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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the rasps (especially with regard to Fig. 1G which disclose that the abrasive surface is an edge not a rasp) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/18/26 has been entered.
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 1-2, 4-9, 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weitzner et al. (US 2018/0206864 A1).
Regarding claim 1, Weitzner discloses a subcutaneous abrasion device (Figs. 7A-7C) comprising: a handle (i.e., handle is located proximally of 215a but may include 215a); an elongated shaft 146a extending distally from the handle (i.e., Fig. 7C); and an abrasive surface (i.e., cutting portions of 146a) disposed on a distal end portion of the elongated shaft (Fig. 7C), wherein the abrasive surface has a width that is greater than a width of the elongated shaft (i.e., as shown in Fig. 7C), wherein the abrasive surface includes a projection (i.e., each of 146a) rigidly fixed to the elongated shaft (i.e., at least by way of 213), wherein the projection includes one or more edges (para. [0041]) extending radially outwards from the elongated shaft (Fig. 7C), wherein the one or more edges extend between a first proximal location (i.e., at 215a) and a second distal location (i.e., at 213) along a length of the elongated shaft (Fig. 7C), and wherein the one or more edges is configured to subcutaneously abrade an inner surface of a dermis of a subject (i.e., by removing the necrotic pocket as disclosed in para. [0041]) without substantially cutting or puncturing the dermis of the subject (i.e., at least since the atraumatic tip 213 protects the tissue wall).
Regarding claim 2, Weitzner discloses the subcutaneous abrasion device of claim 1. Weitzer doesn’t directly disclose wherein the inner surface of the dermis includes a portion of a reticular layer of the dermis of the subject.
The limitation “wherein the inner surface of the dermis includes a portion of a reticular layer of the dermis of the subject” is being interpreted as an intended use limitation. As seen in MPEP section 2114 section 2, 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. Ex parte Masham, 2 USPQ2d 1647. Thus, it’s seen if the prior art has the claimed structure of the invention, it is able to perform the function. As seen here, the device can be positioned such that the head 213 is butted up against the reticular layer of the dermis to protect that layer while the edge cuts the necrotized pocked as disclosed in para. [0041]. Therefore, since the structure of the device protects layers of tissue, the function is met.
Regarding claim 4, Weitzner discloses the subcutaneous abrasion device of claim 1. Weitzer also discloses wherein the abrasive surface includes a head portion (i.e., as indicated along the arrow shown in Fig. 7B) that is wider than the elongated shaft (Figs. 7B-7C).
Regarding claim 5, Weitzner discloses the subcutaneous abrasion device of claim 1. Weitzer also discloses wherein the abrasive surface includes a deployable head that deploys from a first undeployed configuration to a second deployed configuration (Figs. 7B-7C).
Regarding claim 6, Weitzner discloses the subcutaneous abrasion device of claim 5. Weitzer also discloses wherein the deployable head is selectively deployable within a subject (para. [0041]).
Regarding claim 7, Weitzner discloses the subcutaneous abrasion device of claim 1. Weitzer also discloses wherein the elongated shaft is configured to have an adjustable length (Figs. 7A-7C).
Regarding claim 8, Weitzner discloses the subcutaneous abrasion device of claim 1. Weitzer also discloses wherein the elongated shaft is a telescoping elongated shaft (Figs. 7A-7C).
Regarding claim 9, Weitzner discloses the subcutaneous abrasion device of claim 1. Weitzer also discloses wherein at least the abrasive surface is configured to be inserted into an opening in the subject (para. [0041]).
Regarding claim 16, Weitzner discloses the subcutaneous abrasion device of claim 1. Weitzer also discloses wherein the abrasive surface is in a fixed configuration on the distal end portion of the elongated shaft (Fig. 7C).
Regarding claim 17, Weitzner discloses the subcutaneous abrasion device of claim 1. Weitzer also discloses wherein the elongated shaft and abrasive surface are configured to be inserted through an opening formed in a skin of the subject (para. [0041]).
Regarding claim 18, Weitzner discloses a subcutaneous abrasion device (Figs. 7A-7C) comprising: a handle (i.e., proximal to 215a but may also include 215a); an elongated shaft 149 extending from the handle (Fig. 7C), the elongated shaft having a length extending from a proximal end of the elongated shaft adjacent to the handle to a distal tip of the elongated shaft distal from the handle (Fig. 7C); and an abrasive surface (i.e., cutting surface of 146a) disposed along the length of the elongated shaft between the proximal end and the distal tip (Fig 7C), wherein the abrasive surface has a width that is greater than a width of the elongated shaft (Fig. 7C), wherein the abrasive surface includes a projection rigidly fixed to the elongated shaft (i.e., each of 146a are projections and fixed by way of 213), wherein the projection includes one or more edges extending outwards from the elongated shaft (para. [0041]), and wherein the one or more edges are configured to subcutaneously abrade an inner surface of a dermis of a subject without substantially cutting or puncturing the dermis of the subject (para. [0041] at least to cut necrotic tissue without cutting or puncturing the tissue wall by use of 213).
Regarding claim 19, Weitzner discloses the subcutaneous abrasion device of claim 18. Weitzer also discloses wherein the one or more edges extend between a first proximal location (Fig.7A) and a second distal location along the length of the elongated shaft (Fig. 7C) between the proximal end and the distal tip of the elongated shaft (Fig. 7C).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Weitzer in view of Bleich et al. (20140163562)
Regarding claim 3, Weitzer discloses the subcutaneous abrasion device of claim 1. Weitzer doesn’t directly disclose wherein the abrasive surface includes one or more rasps.
In the same field of endeavor of flexible tissue rasps, Bleich et al discloses wherein the abrasive surface includes one or more rasps (para. [0100]).
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 abrasive surface of Weitzer to have one or more rasps as disclosed by Bleich for purposes of providing an abrasive surface on one side of an element without causing damage to nearby non-target tissues as the body is translated (para. [0103]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9, 16-19 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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