DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure (IDS) submitted on 12/14/2021 has been considered by the examiner.
Claim Status
A complete action on the merits of claims 17-37 follows below.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Fig. 5, 260;
Fig. 12, 900, 960; and
Fig 13 1000, 1010, 1015, 1020, 1025, 1030, 1045, 1050, 1060, 1070, 1075, 1085.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “655” has been used to designate both “the lower plate” in Fig. 9C and “tubular skirt” in Fig. 9B.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “925” has been used to designate both “a heat exchanger” and “block.”
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 18 and 28 are objected to because of the following informalities:
In claim 18, amend “thermoelectric heat exchangers” to recite –thermoelectric heat exchanger--.
In claim 28, amend “a second plate,; and” to recite –a second plate; and”
Appropriate correction is required.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 32 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 11,219,550.
Claim 32 is rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 17 of U.S. Patent No. 11,219,550. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘550 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. Claim 32 of the instant application provides for “a second fluid circuit comprising the heat exchange device configured for circulation of a second heat exchange fluid therethrough " whereas claim 17 of patent '550 requires “a refrigeration circuit comprising a compressor for compressing a first heat exchange fluid and circulating the first heat exchange fluid through a condenser.” Therefore, the claims of the instant application are merely broader with respect to the distal and proximal members and would therefore be encompassed by the claim language of the patent. 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 32-37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 32 recites the limitation “a first fluid circuit comprising an external heat exchanger configured for circulation of a first heat exchange fluid therethrough, the external heat exchanger being in thermal communication with the thermoelectric heat exchanger.” Applicant has support for this limitation in Fig. 11 and [00112] of the Specification. Element 825 is an external heat exchanger that allows for circulation of a first heat exchange fluid. The Examiner interprets the circuit that includes external heat exchange element 825 to be a first fluid circuit. The circuit is in thermal communication with a second circuit 835. The second circuit includes a thermoelectric heat exchanger ([00113] thermoelectric heater/cooler 865 is mounted in thermal communication with heat exchange block 855). The claim further recites “a second fluid circuit comprising the heat exchange device configured for circulation of a second heat exchange fluid therethrough, the second fluid circuit being in thermal communication with the first fluid circuit.” It is the position of the Examiner that Applicant does not have support for a second fluid circuit with the heat exchange device. The heat exchange device which is known to be a heat exchange catheter, is in the first fluid circuit. Such fluid circuit allows for a first heat exchange fluid to flow through the external heat exchanger and heat exchange device. The second fluid circuit 835, which is in thermal communication with the first fluid circuit, does not comprise the heat exchange device.
Therefore, the claimed subject matter was not described in the specification in such a way as to reasonably convey one of ordinary skill in the art that the inventor at the time the application was filed had possession of the claimed invention.
For the purposes of compact prosecution, the Examiner interprets this limitation to be –a second fluid circuit comprising the thermoelectric heat exchanger configured for circulation of a second heat exchange fluid therethrough, the second fluid circuit being in thermal communication with the first fluid circuit.—
Claims 33-37 are rejected due to their dependency on rejected claim 32.
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 33-37 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 pre-AIA the applicant regards as the invention.
Claim 33 recites the limitation “the fluid circuit” in line 12. It is unclear if the limitation is one of or in addition to “a first fluid circuit” or “a second fluid circuit.” For the purposes of compact prosecution the Examiner interprets the limitation to be –the first fluid circuit.—
Claims 34-37 are rejected due to their dependency on rejected claim 33.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 17-22, 24-25, 28-29, and 31 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Machold (2007/0203552).
