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 & 119(e) 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 Nos. 16/657319 & 62/769424 provide 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 11/19/2018.
Specification
The disclosure is objected to because of the following informalities: update the first paragraph with an appropriate patent number.
Appropriate correction is required.
Claim Objections
Claim 2 is objected to because of the following informalities: amend “extend extends” to -extends- in ll. 2. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “other radiopaque markers” to -the radiopaque marker- in ll. 2 since ll. 1-2 of the claim recite “each of the plurality of electrodes includes a radiopaque marker”. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: amend “a second lumen” to -a lumen- in ll. 1-2 since no “first lumen” is claimed. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: amend “a third lumen” to -a lumen- in ll. 1-2 since no “first lumen” or “second lumen” is claimed. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: amend “8 %” to -8%- in ll. 2. 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.
Claims 2-4 & 17 are 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 2 recites the limitation “the tubular member” in ll. 1. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend “the tubular member” to -a tubular member- in ll. 1. The claim will be interpreted in this manner.
Claim 2 recites the limitation “the first end” in ll. 2. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend “the first end” to -a first end- in ll. 2. The claim will be interpreted in this manner.
Claim 2 recites the limitation “the second end” in ll. 2. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend “the second end” to -a second end- in ll. 2. The claim will be interpreted in this manner.
Claim 3 recites the limitation “the tubular member” in ll. 1. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend “the tubular member” to -a tubular member- in ll. 1. The claim will be interpreted in this manner.
Claim 4 recites the limitation “the tubular member” in ll. 1. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend “the tubular member” to -a tubular member- in ll. 1. The claim will be interpreted in this manner.
Claim 17 recites the limitation “a first configuration disposed in a tubular member of less than 8 French and a second configuration disposed outside the tubular member of about 30 millimeters”. It is grammatically unclear if the “8 French “ refers to the “first configuration” or to the “tubular member” and it is grammatically unclear if the “about 30 millimeters” refers to the “second configuration” or the “tubular member”. For purposes of examination, the “8 French” will refer to the tubular member size and the “about 30 millimeters” will refer to any dimension of the first expandable membrane second configuration.
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 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,717,344. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite an electrophysiology probe (An electrophysiology probe) comprising: a first expandable membrane having an outer surface disposed about a longitudinal axis, the first expandable membrane having a first expandable membrane portion and a second expandable membrane portion spaced apart from the first expandable membrane portion along the longitudinal axis (a first expandable membrane having an outer surface and an inner surface disposed about the longitudinal axis, the first expandable membrane having a first expandable membrane portion being coupled to the second end of the tubular member and a second expandable membrane portion spaced apart from the first expandable membrane portion along the longitudinal axis, the first expandable membrane configured to be expanded from a compressed shape to a balloon shaped member); a plurality of electrodes disposed on the outer surface of the first expandable membrane, each comprising a substrate (a plurality of electrodes disposed on the outer surface of the first expandable membrane); one or more wires extending from each of the plurality of electrodes (one or more wires connected to each of the plurality of electrodes, each of the one or more wires extending from the tubular member to a respective electrode of the plurality of electrodes); a second expandable membrane that encapsulates the one or more wires between the second expandable membrane and the first expandable membrane ( second expandable membrane that encapsulates the one or more wires between the second expandable membrane and the first expandable membrane so that the one or more wires are constrained between the first and second expandable membranes with the plurality of electrodes exposed to an external ambient environment); and a third expandable membrane disposed proximate the first expandable membrane portion so that the third expandable membrane substantially encircles a portion of the first expandable membrane about the longitudinal axis, wherein the third expandable membrane encapsulates a portion of the substrate for each of the plurality of electrodes between the first expandable membrane and the third expandable membrane (a third expandable membrane disposed proximate the first expandable membrane portion so that the third expandable membrane encircles a portion of the first expandable membrane about the longitudinal axis, wherein the third expandable membrane encapsulates a portion of a substrate for each of the plurality of electrodes between the first expandable membrane and the third expandable membrane), wherein the third expandable membrane is spaced apart from the second expandable membrane along the longitudinal axis (wherein the third expandable membrane is spaced apart from the second expandable membrane along the longitudinal axis). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent 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.
Allowable Subject Matter
Claims 1-17 would be allowed if an appropriate terminal disclaimer is submitted and claims 2-4 & 17 are rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The following is a statement of reasons for the indication of allowable subject matter: the prior art, neither alone nor in combination, disclose “An electrophysiology probe comprising: a first expandable membrane having an outer surface disposed about a longitudinal axis, the first expandable membrane having a first expandable membrane portion and a second expandable membrane portion spaced apart from the first expandable membrane portion along the longitudinal axis; a plurality of electrodes disposed on the outer surface of the first expandable membrane, each comprising a substrate; one or more wires extending from each of the plurality of electrodes; a second expandable membrane that encapsulates the one or more wires between the second expandable membrane and the first expandable membrane; and a third expandable membrane disposed proximate the first expandable membrane portion so that the third expandable membrane substantially encircles a portion of the first expandable membrane about the longitudinal axis, wherein the third expandable membrane encapsulates a portion of the substrate for each of the plurality of electrodes between the first expandable membrane and the third expandable membrane, wherein the third expandable membrane is spaced apart from the second expandable membrane along the longitudinal axis.”
