DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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 .
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 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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/707175 provides adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Accordingly, the claims are given the priority benefit date of 12/9/2019.
Specification
The disclosure is objected to because of the following informalities: update the first paragraph with an appropriate patent number of the priority application.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: amend “the proximal portion” to -a proximal portion- in ll. 22. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: amend “The proximal edge” to -a proximal edge- in ll. 27. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: amend “insultation” to -insulation- in ll. 3. Appropriate correction is required.
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 3 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 3 recites the limitation "the balloon catheter" in ll. 4. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,042,216. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite A medical probe for irreversible electroporation (medical probe for irreversible electroporation) including an expandable balloon mounted on a distal end of a shaft (a shaft for insertion into an organ of a patient and an expandable balloon coupled to a distal end of the shaft), the expandable balloon comprising: an expandable membrane configured to be expanded from a collapsed shape to a balloon shaped member (an expandable membrane having an outer surface and an inner surface, wherein the expandable membrane is configured to be expanded from a collapsed shape to a balloon shaped member); a plurality of electrodes disposed on an outer surface of the expandable membrane, wherein each of the plurality of electrodes are disposed at a same longitudinal distance from the distal end of the shaft (a plurality of electrodes disposed on the outer surface of the expandable membrane, wherein each of the plurality of electrodes are disposed at a same longitudinal distance from the distal end of the shaft); a plurality of wires connected to the plurality of electrodes and extending from the plurality of electrodes along a contour of the expandable member to the distal end of the shaft, wherein each wire of the plurality of wires is insulated in a sleeve (one or more first wires connected to each of the plurality of electrodes, the one or more first wires extending from the distal end to the plurality of electrodes, wherein each of the one or more first wires is insulated in a sleeve and follows a contour of the expandable member); and an expandable cover that encapsulates the plurality of wires between the expandable cover and the expandable membrane so that the plurality of wires is constrained between the expandable cover and the expandable membrane, but the plurality of electrodes is exposed to ambient environment (an expandable cover that encapsulates the one or more first wires between the expandable cover and the expandable membrane so that the one or more first wires are constrained between the expandable cover and the expandable membrane but the plurality of electrodes are exposed to ambient environment), wherein a distal edge of the expandable cover is a circle that extends around a perimeter of the expandable balloon and overlaps only the proximal portion of each of the plurality of electrodes (the expandable cover extends over a portion of the plurality of electrodes and is adhered to the expandable member, wherein a distal edge of the expandable cover is a circle that extends around a perimeter of the expandable balloon and overlaps a proximal portion of each of the plurality of electrodes); and a seal that runs over the distal edge of the expandable cover and is configured to seal the expandable cover to the expandable membrane, wherein the seal directly covers only the proximal edge of each of the plurality of electrodes (a seal that runs over the distal edge of the expandable cover and is configured to seal the expandable cover to the expandable membrane wherein the seal directly covers a proximal edge of each of the plurality of electrodes; and wherein the distal edge of the expandable cover overlaps only the proximal portion of each of the plurality of electrodes and the seal directly covers only the proximal edge of each of the plurality of electrodes).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Claymor (5,779,698, previously cited) teaches lead wires that extend through the shaft and then connect to wires that extend on the exterior of an expandable member to electrodes. Vrba et al. (2017/0348049, previously cited) discloses a medical probe comprising an expandable membrane, a plurality of electrodes and lead wires, and an expandable cover encapsulating the lead wires. Vrba et al. fail to specifically disclose "a seal that runs over the distal edge of the expandable cover and is configured to seal the expandable cover to the expandable membrane, wherein the seal directly covers only the proximal edge of each of the plurality of electrodes".
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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