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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 112 (a) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17370143, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior application fails to provide adequate support for wherein there are thickenings in the neck component along the anatomical course of carotid artery such that it presses on carotid arteries with a tension meter attached to the front of neck portion to tighten the neck portion.
As such, the Application was examined using an effective filling date of 04/19/2024.
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.
Claim 1-15 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 the limitation "the two carotid arteries and the two vertebral arteries of the patient" in line 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the face" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the brain" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the neck component " in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the front of neck portion " in line 13. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the two vertebral arteries " in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the face" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the brain" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the neck coverage" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "a carotid artery" in line 10. It is unclear to the examiner if the Applicant is referring to the one of the two carotid arteries or a new one. For examination purpose, the examiner is interpreting it to be one of the two carotid arteries.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1-15 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 1 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
For instance, the claims are seen to encompass aspects of the human organism as follows:
Claim 1 recites “a covering that covers the head and neck, including the two carotid arteries and the two vertebral arteries of the patient, with the exception of the face of the patient, such that it cools the brain, the two carotid arteries and the two vertebral arteries to the brain” line 3-6. The examiner suggests for the Applicant to amend the claim to read as --a covering is configured to cover the head and neck, including the two carotid arteries and the two vertebral arteries of the patient, with the exception of the face of the patient, such that it is configured to cool the brain, the two carotid arteries and the two vertebral arteries to the brain--.
Claim 1 recites “it presses on carotid arteries with a tension meter attached to the front of neck portion to tighten the neck portion” in line 14. The examiner suggests for the Applicant to amend the claim to read as -- it is configured to press on carotid arteries with a tension meter attached to the front of neck portion to tighten the neck portion--.
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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bhinder (US 2023/0010829) in view of Nilforushan et al. (US 2008/0201818) in further view of DILLIGAN et al. (US 2020/0375793).
Regarding claim 1 and 9, Bhinder discloses a device for providing rapid therapeutic hypothermia to a patient's head and neck comprising: a) a covering that covers the head and neck, including the two carotid arteries and the two vertebral arteries of the patient (the invention 1 is configured to cover the head and neck area which includes carotid arteries and the vertebral arteries), with the exception of the face of the patient, such that it cools the brain (fig.1), the two carotid arteries and the two vertebral arteries to the brain, wherein there are two or more side by side compartments in a single layer (fig.1-3), each compartment capable of accepting a solid CO2 cooled liquid that is between -30°C and 40°C [0033] and wherein the compartments are constructed to produce a turbulent flow in each compartment (fig.3); b) at least one inlet tubing (fig.2; two inlets 4) for each compartment designed to deliver cooled liquid to the compartments (fig.1, see also [0044]); c) at least one outlet tubing (fig.1; the outlet tubing 8) for each compartment designed to remove the cooled liquid from the compartment and return it to the source of the solid CO2 cooled liquid [0044]; and d) a source of solid CO2 cooled liquid (fig.1; system 10, see also [0044]), which delivers the solid CO2 cooled liquid to the at least one inlet tubing [0044]. However, Bhinder does not disclose wherein there are thickenings in the neck component along the anatomical course of carotid artery such that it presses on carotid arteries with a tension meter attached to the front of neck portion to tighten the neck portion.
Nilforushan teaches a temperature altering garment that is configured to transfer heat to selected body part of the wearer. The thermal altering garment comprising air bladder 15 configured to expand (thickenings) for providing increased pressure on the thermal transfer element as the interior surface of the air bladder 15 expands toward the wearer (fig.15, see also [0060]). Nilforushan clearly teaches pressure increases the efficiency of heat transfer by increasing the surface area of the thermal transfer element in contact with the body part, because any gaps between the surface of the thermal transfer and the body part will be flattened out. Furthermore, pressure is also helpful for preventing swelling of an injured body part when a cold pack is applied [0021]. The bladder 15 can be placed at any desired location of a garment [0060]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the device as taught by Bhinder with inflatable bladder that is configured to expand at a desired location (including neck portion) as taught by Nilforushan for the purpose of transfer heat efficiently.
