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 claim amendments filed on 10/22/2025. As directed by the amendment: claims 1, 8, and 17-18 have been amended; and no claims have been added. Thus, claims 1-20 are presently pending in this application.
Applicant’s amendments to claim 17-18 are sufficient to overcome Examiner’s objections and are therefore withdrawn.
Response to Arguments
Applicant's arguments filed 10/22/2025 are not found persuasive. Applicant argues starting page 5 line 22 US 2011/0137255 A1 to Nielsen et al. is configured to be activated with the connection between the needle unit and reservoir and not “configured to be activated upon insertion of a medicament agent into the reservoir” as now claimed. Examiner notes the drug ions as taught by Nielsen, as evidenced by US 6,622,037 B2 to Kasano require both the drug ions inserted in the reservoir trigger cited below (Nielson para. 90) and the drug ions (Kasano col 1:15-19 and col 1:37-48) as both elements are part of the complete electrical circuit that activates the iontophoretic driver circuit. Examiner notes the use of “comprising” language within claim 1, see MPEP 211.03. Therefore, as Nielsen as evidenced by Kasano demonstrates the capability of activating the iontophoretic driver circuit upon insertion of a medicament agent into the reservoir, Applicant argument is not considered persuasive.
Claim Interpretation
Claim 1 recites “wherein the iontophoretic driver circuit is configured to be activated upon insertion of a medicament agent into the reservoir”. This limitation is interpreted under broadest reasonable interpretation to require the wound treatment device of claim 1 to be fully capable of being activated at a point in time after the medicament agent is inserted into the reservoir. In the interest of clarifying the record Examiner notes: The iontophoretic device inherently requires the device to be assembled and placed on the patient’s skin to form a complete electrical circuit between the positive and negative electrodes. Therefore, a medicament that is capable of completing of the iontophoretic circuit (I.e., an electrolyte) and held within a reservoir is considered to demonstrate the capability of activating the iontophoretic driver circuit as it completes its portion of the electrical circuit.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 8-10, 12-13, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2011/0137255 A1 to Nielsen et al., as evidenced by US 6,622,037 B2 to Kasano.
In regard to claim 1:
Nielsen teaches, a wound treatment device (Figs. 1-12 element 1) comprising: a flexible substrate having a top side, a bottom side (Figs. 14, and 15 element 570 Top side considered to side element 560 sites upon, bottom side towards patient with element 571 (“lower adhesive layer”) Fig 1 element 12, para. 80 “the flexible sheet member”) and an opening extending therebetween (Fig. 14 element 572, para. 77) a reservoir comprising a port in fluid communication with the opening (Figs. 13 and 20, element 505, Para. 80) and an iontophoretic driver circuit electrically coupled to a plurality of electrodes (paras. 16, 69, and 77. Iontophoretic driver circuit is considered to be taught by Nielson because, the invention of figs. 13-15 are substantially corresponding to the embodiment of Fig. 1 and Fig. 1 recites replacing the needle with any desirable transcutaneous device, which is defined to include iontophoresis. Kasano (incorporated by reference) demonstrates the iontophoretic driver circuit coupled to a plurality of electrodes Figs. 3a-3c, col 12:55-65.) wherein the iontophoretic driver circuit is configured to be activated upon insertion of a medicament agent into the reservoir (Kasano (incorporated by reference) teaches col 1:15-19 and Col 1:37-48, drug ions considered fully capable of activating the driver circuit as they complete the electrical circuit when the device is fully assembled and ready for use on the patients skin.).
In regard to claim 2:
The device of claim 1, wherein the plurality of electrodes are disposed on the bottom side of the substrate (Kasano (incorporated by reference) Fig 3b elements 2a, 2b, and 4 on the bottom of element 8).
In regard to claim 3:
The device of claim 1, wherein the plurality of electrodes comprises a plurality of active electrodes (Fig. 3B elements 2a, 2b considered two active electrodes) and a plurality of counter electrodes (Fig. 3A and 3B elements 4, considered six electrodes).
In regard to claim 4:
The device of claim 3, wherein the plurality of active electrodes are disposed on a central portion of the substrate (Fig. 3B elements 2a and 2b) and the plurality of counter electrodes are disposed on the substrate outside the central portion (Fig. 3A and 3b elements 4 positioned surrounding the central portion of substrate 8 elements 2a and 2b attached to).
In regard to claim 8:
The device of claim 1, wherein the reservoir comprises a trigger (Figs. 20-21 elements 505 (reservoir) and 588-589 (triggers), para. 90) configured to activate the iontophoretic driver circuit upon insertion of the medicament agent into the reservoir (Paras. 89, 24, and 35. Therefore, the contacts that establish connection between the “needle unit” and reservoir are considered to be the triggers for activating the iontophoretic driver circuit in combination with the rest of the electrical circuit. Considered usable with the iontophoretic process due to para. 70 and 16 previously cited. Kasano (incorporated by reference) teaches col 1:15-19 and Col 1:37-48, drug ions considered fully capable of activating the driver circuit as they complete the electrical circuit when the device is fully assembled and ready for use on the skin of the patient).
