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 .
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 1-10 and 23-25 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 recites “A system for heating/cooling a target unit”. It is unclear if the forward slash mark (/) in this phrase is intended to mean “and” or “or”. That is, it is unclear whether the system is for both heating and cooling or only one of heating or cooling. For the sake of examination, the forward slash (/) is interpreted as meaning “or”; accordingly, the recitation of “heating/cooling” is interpreted as being read upon by anything that both heats and cools, anything that only heats, and anything that only cools. This rejection was set forth in the last Office Action; although many amendments were made to overcome the rejection, the preamble of claim 1 was not amended. It is suggested to amend the preamble of claim 1 to recite “A system for heating and/or cooling”.
Claim 24 recites “the internal fluid pick-up tube extends into a deeper front portion of the heat transfer fluid tank”. It is unclear what the “front portion” is “deeper” relative to. Since the claim sets forth that the reservoir bottom “is angled downward from a back of the heat transfer fluid tank to a front of the heat transfer fluid tank”, it is believed that the claim is intended to require the front portion to be “deeper” than a back portion. Accordingly, this is the interpretation applied for the sake of examination. It is suggested to amend claim 24 to recite “wherein the heat transfer fluid tank includes a reservoir bottom that is angled downward from a back of the heat transfer fluid tank to a front of the heat transfer fluid tank to form a front portion that is deeper than a back portion, and wherein the internal fluid pick-up tube extends into the front portion of the heat transfer fluid tank”.
Double Patenting
The amendments filed 12/3/2025 overcome the double patenting rejections set forth in the last Office Action.
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, 2, 4, 5, 23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Turner et al. (WO 2018/002622) in view of Kammerzell et al. (PG PUB 2022/0249751) and Ielpo et al. (US Pat 6,635,028).
Re claim 1, Turner discloses a system 10+30+40 (Fig 2; it is noted that all reference characters cited below refer to Fig 2 unless otherwise noted) for heating/cooling a target unit (it is noted that the phrase “for heating/cooling a target unit” is met in view of Fig 2 and Col 1, Lines 5-10 that disclose that the target unit 20 is heated/cooled by the system), the system comprising: a heater and/or cooler unit 10+40 including: a heater and/or cooler 10 that includes a heater and/or cooler element 12; and a heat exchanger 40 that includes a heat exchange element (the body of 40 itself), wherein the a first fluid 11 travels through the heater and/or cooler element and the heat exchange element (Page 25, Lines 17-20); and a heat transfer fluid module 30 including a fluid reservoir 42 configured to contain a second fluid 31 that is pumped to and through the heat exchanger to transfer heating and/or cooling between the first fluid and the second fluid (Page 25, Lines 22-24) and pumped to and through the target unit to transfer heating and/or cooling between the second fluid and the target unit (Page 25, Lines 30-31). Although Turner discloses that the first fluid travels between the heater and/or cooler and the heat exchanger, Turner does not explicitly disclose that this is performed by a heater and/or cooler pump in the heater and/or cooler 10; additionally, Turner discloses that the fluid reservoir 42 is provided to allow the second fluid to be added and/or removed to the heat transfer fluid module (Page 26, Lines 4-6), but does not disclose that the fluid reservoir is defined by a heat transfer fluid tank.
Kammerzell, however, teaches a substantially similar system (Fig 1) comprising a heater and/or cooler unit including a heater and/or cooler element 15 (Fig 1), a heat exchanger 14 (Fig 1) and a heater and/or cooler pump 17 (Fig 1) that pumps a first fluid through the heater and/or cooler element and the heat exchange element and back to the heater and/or cooler pump (Para 29) for the purpose of providing a means of circulating the first fluid (Para 29). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to include a heater and/or cooler pump in the heater and/or cooler 10 of Turner, as taught by Kammerzell, for the purpose of providing a means of circulating the first fluid (Para 29). Kammerzell does not disclose that the fluid reservoir is defined by a heat transfer fluid tank.
Ielpo, however, teaches a fluid reservoir in the form of a fluid tank 22 (Fig 1) for the purpose of providing a source of fluid to a tubing pathway that is structurally capable of experiencing the pressure required of a pump to move fluid through the fluid reservoir (Col 2, Lines 35-38). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Turner to include the fluid reservoir as a fluid tank, as taught by Ielpo, for the purpose of providing a source of fluid to a tubing pathway that is structurally capable of experiencing the pressure required of a pump to move fluid through the fluid reservoir (Col 2, Lines 35-38).
