DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and response filed on 1/8/2026 have been received and entered into the case. Claims 2-3 have been canceled. Claims 1 and 4-5 are pending and have been considered on the merits. All arguments have been fully considered.
Withdrawn Objections
Objections are withdrawn in view of applicant’s amendments.
Withdrawn Rejections
Rejections of Claims 2-3 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of applicant’s amendments – Claims 2-3 have been canceled.
Rejections of Claims 2-3 under 35 U.S.C. 101 are withdrawn in view of the cancellation of Claims 2-3.
Rejections under 35 U.S.C. 102(a)(1) / (a)(2) as being anticipated by Huang et al (CN112990462A; 6/18/2021. Cited on IDS. US 2023/0342624 A1 is used as an English translation of CN112990462A) are withdrawn in view of applicant’s amendments.
Rejections of Claim 3 under 35 U.S.C. 103 as being unpatentable over Huang et al (CN112990462A; 6/18/2021. Cited on IDS. US 2023/0342624 A1 is used as an English translation of CN112990462A) in view of Eckel-Mahan et al (Physiol Rev. 2013;93(1):107-135.) are withdrawn in view of applicant’s amendments – Claim 3 has been canceled.
Claim Rejections - 35 USC § 112
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.
Use of the word “means” or “step” or another linking word or phrase, such as “configured to” or “so that” in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” or “step” or another linking word or phrase, such as “configured to” or “so that” in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “configured such that” or “configured to” are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “configured such that” or “configured to” are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
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 and 4-5 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 pre-AIA the applicant regards as the invention.
Claim 1 recites “an enzymatic reaction-based clock oscillator”. An enzyme-based oscillator is a system where enzyme reactions exhibit periodic fluctuations. However, claim 1 simply recites feedback loops, general principles that govern the system behavior. A skill in the art understands that not all feedback loops are enzyme-based oscillators. The recitation is indefinite as it is unclear what is required of the enzymatic reaction-based clock oscillator (besides the principle).
In addition, claim 1 recites “wherein the substance of the output signal is configured such that …” (line 31-35) and “wherein the clock oscillator is configured to …” (line 36-39), which invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to clearly link or associate the disclosed structure, material, or acts to the claimed function such that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function. After a review of the specification, it is not clear exactly which of the disclosed structures are considered to correspond to the recited means. Therefore, these claims are indefinite and are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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 4-5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 1 is directed to an enzymatic reaction-based clock oscillator for biochemical reaction computers, comprising a clock signaling enzyme, an anti-clock signaling enzyme, and a substance of an output signal. This limitation recites a natural product because enzyme-based oscillators occur naturally in biological systems. In addition, “wherein” clauses in claim 1 recites a law of nature because it describes the naturally occurring relationship between enzyme concentration, rate of enzyme activity and output signal of a substance. While these limitations can be categorized under several exceptions (a product of nature and a law of nature), it is adequate for an examiner to identify the limitation as falling under at least one judicial exception and to base further analysis on that identification. The remainder of this discussion is premised on the recited exception as a law of nature. Claim 1 does not recite additional elements. Thus, claim 1 does not amount to significantly more than the law of nature itself. Accordingly, claim 1 is not eligible and should be rejected under 35 U.S.C. § 101.
Claims 4-5 do not recite additional elements. Claims 4-5 do not amount to significantly more than the law of nature itself. Accordingly, claims 4-5 are not eligible and should be rejected under 35 U.S.C. § 101.
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 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 of this title, 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.
Claims 1 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al (CN112990462A; 6/18/2021. Cited on IDS. US 2023/0342624 A1 is used as an English translation of CN112990462A) in view of Eckel-Mahan et al (Physiol Rev. 2013;93(1):107-135.).
