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 .
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 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11547479 B2 and claims 1-20 of U.S. Patent No. 12161289 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims read on the application claims.
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 8-9 and 19-20 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.
Claims 8-9 and 19-20 recite a first temperature threshold and second temperature threshold but do not have any dependency on each other. It is unclear if there is any relation between the two thresholds since a second temperature threshold wouldn’t have a first temperature threshold introduced.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1-3, 7-15, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lastarria (US 9956040 B1) in view of Christian (US 2012/0165812 A1).
Regarding claims 1 and 13, Lastarria discloses A system comprising: an energy source configured to provide treatment energy to a first location inside a body of a patient during a medical procedure (eg. Abstract, Fig. 1, laser source 20, Col. 3, Ln. 30-60); a temperature sensor configured to sense a temperature of an irrigation fluid being supplied to the first location (eg. Fig. 1, temperature sensor 40, Col. 4, Ln. 23-55); and a controller configured to: estimate a temperature at a second location different from the first location based at least in part on (i) the sensed temperature of the irrigation fluid and (ii) an amount of energy emitted from the energy source per unit net volume of the irrigation fluid (eg. Col. 4, Ln. 43 – Col. 6, Ln. 25); and modulate a flow rate of the irrigation fluid during the medical procedure (eg. Col. 6, Ln. 5 – Col. 9, Ln. 15) but does not disclose based at least in part on the estimated temperature at the second location.
Christian teaches an ablation catheter with an irrigation channel using temperature sensors to adjust the flow rate (eg. Abstract, Para. 14-19, 34-35,70-71, 75-85, 91, 94-107).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Lastarria to also have flow rate modulation based on temperature as taught by Christian since both are related to controlling temperature of a laser with irrigation fluid and would provide the predictable result of improving temperature control by having more ways to modulate.
Regarding claims 2 and 14, the combined invention of Lastarria and Christian discloses the controller is configured to estimate the temperature at the second location using a weighted combination of (i) the sensed temperature of the irrigation fluid and (ii) the amount of energy emitted from the energy source per unit net volume of the irrigation fluid (Eg. Christian, Para. 74-76 equations 1-3).
Regarding claims 3 and 15, the combined invention of Lastarria and Christian discloses the controller is further configured to maintain the flow rate of the irrigation fluid according to an upper threshold flow rate (eg. Christian, Abstract, Para. 98).
Regarding claim 7, the combined invention of Lastarria and Christian discloses the first location is an irrigation inlet located outside of the body of the patient, wherein the second location is an irrigation outflow located outside the body of the patient (eg. Col. 4, Ln. 9-25, Col. 5, Ln. 60 - Col. 7, Ln. 10).
Regarding claims 8 and 19, the combined invention of Lastarria and Christian discloses to modulate the flow rate of the irrigation fluid incudes to increase the flow rate when the estimated temperature at the second location exceeds a first temperature threshold (eg. Christian, Para. 84).
Regarding claims 9 and 20, the combined invention of Lastarria and Christian discloses wherein to modulate the flow rate of the irrigation fluid incudes decrease the flow rate when the estimated temperature at the second location is lower than a second temperature threshold (eg. Christian, Para. 84).
Regarding claim 10, the combined invention of Lastarria and Christian discloses comprising an endoscope, wherein the temperature sensor is operably associated with the endoscope (eg. Lastarria, Abstract, Col. 4, Ln. 1-22).
Regarding claim 11, the combined invention of Lastarria and Christian discloses the temperature sensor is operably positioned at a distal end of the endoscope (eg. Lastarria, Col. 4, Ln. 23-55, Col. 5, Ln. 40 – Col. 6, Ln. 5).
Regarding claim 12, the combined invention of Lastarria and Christian discloses the temperature sensor is operably positioned at an outer surface of the endoscope (eg. Lastarria, Col. 4, Ln. 23-55, Col. 5, Ln. 40 – Col. 6, Ln. 5, it would have been obvious to rearrange the location of the distal sensor to measure the temperature as desired, see MPEP 2144.04).
Claim(s) 4-6, and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lastarria (US 9956040 B1) in view of Christian (US 2012/0165812 A1), further in view of Shelton (US 2015/0133950 A1).
Regarding claims 4 and 16, the combined invention of Lastarria and Christian discloses the invention of claim 1, but does not disclose a lithotripsy device operably coupled to the energy source to apply the treatment energy to a calculi target at the first location.
Shelton teaches a lithotripsy device for removing stones (eg. Para. Abstract, 21) that uses an irrigation channel (eg. Para. 4, 34) and an energy delivery waveguide (eg Para. 10, 24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Lastarria and Christian to a lithotripsy device arrangement since the devices are all related to heating and irrigating tissue and would provide the predictable result of controlling the optimal stone breaking energy to the desired area.
Regarding claim 5 and 17, the combined invention of Lastarria, Christian, and Shelton discloses the calculi target is a renal calculi target, wherein the controller is further configured to maintain the flow rate of the irrigation fluid according to a maximal intra-renal pressure (eg. Shelton, Para. 4, 6, 22, 36, 60).
Regarding claims 6 and 18, the combined invention of Lastarria, Christian, and Shelton discloses determine the amount of energy per unit net volume of the irrigation fluid based on a plurality of individual amounts of energy corresponding to a plurality of individual energy pulses emitted by the energy source (Eg. Shelton, Para. 41, 53, Christian, Abstract, 10, 18, 76-79).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
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/MICHAEL J LAU/ Examiner, Art Unit 3796
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