Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This office action is in response to the claims filed 4/16/24. Claims 1-16 are pending in the instant application.
Claim Objections
Claim 1 is objected to because of the following informalities: the language “the onset of the event” (line 6) is objected to as the term ‘the onset’ lacks antecedent basis does not rise to the level of indefiniteness to one of ordinary skill in the art as one would recognize that an event would have an onset or beginning; Examiner suggests amending to read –an onset of the event--. Appropriate correction is required.
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 2-7 and 9-14 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 2 recites the limitation "the CO2 content" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the air inhaled" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the ambient CO2 content" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the air" in line 2-3. There is insufficient antecedent basis for this limitation in the claim.
The term “approximately 10 to 50%” in claim 6 (emphasis added) is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear as to what qualifies, or does not qualify, as being ‘approximately 10 to 50%’.
Claim 9 recites the limitation "the CO2 content" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the air inhaled" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the ambient CO2 content" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the air" in line 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the step of increasing the CO2 content of the inhaled air" (in particular ‘the step’, ‘the content’, and ‘the inhaled air’) in line 1-2. There is insufficient antecedent basis for this limitation in the claim.
The term “approximately 10 to 50%” in claim 13 (emphasis added) is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear as to what qualifies, or does not qualify, as being ‘approximately 10 to 50%’.
Claims 3-5, 7, 11-12, and 14 are rejected based on dependency on a rejected claim.
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.
Claims 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Each of claims 1-16 have been analyzed to determine whether it is directed to any judicial exceptions
Step 2A, Prong 1
Each of claims 1-16 recite a method step for treating a subject, which is grouped as organization of human activity under the 2019 PEG. Accordingly, each of claims 1-16 recites an abstract idea.
Specifically claim 1 recites identifying a subject at risk of an event capable of causing a TBI (observation/organization of human activity); and increasing partial pressure of carbon dioxide in the blood of the subject at onset (managing interactions which is organization of human activity under the 2019 PEG). Identification of a subject is observation which is an abstract idea and increasing the partial pressure of carbon dioxide can read on mere instruction to breathe into a paper bag (see the Shelton reference cited below in the conclusion section).
Specifically claim 8 recites increasing partial pressure of carbon dioxide in the blood of the subject (managing interactions which is organization of human activity under the 2019 PEG). Increasing the partial pressure of carbon dioxide can read on mere instruction to breathe into a paper bag (see the Shelton reference cited below in the conclusion section).
Step 2A, Prong 2
The above-identified abstract idea is not integrated into a practical application under the 2019 PEG because it does not include any additional elements or steps which, either alone or in combination, generally link the use of the abstract idea to a particular technological environment or field of use. Dependent claims 2-3 do not include any additional elements/steps that integrate the abstract idea into a practical application and, while dependent claims 4-7 include a breathing apparatus with enlarged dead space volume, such an element is well-known and conventional (such as the paper bag type apparatus of Shelton and additional breathing apparatuses allowing for rebreathing cited in the pertinent art section below in the conclusion section). Dependent claims 9-10, 15, and 16 do not include any additional elements/steps that integrate the abstract idea into a practical application and, while dependent claims 11-14 include a breathing apparatus with enlarged dead space volume, such an element is well-known and conventional and do not integrate the abstract idea into a practical application (such as the paper bag type apparatus of Shelton and additional breathing apparatuses allowing for rebreathing cited in the pertinent art section below in the conclusion section).
Step 2B
None of claims 1-16 include additional elements that are sufficient to amount to significantly more than the abstract idea as claims 1-3, 8-10, and 15-16 do not include additional elements and while dependent claims 4-7 and 11-14 include a breathing apparatus with enlarged dead space volume, such an element is well-known and conventional and do not amount to significantly more than the abstract idea (such as the paper bag type apparatus of Shelton and additional breathing apparatuses allowing for rebreathing cited in the pertinent art section below in the conclusion section).
Claim Rejections - 35 USC § 102
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.
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 –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(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) 8-12 and 14-15 is/are rejected under pre-AIA 35 U.S.C. 102(a) and (b) as being anticipated by Ailiang et al. (Effects of inhaled CO2 and added dead space on idiopathic central sleep apnea, 1997 American Physiological Society) (see copy provided in parent application 15/968149).
Regarding claim 8, Ailiang discloses a method of treating a condition of a subject that is responsive to changes in intracranial pressure and/or changes in middle cerebral artery blood velocity (see abstract pg. 918, treatment of sleep apnea which Applicant discloses as an example of such a condition to treat, instant claim 15 for example, and accompanying disclosure in the specification) which includes increasing the partial pressure of carbon-dioxide (CO2) in the blood of the subject (pCO2) (see abstract pg. 918, introduction and methods section pg. 920 and protocol section pg. 920; Ailing treats a patient’s central sleep apnea by increased carbon dioxide content of air inhaled via rebreathing of exhaled air which has higher content of carbon dioxide which results in a rise in carbon dioxide in the blood of the subject).