Re claim 2, Turner as modified by Kammerzell in the rejection of claim 1 above discloses that the heater and/or cooler pump, the heater and/or cooler element, and the heat exchange element are a closed circuit containing the first fluid (as seen in Fig 2 of Turner and Fig 1 of Kammerzell).
Re claim 4, Turner discloses that the heat transfer fluid module is a disposable heat transfer fluid module (Page 27, Lines 4-7).
Re claim 5, Turner discloses that the heat transfer fluid module includes the fluid reservoir and a heat transfer fluid pump 44 configured to pump the second fluid from the fluid reservoir to the heat exchanger and the target unit and back to the fluid reservoir (Page 25, Line 33 – Page 26, Line 2).
Re claim 23, Turner as modified by Kammerzell and Ielpo in the rejection of claim 1 above discloses all the claimed features with Ielpo teaching providing the fluid tank with a fluid return tube 3 (Fig 1) and an internal fluid pick-up tube 40 (Fig 2) extending into the fluid reservoir (as seen in Fig 2) for the purpose of providing a way to move fluid through the fluid reservoir (Col 2, Lines 35-38). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Turner to further include the heat transfer fluid tank with a fluid return tube and an internal fluid pick-up tube, as taught by Ielpo, for the purpose of providing a way to move fluid through the fluid reservoir (Col 2, Lines 35-38).
Re claim 25, Turner as modified by Kammerzell and Ielpo in the rejection of claim 5 above discloses all the claimed features with Ielpo teaching that the fluid tank includes a body 22 (Fig 1,2) and a top 25 (Fig 1,2) sealed to the body (Col 3, Lines 38-40); the motivation for including such a fluid tank is the same as set forth in the rejection of claim 1. Further, Ielpo teaches securing a fluid pump 4 (Fig 1) to the top of the fluid tank (as seen in Fig 1,2) for the purpose of providing a way to connect the pump to the tank to withdraw the fluid from the tank (Col 2, Lines 51-54). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Turner to include the pump such that it is connected to the top of the fluid tank, as taught by Ielpo, for the purpose of providing a way to connect the pump to the tank to withdraw the fluid from the tank (Col 2, Lines 51-54).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Turner et al. (WO 2018/002622)/Kammerzell et al. (PG PUB 2022/0249751)/Ielpo et al. (US Pat 6,635,028) in view of Fontenot (US Pat 5,174,285).
Re claim 3, Turner as modified by Kammerzell and Ielpo in the rejection of claim 1 above disclose that the heater and/or cooler pump, the heater and/or cooler element, and the heat exchange element are a closed circuit containing the first fluid (as seen in Fig 2), but does not explicitly disclose that the closed circuit is hermetically sealed so that it is configured to prevent contamination of the second fluid. Fontenot, however, discloses hermetically sealing a closed circuit flow passageway (Col 1, Lines 7-11) for the purpose of ensuring the fluid therein remains sterile (Col 4, Lines 11-15). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Turner/Kammerzell/Ielpo to include the closed circuit such that it is hermetically sealed, as taught by Fontenot, for the purpose of ensuring that the first fluid therein remains sterile (Col 4, Lines 11-15). One of ordinary skill in the art would recognize that, because of such a hermetic seal, the first fluid would be prevented from contaminating the second fluid.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Turner et al. (WO 2018/002622)/Kammerzell et al. (PG PUB 2022/0249751)/Ielpo et al. (US Pat 6,635,028) in view of Dabrowiak et al. (PG PUB 2018/0214303).
Re claim 6, Turner/Kammerzell/Ielpo disclose all the claimed features except that the heat transfer fluid pump is a reversible pump configured to drain the second fluid from the heat exchanger and return the second fluid to the fluid reservoir. Dabrowiak, however, teaches using a reversible pump to remove bubbles from a line (Para 72). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Turner/Kammerzell/Ielpo to include the heat transfer fluid pump as a reversible pump configured to drain the second fluid from the heat exchanger and return the second fluid to the fluid reservoir, as taught by Dabrowiak, for the purpose of ensuring that any bubbles that may be produced in the second fluid are removed are removed from the second fluid (Para 72).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Turner et al. (WO 2018/002622)/Kammerzell et al. (PG PUB 2022/0249751)/Ielpo et al. (US Pat 6,635,028) in view of Svitek et al. (PG PUB 2015/0150715).
