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 without traverse of Group I, claims 1-3, 17 and 18 in the reply filed on 04/30/2026 is acknowledged.
Claims 5-11, 16 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/30/2026.
Claims 1-3, 17 and 18 (claim set filed 12/24/2024) are examined on the merits herein.
Priority
This application is a 371 of PCT/PL2020/000076 filed 09/14/2020. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) based on application POLAND P.431144 filed 09/13/2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/30/2023 complies with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
The specification recites: “e.g. NaCl, KCl, MgCU, MgSCE, (NHAiSCE)” on p. 1, 2nd paragraph of substitute specification filed 12/15/2025. Applicant is suggested to correct recitation with: e.g. NaCl, KCl, MgCl2, MgSO4, (NH4)2SO4” if it was the Applicant’s intention.
Further, MgCl2 is recited throughout the specification as “MgCh” (for instance on p. 5, 4th paragraph) or MgCL (p. 7, 8th paragraph) or MgCk (p. 7, 11th paragraph) or MgCb (p. 10, 1st paragraph), or MgCK (p. 10, 2nd paragraph). Applicant is suggested to correct recitations in specification to MgCl2 if it was the Applicant’s intention.
Appropriate correction is required.
Claim Objections
Claims 3 and 18 are objected to because of the following informalities:
Claim 3 recites “MgCl” in line 4 and claim 18 recites “MgCl” in line 4. Applicant is suggested to replace recitation with MgCl2 if it was the Applicant’s intention.
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.
Claims 1-3 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites: “SEQ ID NO: 3B”. Sequence with SEQ ID NO: 3B is not supported by the specification and is not present in the sequence listing. Thus, since the support for claim 1 is not provided, claim 1 contains new matter. One of ordinary skill in the art would not conclude that the applicant would have been in possession of the subject matter of claim 1 at the time of filing application.
Claims 2, 3 and 18, dependent on claim 1, do not resolve the issue mentioned above and are rejected.
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 1-3 and 18 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 has two issues:
Claim 1 recites: “SEQ ID NO: 3B”. Sequence with SEQ ID NO: 3B is not present in the specification and in the sequence listing. It is not clear what sequence Applicant is referring to.
Claim 1 recites SEQ ID NO: 3B in parenthesis. It is not clear whether SEQ ID NO: 3B is limiting to the claim or optional.
The scope and boundaries of claim 1 are not certain making claim 1 indefinite.
For examination SEQ ID NO: 3B is not considered to be claim 1 limitation.
Claims 2, 3 and 18, dependent on claim 1, do not resolve the issues mentioned above and are rejected.
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.
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 1-3 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lanes (WO 2013121228 A1 on record in IDS) in view of NCBI WP_11219706 (NCBI WP_11219706, endonuclease [Photobacterium profundum], 2013 [retrieved on 1/25/2026]. Retrieved from the Internet: < endonuclease [Photobacterium profundum] - Protein – NCBI >) and ThermoFisher (ThermoFisher, His-tagged proteins, 2015 [retrieved on 1/25/2026]. Retrieved from the Internet: < https://www.thermofisher.com/us/en/home/life-science/proteinbiology/ protein-biology-learning-center/ protein-biology-resource-library/pierce-protein-methods/histagged-proteins-productionpurification. html>).
Regarding claim 1, Lanes teaches endonuclease I or enzymatically active fragment thereof (Abstract). Lanes discloses that the endonuclease isolated from Vibrio salmonicida has the sequence of SEQ ID NO:1 with substitution of one amino acid residue to the negatively charged or polar one (p. 5, lines 1-6). Lanes describes method of isolation and purification of the recombinant endonuclease or an enzymatically active fragment thereof (p. 16, lines 31-37, p. 17, lines 1-21). The sequence of mutant endonuclease of Lanes teaching with SEQ ID NO:6 comprises sequence with 64.9% identity to instant sequence comprising 42-269 amino acids of SEQ ID NO:2. Lanes provides examples of application of endonuclease of his invention to removal of contaminating DNA from DNA polymerase preparation or PCR master mix and removal of DNA from protein purification preparation (Examples 9, 10 and 12).
Lanes does not teach the sequence comprising amino acids 42-269 of SEQ ID NO:2 and does not teach hexa-His purification tag.
NCBI WP_11219706 teaches amino acid sequence for the endonuclease from Photobacterium profundum comprising amino acids residues 20-247 that are identical to amino acid residues 42-269 of instant SEQ ID NO:2 and hence comprises amino acids 42-269 of SEQ ID NO:2. NCBI WP_11219706 describes that Photobacterium profundum belongs to Vibrionaceae family (Organism).
