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 election without traverse of Group I, claims 1-4, 11, in the reply filed on December 21, 2025 is acknowledged.
Claims 5-10, 12 are withdrawn. Claims 1-4, 11 are under consideration.
As an initial matter, it is noted that in Applicants’ amendments/remarks received December 21, 2025, the instant application has the incorrect number of 18131998. It is noted that the instant application number is 18131968. Further correction is requested.
Priority: This application is a CON of PCT/CN2021/116573, filed September 4, 2021, which claims benefit to foreign application CN 202011073250.X, filed October 9, 2020. A copy of the foreign priority document has been received in the instant application on May 12, 2023, and is not in the English language.
Failure to Comply with Sequence Rules
Where the description of a patent application discusses a sequence of 4 or more amino acids or a sequence of 10 or more nucleic acids, reference must be made to the sequence by use of the sequence identifier preceded by “SEQ ID NO:” in the text of the description even if the sequence is also embedded in the text of the description of the patent application (see 37 CFR 1.821, especially paragraphs (a)-(d)). The sequence identifier may be used in either the drawing or the Brief Description of Drawings (see MPEP 2422).
Objection to the Specification:
The specification is objected to for failure to comply with the sequence rules for the
reasons as given above. The specification refers to sequences without identifiers at: see at least paragraphs 0008, 0028 (of the specification filed November 10, 2023).
The sequences must be in computer readable form (CRF) for search. See also MPEP 2422 for sequence compliance requirements. Appropriate correction is required.
Objection to the Claims:
Claim 4 is objected to for failure to comply with the sequence rules for the reasons as given above. Claim 4 recites sequences without identifiers.
The sequences must be in computer readable form (CRF) for search. See also MPEP 2422 for sequence compliance requirements. Appropriate correction is required.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code: see at least paragraph 0003 (of the specification filed November 10, 2023). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 3, 11 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.
Claims 3, 11 recite the CBM is selected from second family CBM. It is generally known that proteins types, in this instance, CBM, are classified into families, i.e. family 1, family 2, family 3, etc. The claims should clarify what is meant by “second family” CBM and if it is meant to be a family 2 CBM. Further clarification and/or correction is requested.
Claim Rejections - 35 USC § 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 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.
Claims 1-3, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Shoseyov et al. (2006 Microbiology and Molecular Biology Reviews 70(2): 283-295) in view of Phelps et al. (1994 Biotechnol Prog 10(4): 433-440). Shoseyov et al. disclose that carbohydrate binding modules (CBMs) were initially classified as cellulose binding domains (CBDs) (at least p. 283). Shoseyov et al. disclose CBMs have been established in different fields of biotechnology and are perfect candidates for many applications (at least p. 285). Shoseyov et al. disclose CBMs utilizing CBMs as analytical tools in research and diagnostics (at least p. 287). Shoseyov et al. disclose a biosensor comprising chemically conjugated CBM-glucose oxidase (citing Phelps et al.) (p. 287). Shoseyov et al. disclose proteins possessing hydrolytic activity typically comprise the a catalytic module joined to the CBM by linker sequences (at least p. 284).
Phelps et al. disclose a biosensor comprising glucose oxidase (GOx) conjugated to CBD with glutaraldehyde (at least p. 433, 434). Phelps et al. disclose that an alternative to chemical conjugation would be to develop an appropriate construct that yields an active GOx-CBD fusion protein (at least p. 436, 439). Phelps et al. disclose the CBD functions independently of the catalytic domain and is joined to the CBD by a linker (at least p. 434).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the references and arrive at the claimed fusion protein comprising glucose oxidase (GOx or GOD) and a carbohydrate-binding module (CBM), and where the GOD is linked to the CBM by a peptide linker (instant claim 1). The motivation to do so is given by the prior art, which disclose biosensors comprising GOD conjugated to a CBM are known and that the biosensors can be developed as a GOD-CBM fusion protein. One of ordinary skill would have further motivation to incorporate a peptide linker to fuse GOD with CBM in the fusion protein because the prior art further disclose that proteins having activity comprise the catalytic domain joined to the CBM by a linker sequence. One of ordinary skill would have a reasonable expectation of success because utilization of CMBs with enzyme proteins is known in the prior art and incorporating linkers in fusion proteins is also a known technique in the art.
Regarding instant claim 2, Phelps et al. disclose the glucose oxidase is from Aspergillus niger (at least p. 434, 436). A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. MPEP 2144.09. In this instance, it would be obvious that the glucose oxidase from Aspergillus niger is structurally similar and functionally the same as the claimed glucose oxidase from Aspergillus niger An76.
Regarding instant claims 3, 11, Shoseyov et al. disclose known CBMs include those from family II CBMS (at least p. 287, 288). Therefore, it would be obvious to one of ordinary skill that the CBM in the fusion protein comprising GOD and CBM linked by a linker peptide can be selected from a family II CBM.
Claims 1-3, 4, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Shoseyov et al. (2006 Microbiology and Molecular Biology Reviews 70(2): 283-295) in view of Phelps et al. (1994 Biotechnol Prog 10(4): 433-440) and Chen et al. (2013 Advanced Drug Delivery Reviews 65: 1357-1369). The teachings of Shoseyov et al. and Phelps et al. over at least instant claims 1-3, 11 are noted above.
Regarding instant claim 4, as noted above, Shoseyov et al. and Phelps et al. reasonably disclose a fusion protein comprising GOD and CBM joined by a linker sequence. Chen et al. disclose that as an indispensable component of recombinant fusion proteins, linkers have shown increasing importance in the construction of stable, bioactive fusion proteins (at least p. 1357). Chen et al. disclose common linkers include (GGGGS)n and (EAAAK)n (at least p. 1360, also Table 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the linker sequence (GGGGS)n of Chen et al. for the linker sequence joining GOD to CBM in the fusion protein comprising GOD and CBM of Shoseyov et al. and Phelps et al. above. One of ordinary skill would have a reasonable expectation of success because linkers are commonly utilized in constructing fusion proteins, including the claimed (GGGGS)n linker sequence.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marsha Tsay whose telephone number is (571)272-2938. The examiner can normally be reached M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Marsha Tsay/Primary Examiner, Art Unit 1656