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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 42 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 42 recites the limitation "the medical device" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 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.
Claims 29-42 are rejected under 35 U.S.C. 103 as being unpatentable over Waugh (US 2016/0242959) in view Usui (US 2014/0031748).
Regarding claim 29, Waugh discloses a wearable patch (fig.1A), comprising backing layer (fig.1A; bandage 2) having first side (inside of bandage 2) an opposing second side (outside of bandage 2); an adhesive layer (substrate 4, see [0103]: “sodium metal 6 was coupled to substrate 4 using petroleum jelly to form a heat-generating component.”) in contact with the first side of backing layer (fig.1A). The examiner is interpreting the adhesive layer to be the petroleum jelly and peripheral adhesive to form a bandage-like device [0142]; an alkali metal selected from a single pure alkali metal and an alloy of multiple pure alkali metals ([0089], [0102] & [0103]), the alkali metal in contact with a first portion of the adhesive layer on the first side of the back layer to define a treatment region (fig.1A); wherein a second portion of the adhesive layer on the first side of the backing layer extends beyond the treatment region (fig.1A-1B). Waugh discloses that structures maybe used to prevent or minimize contact between the ambient air and the alkali metal before the device is ready to be used. Such approaches and structures gas impermeable packaging, nitrogen or other inert gas purging systems that keep oxygen from contact with the heat-generating component of the device while not in operation [0127]. However, Waugh does not disclose specifically disclose a release liner in contact with the adhesive layer and the treatment region.
Usui teaches a heat generating body (fig.1-7) comprising release sheet at a part or the whole of the adhesive layer of the mesh-like sheet, the adhesive layer can be protected until the time of use, and a fall in the adhesive strength of the adhesive layer can be prevented [0037]. The heat generating body includes an air impermeable material located on the side opposite to the mesh-like sheet, and enclosing the heat generating composition between the covering material and the base material so as to form a seal part at the outer peripheral edges of the covering material and base material [0014]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to modify the device of Waugh with a release liner in contact with the adhesive layer as taught by Usui for the purpose of protection the device before use.
Regarding claim 30, Waugh/ Usui teaches the wearable patch of claim 29, wherein the release liner and the backing layer have the same length and width or the same diameter, in both cases greater than the length and width or the diameter of the treatment region (fig.1-7 of Usui).
Regarding claim 31, Waugh/ Usui teaches the wearable patch of claim 29, wherein the release liner extends to or beyond the boundaries of the second portion of the adhesive layer. (fig.7 of Usui).
Regarding claim 32, Waugh/ Usui teaches the wearable patch of claim 29, wherein the backing layer is impermeable to water, oxygen, or both ([0031] of Waugh).
Regarding claim 32, Waugh/ Usui teaches the wearable patch of claim 29, wherein the release liner has a length and a width or a diameter that is greater than the length and width or the diameter of the backing layer (fig.6 and 7 of Usui).
Regarding claim 33, Waugh/ Usui teaches wearable patch of claim 29, wherein the alkali metal is selected from pure sodium and pure potassium or an alloy of pure alkali metals selected from pure sodium and pure potassium (fig.1-6) of Usui).
Regarding claim 34, Waugh/ Usui wearable patch of claim 29, wherein the alkali metal is a continuous layer (fig.1-3, see also [0037] of Usui).
Regarding claim 35, Waugh/ Usui teaches the wearable patch of claim 34, wherein the alkali metal is in the form of a foil ([0037] of Usui). One of the definitions of foil is very thin sheet metal (Merriam Webster dictionary).
Regarding claim 36, Waugh/ Usui teaches wearable patch of claim 35, wherein the foil has a thickness of between about 0.0254 mm and 2.54 mm (fig.1A of Waugh).
Regarding claim 37, Waugh/ Usui teaches wearable patch of claim 29, wherein the adhesive layer is coated on the first side of the backing layer, and wherein the adhesive layer is a pressure sensitive adhesive layer ([0090] of Usui).
Regarding claim 38, Waugh/ Usui teaches the wearable patch of claim 37, wherein the backing layer polyolefin is polyethylene and the adhesive is an acrylate adhesive ([0093] of Waugh).
Regarding claim 39, Waugh/ Usui teaches the wearable patch of claim 29, wherein the treatment region has a geometry and the backing layer has a geometry, and the treatment region geometry is different from the backing layer geometry (fig.4 of Usui).
Regarding claim 40, Waugh/ Usui teaches the wearable patch of claim 29, where in the treatment region has an area and the backing layer has an area (fig.1-7 of Usui). The size of the heat generating member can be suitably changed by forming the adhesive layer on the whole rear face of the mesh-like sheet and sticking the heat generating member to the mesh-like sheet through the adhesive layer. The heat generating body can thereby be made corresponding to an applied part of the body [0027]. However, Usui does not teach the treatment region area is at least 10% smaller than the backing layer area. It would have been obvious to one having ordinary skill in the art at the time the Application was effectively filed to have the desired site of treatment area, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 41, Waugh/ Usui teaches a heat delivery system, comprising: a protective container impermeable to water, oxygen, or both; and the wearable patch of claim 29 removably disposed in the protective container, the protective container comprising a sealed opening that is impermeable to water, oxygen or both ([0127] of Waugh).
Regarding claim 42, Waugh/ Usui teaches a kit ([0120] of Waugh) comprising the heat deliver system of claim 41 and a means for disposal of the medical device (means for a disposal of device claim 27 of Waugh)
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 29-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-26 of U.S. Patent No. US 12,076,271. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. Patent No. US 12,076,271 anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIGIST S DEMIE whose telephone number is (571)270-5345. The examiner can normally be reached Monday-Friday 8am-5Pm.
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/TIGIST S DEMIE/ Primary Examiner, Art Unit 3794
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