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 1-12 and 16-17 are pending.
Claims 10 and 17 are withdrawn (see restriction/election below).
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a CON of a national stage entry of and claims priority to Application Serial No. PCT/US2019/038672, filed 06/24/2019. The application also claims priority to provisional application number 62/688,501, filed on 06/22/2018.
Information Disclosure Statement
All references from IDS(s) received 12/16/2020 and 12/05/2024 have been considered unless marked with a strikethrough.
Response to Arguments
Applicant's arguments filed 7/31/2025 have been fully considered and have been found not persuasive.
In a non-final dated 02/03/2025, Claims 1-9 and 11-16 were examined upon their merits.
In a non-final dated 02/03/2025, Claims 1-9 and 11-16 were rejected under 35 USC 103. In response, the Applicant amended claim 1 to include the limitations of claims 13-15 and cancelled claims 13-15.
With respect to the 103 rejection, the Applicant argues that the prior art provided by the Examiner (“Moturu” and “Schaffer”) fails to teach the cytokines specified in the newly amended claim 1 as well as fails to teach back pain. The Applicant points out that Schaffer teaches pelvic pain but that pelvic pain and back pain may have different causes. The Applicant argues that the third reference (“Cermak”) does teach back pain but does not teach the cytokines in the amended claim 1. The Examiner argues that it would be obvious to combine the previously cited art because Cermak teaches inflammatory back pain and in light of the amendment, the Examiner provides rebuttal evidence by Risbud, M. et al (Nat Rev Rheumatol. 2013 Oct 29;10(1):44–56). Risbud teaches that inflammatory back pain is characterized by an elevation in levels of the inflammatory cytokines tumor necrosis factor (TNF)-α, interleukin (IL)-1 α/β, IL-6 and IL-17. Therefore, it is the Examiner’s position that a person skilled in the art would be motivated to use the combined teachings of the previously cited prior art and apply it to specific cytokines associated with back pain. Therefore, a new 103 rejection is seen below with the additional art as necessitated by amendment.
*NOTE: Although the claim set identifier from 8/1/2025 lists the claims as original format, they have been amended from the claims examined during the non-final. The claim set filed on 7/31/2025 reflects the amended claims and therefore, the new rejection is necessitated by amendment. The rejection is considered final.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9, 11-12, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Moturu, S. et al. (US20160063205A1; cited in the IDS filed 12/16/2020; “Moturu”) in view of Schaffer, A. et al. (US20110014205A1; cited in the IDS filed 12/16/2020; “Schaffer”) and Cermak, J. et al. (US20080280862A1; cited in the IDS filed 12/16/2020; “Cermak”).
With respect to Claim 1, Moturu teaches a method for managing pain through transmitting a log of use dataset and a supplementary data set (Claim 1), which include biometric data/signals/monitoring (p.00227), to generate a predictive model through a computing system in order to indicate the pain related state of an individual (Claim 11) to be used for initiating therapeutic intervention (Claim 17). Moturu also teaches the predicative model can be a regression algorithm, including multiple regression analyses (p.0050), and comparing the pain responsive likelihood value to a pre-determined threshold value (p.0048). Finally, Moturu teaches that this computed algorithm will predict risk that the individual will trend towards a different (whether worsened or improved) state at a future time point (p.0039). Therefore, Moturu teaches all the requirements of Claim 1 with the exception of the “plurality of cytokine measurement levels.”
Moturu fails to teach the plurality of cytokine measurement levels as biometric data for generating a predicative model.
However, Schaffer teaches the detection of chemokines in combination with detection of other chemokines/cytokines, including IL-1, in order to detect or classify disease (p.0019), which in this case in chronic pelvic pain (abstract).
Moturu and Schaffer teach the method for conditions of pain and chronic pelvic pain, respectively. However, Moturu and Schaffer both fail to explicitly teach the condition of acute or chronic low back pain.
Cermak teaches a method of treating pain including clinical pain, namely inflammatory pain, functional pain, nociceptive pain, and neuropathic pain (e.g., peripheral neuropathic pain), whether acute or chronic (p. 0029), including lower back pain (Claim 4). Therefore, with respect to claims 13-14, it would have been obvious to one skilled in the art at the time that the pain as described by Moturu or Schaffer could include acute or chronic lower back pain, as taught by Cermak.
