DETAILED ACTION
Applicant's response, filed 3/24/2026, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/24/2026 has been entered.
Claim Status
Claims 2, 6-9, 12-14, and 16 are pending.
Claims 3-5, 10-11, and 15 are cancelled.
Claims 2, 6-9, 12-14, and 16 are rejected.
Specification
Response to Amendment
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, specifically pages 29: Line 12, 35: Line 7, and 36: Line 21. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “an image signal receiver configured to receive brain image data” in claims 2 and 12, “a determiner configured to determine” in claim 12.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Page 26 and 27 paragraphs 5 and 1-2 respectively provide sufficient structure regarding the “receiver configured to receive”, page 24 paragraph 4 provides sufficient structure regarding the “calculator for calculating”, and page 24 paragraph 3 provides sufficient structure regarding the “analyzer configured to analyze”.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
Response to Amendment
In view of applicant’s amendments to the claims, previous rejections under 35 U.S.C. 112 have been withdrawn.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2, 6-9, 12-14, and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Independent claims 2, 7, and 12 recite a step of “administer a customized brain stimulation to reduce the sustained pain of the subject based on the signature response”. However, the specification is silent to such methods and while pages 1-2 of the Remarks filed 3/24/2026 provide a specification paragraph which details the contribution of the invention to the development of treatment methods and it’s use in monitoring a response to treatment, this is NOT the same as actually providing a treatment itself. Furthermore, the application of administering the brain stimulation is not a function coextensive with a processor and therefore requires an additional component of the system capable of providing the brain stimulation. As the dependent claims cannot cure said deficiencies, all dependent claims are so too rejected.
Claim Rejections - 35 USC § 101
Response to Amendment
In view of applicant’s amendments to the specification the previous rejection under 35 U.S.C. 101 is withdrawn, specifically in regards to the practical application argument on page 4 of the Remarks filed 3/24/2026.
Response to Arguments
Applicant’s arguments, see pages 3-5 of the Remarks, filed 3/24/2026, with respect to claims 2, 6-9, 12-14, and 16 have been fully considered and are persuasive. The rejection of claims 2, 6-9, 12-14, and 16 has been withdrawn, particularly in view of applicant’s arguments on page 4 of the Remarks filed 3/24/2026 regarding practical application and a particular treatment.
Claim Rejections - 35 USC § 103
Response to Amendment
In view of applicant’s amendments previous rejections under 35 U.S.C. 103 have been withdrawn and a new examination of the claims under 35 U.S.C. 103 is provided below.
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 2, 6-9, 12-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (British Journal of Anaesthesia (2013) 64-72; previously cited), Owen et al. (JAMA Neurology (2007) 1-9; previously cited), Kim et al. (Pain (2013) 1343-1351; previously cited), and Bittar et al. (Journal of clinical neuroscience (2005) 515-519; newly cited).
Claim 2 is directed to a system for diagnosing sustained pain using brain image data, an analyzer and calculator along with the biomarker composition from tables 1 and 2.
Claim 7 is directed to a system for diagnosing sustained pain using brain image data collected while applying a stimulus, an analyzer and calculator along with the biomarker composition from tables 1 and 2.
Claim 12 is directed to a system for diagnosing sustained pain and determining the effect of relieving said pain, using brain image data collected while applying a stimulus, an analyzer and calculator along with the biomarker composition from tables 1 and 2.
Lee et al. teaches on page 64, column 2, paragraph 2 “Functional magnetic resonance imaging (fMRI), positron emission tomography (PET), magnetoencephalography (MEG), and scalp electroencephalography (EEG) are commonly used to study the neural bases of pain”, in the abstract “Chronic pain is a state of physical suffering strongly associated with feelings of anxiety, depression and despair. Disease pathophysiology, psychological state, and social milieu can influence chronic pain, but can be difficult to diagnose based solely on clinical presentation. Here, we review brain neuroimaging research that is shaping our understanding of pain mechanisms, and consider how such knowledge might lead to useful diagnostic tools for the management of persistent pain in individual patients”, on page 64, column 2, paragraph 3 “Neuroimaging studies have now identified several cortical regions in humans that are considered to be important for the perception of pain. The primary and secondary somatosensory cortices (insular and anterior cingulate) and the prefrontal cortices (PFCs) are commonly activated, often bilaterally, and during painful experiences. Furthermore, altered activity in subcortical areas (e.g. brainstem periaqueductal grey (PAG), hypothalamus, amygdala, hippocampus, and cerebellum) is also” with subcortical areas being all those brain regions located below the cerebral cortex (the outside layer or first layer of the brain), reading on wherein the subject comprises one of a healthy subject with sustained pain, a subject with subacute or chronic pain, receiving brain image data of the subject from a scanner, wherein the signature response corresponds to the sustained pain, and the brain connectivity regions of Tables 1 and 2.
