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 .
Response to Amendment
The preliminary amendment filed on July 29, 2024 is acknowledged. The application will be examined accordingly.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on November 4, 2024 and November 26, 2024 are being considered by the examiner.
Claim Objections
Claims 1, 2 and 9 are objected to because of the following informalities:
In claim 1, the limitation “compared the” should be changed to “compared to the”.
In claim 2, the limitation “the sympathetic tone dependent location” should be changed to “the one or more sympathetic tone dependent locations”.
In claim 9, both instances of the limitation “a sympathetic” should be changed to “at sympathetic”.
Appropriate corrections are required.
Claim Objections
Applicant is advised that should claims 15-18 be found allowable, claims 20-23 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof, respectively. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
A method claim is defined by its steps. While claim 15 comprises a step of “identifying” whereas claim 20 comprises a step of “verifying”, the basis (variables considered in the mind) for making the mental processes conveyed by the limitations “identifying” and “verifying” is identical. Consequently, despite claims 15 and 20 framing the respective mental processes using different nomenclature (i.e. “identifying” vs “verifying”), the mental processes are considered identical in scope. Consequently, claims 15 and 20 are considered duplicates of one another.
Dependent claims 16-18 are verbatim identical in scope of dependent claims 21-23, respectively.
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 1-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea in the form of laws of nature and/or a mental process without significantly more.
With respect to independent claim 1, it recites a step of determining whether a human subject has a lowered expected survival rate or suffers from an increased risk of contracting type 2 diabetes mellitus based on measuring the subject’s pain threshold. This is dictated by laws of nature, which is considered a judicial exception. Alternatively, the step of making the determination is a mental process, which is also considered a judicial exception. The judicial exception is not integrated into a practical application so as to obviate a rejection under 35 U.S.C. 101 because the claim does nothing with the judicial exception. Moreover, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception so as to obviate the rejection. While the claim further recites steps of exposing the subject to a pain-inducing influence and measuring the subject’s pain threshold, this constitutes data gathering, which is not considered “additional elements that are sufficient to amount to significantly more than the judicial exception”. See MPEP 2106.05(g).
The dependent claims are rejected because they do not cure the deficiencies of claim 1. In other words, the dependent claims do not integrate the judicial exception into a practical application, or include additional elements that are sufficient to amount to significantly more than the judicial exception.
With respect to claims 9 and 13, while treating a patient is considered a practical application of the judicial exception identified above, treatment must be specific. Reciting a generic treatment without specificity fails to integrate the judicial exception into a practical application. See MPEP 2106.04(d)(2). In the case of claim 13, the limitation “free-choice physical and mental exercises” is too abstract to be deemed a “particular” treatment.
With respect to independent claims 15 and 20, the claims recite a step of determining whether a treatment is effective based on measuring the subject’s pain threshold. This is a mental process/calculation, which is considered a judicial exception. Alternatively, this involves laws of nature (a person has higher pain tolerance when healthier). The judicial exception is not integrated into a practical application so as to obviate a rejection under 35 U.S.C. 101 because the claims do nothing with the judicial exception. Moreover, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception so as to obviate the rejection. While the claims further recite steps of exposing the subject to a pain-inducing influence and measuring the subject’s pain threshold, this constitutes data gathering, which is not considered “additional elements that are sufficient to amount to significantly more than the judicial exception”. See MPEP 2106.05(g).
The dependent claims are rejected because they do not cure the deficiencies of claims 15 and 20. In other words, the dependent claims do not integrate the judicial exception into a practical application, or include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 112
In the event the determination of the status of the application as subject to AIA (or as subject to pre-AIA ) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the rationale supporting the rejection would be the same under either status.
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.
Claims 1-23 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 is indefinite because it lacks proper context. The claim recites that the subject’s pain threshold is compared to the subject’s pain threshold without specifying the conditions under which the comparison is made. Presumably, the claim intends to measure a change in the subject’s pain threshold, but the claim does not specify the conditions that induce the change (e.g. Before and after treatment? Over time as disease progresses?).
Similarly, in claim 3, there is insufficient context for “the lowered pain threshold”. The limitation is recited in the context of the human subject exhibiting lowered pain threshold. However, the claim never previously specifies that the human subject exhibits lowered pain threshold. Consequently, it is unclear to what the limitation refers.
Claims 4, 7 and 13 recite “preferably”. It is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Likewise, the limitation “such as” in claims 12, 17 and 22 renders the claims indefinite.
In part 2) of claim 9, the claim recites “the subject”. There is no antecedent basis for the limitation. The claim previously recites “a patient”.