ThermoFisher teaches 6xHis or poly-His tag fused to the N- or C-terminus of the recombinant protein and used for purification via metal affinity chromatography.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try substituting endonuclease of Lanes teaching with endonuclease from NCBI WP_11219706. One would have been motivated to do so with reasonably expected success because Lanes and NCBI WP_11219706 teach endonucleases isolated from bacteria belonging to the same family of Vibrionaceae and having sequences with 65% identity and hence these endonucleases are expected to have similar properties.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add hexa-His purification tag as taught by ThermoFisher to the endonuclease of Lanes and NCBI WP_11219706 teachings. One would have been motivated to do so because 6xHis tag allows to purify the recombinant protein via metal affinity chromatography. A skilled artisan would have reasonably expected success in this combination because Lanes teaches endonuclease and its application for removal of contaminating DNA, NCBI WP_11219706 provides sequence of closely related endonuclease and ThermoFisher discloses sequence modification by attaching hexa-His tag for easier purification. Thus, Lanes, NCBI WP_11219706 and ThermoFisher teachings render claim 1 obvious.
Regarding claim 2, Lanes teaches endonuclease to be substantially (irreversibly) inactivated when incubated at 30°C for 15 min in the presence of 10 mM DTT (p. 5, lines 21-24). Lanes mentions that inactivation can occur at concentrations of DTT of 0.5-50 mM and preferably 1 mM (p. 8, lines 27- 31). Lanes describes various conditions for inactivation of endonuclease in Table 3 (p. 18) one of which is treatment at 50°C for 30 min at 1 mM DTT can corresponds to instant limitation of claim 2.
Regarding claim 3, Lanes teaches that endonuclease of his invention is particularly effective at salt such as NaCl at concentrations of 50 mM-1M (p. 7, lines 1-3). Lanes mentions that concentration of Mg2+ ions is important for endonuclease functioning and for this reason Mg2+ is used at concentrations of 1-20 mM (p. 8, lines 9-11). It is noted that requirements for urea, ammonium sulfate and imidazole start with 0 mM and therefore these substances may not be present. Thus, Lanes teaching covers limitations of claim 3.
Alternatively, the limitations of irreversible inactivation of PPR nuclease at recited conditions (claim 2) and limitation of PPR nuclease being enzymatically active at recited salt concentrations (claim 3) are interpreted as functional properties of the claimed structure. MPEP 2112.01 states: “Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” Therefore, since the prior art teaches the same structure, that structure will have the same properties and would be capable of irreversible inactivation at recited conditions and being enzymatically active at recited salt concentrations.
Thus, Lanes, NCBI WP_11219706 and ThermoFisher teachings render claims 2 and 3 obvious.
Regarding claim 18, Lanes teaches composition of endonuclease to measure its activity including 0.5 M NaCl and 5 mM MgCl2 (p. 23, lines 5-8). That reads on claim 18 limitations. Thus, Lanes, NCBI WP_11219706 and ThermoFisher teachings render claim 18 obvious.
Allowable Subject Matter
Claim 17 is allowed. The closest prior art of Lanes teaches endonuclease or enzymatically active fragment thereof with sequence of SEQ ID NO:1 or mutant thereof that comprises sequence with 59.9%. identity to instant sequence comprising amino acids 23-269 of SEQ ID NO:2. NCBI WP_11219706 teaches amino acid sequence for the endonuclease from Photobacterium profundum comprising amino acids residues 20-247 that are identical to amino acid residues 42-269 of instant SEQ ID NO:2. Amino acid residues 23-41 are not covered by prior art of Lanes and NCBI WP_11219706 and include hexa-His tag followed by cleavage site with N-terminal extension. Cirlto (US 2018011108 A1) teaches addition of hexa-His tag followed by cleavage site to recombinant proteins (for instance in SEQ ID NO:13 on p. 12), however, the tag from Cirlto is not 100% identical to residues 23-41 of instant SEQ ID NO: 2. Therefore, the sequence comprising amino acids 23-269 of SEQ ID NO:2 is not taught or suggested by prior art.
Conclusion
Claims 1-3 and 18 are not allowed. Claim 17 is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIOUBOV G KOROTCHKINA whose telephone number is (571)270-0911. The examiner can normally be reached Monday-Friday: 8:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila G 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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/L.G.K./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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