Owen et al. teaches in the abstract “Recent advances in functional neuroimaging suggest a novel solution to this problem; in several cases, so-called activation studies have been used to identify residual cognitive function and conscious awareness in patients who are assumed to be in a vegetative state yet retain cognitive abilities that have evaded detection using standard clinical methods…Unlike resting blood flow and glucose metabolism, which provide markers of neural capacity and potential so-called activation methods such as radioactive water positron emission tomography and functional magnetic resonance (fMRI) imaging can be used to link residual neural activity to the presence of covert cognitive function”, reading on a subject having difficulty in reporting pain.
Kim et al. teaches on page 1345, column 1, paragraph 1 “The electrocardiogram data were collected with an MRI-compatible Patient Monitoring system”, reading on a receiver configured to receive brain image data of a subject from a scanner. Kim et al. teaches on page 1345, paragraph 2 “fMRI data were preprocessed using the validated FSL, AFNI, and FreeSurfer software packages” and in paragraph 4 “Functional connectivity MRI analysis was performed using the validated dual-regression independent component analysis”, reading on an analyzer configured to analyzing the received brain image data corresponding to one or more brain functional connectivity regions of the subject selected from 1 to 39 of the brain functional connectivity regions listed in Table 1 and Table 2. Kim et al. teaches on page 1345, column 1, paragraph 5 “This approach consists of 3 stages. First, a probabilistic ICA was applied on concatenated, preprocessed functional data from both REST and PAIN runs from all subjects… In the second stage, these independent spatial maps were used in a general linear model as a spatial regressor for each individual subject… In the third stage of dual regression, this fMRI time series from each subject was variance normalized and used in a subject-level general linear model to reconstruct spatial maps for each subject”, reading on a calculator for calculating a signature response based on the analysis of the brain functional connectivity regions. Kim et al. teaches on page 1344, column 2, paragraph 6 “Functional MRI (fMRI) data were acquired using a 3T Siemens TIM Trio MRI system”, reading on a magnetic resonance imaging (MRI) scanner. Kim et al. teaches on page 1345, column 1, paragraph 4 “Functional connectivity MRI analysis was performed using the validated dual-regression independent component analysis” and on page 1346, column 1, paragraph 2 “…we performed a linear regression…”, which reads on equation 1 as it is merely a sum of weighted regions of the brain, which is essentially the right side of a regression. Furthermore, it would have been obvios to optimize the weights and parameters associated with the model as it is merely a regression framework which inherently fits a best fit line according to the data by modifying the specified weights of each feature (brain connectivity region), thereby reading on wherein n is an integer of 1 to 39, wherein i is an integer of n or less, wherein wi is a weight corresponding to the brain functional connectivity of #i, and xi is test data corresponding to the brain functional connectivity of #i,wherein the wi is a weight corresponding to the brain functional connectivity of #i, listed in Table 3 and Table 4.
Bittar et al. teaches in the abstract “Deep brain stimulation (DBS) has been used to treat intractable pain for over 50 years…To better understand its efficacy, we performed a meta-analysis of DBS for pain relief…The long-term pain alleviation rate was highest with DBS of the PVG/PAG (79%), or the PVG/PAG plus sensory thalamus/internal capsule (87%). Stimulation of the sensory thalamus alone was less effective (58% long-term success) (p < 0.05). DBS was more effective for nociceptive than deafferentation pain (63% vs 47% long-term success; p < 0.01). Long-term success was attained in over 80% of patients with intractable low back pain (failed back surgery) following successful trial stimulation. Trial stimulation was successful in approximately 50% of those with post-stroke pain, and 58% of patients permanently implanted achieved ongoing pain relief. Higher rates of success were seen with phantom limb pain and neuropathies. We conclude that DBS is frequently effective when used in well-selected patients”, reading on and administer a customized brain stimulation to reduce the sustained pain of the subject based on the signature response.
