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 .
Response to Amendment
Claims 2-4, 6-24, 26, 28, 30, 32, 35-36, 38-39, 41-63, 71-87, 89 and 92-94 have been cancelled. Claims 1 and 5 have been amended as requested in the amendment filed on 22 September 2025. Following the amendment, claims 1, 5, 25, 27, 29, 31, 33-34, 37, 40, 64-70, 88, and 90-91 are pending in the instant application.
Claims 25, 27, 29, 31, 33-34, 37, 40, 64-70, 88, and 90-91 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant is reminded that it is only when applicant elects claims directed to a product, and the product claims are subsequently found allowable, then withdrawn process claims that depend from or otherwise require all the limitations of the allowable product claim will be considered for rejoinder. However, the converse does not apply if Applicant has elected the process. Further, withdrawn process claims that are not commensurate in scope with an allowable product claim will not be rejoined. See MPEP § 821.04(b).
Claims 1 and 5 are under examination in the instant office action.
Withdrawn Objection:
The amendment to the specification remedies the objection based upon the presence of a hyperlink within the disclosure.
The rejection under 35 USC 103 is withdrawn because the prior art does not teach a complex comprising Nan-Wtrw. However, this is a naturally-occurring product that forms a functional calcium ion channel in Drosophila and produces the natural phenomena of calcium ion mobilization or altered membrane potential in response to innate agonists like nicotinamide.
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 and 5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception(s) without significantly more. The claim(s) rely upon cells co-expressing the insect transient receptor potential channel proteins Nanchung (nan) and Water witch (Wtrw), contacting the complex with a candidate compound, and either (1) assaying for modulation of the channel complex by comparing calcium ion mobilization or (2) comparing a membrane potential of the cell before and after contact with the candidate compound.
The claims recite at least one judicial exception. First, the complex of nanchung with water witch is a naturally-occurring protein complex endogenously expressed in drosophila (Kandasamy et al., Insect Biochemistry and Molecular Biology, 149: 103835, 2022). Kandasamy et al. teach: “Analysis of Drosophila single-nucleus transcriptomic atlas revealed co-expression of nan and wtrw in audio- and mechanosensory neurons” (Abstract). In this way “providing a first cell co-expressing the insect transient receptor potential channel Nanchung protein and the insect transient receptor potential channel Water witch protein” reads upon the naturally occurring complex in Drosophila. Secondly, this complex forms a functional calcium channel that is activated by the “natural agonist” nicotinamide (see section 3.3 in Kandasamy et al., 2022), and opening of calcium channels inherently leads to calcium ion mobilization and altered cell membrane potential. Lastly, the newly added additional steps recite (1) comparing calcium ion mobilization in the first cell in the presence of the candidate compound with a calcium ion mobilization reference level indicative of no modulation of a complex consisting of an insect transient receptor potential channel Nanchung protein and an insect transient receptor potential channel Water witch protein; or (2) comparing a membrane potential in the first cell in the presence of the candidate compound with a membrane potential reference level indicative of no modulation of a complex consisting of an insect transient receptor potential channel Nanchung protein and an insect transient receptor potential channel Water witch protein. “Comparing” itself is a mental process that is one of the enumerated groupings of abstract ideas (MPEP 2106.04(a)). Mental processes include “concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).” Thus, the comparing steps are insignificant activity that must be performed in order to observe the natural phenomenon of the naturally occurring calcium channel complex itself. For all these reasons, the method recites at least one judicial exception. Step 2A Prong One: Yes.
The claims are directed to the judicial exceptions themselves if they do not integrate the judicially excepted subject matter into a practical application. In the instant claims, the judicial exceptions are not integrated into a practical application because the claim(s) does/do not include additional elements that are evidence of integration. See MPEP 2106.05(a-c), (e) and (h). Rather, the steps recited in the claim are mere instructions to apply an exception (MPEP 2106.05(f)). Thus, the steps/elements do not amount to more than a recitation of the words “apply it” regarding the judicially excepted nature-based product and its inherent functions as a calcium channel.
In Mayo, the Supreme Court concluded that a step of determining thiopurine metabolite levels in patients’ blood did not amount to significantly more than the recited laws of nature, because this additional element simply instructed doctors to apply the laws by measuring the metabolites in any way the doctors (or medical laboratories) chose to use. 566 U.S. at 79, 101 USPQ2d at 1968. The instant claims are analogous to the claims in Mayo because the steps merely recite a natural phenomenon (altered calcium mobilization or membrane potential) of the naturally-occurring Nan-Wtrw calcium channel complex. The additional steps of comparing calcium ion mobilization or comparing membrane potential read upon the inherent effects produced by innate compounds such as nicotinamide. Thus, the claims read upon the natural phenomenon of a nature-based product. The additional steps of the instant claims do not purport to improve the function of the technical field. The additional steps of the instant claim do not require any particular machine or transformation. The additional steps do not provide any of the other considerations for integration set forth in MPEP 2106.05(a) through (c), and MPEP 2106.05(e) through (h). Step 2A Prong Two: No.
In Sequenom (at IV) the Court rejected claims in the ’540 patent directed to uses or applications of a naturally-occurring product - cffDNA. The Court noted the claimed methods were also directed to “detecting the natural phenomenon”. The Court stated, “Because generally one must be able to find a natural phenomenon to use it and apply it, claims covering the only commercially viable way of detecting that phenomenon do carry a substantial risk of preempting all practical uses of it.”
The newly added additional steps are directed to “(1) comparing calcium ion mobilization in the first cell in the presence of the candidate compound with a calcium ion mobilization reference level indicative of no modulation of a complex consisting of an insect transient receptor potential channel Nanchung protein and an insect transient receptor potential channel Water witch protein; or (2) comparing a membrane potential in the first cell in the presence of the candidate compound with a membrane potential reference level indicative of no modulation of a complex consisting of an insect transient receptor potential channel Nanchung protein and an insect transient receptor potential channel Water witch protein”. As stated above, the newly added steps of “comparing” are mental processes that are one of the enumerated groupings of abstract ideas (MPEP 2106.04(a)). That section of the MPEP states, mental processes include “concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).”
These additional steps/elements do not amount to significantly more than the judicially excepted subject matter itself. The claimed complex does not markedly differ from the naturally-occurring protein complex comprising Nan and Wtrw, which is a functional calcium channel in Drosophila. Observing and comparing alterations in calcium ion mobilization in the presence of the candidate compound or (2) comparing a membrane potential in the presence of the candidate compound are mere observations of the natural phenomena that innately occur in response to natural agonists like nicotinamide. The Liu et al. prior art of record teaches rescuing a hygrosensing defect by expressing wild-type Wtrw and Nan and state, “These results indicate that wtrw and nan have an important role in hygrosensing” (pg. 296, first paragraph). Thus, the additional steps were not only natural laws/natural phenomenon, but also well-understood routine and conventional steps at the time of filing. Step 2B: No.
Thus, the preponderance of evidence suggests that the claims are not eligible subject matter under 35 USC 101.
Conclusion
No claim is allowed.
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/STACEY N MACFARLANE/ Examiner, Art Unit 1675