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 . 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 (i.e., changing from AIA to pre-AIA ) 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.
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 4, 7 and 14 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.
Regarding claim 4, the first clause of the claim is unclear. The claim recites that the balloon includes an intermediate configuration between the collapsed and expanded configurations. But the claim also recites that the intermediate configuration is “in the collapsed configuration and the intermediate configuration.” It is not clear if the claim is missing language, such as what occurs in the collapsed/intermediate configurations. But in any case it is not clear what the relationship is between the collapsed, intermediate and expanded configurations other than that the intermediate configuration is between the collapsed and expanded configurations. While not clearly part of the indefiniteness issue, it is noted that the second clause has no relationship to the first clause.
Regarding claims 7 and 14, the claim recites that that the primary electrodes are uniform along “at least one of” the outer facing portions or the inner fold portion. But claim 5, from which claim 7 depends, recites that the primary electrodes are located on the outer facing portion while secondary electrodes are on the inner fold portion. That is, there are no primary electrodes on the inner fold portion so that it is unclear how the primary electrodes can be unform on the inner fold portion.
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.
Claims 1, 4, 8, 10, 11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Cao (US 2017/0105793) in view of Lee (US 2015/0141982).
Regarding claims 1, 4, 8, 10, 11 and 19, Cao discloses an ablation catheter with a catheter shaft (130, fig. 5) connected to an inflatable/deflatable ablation balloon (140, [0023]) with an exterior surface having a plurality of uniformly spaced electrodes (542, [0038]-[0039]). The balloon is coupled to an RF generator (112, fig. 1). Cao does not disclose the use of predefined folds to allow bending in a predictable manner. However, predefined folds are very common in the art to allow a balloon to collapse in a predictable manner. Lee, for example, discloses an ablation catheter with a balloon having electrodes (figs. 8-8A) where the ballon may be provided with folds or pleats that allow the balloon to collapse in a predictable and organized manner ([0081]). The balloon having predefined folds thus includes outer facing portions and inner fold portions where the electrodes are on the outer facing portions where the inner fold portions are closer to the longitudinal axis of the balloon than the other portions (figs. 8-8A). There are an infinite number of intermediate configurations between the completely collapsed configuration and the completely expanded configuration (not that the claims define the collapsed/expanded configurations that specifically). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to provide the balloon of Cao with predefined folds creating outer facing portions and inner fold portions with electrodes on at least the outer facing portions as taught by Lee, that would produce the predictable result of allowing the balloon to collapse in a predictable and organized manner. The balloon, having predetermined folds for predictable movement of the balloon, includes electrodes “configured to” to follow a predictable path when the balloon moves since the electrodes are on the balloon.
Claims 3 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Cao and Lee, further in view of Bouchier (US 6,091,993).
Regarding claims 3 and 16, the catheter of Cao as modified does not include a description of how the predetermined folds are formed, presumably because it is a matter of ordinary skill in the art. In fact, use of thermosetting is common in the art and the fact that Applicant has disclosed several different steps for forming the predetermined folds suggests none of them produce an unexpected result. Bouchier discloses an ablation balloon which employs thermosetting to create featured in the balloon (col. 5 lines 52-54). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to use any commonly known method of making the catheter of Cao, including thermosetting as taught by Bouchier, that would produce the predictable result of a balloon having desired features/properties.
Claims 5-7 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Cao and Lee, further in view of Jung (US 2019/0350634)
Regarding claims 5-7 and 12-14, the catheter of Cao as modified does not disclose that some electrodes are located on the inner fold locations. However, placing electrodes on inner folds is common in the art. Jung, for example, discloses a balloon predefined folds and electrodes where the electrodes are located on the inner fold portions (fig. 5C). It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to further modify the catheter of Coa to have electrodes in any commonly known location on the balloon, including on the inner fold portions as taught by Jung, that would produce the predictable result of allowing a user to interact with tissue in a desired manner. The electrodes on the outer facing portions will contact tissue first, being closer to tissue than the electrodes on the inner fold portions. The electrodes are uniform, including “clinically” uniform, as discussed above in the rejection of claim 1 of Cao.
Claims 9, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Cao and Lee, further in view of Jackson (US 5,846,238).
Regarding claims 9 and 17, The catheter of Cao as modified does not include a description of how the predetermined folds are formed, presumably because it is a matter of ordinary skill in the art. In fact, use of “living hinges” (i.e. points of thinned cross-section) is common in the art and the fact that Applicant has disclosed several different steps for forming the predetermined folds suggests none of them produce an unexpected result. Jackson discloses an ablation balloon with predetermined folds that are formed in one of several ways including the use of living hinges (col. 11 lines 41-52). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to use any commonly known method of making the catheter of Cao, including living hinges as taught by Jackson, that would produce the predictable result of a balloon having desired features/properties.
Regarding claim 18, the catheter of Cao does not include a fluid source for delivering fluid to target tissue. However, delivering fluid to target tissue using a fluid source and ablation balloon is common in the art such as taught by Jackson (see discussion associated with fluid ports 147 in figures 39-40B). Therefore, before the application was filed, it would have been obvious to further modify the catheter of Cao to include a fluid source for allowing the balloon to deliver fluid to target tissue, such as taught by Jackson, that would produce the predictable result of allowing a user to provide fluid to tissue in a desired manner.
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 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,082,936. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims 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 2, 15 and 20 will be objected to as being dependent upon a rejected base claim, but allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, once the double patenting issues are resolved. These claims are indicated to contain allowable subject matter for the same reasons the claims in the parent case were allowed (see in particular the reasons for allowance in the Notice of Allowance filed 08 May 2024 in parent application 17/256,997, which is now the U.S. Patent discussed in the double patenting rejection, 12,082,936).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding other ablation balloons with predetermined folds and electrodes, see figure 4B of US 2013/0172877 to Subramaniam, figures 10-11 of US 2002/0087208 to Koblish, figure 18 of US 2005/0171524 to Stern, figures 4A-B of US 6,273,907 to Laufer and figure 9E of US 2017/0348049 to Vrba.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
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