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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Status of claim
Examined:
1
Independent:
1
Priority
As detailed on the 02/08/2024 filing receipt, this claim benefit of U.S. Provisional Application No. 63/429,654 filed 12/02/2022.
Drawings
The drawings filed 12/04/2023 are accepted.
Information Disclosure Statement
No Information Disclosure Statements are provided.
Claim Rejections - 35 USC § 112(a)
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.
Claim 1 is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as based on a disclosure which is not enabling. The disclosure does not enable one of ordinary skill in the art to practice the invention. Claim 1 recites “A kinetic ensemble system....” The claim does not recite the physical structure associated with the recited system, which is/are critical or essential to the practice of the invention but not included in the claim(s). See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976).
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claim 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 claim particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is 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.
Claim 1 recites “A kinetic ensemble system....” The metes and bounds of the recited “system” are not clearly defined and renders the claim indefinite. It is unclear what components or structures are included in the system or what the system encompasses.
Claim 1 recites “A kinetic ensemble system for identifying non-obvious target pockets and/or generating lead compound structures and/or structural components....” The metes and bounds of the recited “and/or” are not clearly defined and renders the claim indefinite. It is unclear whether the claim requires the steps of both identifying non-obvious target pockets and generating the lead compound… or is in the alternative where one of the steps is required. Similarly, it is unclear whether the claim requires both generating lead compound structures and structural components or is in the alternative where either the lead compound structures or structural components is generated.
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.
Matter belonging to no statutory category -- claim 1
Claim 1 is rejected under 35 USC 101 because the claimed inventions are directed to non-statutory subject matter.
Claim 1 is to "system," which is not, in all embodiments within a BRI, interpreted as belonging to any category listed in 101. In a BRI, the claim reads on data and/or software comprising no structure other than data and/or software. The claim is not recited as a process, and the claim is not limited to any particular structure as a 101 machine or manufacture. The claim reads on transitory propagating signals which are not proper patentable subject matter because it does not fit within any of the four statutory categories of invention (In re Nuijten, Federal. Circuit, 2006).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Decherchi (Thermodynamics and Kinetics of Drug-Target Binding by Molecular Simulation. Chem. Rev. 9 December 2020; 120 (23): 12788–12833.; cited on the attached 892 form).
Regarding independent claim 1, Decherchi teaches A system for identifying non-obvious target pockets and/or generating lead kinetic ensemble compound structures and/or structural components with “Structure−activity patterns determined by FEP for ligands of the induced myeloid leukemia cell differentiation protein Mcl-1. Differences of binding free energies (ΔΔG) between pairs of compounds compare favorably with experimental data” Figure 14 (caption, page 12811) and Figure 14.
Decherchi teaches comprising computational components and experimental components or processes, wherein the computational components comprise: physics-based simulation and artificial intelligence; and the experimental components or processes comprise biophysical components and chemical biology components with “Thanks to growing computational power, physics-based simulation is becoming a more viable solution to computational drug discovery, whereas more approximate methods like docking have dominated until now. In this scenario, machine learning (ML) is playing an increasingly prominent role. Machine learning has been used for several years for protein− ligand binding studies in the form of QSAR289 or clustering/projection analysis of trajectories. Today, deep learning is widely available. The basic concepts of deep learning are not new and embody the paradigm of learning from data. Well designed computer libraries and GPUs have now made deep learning computationally feasible.” (page 12821, col. 1, para. 3).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KETTIP KRIANGCHAIVECH whose telephone number is (571)272-1735. The examiner can normally be reached 8:30am-5:00pm EDT.
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/K.K./Examiner, Art Unit 1686
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687
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