Moturu, Schaffer, and Cermak fail to explicitly teach the chemokines listed in claim 1.
Therefore, with respect to claim 1, it would have been obvious to one skilled in the art at the time to modify the method taught by Moturu to include cytokine detection as biometric data, as taught by Schaffer.
With respect to claim 2, Moturu teaches “at the computing system, upon detection that the pain-related state of the individual satisfies a threshold condition, enabling a communicable link with at least one of the mobile device of the individual and a care provider computing device” (Claim 1) and that the data collected can define categories of the individual (p.0054).
With respect to Claim 3, Moturu teaches “intervention provision includes recommendation of a medication or initiation of medication distribution to the individual, recommended medications can be based upon severity of symptoms (e.g., acuteness of symptoms, type of symptoms), magnitude of a difference between a symptom criticality parameter and a threshold condition), type of disorder, as determined from a survey dataset” (p.0069).
With respect to Claim 4, Moturu teaches acuteness of symptoms associated with pain can trigger recommendation of an anti-inflammatory agent, such as a steroid (p.0069). Moturu fails to explicitly teach an epidural steroid injection. However, Schaffer teaches reducing pelvic pain in mice through receiving an adjuvant injection. Therefore, it would have been obvious to one skilled in the art to administer the anti-inflammatory agent, like a steroid, through an epidural injection route.
With respect to Claim 5, Schaffer teaches that detecting the cytokine levels can be used in diagnosis of disease, which implies the measurement levels are obtained prior to an intended treatment date.
With respect to Claim 6, Schaffer teaches the possible administration of antibodies as an intended treatment, in which the protein would be administered every 2 to 6 weeks about 2-10 times total (p.00158), which implies the cytokine values could be measured every week prior to intended treatment date to inform treatment decisions. In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003): "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness."
With respect to claim 7, Moturu teaches the generation of a predictive model using Machine learning algorithms, which includes multiple regression algorithm possibilities. The formula of claim 7 is a linear regression formula, which would be included in Moturu’s teaching of implementing a regression algorithm to generate the predictive model.
With respect to claims 8 and 9, neither Moturu or Schaffer explicitly teach wherein the value of n = 12 or that the pre-determined threshold value is -50%. However, this would be considered routine optimization of variables. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955): "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." The applicant has not determined the criticality of these values within the Specification. Therefore, a skilled artisan would be motivated to optimize the values for a reasonable expectation of success. See MPEP 2144.05(II)(A).
With respect to Claim 11, Schaffer teaches the detection of chemokines in combination with detection of other chemokines/cytokines, including IL-1, in order to detect or classify disease (p.0019).
With respect to Claim 12, Moturu teaches a clinical data value of body mass index (p. 0019).
With respect to claims 15 and 16, Schaffer teaches detecting the levels of cytokines (such as IL-1) in a sample. Biological samples include blood products (e.g., plasma, serum and the like) (p.0117).
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in
Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement
to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a
reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same
field or a different one based on design incentives or other market forces if the variations are
predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of
ordinary skill to modify the prior art reference or to combine prior art reference teachings to
arrive at the claimed invention.
Applying KSR rationale (A), it would have been prima facie obvious to extract the method and the system taught by Moturu to include cytokine detection as biometric data, as taught by Schaffer. Further, it would have been obvious to use the cytokine measurements as biometric data for diagnosis of disease prior to the intended treatment date, as well as taking the measurements prior to treatments to inform treatment decisions, as taught by Schaffer.
Applying KSR rationale (C), it would have been prima facie obvious to extract the technique of using cytokine detection as a form of biometric data, as taught by Schaffer, and apply it to the known method/system of detection taught by Moturu.
Applying KSR rationale (B), it would have been prima facie obvious to substitute the type of pain being managed or treated in the methods taught by Moturu and Schaffer, for lower back pain, including the acute and chronic conditions, as taught by Cermak. A person skilled in the art would have a reasonable expectation of success of treating back pain using the methods of Moturu and Schaffer. Therefore, claims 13-14 would have been obvious to one skilled in the art at the time.
Therefore, through the combination of teachings of Moturu and Schaffer, 1-9, 11-12, and 16 would have been obvious to a person skilled in the art at the time.
Conclusion
Claims 1-9, 11-12 and 16 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621