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.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it has not been submitted on its own sheet. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Furthermore, the lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 30, 32, 67, 78, 81, and 83 are objected to because of the following informalities: In claim 1 (line 1) the first occurrence of “of” should be deleted; In claim 30 (line 3) “sensed falls below the set” should be replaced with -sensed parameter falls below or above the set-; In claim 32 (line 13) “very set” should be replaced with -set very-; In claim 67 (line 3) “occlude” should be replaced with -occluder-; In claim 78 (line 2) -at least one- should be inserted before “ablation element”; In claim 81 (line 5) -the- should be inserted before “detected values”; In claim 83 (lines 3, 7, and 8) “receive,” “monitor,” and “adjust” should be replaced with -receiving,- -monitoring,- and -adjusting- (respectively). 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 1-4, 6, 18-21, 26-30, 32, 50, 56, 59, 64, 67, 78, 79, 81, and 83-85 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 1 is found to be indefinite because Examiner is unsure of what is meant by the scope of the limitation “fluid outlet is equal above a set high bolus” (line 26). Appropriate correction is required.
Claims 18-21 recite the limitation "the control cycle" in line 2. There is insufficient antecedent basis for this limitation in the claims.
Claims 18-19 recite the limitation "controlling the flow regulator to low/high delivery mode" in line 5. There is insufficient antecedent basis for this limitation in the claims.
Claims 20-21 recite the limitation "the flow regulator" in line 5. There is insufficient antecedent basis for this limitation in the claims.
Claim 26 recites the limitation "the flow regulator" in line 2 (also see lines 4 and 7). There is insufficient antecedent basis for this limitation in the claim.
Claims 27 and 29 recite the limitation "the cycle" in lines 1-2 (also see claim 30). There is insufficient antecedent basis for this limitation in the claim.
Claims 27 and 29 recite the limitation "the set low threshold" in line 5 (also see line 7 and claim 30). There is insufficient antecedent basis for this limitation in the claims.
Claims 27 and 29 recite the limitation "the flow regulator" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the flow regulator" in line 2 (also see lines 4 and 8). There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation "the cycle" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation "the one or more parameter values" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation "said high threshold" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation "the ablation energy" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation "the flow regulator" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 50 recites the limitation "the conductive fluid source" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 64 is found to be indefinite because it’s scope is unclear due to its lack of a transitional phrase. Appropriate correction is required.
Claim 81 recites the limitation "the shaft distal end portion" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 81 is found to be indefinite because Examiner is unsure of what is meant by the scope of the limitation “a/the” (lines 11, 13, 15, 17, and 19). Appropriate correction is required.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base 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 1-4, 6, 18-21, 26-30, 32, 50, 56, 59, 64, 67, 78, 79, 81, and 83-85 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 18/380,531 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the claims of the instant application. Accordingly, the application claims are not patentably distinct from the copending claims. Here, the more specific copending 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claim(s) 1, 6, 18, 19-21, 32, 59, 81, and 83-85 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu, WO 2020/052231 (hereinafter Xu; original document and English translation submitted with IDS, see corresponding U.S. 2021/0196374 for English-annotated figures).
Regarding claim 1, Xu discloses (note figs. 21-22 and 25-26) a method comprising the specifically-claimed steps of: advancing a catheter (note paragraph 299); flowing a conductive fluid (note paragraph 214); sensing a control parameter (note paragraphs 198 and 201); and controlling the flow of the conductive fluid in high and low delivery modes based on the control parameter (note fig. 22).
Regarding claim 6, Xu discloses (see above) a method wherein the distal region includes at least one ablation element, the method further comprising the specifically-claimed step of energizing the element (note paragraph 214).
Regarding claims 18-19, Xu discloses (see above) a method comprising the specifically-claimed steps of: verifying the control parameter and controlling the flow (note fig. 22).
Regarding claims 20-21, Xu discloses (see above) a method comprising the specifically-claimed steps of: verifying the control parameter and switching between high and low delivery modes (note fig. 22).
Regarding claim 32, Xu discloses (see above) a method comprising the specifically-claimed steps of: determining the occurrence of a safety relevant event and adjusting the ablation energy accordingly (note paragraph 715).
Regarding claim 59, Xu discloses (see above) a method further comprising deploying the catheter in the specifically-claimed manner (note paragraph 299).
Regarding claim 81, Xu discloses (see above) a method, wherein the step of controlling the flow includes generating an output signal (based on the control parameter) which comprises one or more of the specifically-claimed temperature and electric property outputs (note paragraphs 198 and 201).
