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 .
Election/Restrictions
Applicant’s election of Group A Species III (example 3) in the reply filed on 8/5/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant failed to elect from the other groups as seen in the Restriction Requirement mailed on 6/17/26, where one species of each group must be elected. However, in order to advance prosecution, the examiner has examined the claims.
Specification
The disclosure is objected to because of the following informalities: on page 1, the corresponding patent number for the parent application must be added.
Appropriate correction is required.
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, 11, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 12,324,577. Although the conflicting claims are not identical, they are not patentably distinct from each other because each of the limitations recited in claims 1, 11, and 18 of the instant application are also recited in the combination of claims 1 and 6 of U.S. Patent No. 12,324,577. The difference in the terminology used would be obvious to one of ordinary skill in the art.
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 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) 1-3, 5, 6, 9-13, 15, 17-20, and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by anticipated Trenhaile (2009/0156997).
Trenhaile discloses the following claimed limitations:Claim 1: A method of repairing tissue of a patient, the method comprising: securing at least one suture (one suture seen in Fig. 1-2 and 5-6) to at least one initial point of the patient (Fig. 1-2 and 5-6, [0027, and [0032-33]); coupling the at least one suture to a repair matrix (120, 220) (Fig. 2 and 5-6) comprising a scaffold portion (the patch, 122) (Fig. 2 and 5-6) and an inflatable
Claim 2: wherein the scaffold portion abuts the inflatable
Claim 3: wherein the inflatable
Claim 5: wherein inflating
Claim 6: wherein the inflatable
Claim 9: wherein the repair matrix defines a longitudinal axis (Fig. 4-7), the repair matrix further comprises a plurality of suture channels (channels where suture passes through) generally parallel with the longitudinal axis (Fig. 4-7), each suture passing through at least one of the suture channels (Fig. 4-7).
Claim 10: further comprising ejecting the repair matrix from an inserter, the repair matrix expanding after being ejected (Fig. 1-4 and [0032-33]).
Claims 11-13, 15, and 17: Trenhaile discloses all the limitations as discussed above
Claims 18-20 and 23: Trenhaile discloses all the limitations as discussed above
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 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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trenhaile (2009/0156997) in view of Sengun et al. (2017/0273680).
Trenhaile discloses the claimed invention except for the material used for the scaffold being collagen.
Sengun a tissue repairing device which includes a scaffold portion which can be made of collagen ([0064] and [0219]),
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to make the scaffold portion of Trenhaile out of collagen, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 8, 16, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trenhaile (2009/0156997) in view of Raju (2008/0051627).
Trenhaile teaches all the claimed limitations discussed above however, Trenhaile does not disclose adding a drug to the inflatable portion.
Raju discloses an inflatable balloon that contains therapeutic ingredients like drugs where the inflatable portion being configured to elute the drug to the patient ([0053]).
It would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Trenhaile with a drug in view of the teachings of Raju, in order to treat the tissue directly with a slow release of the medication closer to the site of implantation ([0053]).
Allowable Subject Matter
Claims 4, 14, and 21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited prior art appears to teach some of the claimed limitations.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DIANNE DORNBUSCH/Primary Examiner, Art Unit 3771
