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 .
Status of Claims
Claims 1-6, 10-11, 13, 17, 19, 21-23, and 25-29 are pending.
Claims 7-9, 12, 14-16, 18, 20, 24, and 30-40 have been canceled. Per Applicant’s Remarks, Applicant has canceled claim 9 (Remarks, filed 12/12/2025, p. 12), but the claim still appears as pending on the amended listing of the claims (filed 12/12/2025). For purposes of examination, Examiner is interpreting claim 9 was intended to be canceled.
Response to Arguments
The previous objection to the specification is withdrawn in light of the amended abstract (filed 12/12/2025).
The previous objections to the claims are withdrawn in light of the amendments to the claims (filed 12/12/2025).
Applicant’s arguments with respect to the rejection of the claims under 35 U.S.C. § 101 (Remarks, filed 12/12/2025, pp. 7-9) have been considered but are moot in light of the new ground of rejection, as presented in detail below.
Applicant’s arguments with respect to the rejection of the claims under 35 U.S.C. § 102 have been fully considered and are persuasive (Remarks, filed 12/12/2025, p. 9). The rejections of claims 1, 10-11, 13, 21-22, and 29 under 35 U.S.C. § 102 have been withdrawn. However, a new ground of rejection of the claims under 35 U.S.C. § 103 has been raised, as presented in detail below.
Applicant’s arguments in respect to the rejection of the claims under 35 U.S.C. § 103 (Remarks, filed 12/12/2025, pp. 9-13; Declaration, filed 12/12/2025, pp. 1-8) have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument—with the exception of section 10 of Applicant’s Declaration (Declaration, filed 12/12/2025, p. 5), which argues that none of the secondary references cited, including Shin, describe or suggest any cognitive training. In response, Examiner respectfully directs Applicant’s attention to paragraphs 0058 and 0079 of Shin’s disclosure, which states cognitive rehabilitation training, which is a form of cognitive training aimed at individuals requiring cognitive rehabilitation due to cognitive decline, is conducted during exposure to a hyperbaric oxygen-rich environment.
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 1-6, 10-11, 13, 17, 19, 21-23, and 25-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea(s) without significantly more.
Regarding Claim 1, analyzed as the representative claim:
[Step 1] Claim 1 recites “A method…” which falls within the “process” statutory category of invention under 35 U.S.C. § 101.
[Step 2A – Prong 1] Claim 1 recites “A method of modifying cognitive performance of a subject, the method comprising treating said subject by a plurality of treatment cycles, each treatment cycle comprises subject-specific treatment conditions that comprise: exposing said subject to hyperbaric conditions and oxygen rich environment, exposure to said oxygen rich environment is carried out intermittently during defined time periods, with intervals of administration of lower oxygen levels in between said defined time periods, and carrying out cognitive training during said exposure.” The bolded limitations, under their broadest reasonable interpretation, encompass methods of organizing human activity (managing personal behavior or relationships or interactions between people – including social activities, teaching, and following rules or instructions). That is, the claim encompasses a healthcare practitioner directing a patient to perform cognitive training exercises. Accordingly, the claim recites an abstract idea(s).
[Step 2A – Prong 2] The judicial exception is not integrated into a practical application. Specifically, the claim recites the additional element of exposing the subject to hyperbaric conditions and oxygen rich environment, which amounts to mere insignificant extra-solution activity and/or generally linking the use of the exception to a particular technological environment or field of use. See MPEP §§ 2106.05(g) and 2106.05(h). No additional element integrates the abstract idea(s) into a practical application, e.g., implementing the exception with a particular machine. Thus, the claim is directed to an abstract idea(s).
[Step 2B] The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea(s) into a practical application, the claim does not include additional elements that are sufficient to amount to significantly more than the abstract idea(s). Specifically, the additional element of exposing the subject to hyperbaric conditions and oxygen rich environment amounts to no more than mere insignificant extra-solution activity and/or generally linking the use of the exception to a particular technological environment or field of use, which cannot provide an inventive concept. Accordingly, representative claim 1 is not patent eligible.