Regarding claim 9, the Ailiang method includes a step of increasing the pCO2 including increasing the CO2 content of air inhaled by the subject above ambient CO2 content of the air (see abstract pg. 918, introduction and methods section pg. 920 and protocol section pg. 920; Ailing treats the subject by rebreathing which includes higher content of carbon dioxide in exhaled air than ambient air which is then rebreathed by the subject).
Regarding claim 10, the Ailiang method’s step of increasing the carbon dioxide content of the inhaled air includes forcing the subject to re-breathe a predetermined portion of the carbon dioxide exhaled by the subject while inhaling ambient air (see abstract pg. 918, introduction and methods section pg. 920 and protocol section pg. 920; Ailing treats the subject by rebreathing which includes higher content of carbon dioxide in exhaled air than ambient air which is then rebreathed by the subject via a dead space volume provided to a face mask worn by the patient).
Regarding claim 11, the Ailiang method’s step of forcing the subject to re-breathe carbon dioxide in exhaled air includes placing a breathing apparatus over the mouth of the subject through which the subject must inhale and exhale and includes an enlarged dead space volume which the predetermined portion of carbon dioxide exhaled by the subject collects to be inhaled or re-breathed on the next inhalation (see abstract pg. 918, introduction and methods section pg. 920 and protocol section pg. 920; Ailing treats the subject by rebreathing which includes higher content of carbon dioxide in exhaled air than ambient air which is then rebreathed by the subject via a dead space volume provided to a face mask worn by the patient).
Regarding claim 12, the Ailiang method’s dead space volume is sized in relation to the tidal volume of air displaced by the subject during inhalation and exhalation (see abstract pg. 918, introduction and methods section pg. 920 and protocol section pg. 920; Ailiang includes a rebreathing mask with a dead space volume which has a size and thus the size is in relation to the patient’s tidal volume, i.e. there is a relation between the size of the dead space and the tidal volume).
Regarding claim 14, the Ailiang method’s dead space volume is sized in relation to the weight of the subject (see abstract pg. 918, introduction and methods section pg. 920 and protocol section pg. 920; Ailiang includes a rebreathing mask with a dead space volume which has a size and thus the size is in relation to the patient’s weight, i.e. there is a relation between the size of the dead space and the subject’s weight).
Regarding claim 15, the Ailiang method is such that the condition is one of the claimed list (see abstract pg. 918, treatment of sleep apnea).
Claim Rejections - 35 USC § 103
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.
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.
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 1-3, 8-10, and 15-16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dexter (Rebreathing aborts migraine attacks, British Medical Journal, Volume 284, 30 January 1982) in view of Danilov (2006/0161218) and Duncan et al. (4,628,926).
Regarding claim 1, Dexter disclose a method of treating a subject (see abstract, case reports and comment) which includes identifying a subject at risk of an event to treat (see abstract, case reports and comment; Dexter identifies and treats subjects who suffer from migraines); and increasing the partial pressure of carbon-dioxide to the subject at the onset of the event (see abstract and case reports; patient in case 1 for example suffers from migraines and Dexter treats this patient by having them undergo rebreathing which increased carbon dioxide inhaled via inhalation of previously exhaled carbon dioxide, this results in increased content of carbon dioxide to the patient and treats/prevents their migraine and symptoms including headache, nausea, visual disturbance, see also comment section). Dexter is silent as to the method explicitly being a method for reducing risk of TBI caused by traumatic event and as to the rebreathing explicitly causing an increase the carbon dioxide levels in the subject’s blood; however, Danilov discloses that treatments can be provided for patient’s suffering from migraines or TBIs (see Danilov para. 0060, 0065, 0135) and that TBIs exhibit the same symptoms as migraines such as headaches visual disturbances (see Danilov para. 0652-0654, 0678-0679 for example) and Duncan teaches a rebreathing device/method which explicitly causes an increase in carbon dioxide in the patient’s blood to treat various physiological conditions related thereto (see Duncan abstract, col. 2 ln. 3-18, col. 7 ln. 32-47). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the Dexter method to explicitly treat a user who may suffer from a TBI from an event related thereto and to explicitly have the rebreathing cause an increase in carbon dioxide in the blood of the subject, as taught/evidenced by Danilov and Duncan, as it would have been obvious to apply the method to a subject which may suffer from a similar condition with similar symptoms (treating/preventing TBI instead of migraines in a subject) as this would have been obvious substitution of treating one known condition with particular symptoms with another similar condition with similar symptoms.
