiopaque markers comprise clips attached to the peripheral surface of the three-dimensional structure via preformed holes in the filament into which the clips can be pressed and attached [see 0196] by disclosing the marker 2 may be used to locate a particular location in the GI tract 3, e.g., to facilitate puncturing the wall and enter the body lumen, to clip [see 0196].
Therefore, it is obvious to one skilled in the art at the time the invention was made and would have been motivated to combine Suokas et al and Chi Sing by having the plurality of radiopaque markers comprise clips attached to the peripheral surface of the three-dimensional structure via preformed holes in the filament into which the clips can be pressed and attached; to anchor the markers properly to the structure.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 13-17 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Suokas et al (Pub. No.: US 2007/0141111)
Regarding claim 13, Suokas et al disclose a surgical implant for placement within a surgically created cavity [see 0096];
the surgical implant comprising:
a continuous, bioabsorbable filament forming a plurality of loops, wherein upon full deployment of the surgical implant within the surgically created cavity, [see abstract, 0065, 0069, 0077, 0097 and figs 3-4];
the plurality of loops of the filament forms a three-dimensional structure sized and shaped to be placed within the surgically created cavity and to delineate margins of the surgically created cavity [see abstract, 0065, 0069, 0077, 0097 and figs 3-4];
wherein ends of the plurality of loops are positioned adjacent to one another in the three-dimensional structure [see abstract, 0065, 0069, 0077, 0097 and figs 3-4].
Regarding claim 14, Suokas et al disclose wherein the continuous, bioabsorbable filament forms four loops [see 0069, 0071, figs 3-4].
Regarding claim 15, Suokas et al disclose wherein each of the plurality of loops has an open center [see 0069, 0071, figs 3-4].
Regarding claim 16, Suokas et al disclose wherein, upon full deployment of the surgical implant within the surgically created cavity, the open centers of the plurality of loops are evenly spaced relative to each other about the three-dimensional structure [see fig 3].
Regarding claim 17, Suokas et al disclose wherein the three-dimensional structure defines a hollow internal cavity (opening 2) [see fig 4].
Claims 18-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Suokas et al (Pub. No.: US 2007/0141111) in view of Chi Sing et al (Pub. No.: US 2011/0313288).
Regarding claim 18, Suokas et al don’t disclose wherein the three-dimensional structure has a spherical shape.
Nonetheless, Chi Sing discloses wherein the three-dimensional structure has a spherical shape [see 0083, 0145, 0185, 0189].
Therefore, it is obvious to one skilled in the art at the time the invention was made and would have been motivated to combine Suokas et al and Chi Sing by using a three-dimensional structure that has spherical shape; the spherical shape distributes internal and external pressure evenly across its surface, making it highly resistant to rupture under high pressure and the symmetrical structure allows rapid self-assembly using minimal genetic instructions, conserving energy and resources
Regarding claims 19-21, Suokas et al don’t disclose wherein the plurality of radiopaque markers comprise clips attached to the peripheral surface of the three-dimensional structure via preformed holes in the filament into which the clips can be pressed and attached.
Nonetheless, Chi Sing discloses the plurality of radiopaque markers comprise clips attached to the peripheral surface of the three-dimensional structure via preformed holes in the filament into which the clips can be pressed and attached [see 0196] by disclosing the marker 2 may be used to locate a particular location in the GI tract 3, e.g., to facilitate puncturing the wall and enter the body lumen, to clip [see 0196].
Therefore, it is obvious to one skilled in the art at the time the invention was made and would have been motivated to combine Suokas et al and Chi Sing by having the plurality of radiopaque markers comprise clips attached to the peripheral surface of the three-dimensional structure via preformed holes in the filament into which the clips can be pressed and attached; to anchor the markers properly to the structure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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/JOEL F BRUTUS/Primary Examiner, Art Unit 3797
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