DETAILED ACTION
This action is pursuant to the claims filed on 11/27/2024. Claims 1-20 are pending. A first action on the merits of claims 1-20 is as follows.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/28/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 10 and 12 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 10 recites the limitation "wherein: the torso interface further comprises a foot temperature sensor that is arranged at the interior portion and is configured to measure the temperature of the skin of the foot". It is unclear how the “torso interface” can comprise a “foot temperature sensor” arranged on the interior of the torso interface to measure temperature of the skin of the foot. For examination purposes this limitation will be interpreted to read “wherein: the torso interface further comprises a torso temperature sensor that is arranged at the interior portion and is configured to measure the temperature of the skin of the torso”.
Claim 12 recites the limitation “a controller”. It is unclear if this limitation intends to recite antecedent basis to “a controller” of claim 11 or if the intent is to recite a second controller. For examination purposes this limitation will be read as “the controller”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Diller (U.S. PGPub No. 2013/0317578).
Regarding claim 1, Diller teaches A brain temperature modification system, comprising: a patient support device for supporting a patient (Fig 26 gurney 354); a plurality of temperature modification devices positioned on the support device (Fig 26 heating element 202 and cooling/heating devices 350/352), including at least one temperature modification device positioned to provide heat to or to remove heat from a respective one of a portion of the body of the patient (Fig 26 device 350/352; Fig 4 also discloses system capable of heating or cooling selectively), each of the plurality of temperature modification devices formed of a flexible material (Fig 25-26 devices 350/352 define a slipper and mitten configuration which are formed from flexible materials); a fluid temperature control device configured to heat or cool a fluid used to heat or cool the respective potion of body of the patient (Fig 28 [0178] fluid recirculation device 206 to cool fluid); a plurality of fluid lines for allowing transport of the fluid between the at least one temperature modification device and the fluid temperature control device (Figs 26-28 tubing 208); and at least one temperature sensor sized and dimensioned to acquire a temperature measurement from an Abreu brain thermal tunnel (ABTT) terminus located between an eye and an eyebrow of the patient and configured to transmit a signal representative of the temperature measurement ([0097] temperature sensor 218 capable of being placed on the forehead, and therefore capable of being placed at the ABTT).
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.
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) 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diller (U.S. PGPub No. 2013/0317578) in view of Clifton (U.S. Patent No. 6,113,626).
Regarding claim 7, Diller further teaches a hand interface (Fig 26 hand interface 352); a foot interface (Fig 26 foot interface 350); wherein: the hand interface comprises an interior portion configured to allow a hand of the patient to be placed inside the hand interface (see Fig 26); and an exterior portion comprising an outer surface of the hand interface (see Fig 26), the foot interface comprises an interior portion configured to allow a foot of the patient to be placed inside the foot interface (see Fig 26), and an exterior portion comprising the outer surface of the foot interface (see Fig 26), wherein the at least one temperature modification device is provided on the exterior portion of at least one of the hand interface, the foot interface, or the torso interface (Fig 26-28, each of foot and hand interfaces defined by temperature modification device provided on exterior surface).
Diller fails to teach a torso interface and the torso interface comprises an upper portion configured to cover a torso of the patient, a lower portion configured for being arranged under the torso of the patient.
In related temperature regulation prior art, Clifton teaches a torso interface and the torso interface comprises an upper portion configured to cover a torso of the patient, a lower portion configured for being arranged under the torso of the patient (Figs 3-4 heating and cooling blanket 100 covering front and back of torso and abdomen). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Diller in view of Clifton to incorporate the torso interface to arrive at claim 7. Doing so would advantageously enable the system to cool and/or warm the torso of a patient as needed for increased control of the thermal regulation of the patient (Col 5 lines 64 – Col 6 line 3).
Regarding claims 8-10, an alternative embodiment of Diller teaches wherein a temperature sensor can be provided on the temperature modification element to monitor temperature of the skin in proximity to the temperature modification element ([0111]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Fig 26-28 of Diller in view of Clifton and the second embodiment of Diller to incorporate a temperature sensor on each of the interior portion of the hand interface, torso interface, and the foot interface to measure the temperature of the skin of the hand, torso, and foot to arrive at claims 8-10. Doing so would advantageously enable the device to monitor the temperature of the skin in proximity to each of the temperature modification elements ([0111] disclosing benefit of temperature sensor adjacent to skin and heating element; Fig 26-28 disclosing hand and foot interfaces for temperature modification).
Claim(s) 11-12, 14-16, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diller (U.S. PGPub No. 2013/0317578) in view of Abreu (U.S. PGPub No. 2009/0105605) and Clifton (U.S. Patent No. 6,113,626).
