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 .
Response to Restriction/Election
Applicant's response to the species election without traverse filed on 8/14/2026 is acknowledged. However, it appears that claim 1 is allowable so this restriction requirement and election of species are withdrawn since all methods require the allowable features of claim 1. Therefore claim 1-20, 26, 27, 31, 32, 37, 38, and 54 are pending and considered on the merits.
Claim Objections
Claim 32 is objected to for the indentation bridging “and” with “culturing the host cell or using the cell-free expression system”. This indentation is unnecessary and appears to make two steps when the host cell and cell-free expression systems would be alternatives.
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.
Claim 10 is 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. The following two limitations in claim 10 are indefinite:
“(i) a single-pass transmembrane protein with C-terminus in cytoplasm (type I transmembrane protein)” and“(ii) a single-pass transmembrane protein with N-terminus in cytoplasm (type II
transmembrane protein);”.
The definitions of the type I and type II transmembrane proteins are narrower than which terminus is in the cytoplasm.
Uniprot defies each as follows:
Single-pass type I membrane protein--Protein spanning the membrane once, with its N-terminus on the extracellular side of the membrane and removal of its signal sequence.
Single-pass type II membrane protein--Protein spanning the membrane once, with its N-terminus on the cytoplasmic side of the membrane. The transmembrane domain is located close to the N-terminus and it functions as an anchor.
Since claim 10(i) limits only “a single-pass transmembrane protein with C-terminus in cytoplasm” and does not mention the location of the N-terminus or the signal sequence, it is unclear what limitations are encompassed by the ‘type I transmembrane protein’. Claim 10(ii) does not mention the transmembrane domain’s proximity to the N-terminus, so it is again unclear what limitations are encompassed by the ‘type II transmembrane protein”. The Applicant may want to choose one of each limitation for this claim to remove this rejection.
This is different than the enzyme followed by its abbreviation in claims 11-13 where the enzyme name is written out followed by its abbreviation in parenthesis. The Specification makes it clear these are simply abbreviations for the enzymes and their use is interchangeable.
Claim 32 is rejected because it is unclear if the culturing of the host cell is linked to the limitation “under conditions effective to express the tripartite glycosyltransferase fusion protein”. It is understood that this limitation is linked to the cell-free expression system, however with the Claim Objection above, it is unclear if this limitation applies to the host cell. Applicant may wish to write both scenarios independently to clearly indicate these are separate alternatives with their own steps for expressing the protein to remove this rejection.
Request for Interview
The Examiner believes an interview would be useful in progressing this case since allowable subject matter is present in this invention. The Applicant is encouraged to contact Thane Underdahl at (303) 297-4299 to discuss the claims/claim amendments to place this case in condition for allowance prior to replying to this Office Action.
Claims Free of the Art
Applicant’s own publication (DeLisa et al., Nature Communications 31(1):62325 (2022) in IDS 8/14/16) published Oct 24, 2022 seems to be the first public disclosure of this invention (see Fig 1a).
The closest available prior art appears to be US 8999668. However they do not teach a nucleic acid construct or resulting fusion protein comprising an amphipathic shield domain, a glycosyltransferase and a decoy protein.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
