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 3/14/2023 and election of 3/24/2026
Claims pending 1-28
Claims withdrawn 12-28
Claims currently under examination 1-11
Priority
This application has a filing date of 03/14/2023 and is a 371 of
PCT/US21/49562 09/09/2021
PCT/US21/49562 has
PRO 63/082,682 filed 09/24/2020.
Election/Restrictions
Applicant’s election without traverse of invention group I (claims 1-11) in the current reply filed 3/24/2026 is acknowledged.
Claims 12-28 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the current reply
The requirement is still deemed proper and is therefore made FINAL.
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 1-4,7,9,10 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pines et al (2014 ACS Synth Biol 4:604-14 – PTO 892 2/10/2026; including supporting information provided herein).
As cited previously in the restriction of 2/10/2026, Pines et al teach throughout the document and especially the abstract and first paragraph of the text, a
method for determining a minimum number of cell line clones necessary for complete saturation mutagenesis with codon compression algorithms as an alternative to NNK to produce protein product(s) having a set of unbiased target product attributes in various organisms.
More specifically in the first paragraph of results and discussion, figures 1,3,5,6 as detailed in the methods section (particularly under Library Coverage Calculations); table 2; supporting information figures S1,S4 & S5 and n, Pines et al: acquires (generates) at least one candidate cell line (e.g. E. coli) capable of expressing a polypeptide; measures, using an analytical instrument (e.g. DNA sequencer), a plurality of measured product attribute values of a plurality of clones of the candidate cell line;
receives inputs, via a user interface, representing a set of target product attribute
values for a product; projects, by a processor based upon the plurality of measured values, a minimum number of subject clones of the product using the candidate cell line necessary to produce a subset of the subject clones having product attributes that satisfy one or more conditions associated with the set of target values (e.g. empirical and theoretical probability of meeting a threshold, the threshold being expression of said protein with subsets of all possible nineteen point mutations at 1,2 or 3 residues with zero wild-type or truncated forms with a certain degree of confidence); displays, by the processor, a graph or chart of the minimum theoretical numbers of subject clones as a function of the desired plurality of sets of target values; and generates at least the projected minimum number of subject clones of the product using the candidate cell line. The foregoing reads on claims 1,2,3,4,7,9,10 and 11.
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 are rejected under 35 U.S.C. 101 because the claimed invention is drawn to an abstract idea without significantly more. Sole independent claim 1 is directed to “receiving inputs, via a user interface, representing a set of target product attribute values for a product; and projecting, by one or more processors based upon the plurality of measured values, a minimum number of subject clones of the product using the candidate cell line necessary to produce a subset of the subject clones having product attributes that satisfy one or more conditions associated with the set of target values” that is further described in dependent claims 2-7; 9 lines 7-16; claim 10 lines 5-6; and claim 11 lines 3-6 in terms of thresholds, statistics and/or additional thinking steps. Such reception and projection constitute(s) mental process(es) or else mathematical concepts.
MPEP 2106 eligibility step 1 & 2A prong 1: statutory but a judicial exception ?
While the presently claimed process falls under the four categories of statutory subject matter, as interpreted in MPEP 2106.04(a) particularly at pp 2100-37 or 2100-32, the courts have held methods that can be performed mentally using pen and paper or even aided by a computer; and mathematical concepts including statistical models (e.g. computing probabilities or confidence levels) and equations are judicial exceptions to patent eligible subject matter.
MPEP 2106 eligibility step 2A prong 2: is the judicial exception integrated ?
Such judicial exceptions are not integrated into a practical application in so far as acquiring a cell line, measuring and experimentally growing clones per claim 1 lines 4-6 &12-13; claim 7; claim 9 lines 4-6; and claim 10 lines 3-4 represent extra-solution activity in being mere data gathering. Similarly, the threshold value element set forth inter alia in claims 2,4-5 is deemed post-solution activity (like the alarm limit held to constitute insignificant extra-solution activity under Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 as interpreted MPEP at p 2100-82), and
MPEP 2106 eligibility step 2B: do the additional elements provide an inventive concept with significantly more ?
Measuring doubling time as in claim 8 line 5 and displaying with a processor a graph or chart of claim 11 are insufficient to amount to significantly more than the judicial exception(s), since computer generated graphs of doubling time constitute a well-understood, routine, conventional cell biology technique, as evidenced by Hall et al (2013 Mol. Biol. Evol. 31:232-8; cf figure 1 and second paragraph at p 237). And moreover, acquiring a cell line, measuring and experimentally growing clones as being well-understood, routine, conventional cell biology technique like claim 1 lines 4-6 &12-13; claim 7; and claim 10 lines 3-4 is further shown by the Hall review.
As such considered separately and in combination, the additional elements do not furnish an inventive concept, and as such claims 1-11 represent patent ineligible subject matter.
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.
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, 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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