Regarding claim 11, Diller teaches A brain temperature modification system, comprising: a horizontally-extending patient support device for supporting a patient (Fig 26 gurney 354); a headgear supported on the patient support device (Fig 28 device 202), at least one temperature sensor sized and dimensioned to acquire a temperature measurement from an Abreu brain thermal tunnel (ABTT) terminus located between an eye and an eyebrow of the patient and configured to transmit a signal representative of the temperature measurement ([0097] temperature sensor 218 capable of being placed on the forehead, and therefore capable of being placed at the ABTT); a hand interface supported on the patient support device, comprising an interior portion configured to allow a hand of the patient to be placed inside the hand interface (Fig 26 hand interface 352), an exterior portion comprising an outer surface of the hand interface, and at least one hand temperature modification device provided on the exterior portion to provide heat to or to remove heat from the hand (Fig 26-28, each of foot and hand interfaces defined by temperature modification device provided on exterior surface); a foot interface supported on the patient support device (Fig 26 foot interface 350), comprising an interior portion configured to allow a foot of the patient to be placed inside the foot interface (See Figs 26-28), an exterior portion comprising an outer surface of the foot interface, and at least one foot temperature modification device provided on the exterior portion to provide heat to or to remove heat from the foot (Fig 26-28, each of foot and hand interfaces defined by temperature modification device provided on exterior surface); wherein each of the hand interface, the foot interface and the torso interface are connected to a controller via wires that allow for the respective temperature modification device to be activated to allow for heating or cooling of the respective hand, foot or torso (Fig 26-29B device 206 and computer 224 are connected to each modification device via wires for activating heating/cooling).
Diller fails to teach a headgear supported on the patient support device comprising a support portion, and at least one adjustable arm supported on the support portion, the at least one adjustable arm having, at an end thereof, at least one temperature sensor sized and dimensioned to acquire a temperature measurement from an Abreu brain thermal tunnel (ABTT) terminus located between an eye and an eyebrow of the patient and configured to transmit a signal representative of the temperature measurement.
In related prior art, Abreu teaches a similar headgear supported on the patient support device comprising a support portion, and at least one adjustable arm supported on the support portion (Fig 38 headgear 470 with adjustable arm 478), the at least one adjustable arm having, at an end thereof, at least one temperature sensor sized and dimensioned to acquire a temperature measurement from an Abreu brain thermal tunnel (ABTT) terminus located between an eye and an eyebrow of the patient and configured to transmit a signal representative of the temperature measurement (Fig 38 [0012], [0018], [0562]; sensor 476 is used for measuring brain temperature on surface of skin at the brain thermal tunnel). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the headgear of Diller in view of Abreu to incorporate the support portion with an adjustable arm and temperature sensor at an end thereof for acquiring temperature measurements from the ABTT. Doing so would advantageously enable the system of Diller to directly monitor brain temperature in a non-invasive manner to inform a temperature treatment plan ([0017-0018]).
Diller fails to teach a torso interface supported on the patient support device, comprising a torso temperature modification device, an upper portion configured to cover a torso of the patient, and a lower portion configured for being arranged under the patient.
In related temperature regulation prior art, Clifton teaches a torso interface supported on the patient support device, comprising a torso temperature modification device, an upper portion configured to cover a torso of the patient, and a lower portion configured for being arranged under the patient (Figs 3-4 heating and cooling blanket 100 covering torso and abdomen and underside of patient’s torso). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Diller in view of Clifton to incorporate the torso interface to arrive at claim 11. Doing so would advantageously enable the system to cool and/or warm the torso of a patient as needed for increased control of the thermal regulation of the patient (Col 5 lines 64 – Col 6 line 3).
Regarding claim 12, Diller teaches a controller that includes a processor, a power supply, a non-transitory memory, an input module, and a display ([0116] disclosing display, processor, storage, input device, power for system).
Regarding claims 14-16, in view of the combination of claim 11 above, an alternative embodiment of Diller teaches wherein a temperature sensor can be provided on the temperature modification element to monitor temperature of the skin in proximity to the temperature modification element ([0111]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Fig 26-28 of Diller in view of Clifton and the second embodiment of Diller to incorporate a temperature sensor on each of the interior portion of the hand interface, torso interface, and the foot interface to measure the temperature of the skin of the hand, torso, and foot to arrive at claims 14-16. Doing so would advantageously enable the device to monitor the temperature of the skin in proximity to each of the temperature modification elements ([0111] disclosing benefit of temperature sensor adjacent to skin and heating element; Fig 26-28 disclosing hand and foot interfaces for temperature modification).
Regarding claim 19, in view of the combination of claim 11 above, Diller teaches wherein the upper portion and the lower portion are arranged to surround the torso of the patient such that a front and back of the patient can warm or cool the torso of the patient with the torso temperature modification device (Figs 3-4 heating and cooling blanket 100 covering front and back of torso and abdomen).
Regarding claim 20, Diller teaches wherein the patient support device is one of a bed and a gurney (Fig 26-28 gurney 354).
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 1-19 of U.S. Patent No. 12,178,742 in view of Diller in view of Clifton. Although the claims at issue are not identical, they are not patentably distinct from each other because each of the instant claims are anticipated and/or made obvious in light of the reference claims.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,723,794 in view of Diller, Abreu, and Clifton. Although the claims at issue are not identical, they are not patentably distinct from each other because each of the instant claims are anticipated and/or made obvious in light of the reference claims.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 2-6, 13, and 17-18, the Diller, Zachar, Grahn, and Clifton references fail to teach the systems of claims 2-6, 13, and 17-18 respectively including a plurality of temperature modification devices as claimed, a torso temperature modification device, and a processor as claimed to modify body and/or brain temperature. Any such combination of the above noted references to arrive at the claims would rely on impermissible hindsight using information solely gleaned from the applicant’s specification. No other pertinent prior art reference were found that would overcome the above deficiencies. Therefore, there is no motivation (either in these references or elsewhere in the art) for making such specific and significant modifications thereto to arrive at claim(s) 2-6, 13, and 17-18.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam Z Minchella whose telephone number is (571)272-8644. The examiner can normally be reached M-Fri 7-3 EST.
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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