Regarding claim 2, the modified Dexter method step of increasing carbon dioxide includes increasing the carbon dioxide of air inhaled by the subject above ambient (see Dexter abstract, case reports and comment which discloses rebreathing which is patient inhaling air with increased carbon dioxide content over ambient due to rebreathing exhaled air; see also Duncan abstract, col. 2 ln. 3-18, col. 7 ln. 32-47).
Regarding claim 3, the modified Dexter method step of increasing the carbon dioxide content of the air includes forcing the subject to re-breathe a predetermined portion of the carbon dioxide exhaled by the subject while inhaling ambient air (see Dexter abstract, case reports and comment which discloses rebreathing which is patient inhaling air with increased carbon dioxide content over ambient due to rebreathing exhaled air with ambient air; see also Duncan abstract, col. 2 ln. 3-18, col. 7 ln. 32-47).
Regarding claim 8, Dexter disclose a method of treating a subject (see abstract, case reports and comment) which includes increasing the partial pressure of carbon-dioxide to the subject at the onset of the event (see abstract and case reports; patient in case 1 for example suffers from migraines and Dexter treats this patient by having them undergo rebreathing which increased carbon dioxide inhaled via inhalation of previously exhaled carbon dioxide, this results in increased content of carbon dioxide to the patient and treats/prevents their migraine and symptoms including headache, nausea, visual disturbance, see also comment section). Dexter is silent as to the method explicitly being a method for reducing a condition of a subject responsive to changes in intracranial pressure and/or changes in middle cerebral artery blood velocity, such as TBI/head injury caused by traumatic event and as to the rebreathing explicitly causing an increase the carbon dioxide levels in the subject’s blood; however, Danilov discloses that treatments can be provided for patient’s suffering from migraines or TBIs (see Danilov para. 0060, 0065, 0135) and that TBIs exhibit the same symptoms as migraines such as headaches visual disturbances (see Danilov para. 0652-0654, 0678-0679 for example) and Duncan teaches a rebreathing device/method which explicitly causes an increase in carbon dioxide in the patient’s blood to treat various physiological conditions related thereto (see Duncan abstract, col. 2 ln. 3-18, col. 7 ln. 32-47). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the Dexter method to explicitly treat a user who may suffer from a TBI from an event related thereto and to explicitly have the rebreathing cause an increase in carbon dioxide in the blood of the subject, as taught/evidenced by Danilov and Duncan, as it would have been obvious to apply the method to a subject which may suffer from a similar condition with similar symptoms (treating/preventing TBI instead of migraines in a subject) as this would have been obvious substitution of treating one known condition with particular symptoms with another similar condition with similar symptoms.
Regarding claim 9, the modified Dexter method step of increasing carbon dioxide includes increasing the carbon dioxide of air inhaled by the subject above ambient (see Dexter abstract, case reports and comment which discloses rebreathing which is patient inhaling air with increased carbon dioxide content over ambient due to rebreathing exhaled air; see also Duncan abstract, col. 2 ln. 3-18, col. 7 ln. 32-47).
Regarding claim 10, the modified Dexter method step of increasing the carbon dioxide content of the air includes forcing the subject to re-breathe a predetermined portion of the carbon dioxide exhaled by the subject while inhaling ambient air (see Dexter abstract, case reports and comment which discloses rebreathing which is patient inhaling air with increased carbon dioxide content over ambient due to rebreathing exhaled air with ambient air; see also Duncan abstract, col. 2 ln. 3-18, col. 7 ln. 32-47).
Regarding claim 15, the modified Dexter method is such that the condition is one of the claimed list (see Dexter abstract, case reports and comment; Danilov para. 0060, 0065, 0135, 0652-0654, 0678-0679; modified Dexter treating migraine or TBI which include the condition of dysautonomias).
Regarding claim 16, the modified Dexter method is such that the condition is a recent head injury to the subject (see Dexter abstract, case reports and comment; Danilov para. 0060, 0065, 0135, 0652-0654, 0678-0679; treating TBI/head injury).
Claims 4-7 and 11-14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dexter, Danilov, and Duncan as applied to claims 3 and 10 above, and further in view of Adler et al. (3,455,294).
