DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Preliminary Amendment filed on January 16, 2026, has been received and entered.
3. Applicant’s election with traverse of Group I (claims 1-5, with species) on January 16, 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 § 818.03(a)).
Claim Disposition
4. Claims 1-28 are pending. Claims 1-5 are under examination. Claims 6-28 are withdrawn from consideration pursuant to 37 CFR 1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
5. The Information Disclosure Statements filed on March 24, 2023, have been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action. Note that several references have been lined through because they are missing a date or a proper citation of the reference and date.
Drawings
6. The drawings filed on March 10, 2023, are accepted by the examiner.
Specification Objection
7. The specification is objected to for the following informalities:
The specification is objected to because trademarks are disclosed and they are not capitalized. The use of the trademark such as TRITON-X-100, has been noted in this application (see page 79, for example). It should be capitalized wherever it appears and be accompanied by the generic terminology. Although the use of trademarks is permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner, which might adversely affect their validity as trademarks.
The specification is objected to because the organism name ‘Faustovirus’ is not italicized, see for example page 80.
Claim objection
8. Claims 1-5 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to read, “…recite if the linker is attached on the N or C terminus and if the enzyme is one, two or all three options. The dependent claims hereto are also included.
For clarity it is suggested that claim 2 is amended to read, “The [[An]] immobilized enzyme [[according to]] of claim 1 [[Claim]]….”. In addition, claim 2 is objected to for the recitation of “….enzyme or2’O….”, because it lacks proper spacing.
For clarity it is suggested that claim 3 is amended to spell out the acronym (see also claims 1 and 4-5).
For clarity claim 5 should be amended to italicize the organism name ‘Faustovirus’.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
9. Claims 1-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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 or a joint inventor, or for pre-AlA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention is directed to “an immobilized enzyme” that is defined by its parts but has no structural or functional limitations. The claims encompass an immobilized enzyme, BspQI, T7 RNA polymerase and Faustovirus enzyme.
The claimed method is not adequately described because the claimed products are not adequately described as no correlation is made between structure and function. The invention encompasses ‘an enzyme, peptide linker (any), SNAP tag etc. The claimed invention encompasses a broad variable genus of enzyme structures, peptide linker and tags. The claimed invention is devoid of a structure-function. The claimed invention is overly broad and encompasses a large variable genus of compounds. The art generally acknowledges that when designing a construct with RNA polymerase, the linker sequence must be chosen carefully to maintain the enzymatic activity of the polymerase while support the function of the fused peptide. There are no indicia in the claims as well if the peptide if bonded on the C or N terminus of the immobilized peptide. The specification fails to provide any additional representative species of the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species which are adequately described are representative of the entire genus. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
Accordingly, in the absence of sufficient recitation of distinguishing identifying
characteristics of the claimed method, method steps, host organism and the genus of products encompassed, the specification does not provide adequate written description of the claimed invention, as a whole. Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
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.
10. Claims 1-5 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 and the dependent claims hereto are indefinite for the recitation of “…linker attached to the enzyme…” because three different enzymes are recited in the claim and it also reads on multiple enzymes fused together.
Claim 2 is indefinite for the recitation of a recognition sequence without providing a reference structure where this sequence can be found.
Claims 1-5 contains the trademark/trade name SNAP-tag. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112, second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an assay with regard to the selection of the patient population for the method of treatment, and accordingly, the identification/description is indefinite.
Appropriate correction is required.
Conclusion
11. No claims are presently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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