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 without traverse of Group II (claim 20) in the reply filed on 8/21/2026 is acknowledged.
Claims 1-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 8/21/2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: Figure 5 does not include reference sign “516” mentioned in the specification at [0098].
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Figure 1A includes reference signs 103 and 113 which are not described in the specification.
Figure 1B includes reference sign 113 which is not described in the specification.
Figure 7 includes reference sign 700 which is not described in the specification.
[0040] recites “disease, disorder, or condition on set in a prophylactic manner to inhibit or slow down onset or subsequent progression” instead of “onset”.
Paragraphs 0010 and 0015; 0012 and 0017; 0013 and 0018; and 0014 and 0019 appear to be duplicates.
Appropriate correction is required.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 20 is rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Zhang et al. US 2022/0047777 A1 (published 2/17/2022, cited on the 6/24/2025 IDS).
Zhang teaches a method of reducing a risk of an adverse effect associated with implanting a medical device in a subject in need thereof, the method comprising: inserting the medical device to be implanted into the subject into an encasement structure, the encasement structure comprising at least one sheet comprising a bioscaffold material, the at least one sheet configured to define an internal region that is sized and shaped to hold the medical device therein; applying one or more depots to the encasement structure to form an encased medical device; and implanting the encased medical device into the subject [claim 62].
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Horn et al. US 2013/0144356 A1 (published 6/6/2013, cited on the 6/24/2025 IDS).
Horn teaches a method of treating a patient comprising placing an implantable pocket structure comprising remodelable extracellular matrix (ECM) sheet material (reads on bioscaffold material), which provides an initial pocket structure for receipt of an implantable electronic medical device (reads on encasement structure), into a body location [0011]. An implantable electronic medical device is placed in the initial pocket structure [0011]. Figure 2A depicts an exemplary implantable pocket with top and bottom sheets comprising of harvested remodelable ECM material. An implantable electronic device is positioned between the two sheets, and peripheral regions of the respective sheets are fused together to fully contain the device between the two sheets [0033]. The device is shown to fit snugly between the sheets with some void space in the interior of the pocket [0033] (reads on sheet configured to define an internal region sized and shaped to hold the medical device). The implantable pocket structure may further comprise additional materials or substances that are introduced into the void spaces of the construct and/or into the bioscaffold material prior to competing the implantation procedures [0030]. These may include therapeutic/drug agents [0030]. Drug agents may be incorporated into a bioabsorbable polymer incorporated within or coated on the ECM material of the pocket construct [0040] (reads on depots, see instant specification paragraphs 0018; 0020).
Horn teaches that the remodelable ECM material retains some native collagen microarchitecture of the source extracellular matrix, which provides a scaffold to facilitate and support tissue ingrowth following implantation [0024]. This leads to the regeneration of a newly-remodeled, functional tissue structure providing a pocket-like structure around the implantable medical device [0024]. Horn further teaches that the newly generated functional tissue structure reduces adverse effects such as encapsulation of the medical device in non-functional, rigid, fibrotic scar tissue, which can deform the device and cause irritation and discomfort to the patient [0025].
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 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of U.S. Patent No. 12,514,958 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a method of reducing a risk of an adverse effect associated with implanting a medical device in a subject in need thereof, the method comprising inserting the medical device into an encasement structure to form an encased medical device, the encasement structure comprising: at least one sheet comprising a bioscaffold material, the at least one sheet configured to define an internal region that is sized and shaped to hold the medical device therein, depots associated with the encasement structure; and implanting the encased medical device into the subject.
Claim 20 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18/902,069 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because they are both drawn to an implantable medical product comprising bioabsorbable material, configured with an internal region or cavity to encase a medical device therein. The reference claims teach that the encasement structure reduces biological responses (i.e. adverse effects) associated with conventionally implanted medical devices when implanted into a mammalian body; thus, it would be obvious to use the reference invention in a method for that purpose.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA LYNN CHI whose telephone number is (571)272-0026. The examiner can normally be reached Monday - Friday 9 am-5pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA LYNN CHI/Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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