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 .
Specification
The disclosure is objected to because of the following informalities:
The following portion of Paragraph 0006, lines 3-4 should read: “… to detect small fiber neuropathyand simultaneously collecting…”
The following portion of Paragraph 0006, lines 4-5 should read: “Large fiber neuropathy is then detected using von Frey hairs, which produce a mildly painful electrical stimulus, and likewise simultaneously collecting corresponding EEG data from the patient.”
Paragraph 0010 states that detection of large fiber neuropathy uses von Frey hairs to introduce electrical stimuli. As best understood, von Frey hairs do not provide an electrical stimulus since they are thin nylon filaments of specific diameters calibrated to buckle at a known force. Examiner requests clarification if Applicant intends to refer to a specific von Frey hair instrument which also applies an electrical stimulus.
Appropriate correction is required.
Claim Objections
Claims 1, 3, and 4 are objected to because of the following informalities:
Claim 1 recites “stimulating on the patient a first set of one or more known healthy sites with the laser with an output in the range of 1064 nm to 1500 nm,” which should end with a comma and commensurate with the style of each other element in listed items of claim 1.
Claim 3 should end with a period.
Claim 4 should end with a period.
Appropriate correction is required.
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.
Claims 1 and dependent claims thereof 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.
Re. Claim 1: Claim 1 recites:
“running accumulated electroencephalogram data collected from repeated steps c and g through a neural network trained on data of diagnosed neuropathy patients and healthy patients and corresponding electroencephalogram data to make a statistical determination whether the patient has small fiber neuropathy, large fiber neuropathy, both small fiber and large fiber neuropathy or no neuropathy.”
Applicant’s recitation of a trained neural network may be interpreted as a neural network requiring specific programming (i.e., training) in order to achieve the claimed computer-implemented functional limitation of making a statistical determination of various neuropathies. As per MPEP 2161.01:
It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court’s grant of summary judgment of invalidity for lack of adequate written description where there were genuine issues of material fact regarding "whether the specification show[ed] possession by the inventor of how accessing disparate databases is achieved"). If the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, for lack of written description must be made.
Applicant’s disclosure does not possess adequate written description to reasonably convey to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. A particular or exemplary embodiment of a neural network is not discussed, nor its related architecture or training paradigms. The most detail Applicant provides relates to the data input into the neural network, with little to no discussion of the neural network itself (see Specification, Paragraphs 0011, 0114, 0016).
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.
Claims 1, 3-5, and dependent claims thereof 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.
Re. Claim 1: Claim 1 possesses multiple issues of indefiniteness:
The following limitations are not provided with sufficient antecedent basis:
“the detection;”
“the range of 1064 nm to 1500 nm.”
Claim 1 further recites “painful electrical stimulus.” in light of portions of Applicant’s Specification which provide support for stimulating sites with an electrical stimulus, Applicant’s Specification describes the application of von Frey hairs (Paragraphs 0006, 0010). However, von Frey hairs are not an instrument which provides an electrical stimulus. Instead, the stimulus provided by von Frey hairs is understood to be a tactile stimulus. Examiner requests clarification if Applicant is utilizing a specialized electrical von Frey hair instrument or if Applicant is instead referring to an evoked response due to the tactile stimulus of the von Frey hairs.
Re. Claim 3: The following limitations are not provided with sufficient antecedent basis:
“the 20 ms to 150 ms range.”
Re. Claim 4: Claim 4 possesses multiple issues of indefiniteness:
Claim 4 recites “marked reduction.” The term “marked” is defined as describing a change or difference that is very obvious and easily noticed. However, such a difference is subjective; it is unclear whether the claimed “marked reduction” is relative to observation from a layman, a general physician, or neurologist. Examiner requests clarification as to the context of the term “marked” as it is used in the claim.
The following limitations are not provided with sufficient antecedent basis:
“112b – “the 175 to 600 ms range.”
Re. Claim 5: Claim 5 possesses multiple issues of indefiniteness:
Similar to claim 4, claim 5 recites “marked reduction.” The term “marked” is defined as describing a change or difference that is very obvious and easily noticed. However, such a difference is subjective; it is unclear whether the claimed “marked reduction” is relative to observation from a layman, a general physician, or neurologist. Examiner requests clarification as to the context of the term “marked” as it is used in the claim.
The following limitations are not provided with sufficient antecedent basis:
“the 20 ms to 150 ms range.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JUSTIN XU/ Primary Examiner, Art Unit 3791
