DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Status of claims
Canceled:
9, 14, 16-17
Pending:
1-8, 10-13, 15 and 18-24
Withdrawn:
none
Examined:
1-8, 10-13, 15 and 18-24
Independent:
1
Allowable:
none
Rejections applied
Abbreviations
x
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
102, 103
JE
Judicial Exception
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
x
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 12/11/2025 filing receipt, this application claims priority to no earlier than 12/22/2014. All claims have been interpreted as being accorded this priority date.
Objection to the specification: title
The title should be amended to more specifically reflect the claims, particularly the independent claims and referencing steps/elements: setting the context of the invention, particular to all claims, and distinguishing the instant application from any related applications, for example a title including terms such as: stable, retained, preserved, statistical model, codon preference, optimized. The title should be "descriptive" and "as... specific as possible" (MPEP 606, 1st para. and 37 CFR 1.72; also MPEP 606.01 pertains).
Claim rejections - 112/b
The following is a quotation of 35 USC 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.
Claims 1-8, 10-13, 15 and 18-24 are rejected under 112/b, as indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate. With regard to any suggested amendment below, for claim interpretation during the present examination it is assumed that each amendment suggested here is made. However equivalent amendments also would be acceptable.
The following issues cause the respective claims to be rejected under 112/b as indefinite:
Claim
Recitation
Comment
1
(a) ... stable or retained sequences
Each of the recited "stable" and "retained" is a term of relative or vague degree, neither defined in the specification nor having a well-known definition in the art. The specification does disclose: "By 'stable' or 'retained' sequences is meant that such sequences are maintained in the gene construct that is made based on the method described herein." (p. 7, line 30), however this putative definition leaves several issues which cause the recitation still to render the claim indefinite. First, the definition appears to describe conditions in the synthesized construct while the terms in the claim refer to "a candidate gene... sequence." Second, even if the context is applicable, the definition appears circular in that candidates are identified based on their possessing the quality being sought. Third, substantively the definition only adds to "are maintained" to the already apparently redundant "stable" and "retained." Fourth, no part of the definition addresses the relative nature of the terms, e.g. by providing a threshold as to how stable, over what time frame, under what conditions, etc. (MPEP 2173.05(b) pertains.)
1
(b) disallowed sequences
This is a term of relative or vague degree, neither defined in the specification nor having a well-known definition in the art. The specification does disclose: "As used herein, "disallowed sequences" refer to specific sequences or sequence patterns that are identified for removal or modification if present in the candidate gene nucleic acid sequence" (p. 10, line 30 through p. 11, line 15), however this putative definition does not answer the question of how to determine what sequences are disallowed. The specification also discloses various examples, but it is not clear that any disclosure causes a clarifying limitation to be imported into the claim (MPEP 2173.05(b) pertains.)
1
(d)...(i)... often do not include a preferred codon modification
In this context, "often" is a term of relative or vague degree, neither defined in the specification nor having a well-known definition in the art. (MPEP 2173.05(b) pertains.)
12
or any combination thereof.
It is not clear how to interpret this recitation in the recited context of only the single element, "GC-type content," e.g. a "combination" of which elements?
15
regularly spaced or defined loci
These are terms of relative or vague degree, neither defined in the specification nor having a well-known definition in the art. (MPEP 2173.05(b) pertains.)
20
the frequency of codon preference in the target expression system determined by the statistical
model
Lacks clear antecedent. While the model comprises the frequency, it is not clear how to interpret "determined by the statistical model" and what antecedent relates.
Each issue above causes the scope of the claim to be indefinite because it is unclear how the claim elements relate to each other and to the claim as a whole.
Regarding 35 USC 102 or 103
The claims are free of the analogous art at least because close art, e.g. as cited on the IDSs as well as found in the search notes, either individually or in obvious combination, does not teach the recited combination of identifying conserved and disallowed sequences, using a statistical model, optimizing candidates and making a synthetic gene.
Regarding 35 USC 101
Referring to 101 analysis as organized in MPEP 2106, the claims are patent eligible at least in view of the analysis step 2A, 2nd prong, 4th consideration relating to a transformation in the form of manufacture guided by any possible JE in steps (a-d), the manufacture in this instance comprising at least the recited making according to the design of the preceding steps.
Nonstatutory double patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine to prevent the improper timewise extension of the "right to exclude" granted by a patent and to prevent multiple suits against an accused infringer by different assignees of the same invention (MPEP 804.II.B, 1st para.). A nonstatutory double patenting rejection is appropriate where the conflicting claims (instant v. reference) are not identical, but an examined-application claim (instant claim) is not patentably distinct from a reference claim because the instant claim is either anticipated by, or would have been obvious over, the reference claim (MPEP 804.II.B, 2nd para.).
In cases of double patenting rejections versus reference claims of pending applications, as opposed to claims of an issued patent, the rejections are provisional because the reference claims have not been patented. Presently, no rejections are provisional.
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the application or patent of the reference claim either is shown to be commonly owned with the instant application or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must comply fully with 37 CFR 3.73(b).
Applicant may wish to consider electronically filing a terminal disclaimer (MPEP 1490.V pertains, along with https://www.uspto.gov/patents-application-process/applying-online/eterminal-disclaimer). Electronic filing may lead to faster approval of the disclaimer. Also, if filing electronically, Applicant is encouraged to notify the examiner by telephone so that examination may resume more quickly.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used.
A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Double patenting rejections of instant claims 1-8, 10-13, 15 and 18-24
Instant claims 1-8, 10-13, 15 and 18-24 are rejected on the grounds of nonstatutory double patenting as unpatentable over one or more claims in reference patent 11,041,158 (from application 15/535,760) in view of Gould (as cited on the 5/14/2021 IDS).
Each reference patent and application as well as the instant application recite claims which involve identifying sequences in a candidate gene, identifying disallowed sequences, using a statistical model, generating an optimized candidate gene and making a synthetic gene.
Although the reference claims are not identical to the instant claims, in a BRI they also are not patentably distinct from the instant claims: either (i) because the instant claims recite obviously equivalent or broader limitations in comparison to the reference claims or (ii) because the instant claims recite limitations which are obvious over the cited art. It is not clear that the instant claims recite limitations which are narrower than limitations in the reference claims.
It would have been obvious in view of the cited art to modify reference claims to arrive at the rejected instant claims. Either the instant limitations are interpreted as reading on a reference limitation, or the instant limitations would have been obvious in view of the cited art. That is, to the extent that any instant claims are narrower than reference claims, then any such narrowing would have been obvious over the cited art.
Conclusion
No claim is allowed.
A shortened statutory period for reply is set to expire THREE MONTHS from the mailing date of this communication.
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The examiner for this Office action, G. Steven Vanni, may be contacted at:
(571) 272-3855 Tu-F 8-7 (ET).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D. Riggs, II, may be reached at (571) 270-3062.
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
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