The closest prior art is regarded as: Vrba et al. (2017/0348049 with support in provisional 62/458990, previously cited) discloses an electrophysiology probe comprising a tubular member (405), a first expandable membrane (401) having first and second portions, one or more wires (402) connecting to a plurality of electrodes (403), and a second expandable membrane (414) that encapsulates the one or more wires so that they are constrained between the first and second expandable membranes. While Vrba et al. teach that the membrane (414) can have a variety of embodiments (i.e., “sleeve, or covering 414 that extends over at least a portion of the balloon 401”, “sleeve 414 can be a cylinder that extends along all or a portion of the main body of the balloon 401 or can be formed with a balloon matching waist that extends along the proximal waist or the distal waist of the balloon 401”, “sleeve 414 is sized and adapted to extend over a full length of the balloon 401”, “sleeve 414 is sized and adapted to extend over a partial length of the balloon 401 (such as just over a proximal cone or waist of the balloon)”; [0236]), Vrba et al. fail to specifically disclose “a third expandable membrane disposed proximate the first expandable membrane portion so that the third expandable membrane substantially encircles a portion of the first expandable membrane about the longitudinal axis…wherein the third expandable membrane is spaced apart from the second expandable membrane along the longitudinal axis”. It is noted that Vrba et al. teach an embodiment with first and second sleeves (414A, 414B) in Fig. 8E, but as persuasively argued by Applicant, this embodiment fails to also explicitly disclose the balloon (401) and it is the sleeves (414A, 414B) themselves that form the balloon space (“the proximal sleeve 414A and the distal sleeve 414B overlap to form a substantially enclosed balloon space”; [0242]). Further, there would not be motivation to one of ordinary skill in the art to modify the sleeve (414) of Vrba et al. such that it is two separate sleeves since Vrba et al. teach that a singular sleeve can be of a desired size and shape to cover the desired portions of balloon (401). Smith et al. (2013/0090649) teach a second (318) expandable membrane disposed over a first expandable membrane (314 or 316) and a third expandable membrane (316 or 314) disposed proximate the first expandable membrane, but fails to specifically disclose the third expandable membrane disposed “so that the third expandable membrane substantially encircles a portion of the first expandable membrane about the longitudinal axis”. Byrne et al. (2015/0112256) teach first (16), second (proximal 30), and third (distal 30) expandable membranes, but fail to specifically disclose the third expandable membrane encapsulates a portion of a substrate for each of the plurality of electrodes between the first expandable membrane and the third expandable membrane. Further, it would not be obvious to one of ordinary skill in the art to modify Byrne et al. such that in a modified device of Byrne et al. in view of Vrba et al. the third expandable membrane encapsulates a portion of a substrate for each of the plurality of electrodes between the first expandable membrane and the third expandable membrane since Vrba et al. does not provide for substrates at the very distal end of the balloon where the third membrane of Byrne et al. is located. Salahieh et al. (2016/0374748) teach a catheter balloon comprising a first expandable membrane (904), a plurality of electrodes (920, 922) having proximal and distal substrate portions and second and third expandable membranes (insulative layers over conductive layers on proximal and distal sections 912, 916), but fails to teach the third expandable membrane to encapsulate “a portion of the substrate for each of the plurality of electrodes between the first expandable membrane and the third expandable membrane” since only one of the proximal and distal substrate portions extend proximally or distally for each of the substrates (920, 922). Salahieh et al. (2012/0071870) in Fig. 18P illustrating a catheter balloon with a plurality of electrodes/substrates (87) on substrates that extend distally and proximally over the balloon membrane and Lepak et al. (WO 2017/087549) teach a catheter balloon comprising a plurality of electrodes/substrates (87) that extend distally and proximally over the balloon membrane. It would not have been obvious to one of ordinary skill in the art to modify the balloon catheter of Salahieh et al. ‘870 or Lepak et al. with the insulative layers on the proximal and distal ends of Salahieh et al. ‘748 since the insulative layers of Salahieh et al. ‘748 are taught to electrically insulate the conductive layers therebeneath which are the electrical connection to just two bipolar electrodes and Salahieh et al. ‘870 or Lepak et al. teach multiple electrodes on each substrate and conductive connections through flex circuits. Johnston et al. (4,709,698) teach a catheter balloon (12) comprising a first expandable membrane (16a), a plurality of electrodes (18a or 18b), a second membrane (20b, or 20 & 20b) and a third membrane (20a) that are disposed encapsulate portions of the one or more wires of the electrodes (18a or 18b) and a substrate of the one or more substrates of the electrodes (18a or 18b), but fail to disclose the second expandable membrane encapsulating the “one or more wires between the second expandable membrane and the first expandable membrane” and the third expandable membrane encapsulating “a portion of a substrate for each of the plurality of electrodes between the first expandable membrane and the third expandable membrane, and wherein the third expandable membrane is spaced apart from the second expandable membrane along the longitudinal axis”. Steinke et al. (2013/0274658) teach a basket catheter comprising a plurality of spine substrates having electrodes disposed thereon (and inherent wired connections) and second and third membranes (66, 68), but fail to disclose “a first expandable membrane” nor that the second and third membranes “encapsulate” the one or more wires or substrates. Ghaffari et al. (2013/0274562) teach the use of a polyurethane encapsulant to provide mechanical stability to elements of a flex circuit, including sensing elements themselves, but fail to specifically teach two second and third expandable membranes encapsulating at the specified positions. Applicant provides criticality for both second and third membrane to eliminate exposure of wires to the ambient environment and the likelihood of wires being entangled or mis-connected to the wrong electrode or thermocouple during assembly to optimize connection since the electrical connection between a thermocouple on each electrode may not be optimal when the thermocouple/electrode is connected to wires that extend form inside the balloon due to the number of wires (referenced also as “bifilar”) connecting to ten or more electrodes on the balloon.
Conclusion
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794