It would have been obvious at the time of invention to a person skilled within the art to modify the teachings of Lee et al. for using brain image data on specific regions of the brain to examine chronic pain with the teachings of Owen et al. for identifying residual cognitive function and conscious awareness in coma patients using brain image data, and the methods of Kim et al., specifically the correlated regions of the brain MRI data, and build a simple predictive or diagnostic model using the same regression framework outlined in Kim et al. using brain image data for examining pain in coma patients. This is because all three use the same or similar forms of data (brain image data: MRI, fMRI, etc.) and brain connectivity to examine the effects or presence of pain, and Owen et al. merely shows the ability to examine the presence of such while a patient is in a vegetive state. Furthermore, it would have been obvious to combine the teachings of Owen et al., Kim et al., and Lee et al., with the teachings of Bittar et al. for the application of brain stimulation for pain relief as the latter teaches in the abstract “We conclude that DBS is frequently effective when used in well-selected patients” as well as on page 519, column 1, paragraph 3 “DBS is an effective technique when used in well-selected patients with refractory chronic neuropathic or nociceptive pain. Although the treatment effect is more marked in patients with nociceptive pain, it is nonetheless substantial in patients with deafferentation pain”. One would have had a reasonable expectation of success given that each of the studies are within the same field and examining the same topic of associating brain regions with pain, except for Owen et al. which is merely showing that such studies can be done while a patient is in a coma. Additionally in regards Kim et al. the correlated regions were already identified, as were their effect sizes, and the same general method of regression could be used for prediction. Finally, there would have been a reasonable expectation of success for integrating the teachings of Bittar et al. as they describe within the abstract the treatment being used for over 50 years for the specified criteria. Therefore, it would be obvious to one with ordinary skill in the art to incorporate the teachings of each and to be successful.
Claim 6 is directed to the method of claim 2, but further specifies that the sustained pain lasts for 10 seconds or more.
Kim et al. teaches on page 1344, column 2, paragraph 4 “Subjects provided ratings for each of the 2-minute blocks at the beginning, middle, and end of the 6-minute procedure”, reading on the system of claim 2, wherein the sustained pain lasts for 10 seconds or more.
Claim 8 is directed to the method of claim 7 but further specifies determining that the subject feels more pain with increased connectivity in the regions listed in Table 1.
Lee et al. teaches on page 66, column 1, paragraphs 3-4 “Numerous imaging studies demonstrate that the PFC can regulate the perception and behavioral expression of pain in humans. The PFC is reciprocally connected to limbic regions and these connections form the neural substrates through which the motivational-emotional aspects of pain can be regulated…Frontal-limbic regions are reciprocally connected to the brainstem. This neuroanatomical connection presents another route through which pain can be controlled—via inhibition of neurones within the spinal cord that transmit nociceptive information to the brain. Distraction from pain has been shown to involve activity within the cingulo-frontal cortex, thalamus, and PAG and, more recently, suppression of spinal cord activity”, reading on determining that the subject feels increased pain in response to an increase in connectivity in the brain functional connectivity regions listed in Table 1.
Claim 9 is directed to the method of claim 7 but further specifies determining that the subject feels less pain with less connectivity in the regions listed in Table 2.
Lee et al. teaches on page 66, column 1, paragraphs 3-4 “Numerous imaging studies demonstrate that the PFC can regulate the perception and behavioral expression of pain in humans. The PFC is reciprocally connected to limbic regions and these connections form the neural substrates through which the motivational-emotional aspects of pain can be regulated…Frontal-limbic regions are reciprocally connected to the brainstem. This neuroanatomical connection presents another route through which pain can be controlled—via inhibition of neurones within the spinal cord that transmit nociceptive information to the brain. Distraction from pain has been shown to involve activity within the cingulo-frontal cortex, thalamus, and PAG and, more recently, suppression of spinal cord activity”, reading on determining that a subject feels pain the less the connectivity in Table 2 is present.
Claim 13 is directed to the system of claim 2 but further specifies that the subject be one of those listed in the provided grouping.
Claim 14 is directed to the method of claim 7 but further specifies that the subject be one of those listed in the provided grouping.
Claim 16 is directed to the system of claim 12 but further specifies that the subject be one of those listed in the provided grouping.