Re claim 7, Turner discloses that the system can include a second pump 44 configured to pump the second fluid from the fluid reservoir to the heat exchanger and the target unit and back to the fluid reservoir Page 25, Line 33 – Page 26, Line 2), but discloses that this pump 44 is a part of the heat transfer fluid module, not a part of the heat exchanger. Svitek, however, teaches including a pump as a part of a heat exchanger (Para 16) for the purpose of reducing the amount of space that these components take up in an operating room and reducing the priming volume required (Para 10). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Turner/Kammerzell/Ielpo to include pump 44 as a component of the heat exchanger, as taught by Svitek, for the purpose of reducing the amount of space that the pump and heat exchanger take up in an operating room and reducing the priming volume required (Para 10).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Turner et al. (WO 2018/002622)/Kammerzell et al. (PG PUB 2022/0249751)/Ielpo et al. (US Pat 6,635,028)/Svitek et al. (PG PUB 2015/0150715) in view of Dabrowiak et al. (PG PUB 2018/0214303).
Re claim 8, Turner/Kammerzell/Ielpo/Svitek disclose all the claimed features except that the heat transfer fluid pump is a reversible pump configured to drain the second fluid from the heat exchanger and return the second fluid to the fluid reservoir. Dabrowiak, however, teaches using a reversible pump to remove bubbles from a line (Para 72). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Turner/Kammerzell/Ielpo/Svitek to include the heat transfer fluid pump as a reversible pump configured to drain the second fluid from the heat exchanger and return the second fluid to the fluid reservoir, as taught by Dabrowiak, for the purpose of ensuring that any bubbles that may be produced in the second fluid are removed are removed from the second fluid (Para 72).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Turner et al. (WO 2018/002622)/Kammerzell et al. (PG PUB 2022/0249751)/Ielpo et al. (US Pat 6,635,028) in view of Ritter et al. (PG PUB 2014/0174698).
Re claims 9 and 10, Turner/Kammerzell/Ielpo disclose all the claimed features except an integrated thermal disinfection system around the heat exchanger to provide heat to disinfect the heat exchanger (as required by claim 9), wherein the heat exchanger is emptied of the second fluid and hot disinfected by the thermal disinfection system at a higher temperature for a period to sterilize the heat exchanger and prevent bacterial growth (as required by claim 10). Ritter, however, teaches providing a thermal disinfection system around a heat exchanger to provide heat to disinfect the heat exchanger (Claim 1), wherein the heat exchanger is emptied of a fluid therein and hot disinfected by the thermal disinfection system at a higher temperature for a period to sterilize the heat exchanger and prevent bacterial growth (Para 29,31) for the purpose of ensuring that the second fluid does not become contaminated (Para 19). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Turner/Kammerzell/Ielpo to include an integrated thermal disinfection system, as taught by Ritter, for the purpose of ensuring that the second fluid does not become contaminated.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Turner et al. (WO 2018/002622)/Kammerzell et al. (PG PUB 2022/0249751)/Ielpo et al. (US Pat 6,635,028) in view of Schnell et al. (US Pat 4,723,956).
Re claim 24, Turner/Kammerzell/Ielpo disclose all the claimed features except that the heat transfer fluid tank includes a reservoir bottom that is angled downward from a back of the heat transfer fluid tank to a front of the heat transfer fluid tank, wherein the internal fluid pick-up tube extends into a deeper front portion of the heat transfer fluid tank. Schnell, however, teaches providing a container with a reservoir bottom 16 (Fig 1) that is angled downward from a back (to the left in Fig 1) to a front (to the right in Fig 1) of the container, wherein the fluid is removed from the deeper front portion of the container (as seen in Fig 1; Col 5, Lines 3-12) for the purpose of ensuring that all of the fluid can be removed from the container (Col 5, Lines 3-12). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Turner/Kammerzell/Ielpo to include the fluid tank with a reservoir bottom that is angled downward from a back to a front of the fluid tank and to extend the internal fluid pick-up tube into the deeper front portion of the fluid tank, as taught by Schnell, for the purpose of ensuring that all of the fluid can be removed from the container (Col 5, Lines 3-12).
Response to Arguments
Applicant’s arguments filed 12/3/2025 have been fully considered but are moot in view of the present rejections that utilize the newly cited Ielpo and Schnell references to teach the amended subject matter.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783