Claim 10 recites “is verified”. It is unclear whether the limitation intends to convey a method step or a property of the treatment. If the claim intends to convey a method step, the verb representing the step should be recited in active voice (e.g. “further comprising verifying the treatment’s efficacy…”). Otherwise, the limitation may merely convey that the treatment’s efficacy can be verified.
Claims 12 and 13 recite “personal empowerment”. The limitation is inherently abstract/ambiguous, rendering the claims indefinite. Even Applicant’s specification (and claim 13) discloses/recites that “personal empowerment” encompasses free-choice exercises, which is too vague and ambiguous to convey patentable subject matter.
Claim 14 is grammatically incorrect, rendering the claim indefinite.
Claims 15 and 20 recite “ANSD” without specifying what the acronym represents, rendering the claims indefinite.
Claim 15 is indefinite because the preamble of the claim is not commensurate with the body of the claim. According to the preamble of the claim, the method is directed to “identifying a treatment”. Yet, according to the body of the claim, the method is performed on at least one subject who is already receiving the treatment. Consequently, it is unclear what the method is “identifying”. It appears that the preamble of the claim should be amended to “A method of determining the efficacy of a therapeutic treatment”.
In addition, it is unclear how the method is applied to more than one subject as conveyed by the limitation “at least one subject”. The method identifies a singular treatment, and the method involves a singular pain threshold and a singular body. Further clarification regarding the relationship between the number of subjects, the number of treatments, bodies and pain thresholds is requested.
Likewise, claims 19 and 20 are indefinite.
In claims 16 and 21, there is no antecedent basis for “the onset”.
In claims 18 and 23, there is no antecedent basis for “the at least one measurement”. Moreover, it is unclear to what claims 18 and 23 refer when referencing claim 2. The subject matter of claim 2 is not directed to a mode of carrying out a measurement.
Claims not explicitly rejected are rejected due to dependency.
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.
Claims 1-18 and 20-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ballegaard et al. (“Ballegaard”) (US 2010/0036280 A1).
With respect to claim 1, Ballegaard discloses a method for determining whether a human subject has a lowered expected survival rate (determine the prognosis of a disease, see [0039]), the method comprising:
establishing, via at least one measurement of exposure to a quantifiable pain-inducing influence, the subject's pain threshold at one or more sympathetic tone dependent locations on or in the body (see [0040] and abstract), and
determining that the human subject has a lowered expected survival rate if the subject's pain threshold is reduced compared to the subject's previous pain threshold at said sympathetic tone independent locations (see [0028] and [0041]).
With respect to claim 2, the subject matter of claim 2 merely recites an inherent relationship between two variables. Specifically, it is evident that reduction in pain threshold at the one or more sympathetic tone dependent locations is reflected in a corresponding reduction in the measurement value of the exposure to the quantifiable pain-inducing influence.
With respect to claim 3, the method is applied to a diabetic human subject (see [0238]), meaning the human subject exhibits an elevated HbAlc blood concentration relative to a healthy individual.
With respect to claims 4 and 5 the quantifiable pain-inducing influence is pressure point sensitivity (see [0059]), which is a type of physical pressure.
With respect to claim 6, as discussed above, the method is used to determine the prognosis of an existing medical condition, meaning the human subject a priori has a lowered expected survival rate due to an illness.
With respect to claim 7, the illness is diabetes mellitus (type I or type II) (see [0242]), cancer (see [0243]) or ischemic heart disease (see [0244]).
With respect to claims 8 and 14, the one or more sympathetic tone dependent locations comprises the periosteum of the anterior part of the sternum (see [0425]), and the pain-inducing influence comprises pressure point sensitivity (see [0426]).
With respect to claim 9, Ballegaard also discloses a method of treating a patient suffering from a disease so as to increase the life expectancy of the patient, the method comprising:
using the method of claim 1 to determine whether the human subject has a lowered expected survival rate (see rejection of claim 1), and
treating the subject (e.g. taking SSRI) so as to increase the subject’s pain threshold (see [0203] disclosing that SSRI lowered stress, which corresponds to increase in pain tolerance at sympathetic tone dependent locations).
With respect to claim 10, the method further comprises repeatedly measuring the subject's pain threshold (see [0035] and abstract disclosing what constitutes “determining sympathetic tone”) to determine the efficacy of a treatment. Regarding the rest of the claim limitations, they are directed to an inherent property of the claimed treatment recited in claim 9. Specifically, claim 9 recites that the treatment “increases the subject’s pain threshold”. Naturally, repeatedly measuring the subject’s pain threshold will naturally result in observation of increased pain threshold, and hence a verification of the treatment’s efficacy.