Regarding claim 17, Machold teaches a system for controlling a temperature of a patient using a heat exchange device for exchanging heat with the patient ([Abstract]), comprising:
a thermoelectric heat exchanger (comprises upper plate 280, lower plate 282 and a plurality of thermoelectric modules 284 sandwiched in thermal contact with both [0113]) and
a fluid circuit comprising:
an external heat exchanger configured for fluid communication with the heat exchange device (heat exchange cassette 54 [0102]) the external heat exchanger being in thermal communication with the thermoelectric heat exchanger ([0114] upper plate 280 provides a conductive heat transfer interface between TE modules 284 and the heat exchange cassette inserted within the cavity 242);
a pump for circulating an exchange fluid through the external heat exchanger and the heat (pump 98); and
a controller configured to perform operations comprising:
receiving data indicating a target temperature for the patient;
receiving temperature data representing a measured temperature of the patient from a temperature sensor; and
in response to receiving the data indicating the target temperature for the patient, generating a control signal to cause the thermoelectric heat exchange to warm or cool the heat exchange fluid ([0092] Based on user input or on a comparison between the target temperature and the sensed tissue temperature a determination is made in step 118 as to whether the heat exchanger will be operating a cooling mode, a heat mode, or will remain off. That is, if the target temperature equals the tissue temperature, then there will be no need to initially heat or cool the body fluid).
Regarding claim 18, Machold teaches the limitations of claim 17 as previously rejected above. Machold teaches wherein generating a control signal to cause the thermoelectric heat exchange to warm or cool the heat exchange fluid comprises:
determining whether the target temperature for the patient is higher or lower than the measured temperature of the patient (114, Fig. 3A);
in response to determining that the target temperature for the patient is higher than the measured temperature of the patient, generating a signal to cause a current to flow in a first direction through the thermoelectric heat exchanger that causes the thermoelectric heat exchanger to provide heat to the fluid circuit ([0095][0113]); and
in response to determining that the target temperature for the patient is lower than the measured temperature of the patient, generating a signal to cause the current to flow in a second direction, opposite the first direction, through the thermoelectric heat exchanger that cause the thermoelectric heat exchangers to absorb heat from the fluid circuit ([0094][0113]).
Regarding claim 19, Machold teaches the limitations of claim 18 as previously rejected above. Machold teaches wherein the control signal specific an amount of the current based on the different between the target temperature for the patient and the measured temperature of the patient ([0113] The amount of heat or cold generated can also be adjusted by controlling the amount of current flowing through the TE modules).
Regarding claim 20, Machold teaches the limitations of claim 17 as previously rejected above. Machold teaches a plate coupled to the thermoelectric heat exchanger (upper pressure plate 260, Fig. 6B), wherein the external heat exchanger is configured to fit between the plate and the thermoelectric heat exchanger ([0111]); and a lower guide assembly including a pair of side walls each having a guide slot that is sized to receive side edges of the external heat exchanger to direct the external heat exchanger into a gap defined between the plate and the thermoelectric heat exchanger ([0115] the lower guide assembly 266 includes a pair of upstanding side walls 290a, 290b each having guide slot 292a, 292b facing inward toward the other. The guide slots 292a, 292b are sized to receive the side edges of the desirably plate-like external heat exchanger and reliably directed it into the narrow gap defined between the upper pressure plate 260 and the upper plate 280).
Regarding claim 21, Machold teaches the limitations of claim 20 as previously rejected above. Machold teaches a pump drive mechanism attached to and depending downward from the lower guide assembly ([0111] pump drive mechanism 268 attached to and depending downward from the lower guide assembly); and an air cooler disposed adjacent to the thermoelectric heat exchanger (air cooler 274 disposed directly below the heater/cooler subsystem).
Regarding claim 22, Machold teaches the limitations of claim 17 as previously rejected above. Machold teaches wherein the thermoelectric heat exchanger comprises an upper plate that provides a conductive heat transfer interface between one or more thermoelectric modules of the thermoelectric heat exchanger (upper plate 280) and the external heat exchanger is configured to be inserted into a slot adjacent to the upper plate (heat exchange cassette-receiving cavity 242), wherein the upper plate is configured to distribute discrete temperature differentials provided by the one or more thermoelectric modules to prevent localized heating or cooling of the external heat exchanger ([0114] The upper plate 280 provides a conductive heat transfer interface between TE modules 284 and the heat exchange cassette inserted within the cavity 242, and tends to distribute the discrete temperature differentials provided by the TE modules 284 over its surface. This helps to prevent localized heating or cooling of the heat exchange cassette).
