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 .
Status of Application/Restriction/Claims
Applicant’s election without traverse of Group II (claim 16) and species (negative regulation of the output molecule by the first and second actuator molecule) in the reply filed on 12/22/2025 is acknowledged. Claims 12 and 15-16 have been canceled. Claims 1-11 and 13-14 have been amended such that Group II is encompass by newly amended claim 1. Thus, the restriction between Groups I and II has been withdrawn while the species restriction is maintained. Claims 1-11 and 13-14 are pending and are the subject of the present Official action.
Priority
Applicant’s claim for the benefit of a prior-filed application EP 20206417.6 and EP21187316.1 and 371 of PCT/EP2021/081158 filed on 11/9/2020, 7/22/2021 and 11/9/2021, respectively, under 35 U.S.C 119(e) or under 35 U.S.C 120, 121 or 365(c) is acknowledged.
Accordingly, the effective priority date of the instant application is granted as 11/9/2020
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 5/9/2023 and 12/7/2025 were received. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the examiner.
Claim Interpretation
With respect to the “particularly an ex vivo method” language recited in independent claim 1, it is emphasized that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure, see MPEP 2111.04. A similar analysis is applied to “particularly” as recited in claim 1 part ii), claim 8, 9, 13 and 14.
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 1-11 and 13-14 are rejected under 35 U.S.C. 101 because the claimed invention directed to non-statutory subject matter as evidenced by Wolkenhauer et al. "A systems-and signal-oriented approach to intracellular dynamics." (2005): 507-515 (hereinafter Wolkenhauer). The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims do not purport to claim a process, machine, manufacture or composition.
The most recent update to the Office’s patent eligibility requirements are the 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG) published on January 7 and October 17, 2019 (84 Fed. Reg. 50), which provides the following analysis to determine patent eligibility, derived from the decisions rendered in Mayo Collaborative Svcs. V. Prometheus Labs., 566 U.S. _, 132 S. Ct. 1289, 101 U.S.P.Q.2d 1961 (2012) (hereinafter “Mayo”), and in Alice Corp. Pty. Ltd. v CLS Bank Int’l, 573 U.S._, 134 S. Ct. 2347, 110 U.S.P.Q.2d 1976 (2014) in subsequent court cases:
Step 1 is to determine whether the claim is directed to a process, machine, manufacture, or composition of matter. If the claim is directed to a statutory category, proceed to Step 2.
Step 2 is the two-part analysis from Alice Corp.
Step 2A has been divided into 2 prongs.
Step 2A, prong 1 requires determining whether the claim is directed to the judicial exceptions of an abstract idea, a product of nature, or a law of nature or natural phenomenon other than a product of nature. To determine if the claim recites a nature-based product limitation, the markedly different characteristics analysis is use to evaluate whether the claim is directed to a “product of nature” that falls under the law of nature and natural phenomenon exceptions. In this analysis, markedly different characteristics can be expressed in terms of the product’s structure, function, and/or other properties. If YES, the claim is directed to a judicial exception, proceed to step 2A, prong 2.
Step 2A, prong 2 requires evaluating whether a judicial exception is integrated into a particular application (e.g. improving technology, effecting a particular treatment or prophylaxis, implementing with a particular machine, ect.) identified by the Supreme Court and the Federal Circuit, to ensure that the claim as a whole “integrates [the] judicial exception into a particular application [that] will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.”
If NO, the claim does not integrate the judicial exception into a practical application, then proceed to step 2B.
Step 2B requires analyzing whether the claim as a whole amounts to significantly more than the exception by determining whether any element, or combination of elements, in the claims is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception. To be patent-eligible, a claim that is directed to a judicial exception must include additional features to ensure that the claim describes a process or product that applies the exception in a meaningful way, such that it is more than a drafting effort designed to monopolize the exception. The Supreme Court has identified the following non-limiting considerations for determining whether a claim with additional elements amounts to significantly more than the judicial exception itself:
Improvements to another technology or technical field;
Improvements to the functioning of the computer itself;
Applying the judicial exception with, or by use of, a particular machine;
Effecting a transformation or reduction of a particular article to a different state or thing;
Adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application; or
Other meaningful limitation beyond generally linking the use of the judicial exception to a particular technological environment.
Claim 1 describes a method for controlling a network in a cell comprising expressing the at least one recombinant gene of an expression system in a cell, wherein the network comprises an actuator molecule and an output molecule which is negatively regulated. Although claimed as a method, the claims fail to state a material use of the method for controlling a network in a cell. As stated in MPEP 2173.05(q), claim 1 merely recites a use but fails to recite steps which would classify it as a process under 35 U.S.C 101. The claims do mention “the at least one recombinant gene”, however as explained in the 112b rejection below, this term lacks antecedent basis and it is unclear whether the claimed method is used to control the expression of said recombinant protein or for another unspecified aim. This rejection is supported by the disclosure of Wolkenhauer, wherein negative synthetic feedback loops in molecular circuits are discussed (Wolkenhauer, abstract). For example, the Ras-MEK-ERK MAPK kinase pathway involves multiple negative feedback loops (RAF1 inhibition and MEK) which act to control the magnitude, duration and location of signaling (Wolkenhauer, p511 and Fig 2). Although this is a naturally occurring process, the molecular circuit is still used to generate an output of activated MAPKs like ERK which acts to regulate gene expression in the nucleus involving proliferation and differentiation (Wolkenhauer, p511 and Fig 2). In contrast, the instant claims merely recite a use but fails to recite steps which would classify it as a process under 35 U.S.C 101.
Claim Rejections - 35 USC § 112b
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 1-11 and 13-14 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 describes a method for controlling a network in a cell comprising expressing “the at least one recombinant gene” of an expression system in a cell. There is a lack of antecedent basis for the term “the at least one recombinant gene” since the claims do not previously describe a recombinant gene. As a result of this indefinite term, one of ordinary skill in the art would not understand what recombinant gene is expressed and if this is related to the controlled network of the cell. A claim is indefinite when it contains words or phrases whose meaning is unclear, see MPEP2173.05(e). Claims 2-11 and 13-14 are rejected for their dependency on indefinite claim 1.
Claims 1-11 and 13-14 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 describes a method for controlling a network in a cell comprising expressing at least one recombinant gene of an expression system in a cell, wherein the network comprises an actuator molecule and an output molecule which is negatively regulated. Claim 1 merely recites a process without setting forth any active steps delimiting how this use is actually practiced which is considered indefinite, see MPEP 2173.05(q). Although the specification provides block diagram and abstract examples illustrating such control networks, it should be emphasized that it is improper to read limitations contained in the specification into the claims. Dependent claims 2-11 and 13-14 do not provide further active steps and merely describe further descriptive and abstract elements of the network. As a result, one of ordinary skill would not understand the practical steps needed in order to practice the claimed method for controlling a network in a cell.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dr. ALEXANDER NICOL whose telephone number is (571)272-6383. The examiner can normally be reached on M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached on (571)272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Alexander Nicol
Patent Examiner
Art Unit 1634
/ALEXANDER W NICOL/Examiner, Art Unit 1634