The combination of device (Bhinder/Nilforushan) remains silent regarding a tension meter attached to the front of neck portion to tighten the neck portion.
DILLIGAN teaches one or more chambers of the inflatable member may be inflated to a predetermined pressure (inflation pressure) with, for example, air and/or an inert gas. A fluid pump may be actuated by the patient, which may allow the patient to adjust the force applied [0097]. This may allow for increased adjustability and comfort of the device, and may allow for a degree of contact between the heat exchanger and the body [0097]. The system includes pressure sensor (tension meter) to control the inflation pressure in the inflatable member ([0088] and [0126]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to further modify the device as taught by Bhinder/Nilforushan with a pressure sensor (tension meter) as taught by DILLINGAN for the purpose of comfort and safety.
Regarding claim 2, Bhinder/Nilforushan/DILLIGAN teaches the device for providing rapid therapeutic hypothermia to a patient's head and neck according to claim 1, wherein there is a left hemisphere and a right hemisphere compartment (fig.2 of Bhinder).
Regarding claim 3, Bhinder/Nilforushan/DILLIGAN teaches the device for providing rapid therapeutic hypothermia to a patient's head and neck according to claim 1, wherein there are 4 inlet tubes and 4 outlet tubes (fig.2 of Bhinder).
Regarding claim 4, Bhinder/Nilforushan/DILLIGAN teaches the device for providing rapid therapeutic hypothermia to a patient's head and neck according to claim 1, wherein turbulent flow is created by a plurality of baffles in the compartments (fig.3).
Regarding claim 5, Bhinder/Nilforushan/DILLIGAN teaches the device for providing rapid therapeutic hypothermia to a patient's head and neck according to claim 1, wherein at least one of a portion of the inlet or outlet tubing is insulated ([0039] of Bhinder).
Regarding claim 6, Bhinder/Nilforushan/DILLIGAN teaches the device for providing rapid therapeutic hypothermia to a patient's head and neck according to claim 1, wherein the cooled liquid is acetone ([0037] of Bhinder).
Regarding claim 7, Bhinder/Nilforushan/DILLIGAN teaches the device for providing rapid therapeutic hypothermia to a patient's head and neck according to claim 1, wherein the device is used to re-warm the patient's head and neck ([0037] of Bhinder).
Regarding claim 8, Bhinder/Nilforushan/DILLIGAN teaches the device for providing rapid therapeutic hypothermia to a patient's head and neck according to claim 1, wherein the device is portable ([0012] of Bhinder).
Regarding claim 10, Bhinder/Nilforushan/DILLIGAN teaches the method according to claim 9, wherein the removed cooled liquid is returned to the solid CO2 source to re-cool ([0037] of Bhinder).
Regarding claim 11, Bhinder/Nilforushan/DILLIGAN teaches the method according to claim 9, wherein the cooled liquid is acetone ([0037] of Bhinder).
Regarding claim 12, Bhinder/Nilforushan/DILLIGAN teaches the method according to claim 9, which is used in neurological and cardiological emergencies ([0033] of Bhinder).
Regarding claim 13, Bhinder/Nilforushan/DILLIGAN teaches the method according to claim 12, wherein the emergencies are selected from the group comprising:a) Cardiac arrest; b) Seizure; c) Stroke; d) Trauma; e) Intracranial hypertension; and f) Cardiological surgeries ([0033] of Bhinder).
Regarding claim 14, Bhinder/Nilforushan/DILLIGAN teaches the device according to claim 1 which can be used to treat cardiac and neurological emergencies ([0033] of Bhinder).
Regarding claim 15, Bhinder/Nilforushan/DILLIGAN teaches the device according to claim 14, wherein the emergencies are selected from the group comprising: a) Cardiac arrest; b) Seizure; c) Stroke; d) Trauma; e) Intracranial hypertension; and f) Cardiological surgeries ([0033] of Bhinder).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIGIST S DEMIE whose telephone number is (571)270-5345. The examiner can normally be reached Monday-Friday 8am-5Pm.
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794