Regarding claim 24, Machold teaches the limitations of claim 17 as previously rejected above. Machold teaches a user interface, the user interface comprising one or more indicators configured to display a mode of the system, the mode including a cooling mode, a warming mode, or a maintaining mode [0106] Only one of the indicators 184 lights up at any one time, depending on whether the system is in the COOLING, WARMING, or MAINTAINING mode. In lieu of the mode indicators 184, the display 180 may carry the message COOLING PATIENT, WARMING PATIENT, or MAINTAINING so that the operator can easily identify the mode of functioning of the controller).
Regarding claim 25, Machold teaches the limitations of claim 17 as previously rejected above. Machold teaches wherein the heat exchange device comprises an intravascular catheter (catheter 424).
Regarding claim 28, Machold teaches a system for controlling a temperature of a patient using an intravascular catheter ([Abstract]), the system comprising:
a thermoelectric heat exchanger comprising an array of thermoelectric modules sandwiched between a first plate and a second plate (upper plate 280, lower plate 282 and a plurality of thermoelectric modules 284 sandwiched in thermal contact with both [0113]); and
a fluid circuit comprising:
a heat exchange cassette configured for fluid communication with the intravascular catheter (heat exchange cassette 54 [0102]), the heat exchange cassette being in thermal communication with the thermoelectric heat exchanger and being removable from a slot of the thermoelectric heat exchanger ([0114] upper plate 280 provides a conductive heat transfer interface between TE modules 284 and the heat exchange cassette inserted within the cavity 242);
a pump for circulating a heat exchange fluid through the heat exchange cassette and the intravascular catheter (pump 98); and
a controller configured to perform operations comprising: receiving data indicating a target temperature for the patient;
receiving temperature data representing a measured temperature of the patient from a temperature sensor; and
in response to receiving the data indicating the target temperature for the patient, generating a control signal to cause the thermoelectric heat exchanger to warm or cool the heat exchange fluid ([0092] Based on user input or on a comparison between the target temperature and the sensed tissue temperature a determination is made in step 118 as to whether the heat exchanger will be operating a cooling mode, a heat mode, or will remain off. That is, if the target temperature equals the tissue temperature, then there will be no need to initially heat or cool the body fluid).
Claim 29 recites the same limitations of claim 18 as previously rejected above. Machold teaches wherein the heat exchange fluid comprises saline ([0120] the working fluid may be, for example, saline).
Regarding claim 31, Machold teaches the limitations of claim 28 as previously rejected above. Machold teaches wherein the intravascular catheter comprises a collapsible balloon, and wherein the pump is configured to circulate the heat exchange fluid within the collapsible balloon ([0084] a heat exchange balloon operated using a closed-loop flow of a biocompatible fluid that serves as the heat exchange medium).
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 negatived by the manner in which the invention was made.
Claims 23, 30, 32, and 33-36 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Machold (2007/0203552) in view of Noda (Patent No. 6,878,156).
Regarding claim 23, Machold teaches the limitations of claim 22 as previously rejected above. Machold does not teach wherein the upper plate comprises at least one channel that is configured to receive a refrigerant, the at least one channel connecting an inlet and an outlet port of the upper plate, and wherein the at least one channel enables the refrigerant to expand within the at least one channel to cool the upper plate.
However, Noda teaches a device within the same field of invention (Col. 1 lines 5-6; The present invention relates generally to coolers for heat exchange catheters) comprising a plate with an inlet and outlet port configured to receive refrigerant (Fig. 2 ; Col. 4 lines 8-16; From the condenser 42 the freon flows through freon lines 44 to preferably two heat exchange plates 46 made of, e.g., copper or steel or other metal. A heat exchange element 48, mentioned above as being disposable in the slot 24 of the housing 16 and discussed further below, is sandwiched between the plates 46 in thermal contact therewith to cool the heat exchange element. After passing through the plates 46 freon is sent back to the compressor through return freon lines 50).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to have modified the upper plate in Machold to include a channel with an inlet and outlet port that is configured to receive refrigerant for the purposes of cooling the plate to further control patient temperature.
Claim 30 recites the same limitations as claim 23 as previously rejected above.
