DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 13-15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over 6,607,517 B1 to Dae et al. (Dae) in view of US 2004/0210281 A1 to Dzeng et al. (Dzeng) and US 2006/0122673 A1 to Callister et al. (Callister).
Regarding claim 13, Dae teaches a system (Fig. 15) for controlling core body temperature (Col. 16, lines 39-50) of a patient comprising, a heat transfer tube (260) instertable within the esophagus of a subject (Col. 4, lines 19-23 which state in part “it may be a het exchange catheter having a heat exchange region placed in the esophagus of a patient and exchange heat with blood in the esophageal wall…”), an external heat exchanger (276) containing a heat transfer fluid, a pump (pump head 316 engaged with pump driver 290) for flowing the heat exchange fluid through a circuit within the heat transfer tube (Col. 16, lines 7-20 which state in part “Therefore, when the heat exchanger unit 276 is properly installed in the control unit 270, the heater/cooler 288 may act to heat or cool the heat exchange fluid as that fluid is circulated through the serpentine pathway 318 and thereafter through the flow lines leading to the in-dwelling heat exchange region 262.”), a heat transfer element (262) in contact with the external heat exchanger and a sensor for detecting a parameter and generating a signal representative of the parameter (Col. 16, lines 21-34), wherein a signal is transmitted to a processor to control (i) the flow of heat transfer fluid within the circuit or (ii) the temperature of the heat transfer fluid (Col. 16, lines 39-50). However, Dae does not specifically teach wherein the tube is configured to contact the epithelial lining of the esophagus or that the processor is a microprocessor.
Dzeng teaches an analogous heat exchange catheter (title) that is inserted into the lumen of an anatomical structure such as an esophagus. A thermal exchange composition is pumped through one of the elongate tubular bodies into the balloon which expands filling a lumen of the anatomical structure and cooling the surrounding tissue and any other tissue that may be in contact with this tissue ([0035-0036]). It would have been obvious to one having ordinary skill in the art at the time of the invention to have modified Dae with the epithelial contacting balloon of Dzeng in order to facilitate cooling the surrounding tissue and any other tissue that may be in contact with this tissue as taught By Dzeng.
Callister teaches an analogous system (title) to that of Dae including the use of a microprocessor programmed to receive a target temperature input and a sensor signal that represents a sensed patient temperature. The microprocessor is programmed and configured to provide signals to the heat exchanger to add heat to the heat exchange medium of a heat exchange catheter if the target temperature is above the patient temperature and remove heat from the heat exchange medium if the target temperature is below the patient temperature, and to periodically interrupt fluid circulation within the heat exchange unit and the heat transfer catheter, and wherein the microprocessor responds to the signal from the sensor with a proportional integrated differential (PID) response such that the rate at which patient temperature approaches the target temperature is controlled ([0026]). It would have been obvious to one having ordinary skill in the art at the time of the inventio to have modified Dae with the microprocessor of Callister to allow for adding heat to the heat exchange medium of a heat exchange catheter if the target temperature is above the patient temperature and removing heat from the heat exchange medium if the target temperature is below the patient temperature, and to periodically interrupt fluid circulation within the heat exchange unit and the heat transfer catheter, and wherein the microprocessor responds to the signal from the sensor with a proportional integrated differential (PID) response such that the rate at which patient temperature approaches the target temperature is controlled ([0026]) which allows the achievement of the target temperature very gently and avoids overshoot or dramatic and potentially damaging swings in the electronic power as taught by Callister ([0122]).
Regarding claim 14, the combination teaches the system of claim 13 as well as Dae teaching wherein the sensor is a temperature sensor positioned distal to the heat transfer tube and configured to generate a signal representing the core body temperature of the subject (Col. 14, lines 41-64 and Col. 15, lines 24-30).
Regarding claim 15, the combination teaches the system of claim 14 as well as Callister teaching wherein the microprocessor receives a target temperature input and responds to the signal from the temperature sensor with a proportional integrated differential response to control the rate at which the subject approaches the target temperature ([0026]). It would have been obvious to one having ordinary skill in the art at the time of the invention to have modified Dae to include the PID control of Callister to allow the achievement of the target temperature very gently and avoids overshoot or dramatic and potentially damaging swings in the electronic power as taught by Callister ([0122]).
Claim 16 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dae, Dzeng and Callister as applied to claim 14 above, and further in view of US 2004/0039431 A1 to Machold et al. (Machold).
Regarding claim 16, Dae in view of Dzeng and Callister teaches the system of claim 14, but not wherein the sensor is a bubble detector and configured to generate a signal representing the presence of air in the circuit. Machold teaches an analogous system to that of Dae including a safety system for detecting problems in the circuit ([0019]). The safety system includes a plurality of sensors that generate signals indicative of respective parameters of the system and/or patient which are transmitted to the microprocessor which responds by controlling the operation of the generating element and mechanical drive unit ([0019]). The safety system may include sensors for detecting bubbles in the circuit at various locations on the flow lines to detect any bubble that may be pumped into the fluid system ([0248]). It would have been obvious to one having ordinary skill in the art at the time of the invention to have modified Dae to include the bubble detectors of Machold so as to detect any bubbles in the flow lines and may be pumped into the fluid system as taught by Machold.
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 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-20 of U.S. Patent No. 8,231,664 B2. 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.
Claims 1, 7 and 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-6 of U.S. Patent No. 10,716,703 B2. 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.
Claims 4, 8 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 10,716,703 B2.
Regarding claim 4, claim 1 of the patent teaches the limitations of the heat transfer device of claim 1 of the instant application. However, the patent does not teach wherein the heat transfer region comprises a semi-rigid material. It would have been obvious to one having ordinary skill in the art at the time of the invention to have selected a semi-rigid material, since 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.
Regarding claim 8, claim 2 of the patent teaches the limitations of the heat transfer catheter of claim 7 of the instant application. However, the patent does not teach wherein the heat transfer region has a surface area of about 120 cm2. It would have been obvious to one having ordinary skill in the art at the time of the invention to have made the heat transfer region having a surface area of about 120 cm2, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
Regarding claim 9, claim 1 of the patent teaches the limitations of the heat transfer catheter of claim 1 of the instant application. However, the patent does not teach wherein the heat transfer medium supply tube and the heat transfer medium return tube have diameters of about 1.0 to about 2.0 centimeters. It would have been obvious to one having ordinary skill in the art at the time of the invention to have selected diameters of the heat transfer medium supply and return tubes to be between about 1.0 and 2.0 centimeters, 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.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 10,716,703 B2 in view of WO 2005/027722 A2 to Sharratt (Sharratt).
Regarding claim 3, claim 1 of the patent teaches the limitations of the heat transfer device of claim 1 of the instant application. However, the patent does not teach an anti-bacterial coating. Sharratt teaches a bacteria resistant coating for surgical instrument (title) that teaches providing an anti-bacterial coating disposed on a surgical surface of that is positioned within a surgical site (Page 4, lines 24-25). It would have been obvious to one having ordinary skill in the art at the time of the invention to have modified the patent to include the anti-bacterial coating of Sharratt to provide an anti-microbial effect at the surgical site (Page 4, lines 26-29).
Allowable Subject Matter
Claims 2, 5 and 6 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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 KAITLYN E SMITH whose telephone number is (571)270-5845. The examiner can normally be reached Monday-Friday 9am-5pm.
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/KAITLYN E SMITH/Primary Examiner, Art Unit 3794
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