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 .
Examiner’s Notes
It is to be noted that in device/apparatus claims, such as claims 1-10, only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claims 1, 4, 11 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (US PG Pub. 2017/0367807), as disclosed in the IDS dated 12/20/2024, hereinafter Chen.
Regarding claims 1, 4, 11 and 14, Chen discloses a composite bolster scaffold (400) and a method of using said composite bolster scaffold, illustrated in Figures 9A and 9B, comprising selecting a tissue scaffold (410), securely coupled to an anchor bolster (455), comprising a non-biologic biocompatible material, the anchor bolster (455) comprising a first surface, a second surface, and a first thickness between the first and second surfaces; positioning the tissue scaffold (410) proximate to an anatomic structure, specifically a chest wall; attaching at least one surgical anchor to the anchor bolster (455); and securing the anchor to the anatomic structure ([0002], Lines 1-4; [0108]; [0109], Line 1-5 & [0117]).
Claims 1-3, 5, 6, 9-13, 15, 16, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barere et al. (US PG Pub. 2018/0055624), hereinafter Barere.
Regarding claims 1, 2, 11 and 12, Barere discloses a composite bolster scaffold (200/900) and a method of using said composite bolster scaffold (200), illustrated in Figures 8B and 9, comprising selecting a tissue scaffold (TS), specifically an acellular dermal matrix, securely coupled to an anchor bolster (AB/910), wherein the anchor bolster (AB/910) comprises a first surface, a second surface, and a first thickness between the first and second surfaces, illustrated in Figures 8B, 9 and modified figure 8B, below; positioning the tissue scaffold (TS) proximate to an anatomic structure, specifically a chest wall; attaching at least one surgical anchor to the anchor bolster (AB); and securing the anchor to the anatomic structure, illustrated in Figure 8B and modified figure 8B, below ([0026]; [0037], Lines 11-14; [0047]; [0061] & [0072]).
PNG
media_image1.png
494
383
media_image1.png
Greyscale
Regarding claims 3 and 13, Barere discloses the bolster scaffold and method of claims 1 and 11, wherein the tissue scaffold (TS) is a three-dimensional formed acellular tissue matrix scaffold, illustrated in Figure 8B and modified figure 8B, above ([0037], Lines 11-14 & [0047] – it is to be noted that the tissue scaffold has a height, width and depth, and therefore constitutes a three- dimensional scaffold).
Regarding claims 5 and 15, Barere discloses the bolster scaffold and method of claims 1 and 11, wherein the anchor bolster comprises at least one anchor fixation point and wherein the at least one surgical anchor/suture (60) is attached to an anchor fixation point of the at least one anchor fixation points, illustrated in Figure 8B.
Regarding claims 6 and 16, Barere discloses the bolster scaffold and method of claims 5 and 15, wherein the anchor fixation point is an opening extending through the first surface and the second surface of the anchor bolster, illustrated in Figure 8B.
Regarding claims 9 and 19, Barere discloses the bolster scaffold and method of claims 1 and 11, wherein the anchor bolster is shaped as a tab (910), illustrated in Figure 9 ([0062], Lines 1-5).
Regarding claims 10 and 20, Barere discloses the bolster scaffold and method of claims 1 and 11, wherein the anchor bolster (AB) is shaped as a ribbon, wherein the ribbon follows a contour of a perimeter of the tissue scaffold (TS), illustrated in Figure 8B and modified figure 8B, above.
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.
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Barere as applied to claims 5 and 15 above, and in view of Baxter, III et al. (US PG Pub. 2015/0136832), hereinafter Baxter.
Regarding claims 7 and 17, Barere discloses the bolster scaffold and method of claims 5 and 15, but does not specifically disclose the anchor fixation point comprises a second thickness less than the first thickness; however, it is disclosed that the device can include features which would guide or make the placement of sutures/anchors easier ([0061]).
However, Baxter teaches that having weakened portions/thin cross-sections can aid in the penetration of an anchor ([0688], Last 10 Lines & [0874]). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the anchor fixation point, of the device and method of Barere, to have a second thickness less than first thickness, i.e. have a thinner cross-section, in order to aid in guiding/making the placement of the anchor easier, as taught by Baxter and Barere.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Barere.
Regarding claims 8 and 18, Barere discloses the bolster scaffold and method of claims 5 and 15, wherein the anchor fixation point comprises a third thickness greater than the first thickness ([0061], Lines 1-6 – to clarify, it is stated that additional material can be added to the device/scaffold to aid in attachment; thus the additional material would equate to a greater, third, thickness); and though it is not specifically disclosed the additional material is in the form of a rim of the anchor fixation points, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to determine appropriate placement of the additional material in order to aid in attachment, including forming a rim around the openings of the anchor fixation points, in order to reinforce the fixation points.
Double Patenting
Claim 1 of this application is patentably indistinct from claim 1 of Application No. 18/612,604. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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, Jerrah Edwards can be reached at 408-918-7557. 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.
/DINAH BARIA/Primary Examiner, Art Unit 3774
Prosecution Insights