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 .
Response to Amendment
This office action is responsive to the amendment filed on 4/24/26. As directed by the amendment: claim 44 has been amended, claims 1-43, 45, 48, 51-53, 56-63, and 66-82 have been cancelled, and new claims 83-94 have been added. Thus, claims 44, 46, 47, 49, 50, 54, 55, 64, 65, and 83-94 are presently pending in this application.
Election/Restrictions
Newly submitted claims 86 and 89-92 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claims 86 and 89-92 are directed to mechanisms for stimulation which are alternative to the previously recited mechanism for electrical stimulation in the form of a stimulating electrode, as originally presented in claim 54. The common technical features of shared parent independent claim 44 are disclosed by Mansoor et al. as set forth in the rejection under 35 U.S.C. 102(a)(1) below.
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 Accordingly, claims 86 and 89-92 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. Note that claim 87 is considered generic to the various embodiments claimed, including the one originally presented in claim 54.
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
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) 44, 46, 54, 64, 65, 83-85, 87, and 88 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mansoor et al. (US 20200078575).
Regarding claim 44, Mansoor et al. discloses a device (fig. 1-5B) for evaluating and/or treating neuropathy in a subject (the device of fig. 1-5B which is disclosed as capable of communicating/receiving electrical signals in par. 0064, is fully capable of performing this intended use) comprising: a substrate 12; and an array of needles 24 disposed on or through the substrate; wherein one or more of the needles is hollow through the entire length of the needle (par. 0060-0066); wherein the array is configured to allow fluid transport through at least one hollow needle of the array (par. 0060-0066); wherein the array is configured to receive one or more electrical signals from one or more nerves (par. 0064, electrodes communicate both to and from tissue and are fully capable of doing so relative to nerve tissue); and wherein the array is configured to communicate one or more electrical signals to the one or more nerves (par. 0064, electrodes communicate both to and from tissue and are fully capable of doing so relative to nerve tissue), wherein the length of one or more needles is configured to allow electrical measurement in and/or therapeutic delivery to a target depth within the skin and/or subcutaneous tissue of a subject for evaluating and/or treating neuropathy (the needles have lengths and communicate signals to/from tissue, as disclosed in par. 0064, and are therefore fully capable of performing this claimed function; the needles additionally have adjustable depth of penetration using a spacer, further enhancing capability of performing this claimed function, according to fig. 5A-B and par. 0078).
Regarding claim 46, Mansoor et al. discloses one or more needles in the array further comprises a coating to penetrate skin to epidermis, dermis, or further beneath the skin (par. 0064, fig. 3A).
Regarding claims 54, 87, and 88, Mansoor et al. discloses one or more of the needles is a stimulating electrode/mechanism of stimulation (par. 0064, fig. 3A) which is fully capable of administration of approximately 20% greater voltage/current than required for maximal stimuls.
Regarding claims 64 and 65, Mansoor et al. discloses a substrate/array configuration that is fully capable of being adjusted for different depths of penetration by a spacer (see structure in fig. 3A). Additionally, Mansoor et al. discloses utilizing a spacer (36; fig. 5A-B) which alters penetration depth of the needles (par. 0078).
Regarding claim 83, Mansoor et al., in the device of fig. 1-5B, is fully capable of performing the claimed function relative to peripheral nerves.
Regarding claims 84 and 85, Mansoor et al. discloses the device of fig. 1-5B is capable of receiving signals, and therefore fully capable of receiving signals which comprise a measure of nerve conductance and/or local field potentials.
Claim Rejections - 35 USC § 103
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.
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(s) 47, 49, 50, and 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansoor et al. in view of Arias et al. (US 20020133129).
Regarding claims 47, 49, 50, and 55, Mansoor et al. discloses the device as claimed, except for specifically disclosing one or more needles in the array comprise a coating to insulate an electrical signal, one or more needles in the array is coated with an electrically conductive material, one or more needles in the array is at least partially filled with an electrically conductive material, and/or one or more needles is a reference or ground electrode. However, Arias et al. teaches providing insulative coatings on microneedles (par. 0156), conductive coatings on microneedles (par. 0162), filling microneedles with an electrically conductive material (par. 0162), and/or utilizing a reference electrode (par. 0066). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Mansoor et al. to utilize any combination of the structures of claims 47, 49, 50, and 55, as taught by Arias et al., since Arias et al. teaches that these structures are all options for fabricating/arranging microneedles in an electrically active array depending on their desired properties.
Claim(s) 64 and 65, in the alternative, is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansoor et al. in view of Hantash et al. (US 20070142885).
Regarding claims 64 and 65, in the alternative to what is disclosed by Mansoor et al. as discussed under 35 U.S.C. 102 above, Hantash et al. teaches utilizing an adjustable spacer 106 to create a desired penetration depth for a needle array (par. 0071; fig. 13). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Mansoor et al. to utilize an adjustable spacer such as the one taught by Hantash et al. for the purpose of providing sufficient structure for the spacer to enable a variety of possible penetration depths as needed.
Claim(s) 93 and 94 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansoor et al. in view of Trautman et al. (US 6083196).
Regarding claim 93, Mansoor et al. discloses the device as claimed, except for disclosing a flexible backing. However, Trautman et al. teaches utilization of either a flexible or a rigid backing 15 as both being appropriate options, with flexible backing providing the benefit of increased conformation (col. 6, ln. 66 – col 7, ln. 10). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Mansoor et al. device to utilize a backing, including a flexible backing, for the purpose of providing structural support to the array with sufficient flexibility for normal use (Trautman et al. col. 6, ln. 66 – col 7, ln. 10).
Regarding claim 94, Mansoor et al. discloses the device as claimed, except for specifically disclosing the substrate has a surface area of at least 1 square inch. However, Trautman et al. teaches that surface area is a factor/variable of device design for transdermal patches with other design parameters being correlated to a chose “skin-contact area” (col. 7, ln. 11-41). Trautman et al. further teaches an example embodiment where an area of 2 square centimeters (0.78 square inches) is chosen for the application (col. 13, ln. 9-30). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the substrate surface area of Mansoor et al. to be at least 1 square inch, since surface area is taught by Trautman et al. to be a result effective variable which defines treatment area. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Mansoor et al. device to have a surface area within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Mansoor et al. by making the surface area greater than 1 square inch as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant's arguments filed 4/24/26 have been fully considered but they are not persuasive.
Applicant argues on page 7 of the Remarks that Mansoor et al. does not teach or suggest a device for evaluating and/or treating neuropathy. Applicant’s arguments rely on language solely recited in preamble recitations in claim(s). When reading the preamble in the context of the entire claim, the recitation is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02. Additionally, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As noted above, Mansoor et al.’s device meets the structural limitations of claim 44 and the structure is fully capable of operating according to this intended use.
Applicant further argues on page 7 of the Remarks that Mansoor et al. does not disclose receiving electrical signals from nerves. However, as noted in the rejection of claim 44, Mansoor et al. discloses needles that both send and receive signals, and are therefore fully capable of receiving a signal from a nerve.
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 NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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