DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-9, drawn to a subcutaneous abrasion device, classified in A61B17/32.
II. Claims 10-15, drawn to a method of treating a section of skin of a subject, classified in A61B2017/00761.
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the process for using the product as claimed can be practiced with another materially different product such as a product that has a handle and oscillating head but does not require an elongated shaft extending distally from the handle.
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 require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different 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.
During a telephone conversation with Joseph Noreika on January 20, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-9. Affirmation of this election must be made by applicant in replying to this Office action. Claims 10-15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1-4, 9 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Moody et al. (US 2014/0364890 A1).
Regarding claim 1, Moody discloses a subcutaneous device 601 comprising: a handle 610; an elongated shaft 620 extending distally from the handle (Fig. 6B); and an abrasive surface 631 disposed on a distal end portion of the elongated shaft (Fig. 6B), wherein the abrasive surface is configured to subcutaneously abrade an inner surface of a dermis of a subject without substantially cutting or puncturing the dermis of the subject (i.e., para. [0084] discloses that the skin is not cut or otherwise disrupted by a DDM even when significant pressure is applied).
The limitation “subcutaneously abrade an inner surface of a dermis” 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 (explain the situation and how all the structure is met, thus the function is met).
Regarding claim 2, Moody discloses the subcutaneous abrasion device of claim 1. Moody also discloses wherein the inner surface of the dermis includes a portion of a reticular layer of the dermis of the subject (i.e., para. [0211] discloses reticular fibers).
Regarding claim 3, Moody discloses the subcutaneous abrasion device of claim 1. Moody also discloses wherein the abrasive surface includes one or more rasps 375 (i.e., Fig. 6 series is disclosed to be a DDM Type III, and so is an embodiment of Fig. 3E which discloses tissue engaging surface 370 and shows rasps along the surface; see also paras. [0069-[0070]] disclose 370 as having projections 375).
Regarding claim 4, Moody discloses the subcutaneous abrasion device of claim 1. Moody also discloses wherein the abrasive surface includes a head portion that is wider than the elongated shaft (Fig. 6B).
Regarding claim 9, Moody discloses the subcutaneous abrasion device of claim 1. Moody also discloses wherein at least the abrasive portion is configured to be inserted into an opening in the subject (paras. [0003], [0009], [0016], [0068]).
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.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Moody
Regarding claim 5, Moody discloses the subcutaneous abrasion device of claim 1. The embodiment of Fig. 6B doesn’t directly disclose Moody also discloses wherein the abrasive surface includes a deployable head that deploys from a first undeployed configuration to a second deployed configuration. However, para. [0091] discloses the 6B device must be modified since it is difficult to position the tissue engaging surface against a tissue without blocking the operator’s view. Additionally, para. [0093] discloses the embodiment of 6D being similar to instrument 602 of 6B and includes a Type III DDM. The embodiment of 6D also discloses the abrasive surface includes a deployable head that deploys from a first undeployed configuration (i.e., straight configuration; see para. [0093]) to a second deployed configuration (i.e., 6D, para. [0093]).
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 embodiment of Fig. 6B with the embodiment of Fig. 6D of Moody such that the head has a deployed configuration for purposes of making it easier to position the tissue engaging surface without blocking the operator’s view (para. [0091])
Regarding claim 6, Moody discloses the subcutaneous abrasion device of claim 5. Moody also discloses wherein the deployable head is selectively deployable within a subject (paras. [0090]-[0091]).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Moody in view of Yang et al. (US 2019/0336727 A1).
Regarding claims 7 and 8, Moody discloses the subcutaneous abrasion device of claim 1. Moody doesn’t directly disclose wherein the elongated shaft is configured to have an adjustable length, and wherein the elongated shaft is a telescoping elongated shaft.
In the same field of endeavor, namely neurovascular catheter having atraumatic tip, Yang discloses a similar device to Moody including a catheter having an adjustable, telescoping structure (para. [0075]).
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 device of Moody such that shaft 620 is telescoping for purposes of use in various anatomies (paras. [0075], [0217]).
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.
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 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