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 .
Claim Objections
Claims 38, 41, 44, and 45 objected to because of the following informalities: please italicize all binomial species names. Appropriate correction is required.
Applicant is advised that should claim 1 be found allowable, claim 54 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Note that the claimed “instructions” are considered nonfunctional descriptive material that does not materially affect the nature of the claimed “host cell.” See MPEP 2111.05.
Claim Interpretation
The claims provide for a number of “optional” limitations. As these are considered “optional” they are not considered a necessary part of the invention. While the limitations will be considered by the Examiner in the context of the invention, these optional limitations are clearly not necessary for the invention to function properly, and as such, should not be given patentable weight. If these limitations are important, they should be provided as definite limitations.
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 1, 2 and 38-55 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite because it is unclear which vectors should be considered part of the claimed host cell. The claim language “one or more vectors” suggests that the artisan must choose one or more of the pathways and genes listed in the claim; that is to say, if a host cell has a mevalonate pathway inserted into it, it would read upon the invention, since the preamble suggests that the other pathways/gene are one or more options for the artisan to choose from, and the claim reads as a Markush-type limitation. See MPEP 2117. For the sake of examining the claims on their merit, it will be assumed that all four pathways/genes must be present for the limitation to be fulfilled.
Claims 2 and 38-55 are rejected insofar as they ultimately claim dependence on claim 1, but do not make it clear the number of genes/pathways that must be present in the host cell.
Claim Rejections - 35 USC § 102/103
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.
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 38-46 and 48-54 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Zhang, et al (WO 2018/156086 [IDS Reference]) and evidenced by Seaver, et al (Journal of Bacteriology, 183, 7173-7181, 2001). Zhang teaches a host cell that possesses one or more exogenously added polynucleotide sequences. See “Abstract” section, paragraph [0007]. Zhang notes that the cell expresses a mevalonate pathway, a lycopene pathway, and an α-ionone pathway. See paragraph [0016] [0017] [0023]. Although Zhang does not teach the further insertion of a hydroperoxide reductase gene, Zhang utilizes Escherichia coli, which naturally possesses an endogenous hydroperoxide reductase gene. See Zhang, paragraph [0021]; Seaver, page 7173, “Abstract” section. As such, although Zhang does not teach the further insertion of a hydroperoxide reductase gene, since E. coli inherently possesses this gene, the insertion of the other pathways would lead to a functionally identical host cell. Since E. coli naturally possesses hydroperoxide reductase genes, and Zhang shows the further insertion of the other claimed pathways, the claimed host cell is functionally identical to the host cell taught in Zhang. Since the claimed cell and that of Zhang possess identical functionalities because of the inserted pathways, Zhang anticipates a functionally identical cell. However, since the claim provides for the insertion of a hydroperoxide reductase gene, the claimed cell can be considered an obvious variant of Zhang, wherein the claimed cell and that of Zhang perform identical functions.
With respect to claims 1, and 54, Zhang teaches a cell that appears to be functionally identical to that claimed, wherein the only difference is the exogenous addition of a gene that is already [endogenously] present in the cell of Zhang.
With respect to claim 2, Zhang teaches the insertion of hmgS. See paragraph [0009].
With respect to claim 38, Zhang teaches the insertion of crtB. See paragraph [0009].
With respect to claim 39, Zhang teaches a cell that includes a lycopene cyclase. See paragraph [0017].
With respect to claims 40 and 41, Zhang teaches one or more additional carotenoid cleavage dioxygenase genes, including CCD1. See paragraph [0010].
With respect to claims 42 and 43, Zhang provides for mutated ofCCD1 genes, wherein the mutations appear consistent with that claimed. See paragraph [0022]- [0027] [0097] [0098].
With respect to claim 44, Zhang teaches LCYe. See paragraph [0010].
With respect to claim 45, the claim describes a gene that would be endogenous to the E. coli used in Zhang. This is underscored by the fact that the claim is limited to E. coli-based hydroperoxide reductase.
With respect to claim 46, Zhang teaches the T7 promoter. See paragraph [0019].
With respect to claims 48-53, Zhang teaches the claimed method. See paragraph [0086].
With respect to claim 54, in the above example Zhang provides the host cells in a liquid medium. This fulfills the claim limitation.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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 reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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.
Claims 1, 2, 38-46 and 48-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 13 and 14 of U.S. Patent No. 11,920,137 and evidenced by Seaver, et al (Journal of Bacteriology, 183, 7173-7181, 2001). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited patent provides for claims that would anticipate the cited claims of the instant patent. For an analysis of US Pat. 11,920,137, see the rejections above, since the cited patent cited foreign priority to the described foreign document. Briefly, the patent provides for methods of making α-ionone by inserting certain pathways into a host cell. The patent described the same pathways as those claimed, wherein the instant application provides for claims that are broader than those of the patent. The primary difference between the instant claim-set and that of the patented claims is that the patented claims provide for a narrower method and host cell, wherein the cell is claimed to only produce α-ionone, whereas the instant claims describe methods of making α-ionone and other apocarotenoids. While it is noted that Zhang does not insert one or more hydroperoxide reductase genes into the cell, these would be inherently present in the E. coli cell described by Zhang, wherein the instant claims explicitly describe the insertion of E. coli-based hydroperoxide reductase genes. Since the cell and method of Zhang is anticipated by the cited patent, the claims are considered non-statutory double patenting with Zhang.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
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