Regarding claim 4, the modified Dexter method’s step of forcing the subject to re-breathe the predetermined portion of carbon dioxide includes placing a breathing apparatus to the mouth through which the subject inhales and exhales and which includes an enlarged dead space volume which the predetermined portion of carbon dioxide exhaled by the subject collects to be inhaled or re-breathed on the next inhalation (see abstract, case reports and comment which discloses rebreathing which is patient inhaling air with increased carbon dioxide content over ambient due to rebreathing exhaled air with ambient air; see also Duncan abstract, col. 2 ln. 3-18, col. 7 ln. 32-47). Modified Dexter is silent as to the breathing apparatus being placed over a mouth of the subject; however, Adler discloses a similar re-breathing device/method which includes a mouthpiece (as in Duncan) or a mask which is placed over a subject’s mouth (see Adler col. 2 ln. 18-29). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the modified Dexter method’s breathing apparatus to be placed over the mouth, as taught by Adler, as this would have been obvious substitution of one known patient interface element for another and one would expect the modified Dexter method to perform equally as well.
Regarding claim 5, the modified Dexter method’s dead space volume is sized in relation to the tidal volume of air displaced by the subject during inhalation and exhalation (see abstract, case reports and comment, Duncan abstract, col. 2 ln. 3-18, col. 7 ln. 32-47, and Adler Figs and col. 2 ln. 8-47; modified Dexter includes a rebreathing mask with a dead space volume which has a size and thus the size is in relation to the patient’s tidal volume, i.e. there is a relation between the size of the dead space and the tidal volume).
Regarding claim 6, the modified Dexter method discloses an adjustable dead space volume of the rebreathing apparatus (see Adler Figs and col. 2 ln. 8-47, figures and abstract of Duncan), but is silent as to the volume being 10-50% of the tidal volume; however, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the modified Dexter method’s dead space volume to be 10-50% of a tidal volume to provide a desired level of rebreathing and furthermore, it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 7, the modified Dexter method’s dead space volume is sized in relation to the weight of the subject (see abstract, case reports and comment, Duncan abstract, col. 2 ln. 3-18, col. 7 ln. 32-47, and Adler Figs and col. 2 ln. 8-47; modified Dexter includes a rebreathing mask with a dead space volume which has a size and thus the size is in relation to the patient’s weight, i.e. there is a relation between the size of the dead space and patient weight).
Regarding claim 11, the modified Dexter method’s step of forcing the subject to re-breathe the predetermined portion of carbon dioxide includes placing a breathing apparatus to the mouth through which the subject inhales and exhales and which includes an enlarged dead space volume which the predetermined portion of carbon dioxide exhaled by the subject collects to be inhaled or re-breathed on the next inhalation (see abstract, case reports and comment which discloses rebreathing which is patient inhaling air with increased carbon dioxide content over ambient due to rebreathing exhaled air with ambient air; see also Duncan abstract, col. 2 ln. 3-18, col. 7 ln. 32-47). Modified Dexter is silent as to the breathing apparatus being placed over a mouth of the subject; however, Adler discloses a similar re-breathing device/method which includes a mouthpiece (as in Duncan) or a mask which is placed over a subject’s mouth (see Adler col. 2 ln. 18-29). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the modified Dexter method’s breathing apparatus to be placed over the mouth, as taught by Adler, as this would have been obvious substitution of one known patient interface element for another and one would expect the modified Dexter method to perform equally as well.
Regarding claim 12, the modified Dexter method’s dead space volume is sized in relation to the tidal volume of air displaced by the subject during inhalation and exhalation (see abstract, case reports and comment, Duncan abstract, col. 2 ln. 3-18, col. 7 ln. 32-47, and Adler Figs and col. 2 ln. 8-47; modified Dexter includes a rebreathing mask with a dead space volume which has a size and thus the size is in relation to the patient’s tidal volume, i.e. there is a relation between the size of the dead space and the tidal volume).
Regarding claim 13, the modified Dexter method discloses an adjustable dead space volume of the rebreathing apparatus (see Adler Figs and col. 2 ln. 8-47, figures and abstract of Duncan), but is silent as to the volume being 10-50% of the tidal volume; however, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the modified Dexter method’s dead space volume to be 10-50% of a tidal volume to provide a desired level of rebreathing and furthermore, it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 14, the modified Dexter method’s dead space volume is sized in relation to the weight of the subject (see abstract, case reports and comment, Duncan abstract, col. 2 ln. 3-18, col. 7 ln. 32-47, and Adler Figs and col. 2 ln. 8-47; modified Dexter includes a rebreathing mask with a dead space volume which has a size and thus the size is in relation to the patient’s weight, i.e. there is a relation between the size of the dead space and patient weight).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Saul (5,647,345), Frolov et al. (5,755,640), Shelton (2,304,033), Hardwick (4,192,301), Exler (3,513,843), and Shelton (2,321,256) disclose rebreather devices/methods of use.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN W STUART whose telephone number is (571)270-7490. The examiner can normally be reached M-F: 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justine Yu can be reached at 571-272-4835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/COLIN W STUART/Primary Examiner, Art Unit 3785