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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/03/2025 has been entered.
Response to Amendment
This Office Action is a response to applicant’s arguments filed 08/21/2025. Claims 1 and 5-7 are currently pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed 08/21/2025, with respect to the rejection(s) of claim(s) 1-7 under 35 U.S.C. 103 as being unpatentable over Carpenter in view of Castro, have been fully considered but are not persuasive.
Applicant argues Carpenter fails to teach, suggest, disclose, imply or otherwise render obvious any element provided for seton drain insertion as claimed (Remarks, pgs. 5-7).
In response to applicant’s argument, it is respectfully submitted the claimed limitations are recited functionally and do not affect the structure of the claimed invention. The claimed limitations recite how the probe head is used, however, the claim is an apparatus claim, and as discussed in MPEP 2114(II), a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. Therefore, as discussed below, Carpenter discloses the structural limitations of the claim, such that the instrument of Carpenter is fully capable of being used to traverse a tract of an anal fistula and thread a seton.
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.
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(s) 1 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Carpenter (US 10,238,417 B1) in view of Castro (US 2016/0143660 A1) (all references previously of record).
Regarding claim 1, Carpenter discloses (abstract; col. 2 line 55-col. 6 line 5; figs. 1-7) a double-headed surgical instrument (apparatus 10, fig. 1), comprising:
a handle (curette 11 including finger grips 17, depicted in sections ‘C’ and ‘D’ in fig. 1);
a first shaft (shaft of depth probe 15, depicted in fig. 1, col. 4 lines 26-54) extending out of the handle in a first direction (fig. 1);
a probe head (ball tip 18, col. 4 lines 26-54) located at a distal end of the first shaft (fig. 1);
a second shaft (shaft of cutting end 13, depicted in fig. 1, col. 2 line 64-col. 3 line 6) extending out of the handle in a second direction (extends in opposite direction of ball tip 18 along longitudinal axis of apparatus 10, fig. 1); and
a curette head (cutting end 13, which is considered to be a head of curette 11 due to loop shape and cutting capability, col. 2 line 64-col. 3 line 6) located at a distal end of the second shaft (fig. 1),
wherein the first shaft, the handle, and the second shaft are axially aligned with respect to one another (depicted as aligned along the longitudinal axis of apparatus 10, fig. 1),
wherein the probe head is configured as an anal probe head (considered to be capable of use as an anal probe head, since ball tip 18 is shaped to decrease the chance of puncturing vital tissue when inserted and therefore capable of use as an anal probe, col. 4 lines 26-37), and
wherein the anal probe head is adapted to traverse a tract of an anal fistula (considered to be capable of traversing a fistula tract, because ball tip 18 is inserted into tissue to measure the depth of wounds as well as curved wound tunnel depth, and therefore shaped appropriately to traverse tissue such as a fistula tract, col. 4 lines 26-47) and is configured for probing and curing the anal fistula (considered to be capable of probing and curing an anal fistula, since ball tip 18 is shaped to decrease the chance of puncturing vital tissue when inserted and therefore shaped appropriately for use as a probe within tissue such as an anal fistula, col. 4 lines 26-37) by using the probe head to thread a seton through the tract of the anal fistula, by using the probe head to secure the seton to the anal fistula, and by tying off the seton such that the seton functions as a drain (note the probe head is fully capable of being used to thread a seton, secure the seton and tie off the seton as claimed, because the limitations are merely functional limitations and do not affect the structure of the claimed invention, see MPEP 2114(II)).
However, Carpenter fails to disclose wherein the curette head includes a sensor.
Castro teaches (abstract; paras. [0044]-[0046], [0109]-[0110], [0114] and [0131]-[0132]; fig. 1), in the analogous art of the claimed invention, a curette head (100) including a sensor (sensor may be disposed in the curette head, para. [0109]), for the purpose of sensing physical properties of a wound site, providing the capability of distinguishing between living tissue and non-living tissue debris (para. [0109]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the curette head of Carpenter to include a sensor, in order to provide the capability of sensing physical properties of a wound site, distinguishing between living tissue and non-living tissue debris during debridement of a wound, based on the teachings of Castro (para. [0109]).
Regarding claim 5, Carpenter (as modified) teaches the instrument of claim 1. Carpenter further discloses wherein at least one of the first shaft and the second shaft comprises an elastically deformable material (depth probe 15 serves as a packing tool 16 which may be made of an elastomer, a known elastically deformable material, as evidenced by para. [0196] in US 2015/0374915 A1 to Hyde, describing an elastomer as a reversibly deformable material, col. 4 lines 38-47 of Carpenter).
Regarding claim 6, Carpenter (as modified) teaches the instrument of claim 1. Carpenter further discloses wherein the curette head is adapted to traverse a sinus cavity (cutting end 13 considered to be capable of traversing tissue such as a sinus cavity because cutting end 13 is inserted into tissue to debride portions of wounds and therefore capable of traversing tissue, col. 2 lines 64-col. 3 line 6).
Regarding claim 7, Carpenter (as modified) teaches the instrument of claim 6. Carpenter further discloses wherein the curette head is configured for treating a pilonidal sinus disease (cutting end 13 considered to be capable of traversing tissue for treatment of diseases such as a pilonidal sinus disease, because cutting end 13 is inserted into tissue to debride portions of wounds and therefore capable of traversing tissue, further note this limitation recites intended use and does not result in a structural difference between the apparatus of Carpenter and the claimed invention, see MPEP 2114(II), col. 2 lines 64-col. 3 line 6).
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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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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/BRIGID K BYRD/Examiner, Art Unit 3771
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