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
This is a first action on the merits for this regular application filed on 06/16/2022
Election/Restrictions
Applicant’s election without traverse of claims 8-13 in the reply filed on 10/20/25 is acknowledged.
Claims 1-7 and 14-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected single-use medical device, retractable surgical knife, a process for use with a single-use medical device and a single-use medical awl, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/20/25.
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.
Claims 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DiMatteo et al. (US 5,810,859).
Regarding claim 8, DiMatteo et al. discloses a single use medical device (col.1, lines 59-64 and Fig.1:10), comprising:
a handle (Fig.1:50);
a medical implement (Fig.1:150) attached (Fig.1:84) to the handle; and
a thermally deformable destruct element (Fig.1:172) attached to the handle or the medical implement (Fig.1:150, 172 and 120), wherein the thermally deformable destruct element is made of a material having a melting point of less than an autoclaving sterilization temperature (col.11, lines 61-67 through col.12, lines 1-7, and col.14: lines 41-55), wherein the thermally deformable destruct element at least partially deforms when exposed to the autoclaving sterilization temperature.
Regarding claim 9, DiMatteo et al. discloses a movable part (Fig.1: 172 and 120) for moving the medical implement between a first position (detached position; col.13, lines 35-59) and a second position (attached position).
Regarding claim 10, DiMatteo et al. discloses that thermally deformable destruct element (Fig.1:172) is in direct contact with or forms a portion of the movable part (Fig.1:172 and 120), wherein deformation of the thermally deformable destruct element prevents the movable part from moving between the first position and the second position (col.14, lines 50-54).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over DiMatteo et al. (US 5,810,859).
DiMatteo et al. discloses using one thermally deformable destruct element (Fig.1:172; col.11, lines 61-67 through col.12, lines 1-7, and col.14: lines 41-55)).
DiMatteo et al. appears silent to teach using a second thermally deformable destruct element. However, one of ordinary skill in the art would readily recognize that there are various different types of surgical or diagnostics, or dental devices that are intended for single use only and would require more than one thermally deformable destruct element. Therefore, adding more than one thermally deformable destruct element is an obvious matter that depends on the type of the single use medical device. 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 to add more than one thermally deformable destruct element in order to prevent single use medical and dental devices from being reused again.
Allowable Subject Matter
Claims 11-12 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: The closest prior art found (DiMatteo et al.) does not teach or fairly suggest the use of a bias force element that partially expand when the thermally deformable destruct element is exposed to autoclaving and where the bias force element deform the thermally deformable destruct element.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONZER R CHORBAJI whose telephone number is (571)272-1271. The examiner can normally be reached M-F 5:30-12:00 and 6:00-9:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jill J Warden can be reached at (571)272-1267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MONZER R CHORBAJI/Primary Examiner, Art Unit 1799