Owen et al. teaches in the abstract “Recent advances in functional neuroimaging suggest a novel solution to this problem; in several cases, so-called activation studies have been used to identify residual cognitive function and conscious awareness in patients who are assumed to be in a vegetative state yet retain cognitive abilities that have evaded detection using standard clinical methods…Unlike resting blood flow and glucose metabolism, which provide markers of neural capacity and potential so-called activation methods such as radioactive water positron emission tomography and functional magnetic resonance (fMRI) imaging can be used to link residual neural activity to the presence of covert cognitive function”, reading on wherein the subject is categorized as being one of a patient in a vegetative state, an aphasia patient, an elderly patient, and an infant.
Response to Arguments
Applicant's arguments filed 3/24/2026 have been fully considered but they are not persuasive.
Applicant asserts on page 33 of the Remarks filed 3/24/2026 that the cited references do not disclose constructing a connectivity-pair-specific weighted predictive model. However, examiner reminds applicant Lee et al. teaches page 64, column 2, paragraph 3 “Neuroimaging studies have now identified several cortical regions in humans that are considered to be important for the perception of pain. The primary and secondary somatosensory cortices (insular and anterior cingulate) and the prefrontal cortices (PFCs) are commonly activated, often bilaterally, and during painful experiences. Furthermore, altered activity in subcortical areas (e.g. brainstem periaqueductal grey (PAG), hypothalamus, amygdala, hippocampus, and cerebellum) is also” with Kim et al. teaching on page 1345, column 1, paragraph 4 “Functional connectivity MRI analysis was performed using the validated dual-regression independent component analysis”. While the specific invention is not taught by any one reference the use of multiple regression along with previous research isolating specific regions of the brain for determining pain, prediction of brain regions using regressions for diagnosing sustained pain would be obvious as these models are used primarily to model correlated and causal features with a specified outcome. Moreover, the models are machine learning models, capable of increased predictive power through optimization of input, features, and weights, meaning it would be obvious to a person skilled in the art to refine their model using the highest predictive features to obtain the most accurate weights for the prediction.
Applicant further asserts that the connectivity pairs are not arbitrary. However, examiner reminds applicant this was never asserted by the examiner, rather Lee et al. teaching on page 64, column 2, paragraph 3 “Neuroimaging studies have now identified several cortical regions in humans that are considered to be important for the perception of pain. The primary and secondary somatosensory cortices (insular and anterior cingulate) and the prefrontal cortices (PFCs) are commonly activated, often bilaterally, and during painful experiences. Furthermore, altered activity in subcortical areas (e.g. brainstem periaqueductal grey (PAG), hypothalamus, amygdala, hippocampus, and cerebellum) is also” was asserted as motivation for the selection of various brain regions as potentially linked to sustained pain phenotypes.
Applicant asserts a lack of motivation to combine the cited references. However, examiner reminds applicant that the references do not need to specifically say to combine with another, rather similar research would be obvious to a person skilled in the art to combine. Here, the motivation of pain-related networks in the brain (brain regions that influence sustained pain), connectivity changes during sustained pain, the use of fMRI in brain signaling, and the treatment of sustained pain via brain stimulation, would be motivation enough for a person to combine to arrive at the present invention as all three initial references use the same or similar forms of data (brain image data: MRI, fMRI, etc.) and brain connectivity to examine the effects or presence of pain, and the final newly cited reference provides a treatment for the sustained pain via brain stimulation.
Applicant asserts that there is a lack of reasonable expectation of success. However, examiner reminds applicant that the methods being used are all similar, routine and conventional methods that are well known for describing relationships and building precise models to accurately predict outcomes across the spectrum of scientific inquiry (basic regressions). Furthermore, these methods refine themselves, calculating weights based upon selected features that most accurately predict the outcomes in question.
Finally, applicant asserts that the claimed invention integrates the predictive model into a therapeutic control. Examiner agrees that this was not taught previously within the cited references, but has provided reference Bittar et al. in order to cure this deficiency.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEENAN NEIL ANDERSON-FEARS whose telephone number is (571)272-0108. The examiner can normally be reached M-Th, alternate F, 8-5.
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/K.N.A./ Examiner, Art Unit 1687
/OLIVIA M. WISE/ Supervisory Patent Examiner, Art Unit 1685