Regarding claim 32, Machold teaches a system for controlling a temperature of a patient using a heat exchange device for exchanging heat with a patient ([Abstract]), comprising:
a thermoelectric heat exchanger (comprises upper plate 280, lower plate 282 and a plurality of thermoelectric modules 284 sandwiched in thermal contact with both [0113]); and
a first fluid circuit ([0079]) comprising an external heat exchanger (heat exchange cassette 54 [0102]) configured for circulation of a first heat exchange fluid therethrough, the external heat exchanger being in thermal communication with the thermoelectric heat exchanger ([0114] upper plate 280 provides a conductive heat transfer interface between TE modules 284 and the heat exchange cassette inserted within the cavity 242);
a controller configured to perform operations comprising:
receiving data indicating a target temperature for the patient;
receiving temperature data representing a measured temperature of the patient from a temperature sensor; and
in response to receiving the data indicating the target temperature for the patient, generating a control signal to cause the thermoelectric heat exchange to warm or cool the first heat exchange fluid ([0092] Based on user input or on a comparison between the target temperature and the sensed tissue temperature a determination is made in step 118 as to whether the heat exchanger will be operating a cooling mode, a heat mode, or will remain off. That is, if the target temperature equals the tissue temperature, then there will be no need to initially heat or cool the body fluid).
While Machold provides for the thermoelectric heat exchanger ([0114] The upper plate 280 provides a conductive heat transfer interface between TE modules 284 and the heat exchange cassette inserted within the cavity 242, and tends to distribute the discrete temperature differentials provided by the TE modules 284 over its surface. This helps to prevent localized heating or cooling of the heat exchange cassette), it does not teach a second fluid circuit comprising the thermoelectric heat exchanger configured for circulation of a second heat exchange fluid therethrough, the second fluid circuit being in thermal communication with the first fluid circuit.
However, Noda teaches a device within the same field of invention (Col. 1 lines 5-6; The present invention relates generally to coolers for heat exchange catheters) comprising a plate with an inlet and outlet port configured to receive refrigerant (Fig. 2 ; Col. 4 lines 8-16; From the condenser 42 the freon flows through freon lines 44 to preferably two heat exchange plates 46 made of, e.g., copper or steel or other metal. A heat exchange element 48, mentioned above as being disposable in the slot 24 of the housing 16 and discussed further below, is sandwiched between the plates 46 in thermal contact therewith to cool the heat exchange element. After passing through the plates 46 freon is sent back to the compressor through return freon lines 50).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to have modified the upper plate in the thermoelectric heat exchanger of Machold to create a secondary fluid circuit that would allow for a second heat exchange fluid to circulate for the purposes of cooling the plate and controlling the temperature of the first fluid circuit , and thereby controlling patient temperature.
Claim 33 recites the same limitations of claim 18 as previously rejected above.
Claim 34 recites the same limitations of claim 33 as previously rejected above.
Claim 35 recites the same limitations of claim 20 as previously rejected above.
Claim 36 recites the same limitations of claim 25 as previously rejected above.
Claims 26-27 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Machold (2007/0203552) in view of Machold (2003/0135252).
Regarding claim 26, Machold teaches the limitations of claim 17 as previously rejected above. Machold does not teach wherein the heat exchange device comprises a pad or blanket configured to contact the patient externally.
However, Machold ‘252 teaches a device within the same field of invention comprising a blanket configured to contact the patient externally (Fig. 1, 46; [0061] The controller might also activate or de-activate other apparatus, for example external heating blankets or the like, in response to sensed temperatures).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have included an external blanket since Machold provides control unit 22 may operate multiple heat transfer units to independently heat or cool different selected heat transfer sections of the heat exchange controller to attain desired or preselected temperatures in body regions.
Regarding claim 27, Machold in view of Machold ‘252 teaches the limitations of claim 26 as previously rejected above. Machold ’252 teaches wherein the pad or blanket is configured to warm the patient to prevent or reduce shivering in the patient ([0061]).
Claims 37 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Machold (2007/0203552) in view of Noda (Patent No. 6,878,156), and in further view of Machold (2003/0135252).
Claim 37 recites the same limitations of claim 26 as previously rejected above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASAMIN EKRAMI whose telephone number is (571)272-9803. The examiner can normally be reached 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne M. Hoffman can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Y.E/Examiner, Art Unit 3794
/KAITLYN E SMITH/Primary Examiner, Art Unit 3794