DETAILED ACTION
This Office Action is a Response to Applicant’s Arguments and Amendment submitted 02/002/2026.
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
Newly submitted claims 24-26 and 27-29 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-6, 9, 11, 13-14, 16, and 21-23, drawn to a reinforced surgical pad device, classified in a61b2017/0406.
II. Claims 24-26 and 27-29, drawn to a cardiac tissue anchoring system and a medical implant for anchoring to a tissue wall of a heart, classified in a61f2/2442.
The inventions are independent or distinct, each from the other because:
Inventions I and II are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have a materially different mode of operation, function or effect, in that invention II is designed specifically for use in anchoring cardiac tissue on a surface of the heart, whereas invention I is a generic reinforced surgical pad device that is capable of being applied to any tissue anywhere in the body for reinforcing a mesh, such as occluding an opening or sealing a hole or wound. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a separate status in the art in view of their different classification;
The inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
The inventions require a different field of search (e.g., searching different classes /subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 24-26 and 27-29 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2013/0060263 A1 to Bailly et al. (hereinafter “Bailly”) (previously made of record by the Examiner).
Regarding claim 1, Bailly discloses (see abstract; Figs. 3-15; and [0056]-[0107]) a reinforced surgical pad device (300), comprising: a surgical pad (1) configured to be positioned over an opening in a target tissue; and a reinforcement member (200) coupled to the surgical pad, the reinforcement member comprising: a central portion (201a and 205) coupled to the surgical pad, and a circumferential portion (201b) disposed around the central portion, at least a portion of the circumferential portion being sized to extend laterally beyond an outer edge of the surgical pad (see [0100]), wherein the surgical pad and the reinforcement member are configured to be disposed parallel to each other when deployed at the opening in the target tissue (see Figs. 6/15).
Regarding claim 23, Bailly discloses wherein the surgical pad comprises a flexible material (see Fig. 5 and [0059]) capable of having one or more tethers (303) pass through and anchor to the surgical pad (see Figs. 13-15 and [0096]).
Allowable Subject Matter
Claims 2-3, 4-6, 9, 11, 13-14, and 21-22 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.
The following is a statement of reasons for the indication of allowable subject matter: with respect to claims 2 and 3, neither Bailly nor any other prior art of record teaches a central portion of the reinforcement member comprises a recess or an opening sized to fit the surgical pad inset into the recess or sized to fit into the opening. While Bailly teaches a central portion (i.e., defined by element 205 in Figs. 3/7), the surgical pad is never inset into or sized to fit within the central portion – rather it is adjoining the reinforcement member and its central portion. It is also noted that the EPO indicated similar language as being allowable in the corresponding European application.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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