DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 15, 2025 has been entered.
Response to Arguments
Applicant's arguments filed July 15, 2025 have been fully considered but they are not persuasive. Applicant has amended the claims in an attempt to overcome the rejections under 35 U.S.C. 112(b) detailed in the Final Rejection dated April 15, 2025. In amending the claims, Applicant has overcome some of the rejections under 35 U.S.C. 112(b), but as detailed below, claims 1 and 21 still do not comply with 35 U.S.C. 112(b) as detailed below. Also, after reviewing the instant claims, the Examiner contends that the claims do not comply with 35 U.S.C. 101 as the claims recite an abstract idea without significantly more. The Examiner contends that the steps of evaluating, identifying, and forming a derivative data set are abstract ideas with no practical application. The Examiner also contends that the processor steps are directed to performing a mental process on a generic computer, or using a computer as a tool to perform a mental process. As such, the Examiner contends that the instant claims do not comply with 35 U.S.C. 101 as detailed below.
Claim Objections
Claim 19 is objected to because of the following informalities: at line 2 “is” should be changed to --are--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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, 5-10, and 19-21 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.
For claim 1, the claim does not recite a structural nexus between the housing, detector, illumination source, and test device. As such, itis unclear how the components of the claimed “apparatus” are connected to each other.
For claim 1, the claimed signal data is unclear as the Examiner is unable to determine what constitutes signal data. Claim 1 states that the detector “receives signal data in response to illumination of the test device,” but does not state what constitutes signal data, or what the signal data represents. As such, the Examiner cannot determine the metes and bounds of the claim as the signal data is unclear.
For claim 1, it is unclear where the label pad, reference line, and analyte specific test line are located relative to each other, and how they are connected to each other. Also, because the location of the label pad, reference line, and analyte specific test line are not oriented relative to each other, the Examiner is unable to determine what Applicant regards as downstream from the label pad as the claim does not provide a relative basis of flow on the test strip. Claims 5-10 and 19-21 depend directly or indirectly from claim 1 and are also indefinite.
For claim 21, the Examiner notes that the claim recites a negative control line comprising antibodies. Claim 20 also recites a reference line comprising antibodies. As such, the Examiner is unable to determine a structural difference between the reference line of claim 20 and the negative control line of claim 21 as they both claims generically recite the lines as comprising antibodies. Given this view, the Examiner is unable to determine a structural difference between the reference line and the negative control line.
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, 5-10, and 19-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) an abstract idea in that the claims recite mental processes that can be performed on a generic computer, via pencil and paper, or in a person’s mind. Independent claim 1 recites a processor comprising software that directs an apparatus to generate a one-dimensional data array, evaluate data in the one-dimensional data array, identify minimum and maximum peaks corresponding to a reference line, and forming a derivative data set based on positive and negative peaks in the derivative data set. The Examiner contends that these limitations are directed to performing a mental process on a generic computer, or using a computer as a tool to perform a mental process. The steps of evaluating data, identifying minimum and maximum peaks, and forming a derivative data set based on positive and negative peaks can all be performed in a person’s mind, or with a pen and paper. As such, these limitations are all abstract ideas (MPEP 2106.04(a)(2) III C). The step of generating a one-dimensional data step can be considered as an abstract idea, or a mathematical concept which is also an abstract idea (MPEP 2106.04(a)(2). In light of these views, the Examiner contends that claim 1 clearly recites an abstract idea. This judicial exception is not integrated into a practical application because the claim does not recite any practical steps being performed after the abstract ideas. Independent claim 1 does not recite any steps taken after the derivative data set based on positive and negative peaks is formed, thus the claim does not recite a practical application of the judicial exceptions recited in the claim. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements of the claim are directed to structural elements that are presented at a high level of generality. The MPEP stats that “a general purpose computer that applies a judicial exception, such as an abstract idea, by use of a convention computer functions does not qualify as a particular machine” (MPEP 2106.05(b). Independent claim 1 recites a system comprising an apparatus, a processor, and a test device wherein the apparatus further comprises a detector and an illumination source. The structural elements of claim 1 are presented at a high level of generality such that any system comprising a processor, test device, detector, and illumination source meets the claimed limitations. As such, the additional limitations of independent claim 1 do not amount to significantly more as they are directed to structural elements that are presented at a high level of generality. Therefore, based on the rationale detailed above, the Examiner contends that independent claim 1 is directed to a judicial exception without significantly more, thus the claim does not comply with 35 U.S.C. 101. For the sake of brevity, the Examiner has detailed the rejection with respect to claim 1, but notes that the rationale also holds true for the dependent claims.
Conclusion
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/DWAN A GERIDO/Examiner, Art Unit 1797