Claims 2-6, 10-11, 13, 17, 19, 21-23, and 25-29 are dependent on representative claim 1 and include all of the limitations of claim 1. Therefore, the dependent claims recite the same abstract idea(s) as those recited in the independent claim or contain limitations reciting extra solution activities and/or generally linking the use of the exception to a particular field of use. While the dependent claims may have a narrower scope than the representative claim, no claim contains an additional element to integrate the abstract idea(s) into a practical application or to render an inventive concept that transforms the corresponding claim into a patent eligible application of the otherwise ineligible abstract idea(s). Thereby, claims 2-6, 10-11, 13, 17, 19, 21-23, and 25-29 are also patent ineligible.
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 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 1-4, 6, 10-11, 13, 17, 19, 21-22, 26, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Hadanny, and further in view of Shin.
Regarding Claim 1, Hadanny discloses a method of modifying cognitive performance of a subject (p. 472, Introduction: “cognitive improvements after HBO2”), the method comprising treating said subject by a plurality of treatment cycles (p. 472, sec. 2.2: patients given 60 sessions), that comprise:
exposing said subject to hyperbaric conditions and oxygen rich environment, exposure to said oxygen rich environment is carried out intermittently during defined time periods, with intervals of administration of lower oxygen levels in between said defined time periods (p. 474, sec. 2.2: “Each session consisted of 60 minutes exposure to 100% oxygen at 1.5 ATA with 5 minutes air breaks every 30 minutes”).
Hadanny does not disclose the treatment conditions are subject-specific nor any explicit cognitive training. However, Shin discloses each treatment cycle comprises subject-specific treatment conditions (par. 0059: “a biosignal measuring device for monitoring a patient’s physical condition… the patient’s physical condition changes and additional simulation treatments can be performed during the treatment, thereby further improving the safety and effectiveness [for] the patient;” Examiner notes the treatment conditions can change based on the user’s measured physical condition at any given moment), that comprise: carrying out cognitive training during said exposure (par. 0079: “the cognitive… rehabilitation therapy is… cognitive rehabilitation training provided through the output of the image to enhance the rehabilitation effect in parallel during the standing treatment. It may be at least one or more of a simple game;” par. 0058: “when performing the standing exercise treatment in the sealed pressurized oxygen capsule 110… cognitive / movement rehabilitation therapy… can be performed in parallel, thereby maximizing the effects of rehabilitation treatment by performing pressurized oxygen treatment… and cognitive… rehabilitation treatment;” Examiner notes cognitive rehabilitation training is a form of cognitive training). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the subject-specific treatment conditions and cognitive training of Shin with the hyperbaric oxygen sessions of Hadanny in order to maximize safety, effectiveness (Shin, par. 0059), and the effects of the cognitive training/rehabilitation (Shin, par. 0058).
Regarding Claim 2, Hadanny further discloses at least 2 treatment cycles (p. 472, sec. 2.2: patients given 60 sessions).
Regarding Claim 3, Hadanny further discloses between 5 and 120 cycles (p. 472, sec. 2.2: patients given 60 sessions).
Regarding Claim 4, Hadanny further discloses the treatment conditions are the same in each treatment cycle (p. 472, sec. 2.2: “each session consisted of 60 minutes exposure to 100% oxygen at 1.5 ATA”).
Regarding Claim 6, Hadanny further discloses assessing cognitive performance of the subject before said exposure to obtain a first score, assessing cognitive performance of said subject after said exposure to obtain a second score (p. 473, sec. 2.3: patients given cognitive test before and after exposure), and comparing said first score and second score to obtain an evaluation score of the subject (p. 475, Table 2: comparison of scores before and after HBO2 sessions).
Regarding Claim 10, Hadanny further discloses said hyperbaric conditions comprise exposing the subject to a pressure of between about 1.1 absolute atmospheres (ATA) and about 3.2 ATA (p. 474, sec. 2.2: “Each session consisted of… exposure to 100% oxygen at 1.5 ATA”).
Regarding Claim 11, Hadanny further discloses said oxygen rich environment comprises between about 22 vol% and about 100 vol% oxygen (p. 474, sec. 2.2: “Each session consisted of… exposure to 100% oxygen at 1.5 ATA”).