With respect to claim 11, as discussed above (see rejection of claim 6), the subject a priori has a lowered expected survival rate due to an illness.
With respect to claims 12 and 13, the treatment comprises an exercise program (see [0202]), which is within the scope of “personal empowerment” intended by Applicant.
With respect to claim 15, as discussed above (see rejection of claim 10), Ballegaard also discloses a method of determining the efficacy of a therapeutic treatment for a disease such as diabetes or ischemic heart disease (see [0242]-[0244]), the method comprising:
using at least two measurements of exposure to a quantifiable pain-inducing influence to determine a pain threshold at one or more sympathetic tone dependent locations on or in the body of the subject (see [0199]); and
identifying the treatment as the appropriate treatment if the subject exhibits a significant increase in pain threshold (see [0200] disclosing that the treatment is adjusted if the subject does NOT exhibit a significant increase in pain threshold, meaning if the subject exhibits a significant increase in pain threshold, then the treatment is deemed effective).
With respect to claim 16, the subject matter of the claim appears to be directed to a state of the at least one subject long before the performance of the method (e.g. before starting the treatment). A method is defined by its step(s). Because the subject matter of the claim is unrelated to the claimed method, it does not further limit the claimed invention. Nevertheless, it is evident that the at least one subject at the onset (before treatment) exhibited a reduced pain threshold at the one or more sympathetic tone dependent locations.
With respect to claim 17, by definition, making at least two measurements of the at least one subject’s pain threshold (see language of claim 15) constitutes “repeatedly determining the at least one subject's pain threshold”. That said, because claim 15 is rejected, claim 17 is rejected.
With respect to claim 18, as discussed above (see rejection of claim 2), the subject matter of claim 2 merely recites an inherent relationship between two variables. Specifically, it is evident that reduction in pain threshold at the one or more sympathetic tone dependent locations is reflected in a corresponding reduction in the measurement value of the exposure to the quantifiable pain-inducing influence. In other words, claim 2, and hence claim 18, does not further limit the claimed invention. Consequently, claim 18 is rejected.
With respect to claim 20, as discussed above (see rejection of claim 10), Ballegaard also discloses a method of determining the efficacy of a therapeutic treatment for a disease such as diabetes or ischemic heart disease (see [0242]-[0244]), the method comprising:
using at least two measurements of exposure to a quantifiable pain-inducing influence to determine a pain threshold at one or more sympathetic tone dependent locations on or in the body of the subject (see [0199]); and
verifying the treatment as the appropriate treatment if the subject exhibits a significant increase in pain threshold (see [0200] disclosing that the treatment is adjusted if the subject does NOT exhibit a significant increase in pain threshold, meaning if the subject exhibits a significant increase in pain threshold, then the treatment is deemed effective).
With respect to claim 16, the subject matter of the claim appears to be directed to a state of the at least one subject long before the performance of the method (e.g. before starting the treatment). A method is defined by its step(s). Because the subject matter of the claim is unrelated to the claimed method, it does not further limit the claimed invention. Nevertheless, it is evident that the at least one subject at the onset (before treatment) exhibited a reduced pain threshold at the one or more sympathetic tone dependent locations.
With respect to claim 22, by definition, making at least two measurements of the at least one subject’s pain threshold (see language of claim 20) constitutes “repeatedly determining the at least one subject's pain threshold”. That said, because claim 20 is rejected, claim 22 is rejected.
With respect to claim 23, as discussed above (see rejection of claim 2), the subject matter of claim 2 merely recites an inherent relationship between two variables. Specifically, it is evident that reduction in pain threshold at the one or more sympathetic tone dependent locations is reflected in a corresponding reduction in the measurement value of the exposure to the quantifiable pain-inducing influence. In other words, claim 2, and hence claim 23, does not further limit the claimed invention. Consequently, claim 23 is rejected.
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 19 is rejected under 35 U.S.C. 103 as being unpatentable over Ballegaard.
With respect to claim 19, Ballegaard does not disclose that the method is applied to more than one subject. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the method to a plurality of subjects for the purpose of determining the efficacy of the respective treatments partaken by the subjects. It is well-known that a medical facility where the method would take place (e.g. doctor’s office, hospital) caters to multiple patients who are potentially in need of determining the efficacy of ongoing treatments.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached at 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL S HYUN/Primary Examiner, Art Unit 1796
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