Regarding claim 83, Xu discloses (see above) a method further comprising the specifically-claimed steps of: receiving temperature signals, monitoring temperature at the target, and adjusting ablation energy to maintain temperature values (note paragraphs 529-531).
Regarding claim 84, Xu discloses (see above) a method performed at the specifically-claimed temperature (note paragraphs 500, 508, and 511).
Regarding claim 85, Xu discloses (see above) a method wherein the catheter advancing step includes the specifically-claimed navigating step (note paragraph 55).
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.
Claim(s) 2-4 and 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xu in view of Christopherson, U.S. 2002/0058933 (hereinafter Christopherson).
Regarding claims 2-4 and 26-28, Xu discloses (see above) a method of treating lung issue that comprises controlling the flow of conductive fluid to a catheter, in high and low delivery modes, based on a control parameter. However, Xu fails to explicitly disclose a method that accomplishes this using the specifically-claimed flowrates and durations. Christopherson teaches (note paragraphs 34 and 194) a similar method that comprises controlling the flow of conductive fluid to a catheter (in high and low delivery modes) based on a control parameter, wherein the method is performed using the specifically-claimed flowrates and durations (note paragraph 119). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed, to have modified the procedure of Xu to utilize the specific flowrates and durations taught by Christopherson. This is because this modification would have merely comprised a simple substitution with known parameter values in order to produce a predictable (and desirable) result (see MPEP 2143). Regarding claim 27, it should be noted that the ‘sub-routine’ limitation has not been positively recited by (i.e., is not required due to) the current claim language and it’s use of the term ‘optionally’.
Claim(s) 50, 78, and 79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xu.
Regarding claim 50, Xu discloses (see above) a method of treating lung issue that comprises controlling the flow of conductive fluid to a catheter. While the conductive fluid utilized by Xu comprises saline, Xu fails to explicitly disclose using saline having the specifically-claimed NaCl concentration. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have utilized saline with this concentration, 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. Furthermore, it should be noted that it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claims 78-79, Xu discloses (see above) a method of treating lung issue that comprises controlling the flow of conductive fluid to a catheter, wherein the catheter comprises at least one ablation element. While Xu discloses that the at least one ablation element may comprise a pair of spaced-apart electrodes (note paragraph 299), Xu fails to explicitly disclose the dimensions of the electrodes or the distance between them. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have modified the electrodes of Xu accordingly (i.e., modified their dimensions/spacing), 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. Furthermore, it should be noted that a change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim(s) 56, 64, and 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xu in view of Sharma, U.S. 2016/0354140 (hereinafter Sharma).
Regarding claims 56 and 67, Xu discloses (see above) a method of treating lung issue that comprises controlling the flow of conductive fluid to a catheter. However, Xu fails to explicitly disclose using a catheter that comprises deployable occlusion balloons, wherein the balloons are axially-spaced at a distal region thereof. Sharma teaches (note paragraphs 537 and 645) a similar method that comprises controlling the flow of conductive fluid to a catheter, wherein the catheter comprises deployable occlusion balloons that are axially-spaced at a distal region thereof (note fig. 40; paragraph 706). It is well known in the art (as can be seen in the different embodiments of Sharma) that these different energy emitter configurations are widely considered to be interchangeable, and that utilizing this specific configuration would minimize unwanted movement (thereby resulting in increased safety and efficiency). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed, to have modified the procedure of Xu to utilize a catheter comprising deployable occlusion balloons that are axially-spaced at a distal region thereof (as taught by Sharma). This is because this modification would have merely comprised a simple substitution if interchangeable energy emitter configurations in order to (predictably) increase safety and efficiency (see MPEP 2143).
Regarding claim 64, Xu discloses (see above) a method of treating lung issue that comprises controlling the flow of conductive fluid to a catheter. However, Xu fails to explicitly disclose using a catheter that comprises a suction opening in fluid communication with a vacuum source. Sharma teaches (note paragraphs 537 and 645) a similar method that comprises controlling the flow of conductive fluid to a catheter, wherein the catheter comprises both an infusion port and a suction port, and wherein the suction port is in fluid communication with a vacuum source (note paragraph 458). It is well known in the art that this fluid delivery configuration would enable fluid to be circulated/removed, thereby resulting in increased safety and efficiency. Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was filed, to have modified the procedure of Xu to utilize a catheter comprising a suction opening in fluid communication with a vacuum source (as taught by Sharma), in order to increase safety and efficiency.
Allowable Subject Matter
Claims 29-30 would be allowable if 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 (along with the Double Patenting rejections) and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794