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 .
Election/Restrictions
Applicant’s election of the invention of Group I, claims 3, 9, and 12-23, and the species of split 3-19, split 23-297, a purified protein, and analyte binding domain of the protein of the first fragment in the reply filed on 04/07/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Status
The amendment of 04/07/2026 has been entered. Claims 3, 9, and 12-23 are currently pending in this US patent application and were examined on their merits.
Information Disclosure Statement
The information disclosure statements filed in this application on 03/05/2024 and 06/14/2024 have been received and considered.
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.
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 3, 9, and 13-23 are rejected under 35 U.S.C. 103 as being unpatentable over US patent application publication 2010/0273186 filed by Wood, published 10/28/2010.
Wood teaches a system having two fragments of a hydrolase with an N- or C-terminus at a residue corresponding to a residue in a region including residue 14-24 of a dehalogenase, which may be DhaA (see entire document, including paragraph 0014; cf. claims 3, 9, and 13-23; the Examiner notes that BLAST alignment indicates that DhaA has greater than 90% sequence identity with instant SEQ ID NO: 1, and so multiple fragment split sites in the range of residues 14-24 of DhaA, as suggested by Wood, would produce fragments comprising at least 70% sequence identity with Applicant’s elected fragments of SEQ ID NO: 1, in light of the open-ended language used in Applicant’s claims). The N- and/or C-terminus of the hydrolase fragment may include deletions relative to the sequence of a corresponding full-length mutant or wild-type hydrolase or may be fused to a heterologous amino acid sequence, such as hydrolase sequences found in one of the hydrolase fragments that interact with a molecule of interest (paragraph 0014; cf. claims 13, 16-19, and 23; the Examiner notes that, in the absence of further limitation, any protein may be considered a “protein of interest” as elected by Applicant and a “molecule of interest” as recited in instant claim 23). In certain embodiments, the heterologous amino acids sequences interact, yielding a complex of the two fusion proteins under certain conditions but not under other conditions (paragraph 0015; cf. claims 20-21). In certain embodiments, the heterologous amino acid sequence is a mitochondrial or nuclear localization sequence (paragraph –16; cf. claim 22). In certain embodiments, one of the fusion proteins is a polyHis sequence (paragraph 0018; cf. claim 14; the Examiner notes that any fusion protein attached to one of the fragments of Wood would intrinsically be present on one “side” of the split site and that claim 14 does not require any particular proximity between the split site and the duplicated sequences). In certain embodiments, the dehalogenase is capable of forming a covalent bond with a haloalkane substrate (paragraph 0168; cf. claim 15).
However, Wood does not explicitly teach the fragments of DhaA suggested in Wood’s teachings.
While Wood does not explicitly teach fragments with an N- or C-terminus at a residue corresponding to a residue in a region including residue 14-24 of DhaA, it would have been obvious to one of ordinary skill in the art to do so because Wood suggests constructing such fragments, along with the other structural elements cited above. One of ordinary skill in the art would have a reasonable expectation that protein fragments made according to the suggestions of Wood would successfully result in the production of protein fragments that are capable of performing the dehalogenase reporting function described by Wood.
Therefore, claims 3, 9, and 13-23 are rendered obvious by Wood and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau, can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 07/07/2026
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