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 .
Applicant’s reply dated 1/15/26 has been received.
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.
The previous rejection of claims 1-4 and 6-26 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in like of the clarifying amendments to the claims.
Claims 1,2,4,6-26 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 unclear in ending with “or a promoter of SEQ ID NO:1”. It is not clear if Applicant intends to be limiting the reference sequence to the sequence set forth in SEQ ID NO1 or any promoter sequence within SEQ ID NO:1. This is important because SEQ ID NO:3 is a sequence within SEQ ID NO:1 and thus the claim would encompass comparing the more active 400 nt fragment to itself. Dependent claims fail to remedy the matter.
Written Description
Claims 1,2,4,6-26 remain rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
As amended, the claimed invention is drawn to an isolated nucleic acid capable of directing transcription of a heterologous coding sequence positioned downstream therefrom, wherein the nucleic acid between 400bp and 425bp and comprises the sequence set forth in SEQ ID NO:3, which is 400bp. Thus the claims encompass the sequence set forth in SEQ ID NO:3 as well as variants that add up to and including a total of 25 nucleotides at the 5’ and/or 3’ ends of the sequence set forth by SEQ ID NO:3.
No functional equivalents of the sequence set forth by SEQ ID NO:3 are disclosed. The Specification supports that addition of 100 nucleotides to the 400 nucleotide sequence of SEQ OD NO:3 decreases promoter activity. The Specification does not teach addition of any amounts shorter than 100 nts and does not characterize how those 100 additional nucleotides decrease promoter activity. Thus, the requisite knowledge needed to envision which 25 nucleotides can be added, and to which end, is not provided such that one of ordinary skill in the art could readily envision encompassed sequences that would lead to the claimed 10-30% increased expression activity. In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. While the specification discloses the general genus terms, “functional fragments of SEQ ID NO:3” and “functional equivalent of SEQ ID NO:3”, the specification does not describe any species or functional characteristics of the species that would be considered a functional equivalents of SEQ ID NO:3. Therefore the specification does not teach the complete structure of a representative number of species of the claimed genus.
Next, it is determined whether a representative number of species have been sufficiently described by other relevant characteristics, specified features or functional attributes that would distinguish different members of the claimed genus. Given that no species of the genus of functional variants of SEQ ID NO:3 or the genus of functional equivalents of SEQ ID NO:3 are disclosed, no inherent special identifying features/characteristics of the genus of functional equivalents of SEQ ID NO:3 have been disclosed by the specification as well, the written description requirement has not been met.
Applicant has previously argued in their Remarks dated 02/05/2025, with regard to the previous obviousness rejections, the potential variants are numerous and the art fails to provide one of skill in the art with the necessary guidance to generate additional variants with a reasonable expectation that they would be improved relative to a wild-type promoter (Remarks, 9, 2/5/25). Applicant argues with regard to the Annex reference, that Annex provides a list of promoter lengths ranging from 3050bp to 325bp and provides no suggestion that any one of these will drive increased expression to lead one to choose the claimed length (Remarks, 10). Likewise, the Specification fails to provide this same guidance as to whether further truncations, and which ones, will lead to or maintain increased expression. Additionally, Pedersen et al (Com Chem 23:191-207, 1999) teach that the art of promoter prediction is from database and the ability to identify functional promoters is unpredictable. Pedersen et al teach that the number of false positives in database promoter prediction and identification is quite high and is due in part the unique combination of transcriptional and regulatory elements associated with each promoter (p. 192, col 1 and p. 195 col 1, par 1).
For an artisan envision the instantly claimed functionally equivalent variants, an artisan would first have to identify if the sequences had promoter activity and if they were capable of driving transcription
Applicant has previously argued that 25 bp could be added to the ends or removed from the ends and not alter the improved activity of SEQ ID NO:3. In response, the state of the art supports that distance, regardless of sequence, is often important for promoter function. Inserting 25 nucleotides upstream of the Transcription Start Site (TSS) generally alters the promoter architecture, impacting the spacing between critical regulatory elements (like the TATA box) and the actual site of transcription initiation. Because the precise distance (typically 25-30 bp for TATA) is crucial for efficient Pre-Initiation Complex assembly, such an insertion often reduces transcriptional activity, changes the TSS position or alters the overall transcription initiation profile (see, for example, Butler, 2002, Genes and Development, 16:2583-2592, specifically Figure 1).
Conclusion
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/VALARIE E BERTOGLIO/ Primary Examiner, Art Unit 1632
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