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 .
Claim Rejections - 35 USC § 112
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.
Claim 1, and dependent claims 2-4 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claim purports to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, but fails to recite a combination of elements as required by that statutory provision and thus cannot rely on the specification to provide the structure, material or acts to support the claimed function. As such, the independent claim recites a function that has no limits and covers every conceivable means for achieving the stated function, while the specification discloses at most only those means known to the inventor. Accordingly, the disclosure is not commensurate with the scope of the claim. See In re Hyatt, 708 F.2d 712, 714-715, 218 USPQ 195, 197 (Fed. Cir. 1983).
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.
Claim limitations “non-contact immersive virtual stimulation unit”, “pain detection unit”, “detected pain imaging unit”, ‘extended reality display unit” “non-contact virtual stimulation pain analysis unit”, “pain trend prediction unit”, “pain diagnosis unit”, “virtual stimulation image data unit”, and “image response calculation pain image selection unit” has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the recitations of the functions of the elements appear to invoke elements which would be specific to the claims (examples are the designations of “non-contact” “detected pain” “extended reality” “virtual stimulation” “trend prediction”. The boundaries of these claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
Claims 1-4 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. Regarding claim 1, the claim is a single means claim, and therefore the elements of claims 2-4 are unclear (as they depend from claim 1). With respect to claims 2-4, the elements of “non-contact immersive virtual stimulation unit”, “pain detection unit”, “detected pain imaging unit”, ‘extended reality display unit” “non-contact virtual stimulation pain analysis unit”, “pain trend prediction unit”, “pain diagnosis unit”, and “virtual stimulation image data unit” from those claim are unclear as it is ambiguous as to which functional aspects of claim 1 are being met by each recited element. Additionally, the elements of claims 2-3 differ in antecedent basis from the functional recitation of claim 1, making it unclear if those elements are meant to provide specifically the functions recited in claim 1, or new/additional functionality.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Specific to claim 2, it is unclear what does and does not meet the limitation of “virtual stimulation” particularly with respect to the recited “pain induced to a diagnostic target” as there is no “pain signal” or “pain stimulation” recited in the stimulation. Additionally, “visualizing pain” appears to possibly denote the imaging of a signal which can be interpreted as pain, as “pain” itself is not an “imageable” phenomenon (signals which indicate pain, yes, but not pain itself). Additionally, the recitation of the “non-contact virtual stimulation pain analysis unit” is unclear and appears to be a cyclical recitation of previously cited elements/functions, ending with a generic recitation of “analyze the pain”. Finally, the “pain trend for the stimulation of the diagnosis target” is unclear as to what is being recited.
Specific to claim 3, it is appreciated that a unit can store an image for display on a mixed reality, augmented reality, or other extended reality display, but it is unclear if “a virtual stimulation image” of the recitation is meant to be a specific recitation of “induce virtual stimulation to a patient in a non-contact manner in an extended reality state”, as the recitation states that the image is “stored for displaying… for the non-contact immersive virtual stimulation”, but it is not positively recited that this image “is” the actual stimulation recited previously.
Specific to claim 4, “to which response sensitivity is sensitive” is unclear and needs to be clarified. Additionally, “image response calculation pain image selection unit” which is recited as detecting a heart rate change for an image provided to a diagnosis target, extract a virtual stimulation image which maxes heart rate, and provides the image to another unit, is unclear. The unit would require to take multiple or a plurality of images while monitoring or detecting the heart rate in order to provide a maximum thereof, as a single image cannot be the basis for a maxima.
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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daniels (US 2025/0229080, Pub as WO 2023/196805. Daniels discloses and teaches a pain related diagnostic system which is capable of providing stimulation to a patient via a non-contact stimulation (Fig 43, 0272, 0286-0287, 0294). Daniels specifically discloses the use of both audio and visual sensory cues (0270) for stimulation and monitoring as well as diagnosis. Imaging with fmri (0300), skin images (0240), and HHMI event imagery (0311, 0320-0322) are all utilized to provide images of diagnostic information, heart rate monitoring is disclosed (0131, 0135, the maxima of which would be a result effective variable), and algorithms for a comparison of physiological changes versus a baseline value or values are utilized for diagnostic purposes (Fig 1, 6-9).
Finally, alerts and diagnostic warnings based on the virtual stimuli are disclosed (including those based on heart rate (0131-0146). While it is not fully understood how each of the indefinite elements of the instant recitation are to be limited, it is believed that one of ordinary skill in the art at the time of the invention would utilize the teachings of Daniels to provide a diagnostic feedback system for neuropathic pain in a patient, and includes the use of non-contact stimuli and image-based analysis, as well as heart rate monitoring (abs, 0183, 0209, 0331).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL M. LAMPRECHT whose telephone number is (571)272-3250. The examiner can normally be reached Mon - Fri 9:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOEL LAMPRECHT/ Primary Examiner, Art Unit 3798
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