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 .
DETAILED ACTION
Responsive to preliminarily amended claim-set of 1/9/2024
Claims pending 1,4,7,11-12,16,20,23-24,27-30,32-36,44-45
Claims currently under consideration 1,4,7,11-12,16,20,23-24,27-30,32-36,44-45
Priority
This application has an actual filing date of 01/09/2024 and has
PRO 63/479,092 filed 01/09/2023
Claim Rejections - 35 USC § 102
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.
Claims 1,4,7,11,16,20,24,33,34,36,44,45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DeBenedictis et al (2022 Nature Methods 19:55-64) as evidenced by Badran et al (2015 Nature Communications 6,8425 ten pages)
DeBenedictis et al teach throughout the document and especially the title and abstract, methods of performing and apparatuses for phage- and robotics-assisted near-continuous evolution (PRANCE). More particularly figures 1-2,4 as detailed in the Methods section, DeBenedictis et al: (A) prepares an evolution circuit comprising mutagenesis plasmid and a plurality of molecules capable of forming a multi-body complex (e.g MP6* and phage infection induced expression of T7 RNA polymerase as bound to an accessory plasmid as well as a NTP and/or mRNA) with an automated, high-throughput turbidostat and software for running a robot that handles bacteria + phage culture; (B) forms the multi-body complex comprising the plurality of molecules in the prepared evolution circuit; (C) determines for all of the plurality of molecules, equilibrium conditions in the prepared evolution circuit capable of producing an equimolar ratio of each of the plurality of molecules in the evolution circuit; (D) selects one or more evolution conditions (e.g. with a mutagenesis plasmid) for the plurality of molecules based at least in part on the one or more equilibrium conditions determined for each of the plurality of molecules; (E) maintains the selected one or more evolution conditions; and (F) evolves one or more of the molecules of the multibody complex under the maintained selected evolution conditions. The foregoing reads on claims 1,4,7,11,16,20,33,34,36,44,45
* As cited by DeBenedictis et al, MP6 as developed by Badram et al, includes arabinose-induced expression of dnaQ62, a dominant negative variant of E. coli DNA polymerase III epsilon proofreading domain
Claim Rejections - 35 USC § 103
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, 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 1,4,7,11,16,20,24,33,34,36,44,45 and 27,35 are rejected under 35 U.S.C. 103 as being unpatentable over DeBenedictis et al (2022 Nature Methods 19:55-64 – IDS 4/4/2024) in view of Britschgi et al (2006 Oncogene 25:2030-9)
DeBenedictis et al is relied on as above.
DeBenedictis et al do not teach: light induced expression of an endogenous protein like claims 27 and 35.
Britschgi et al teach throughout the document and especially the abstract and figures 2 & 4, UV irradiation induced expression of endogenous p53, a transcription factor that, in turn, induces expression of endogenous HIC1 (hypermethylated in cancer 1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the evolution apparatus developed by DeBenedictis et al for measuring light induced endogenous protein expression, as suggested by Britschgi et al.
One of ordinary skill in the art would have been motivated to have utilized the evolution apparatus developed by DeBenedictis et al for measuring light induced endogenous protein expression, as suggested by Britschgi et al in the interest of investigating cell pathways regulating cellular growth and/or differentiation vs. apoptosis (the former two leading to tumorigenesis), as described by Britschgi et al in the last two paragraphs of the text.
One of ordinary skill in the art would have had a reasonable expectation of success in using light mediated induction of endogenous genes like Britschgi et al for evolution studies as in DeBenedictis et al in so far as development of cancer is indeed a microevolutionary process.
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 12,23,28,29,30,32 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 12 recites the limitation "the third molecule" twice in line 5 and again in line 6. Similarly, claim 23 recites the limitation "the...third molecules in line 2. Claim 29 recites the limitation "the produced kinetic equilibrium" in lines 1-2. There is insufficient antecedent basis for these limitations in each of said claims, rendering their metes and bounds uncertain.
Claim 30 line 1 recites the ambiguous limitation “...claim 1,29...”, which is grammatically incongruent, rendering what the claim intends to encompass unclear.
In accordance with MPEP 2173.02: If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. See Morton Int ’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
In so far as the metes and bounds of the offending claim(s) may not be interpreted properly for the reasons above, all dependent claims therefrom claims 23 and 30 are rejected as being indefinite as well.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M GROSS whose telephone number is (571)272-4446. The examiner can normally be reached M-F 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on (571)272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER M GROSS/Primary Examiner, Art Unit 1684
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