In regard to claim 9:
The device of claim 1 further comprising: a battery disposed on the substrate and electrically coupled to the iontophoretic driver circuit and the plurality of electrodes (Kasano (incorporated by reference) col 1:54-60. Nielsen para. 89. Element 586 considered disposed on the substrate as element 505 is disposed upon said substrate).
In regard to claim 10:
The device of claim 1, wherein the iontophoretic driver circuit is a single channel iontophoretic driver circuit (Kasano (incorporated by reference) col 1:54-60. Nielsen para. 89. Considered a single channel iontophoretic driver circuit as a battery is a single channel power supply).
In regard to claim 12:
The device of claim 1, wherein the plurality of electrodes are configured for current polarization (Kasano (incorporated by reference) Fig. 1B elements 2a, 2b, and 4 Ion distribution demonstrates the current polarization of the electrodes).
In regard to claim 13:
The device of claim 1 further comprising: at least one of a skin adhesive flange and retaining strap (Fig. 14 element 571 “lower adhesive layer”).
In regard to claim 19:
A kit comprising the device (Fig. 1 elements 1 including elements 2 and 5) of claim 1 and a prepackaged agent configured to rupture upon insertion into the reservoir (para. 29, and 88).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0137255 A1 to Nielsen et al., as evidenced by US 6,622,037 B2 to Kasano, in view of US 6,385,487 B1 to Henley (hereinafter Henley ‘487)
In regard to claim 5:
The device of claim 1, taught by Nielsen, as evidenced by Kasano, as described in parent claim rejection above.
Nielsen does not appear to teach the absorptive layer as claimed. Henley ‘487 teaches, further comprising: an absorptive layer (Fig. 2 element 27, subcomponent of element 12, col 7:5 “open-celled sponge-like material 27”) connected to the bottom side of the flexible substrate (Fig. 1 element 12, positioned at the bottom of substrate element 14) and in fluid communication with the opening and the reservoir (Fig. 1 element 12 within the opening of substrate element 14. Subcomponent element 27 (absorptive layer) in fluid communication with reservoir 26 as seen in Fig. 2)
It would have been obvious to one of ordinary skill in the art prior to the effective date of filing, to modify the iontophoretic device taught by Nielson to include an absorptive layer connected to the bottom side of the flexible substrate in fluid communication with the reservoir as taught by Henley ‘487. This would have been motivated by Henley ‘487 col 5:30-40. Using the open-cell foam facilitates the use of indicating agents to show the device has been used and by extension reduce the chances of cross contamination of patients through re-use of used iontophoretic delivery devices. This would in turn increase the quality of patient treatment.
In regard to claim 6:
The device of claim 5, taught by Nielsen, as evidenced by Kasano, as described in parent claim rejection above.
Nielsen does not appear to teach the absorptive layer disposed between the plurality of active electrodes as claimed. Henley ‘487 teaches, wherein the absorptive layer is a sponge layer (Fig. 2 element 27, subcomponent of element 12, col 7:5 “open-celled sponge-like material 27”) disposed within gaps between a plurality of active electrodes (Fig. 1 element 12 disposed in gap between elements 16. Col 3:65-col 4:5.
It would have been obvious to one of ordinary skill in the art prior to the effective date of filing, to modify the iontophoretic device taught by Nielson to include an absorptive layer disposed within the gaps between a plurality of active electrodes the reservoir as taught by Henley ‘487. This would have been motivated by Henley ‘487 col 5:30-40. Using the open-cell foam facilitates the use of indicating agents to show the device has been used and by extension reduce the chances of cross contamination of patients through re-use of used iontophoretic delivery devices. This would in turn increase the quality of patient treatment.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0137255 A1 to Nielsen et al., as evidenced by US 6,622,037 B2 to Kasano, in view of US 2019/0374482 A1 to Schaller et al.
In regard to claim 7:
The device of claim 1, taught by Nielsen, as evidenced by Kasano, as described in parent claim rejection above.
Nielsen does not appear to teach the reservoir cap is removable as claimed. Schaller teaches, wherein the reservoir comprises a removable cap (Fig. 2b element 225).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the reservoir taught by Nielsen to be include a removable cap as taught by Schaller. This would have been motivated allowing the reservoir to be inspected, cleaned, sterilized and refilled without having to replace the reservoir unit.
Claim(s) 11, 14-16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0137255 A1 to Nielsen et al., as evidenced by US 6,622,037 B2 to Kasano, in view of US 2007/0276318 A1 to Henley (hereinafter Henley ‘318.
In regard to claim 11:
The device of claim 1, taught by Nielsen, as evidenced by Kasano, as described in parent claim rejection above.
Nielsen does not appear to teach a multichannel iontophoretic driver circuit as claimed. Henley ‘318 teaches, wherein the iontophoretic driver circuit is a multichannel iontophoretic driver circuit (para. 22).