The instant claims recite an enzymatic reaction-based clock oscillator for a biochemical reaction computer, comprising a clock signaling enzyme, an anti-clock signaling enzyme, and a substance of an output signal, wherein the concentration or activity of the clock signaling enzyme is affected by that of the anti-clock signaling enzyme, the concentration or activity of the anti-clock signaling enzyme is affected by that of the clock signaling enzyme, the generation and consumption rate of the substance of the output signal is affected by the concentration or activity of the clock and anti-clock signaling enzymes, or the activity of the substance of the output signal is affected by the concentration or activity of the clock and anti-clock signaling enzymes: wherein the concentration or activity of the clock signaling enzyme is affected by that of the anti-clock signaling enzyme: when the concentration or activity of the anti-clock signaling enzyme is high, the generation of the clock signaling enzyme will be inhibited, or the consumption of the clock signaling enzyme will be promoted, or the activity of the clock signaling enzyme itself will be inhibited, resulting in the decrease of the concentration or activity of the clock signaling enzyme; when the concentration or activity of the anti-clock signaling enzyme is low, the generation of the clock signaling enzyme will be promoted, or the consumption of the clock signaling enzyme will be inhibited, or the activity of the clock signaling enzyme itself will be activated, resulting in the increase of the concentration or activity of the clock signaling enzyme; wherein the concentration or activity of the anti-clock signaling enzyme is affected by that of the clock signaling enzyme: when the concentration or activity of the clock signaling enzyme is high, the generation of the anti-clock signaling enzyme will be promoted, or the consumption of the anti-clock signaling enzyme will be inhibited, or the activity of the anti- clock signaling enzyme itself will be activated, resulting in the increase of the concentration or activity of the anti-clock signaling enzyme; when the concentration or activity of the clock signaling enzyme is low, the generation of the anti-clock signaling enzyme will be inhibited, or the consumption of the anti-clock signaling enzyme will be 2 promoted, or the activity of the anti-clock signaling enzyme itself will be inhibited, resulting in the decrease of the concentration or activity of the anti-clock signaling enzyme; wherein the substance of the output signal is configured such that the concentration or activity of the substance of the output signal is capable of varying with changes in the concentration of the clock and anti-clock signaling enzymes, so as to output a periodic oscillation signal, such that the clock oscillator is capable of outputting a chemical signal representing the concentration or activity of the substance of the output signal; and wherein the clock oscillator is configured to cascade with a biochemical reaction logic gate and a biochemical reaction latch of the biochemical reaction computer, thereby providing the chemical signal to the biochemical reaction computer as a clock signal for synchronizing a timing logic of the biochemical reaction computer.
Limitations of “wherein the substance of the output signal is configured such that …” (line 31-35) and “wherein the clock oscillator is configured to …” (line 36-39) are interpreted as functional limitations.
Huang teaches a biochemical computer latch based on enzymatic reactions (an enzymatic reaction-based clock oscillator for biochemical reaction computers), comprising an input signal, an output signal, and a storage signal, wherein the input signal and the output signal are concentrations or activities of substances, the storage signal is a concentration or activity of enzymes, and the storage signal includes an information storage enzyme and an inverse information storage enzyme (para 0006), the concentration or activity of the information storage enzyme is influenced by the inverse information storage enzyme: in the case that the concentration or activity of the inverse information storage enzyme is high, generation of the information storage enzyme is inhibited or consumption of the information storage enzyme is promoted, resulting in a decrease of the concentration or activity of the information storage enzyme; and in the case that the concentration or activity of the inverse information storage enzyme is low, the generation of the information storage enzyme is promoted or the consumption of the information storage enzyme is inhibited, resulting in an increase of the concentration or activity of the information storage enzyme (para 0007).
Huang does not teach the claimed relationship between enzyme concentration and rate of enzyme activity (claims 1 and 4-5).
However, Huang does teach a biochemical computer latch based on enzymatic reactions where enzymatic reactions interact with each other, enzymatic reactions are catalyzed by each other, and a feedback regulation of enzyme concentration or activity is achieved. Eckel-Mahan teaches enzymes act differently in an enzymatic oscillator based on their specific kinetic properties, catalytic mechanisms, and the type of feedback (p.124 col right – last para, p.125 col left – para 1-2, col right – para 1-3, p.126 col right – para 2).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate an enzyme using optimized parameters to achieve desired concentration or activity of the enzyme, since Huang and Eckel-Mahan both disclose oscillation in enzyme reactions, and Eckel-Mahan discloses that enzymes act differently in an enzymatic oscillator based on their specific kinetic properties, catalytic mechanisms, and the type of feedback. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to incorporate an enzyme using optimized parameters to achieve desired concentration or activity of the enzyme, with a reasonable expectation of success.
Response to Arguments
Applicant argues that the amended claim 1 as a whole amount to significantly more than the law of nature itself.
These arguments are not found persuasive because claim 1 only requires enzymes and a substance, which recites a natural product because enzymes and a substance occur naturally in biological systems. In addition, “wherein” clauses in claim 1 recites a law of nature because it describes the naturally occurring relationship between enzyme concentration, rate of enzyme activity and output signal of a substance. Claim 1 as a whole does not amount to significantly more than the law of nature itself.
Applicant argues that the subject matter the Office relies upon from Huang (CN112990462A) to reject the claims was made by the same inventors of the above-identified application. Huang (CN112990462A) was publicly available on June 18, 2021, which is less than one year before the effective filing date (August 9, 2021) of the present application. The applicant hereby submits a declaration along with this response. Therefore, Huang does not qualify as prior art.
These arguments are not found persuasive because the priority document (CN112990462A) does not appear to be made on record. The filing date of the priority document is not perfected unless applicant has filed a certified priority document in the application.
Applicant argues that Eckel-Mahan alone does not discloses each and every limitation of claim 1.
These arguments are not found persuasive because Eckel-Mahan is relied upon to demonstrate that enzymes act differently in an enzymatic oscillator based on their specific kinetic properties, catalytic mechanisms, the type of feedback, and a skill in the art would incorporate enzymes and substances using optimized parameters to achieve desired concentration or activity of the enzymes.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached on (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759