Regarding Claim 13, Hadanny further discloses each treatment cycle comprises a total time of exposure to said oxygen rich environment of between about 1 minute and about 240 minutes (p. 474, sec. 2.2: “Each session consisted of 60 minutes exposure to 100% oxygen at 1.5 ATA”).
Regarding Claim 17, Hadanny further discloses a compression stage before said treatment cycle (pp. 472-473, sec. 2.2: “acceptable compression… rates of 0.8 meters per minute were used”).
Regarding Claim 19, Hadanny further discloses a decompression stage after said treatment cycle (pp. 472-473, sec. 2.2: “acceptable… decompression rates of 0.8 meters per minute were used”).
Regarding Claim 21, Hadanny modified by Shin further discloses said cognitive training comprises one or more tasks selected from the group consisting of verbal memory task, nonverbal memory task, immediate memory task, delayed memory task, information processing speed task, attention task, executive function task, motoric task, visual perception task, multi-tasking assignment, visual spatial task, verbal task, navigational task, intelligence task, working memory task, task switching, response inhibition task, psychomotor speed task, verbal functions task (fluency/naming/vocabulary), response time, double decision, sustained attention, divided attention, selective attention, working memory, long term memory, reasoning, auditory processing, and combinations thereof (Shin, par. 0058: “Since the monitor 140 and the microphone / speaker can be installed, cognitive… rehabilitation therapy (motor imagery, motor observation) based on interaction with medical staff, video and virtual reality (VR)… a simple game, etc.;” Examiner notes these can be considered at least motoric tasks, visual perception tasks, and/or auditory processing tasks). The combination of the hyperbaric oxygen sessions of Hadanny with the particular treatment conditions of Shin described above for Claim 1 would have included this training task.
Regarding Claim 22, Hadanny modified by Shin further discloses said treatment cycle further comprises at least one physical training task carried out under said hyperbaric conditions and oxygen rich environment (Shin, par. 0009: “a high-pressure oxygen treatment device for rehabilitation treatment and its operation method that can be expected at the same time the therapeutic effect of the oxygen supply and the therapeutic effect of the standing exercise;” par. 0010: “for improving concentration, such as… exercise through the pressurized oxygen capsule;” par. 0079: “motor rehabilitation therapy is… exercise rehabilitation training… to enhance the rehabilitation effect in parallel during the standing treatment;” Examiner notes the standing exercise and the exercise (rehabilitation) training are each forms of physical training). The combination of the hyperbaric oxygen sessions of Hadanny with the particular treatment conditions of Shin described above for Claim 1 would have included this physical training task.
Regarding Claim 26, Hadanny modified by Shin further discloses the subject suffers from aging-related cognitive functional decline (Shin, par. 0004: “the aging society, number of [aging] patients who need rehabilitation is continuously increasing;” par. 0036: “the hyperbaric oxygen treatment apparatus 100 may be provided as a hyperbaric oxygen treatment apparatus for providing a personal space for improving concentration, such as studying, work;” Examiner notes Shin discloses there are aging patients who need rehabilitation for various health-related reasons and then suggests improving cognition as one such need or use of hyperbaric oxygen therapy in those patients, and therefore, it is understood that those patients are suffering from aging-related cognitive decline). The combination of the hyperbaric oxygen sessions of Hadanny with the particular treatment conditions of Shin described above for Claim 1 would have included the usage of the treatment for subjects suffering from aging-related cognitive functional decline.
Regarding Claim 29, Hadanny modified by Shin further discloses the subject is a healthy subject (Shin, par. 0010: “for the general user as well as… the user requiring rehabilitation treatment;” Examiner is interpreting a “general user,” which is explicitly contrasted with users needing treatment, as a typical/healthy subject). The combination of the hyperbaric oxygen sessions of Hadanny with the particular treatment conditions of Shin described above for Claim 1 would have included the usage of the treatment for typical/healthy subjects.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hadanny in view of Shin as applied to claim 1 above, and further in view of RU 2735758 (hereinafter “Vasilevna”).