It would have been obvious to one having ordinary skill in the art, prior to the effective date of filing, to modify the single channel iontophoretic driver circuit taught by Nielsen to be a multichannel iontophoretic driver circuit as taught by Henley ‘318. This would have been motivated by Henley ‘318 para. 22 “can be used to treat large dermal areas” (emphasis added). This is considered to be increasing ability of the device to treat different would sizes by increasing the size of the dermal treatment area.
In regard to claim 14:
The device of claim 1 further comprising: taught by Nielsen, as evidenced by Kasano, as described in parent claim rejection above.
Nielsen does not appear to explicitly disclose the ultrasonic vibrational element as claimed. Henley ‘318 teaches, an ultrasonic vibrational element attached to the substrate (para. 22).
It would have been obvious to one having ordinary skill in the art, prior to the effective date of filing, to modify the iontophoretic applicator taught by Nielsen to include the ultrasonic vibrational element attached to the substrate as taught by Henley ‘318. This would have been motivated by Henley ‘318 para. 22 “can be used to treat large dermal areas” (emphasis added). This is considered to be increasing ability of the device to treat different would sizes by increasing the size of the dermal treatment area.
In regard to claim 15:
Device of claim 1, taught by Nielsen, as evidenced by Kasano, as described in parent claim rejection above.
Nielsen does not appear to explicitly disclose the use of anesthetic agent as claimed. Henley ‘318 teaches, a method of wound treatment comprising: depositing an anesthetic agent into the reservoir (para. 30) of the device of claim 1 (see claim 1 rejection above for details); activating the plurality of electrodes to drive the anesthetic agent iontophoretically into a wound (Paras. 44 and 60).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filling, to modify the medication to be delivered taught by Nielson to include an anesthetic agent as taught by Henley ‘318. This would have been motivated by Henley ‘318 para. 61. Considered motivation as it would expand the types of treatment that can be delivered by the device through the use of various medications.
In regard to claim 16:
Device of claim 1, taught by Nielsen, as evidenced by Kasano, as described in parent claim rejection above.
Nielsen does not appear to explicitly disclose the use of antimicrobial agent as claimed. Henley ‘318 teaches, a method of wound treatment comprising: depositing an antimicrobial agent into the reservoir (para. 30) of the device of claim 1 (see claim 1 rejection above for details); activating the plurality of electrodes to drive the antimicrobial agent iontophoretically into a wound (Paras. 44 and 60).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filling, to modify the medication to be delivered taught by Nielson to include an antimicrobial agent as taught by Henley ‘318. This would have been motivated by Henley ‘318 para. 61. Considered motivation as it would expand the types of treatment that can be delivered by the device through the use of various medications.
In regard to claim 20:
The kit of claim 19, taught by Nielsen, as evidenced by Kasano, as described in parent claim rejection above.
Nielson teaches, further comprising: a plurality of prepackaged agents (paras. 39, and 88).
Nielson does not appear to explicitly describe the agents listed within the claim. Henley ‘318 teaches, including two or more of an anesthetic agent, antimicrobial agent, hemostatic clotting promoting agent and a vasoconstrictive agent (para. 30).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filling, to modify the prepackaged agents taught by Nielson to include two or more of an anesthetic agent, antimicrobial agent as taught by Henley ‘318. This would have been motivated by Henley ‘318 para. 61. Considered motivation as it would expand the types of treatment that can be delivered by the device through the use of various medications.
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0137255 A1 to Nielsen et al., as evidenced by US 6,622,037 B2 to Kasano, in view of US 2005/0222615 A1 to Levinson.
In regard to claim 17:
Device of claim 1, taught by Nielsen, as evidenced by Kasano, as described in parent claim rejection above.
Nielson teaches, a method of wound treatment comprising: depositing a hemostatic clotting promoting agent into the reservoir (para. 88) of the device of claim 1 (see claim 1 rejection above for details); activating the plurality of electrodes to drive the agent iontophoretically into a wound (para. 16)
Nielsen does not appear to explicitly disclose the use of hemostatic clotting promoting agent as claimed. Levinson teaches, a hemostatic clotting promoting agent (paras. 4, and 9).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filling, to modify the prepackaged agents taught by Nielson to include a hemostatic clotting promoting agent as taught by Levinson. This would have been motivated by Levinson para. 9.
In regard to claim 18:
Device of claim 1, taught by Nielsen, as evidenced by Kasano, as described in parent claim rejection above.
Nielson teaches, a method of wound treatment comprising: depositing a vasoconstrictive agent into the reservoir (para. 88) of the device of claim 1 (see claim 1 rejection above for details); and activating the plurality of electrodes to drive the agent iontophoretically into a wound (para. 16).
Nielsen does not appear to explicitly disclose the use of vasoconstrictive agent as claimed. Levinson teaches, a vasoconstrictive agent (paras. 4, and 9).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filling, to modify the prepackaged agents taught by Nielson to include a vasoconstrictive agent as taught by Levinson. This would have been motivated by Levinson para. 9.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/M.A.I./Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783