Regarding Claim 5, modified Hadanny implies but does not explicitly state treatment conditions differ from cycle to cycle. However, Vasilevna discloses the treatment conditions differ from treatment cycle to treatment cycle (par. 0023: “the first session of HBO for 60 minutes, while during the first 20 minutes HBO is carried out in the mode of a smooth continuous increase in pressure in the pressure chamber from 1.0 ATM to the maximum value selected from the range of 1.4-1.6 ATM, depending on the hemodynamic parameters of the patient, taking into account his complaints (while monitoring the heart rate of no more than 100 beats per minute and a change in blood pressure of no more than 130 mm Hg), the next 20 minutes of HBO are carried out at the maximum ATM value selected for the patient, the remaining 20 minutes of HBO are carried out with a smooth continuous decrease in pressure from the maximum value to the initial value - 1.0 ATM;” par. 0026: “second HBO session is carried out with an increase in the time spent at the maximum pressure value by 5-10 minutes”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the differing treatment conditions of Vasilevna with the hyperbaric oxygen sessions of Hadanny in order to determine the most effective conditions for the individual patient and make decisions concerning future treatment cycles (Vasilevna, pars. 0027-0028).
Claims 23 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Hadanny in view of Shin as applied to claim 1 above, and further in view of Shahaf.
Regarding Claim 23, modified Hadanny does not disclose the subject has a history of brain injury. However, Shahaf discloses the subject has a history of brain injury (col. 36, lines 1-20: “some of the ailments that can be effectively treated by hyperbaric therapy include: cerebral edema, traumatic head and spinal cord injury, chronic stroke, post stroke, … brain ischemia, brain blood circulation disturbances and headache disorder”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the cognition-improving hyperbaric oxygen sessions of modified Hadanny with the particular subjects of Shahaf because these particular patients often suffer cognitive decline, so the sessions would be particularly helpful for them (Shahaf, col. 61, lines 21-45). Furthermore, Shahaf also discloses treating these patients with hyperbaric oxygen therapy (Shahaf, col. 36, lines 1-20).
Regarding Claim 28, modified Hadanny does not disclose the subject suffers from abnormal development. However, Shahaf discloses the subject suffers from abnormal development (col. 36, lines 1-20: “some of the ailments that can be effectively treated by hyperbaric therapy include: … early organic brain syndrome [and] brain stem syndromes”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the cognition-improving hyperbaric oxygen sessions of modified Hadanny with the particular subjects of Shahaf because these particular patients often suffer cognitive decline, so the sessions would be particularly helpful for them (Shahaf, col. 61, lines 21-45). Furthermore, Shahaf also discloses treating these patients with hyperbaric oxygen therapy (Shahaf, col. 36, lines 1-20).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Hadanny in view of Shin as applied to claim 1 above, and further in view of You.
Regarding Claim 25, modified Hadanny does not disclose the subject suffers from a neurodegenerative disease or dementia. However, You discloses the subject suffers from a neurodegenerative disease, dementia, or mild cognitive impairment (p. 2, Conclusion: “HBOT can be recommended as an effective and safe complementary therapy for the treatment of [vascular dementia]”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the cognition-improving hyperbaric oxygen sessions of modified Hadanny with the particular subjects of You because these particular patients often suffer cognitive decline, so the sessions would be particularly helpful for them (You, p. 1, Background; p. 2, Introduction). Furthermore, You also discloses treating these patients with hyperbaric oxygen therapy (You, p. 2, Conclusion).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Hadanny in view of Shin as applied to claim 1 above, and further in view of Yan.
Regarding Claim 27, modified Hadanny does not disclose the subject suffers from cerebral palsy. However, Yan discloses the subject suffers from cerebral palsy (p. 2, cols. 1-2: “the following nonemergency indications are approved for use [of hyperbaric oxygen therapy]: … cerebral palsy”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the cognition-improving hyperbaric oxygen sessions of modified Hadanny with the particular subjects of Yan because these particular patients often suffer cognitive decline, so the sessions would be particularly helpful for them (Yan, p. 2, cols. 1-2; p. 4, col. 2). Furthermore, Yan also discloses treating these patients with hyperbaric oxygen therapy (Yan, Abstract).
Conclusion
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/J.G.D./Examiner, Art Unit 3715
/DMITRY SUHOL/Supervisory Patent Examiner, Art Unit 3715