DETAILED ACTION
Status of the Application
Claims 1-35 are pending.
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 amendment of claims 1, 4-8, 11, 31-32, 34, and amendments to the specification, as submitted in a communication filed on 8/13/2025 is acknowledged.
Applicant elected with traverse Group I, claims 1-18, 24-27, 31-35, drawn in part to a DNase I having at least 90% sequence identity to the polypeptide of SEQ ID NO: 1, a kit and a composition comprising said DNase I, position 121 as the unmodified position, and substitutions N74R and S206K. As previously indicated, claim 2 requires non-elected identical positions, while claims 3, 6 and 9 do not require the two elected substitutions and/or require additional non-elected substitutions.
Claims 2-3, 6, 9, 13-15, 19-23, 28-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/22/2024.
Claims 1, 4, 5, 7-8, 10-12, 16-18, 24-27, 31-35 are at issue and will be examined to the extent they encompass the elected invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Specification
The first paragraph of the specification was objected to because it did not provide the current status of related applications. In view of Applicant’s amendment, this objection is hereby withdrawn.
The specification was objected for not complying with sequence rules. In view of Applicant’s amendment, this objection is hereby withdrawn.
Claim Objections
Claims 4, 5, 8, 11, 16, 18, 24 remain objected to due to the recitation of “a DNase I variant according to Claim 1/7/10”. Applicant states that the Examiner provided no basis for imposing this requirement and cites MPEP § 608.01(n)(I)(A) in support of the argument that dependent claims may be expressed with an indefinite article. The Examiner acknowledges the examples related to multiple dependent claims provided in MPEP § 608.01(n)(I)(A). However, the Examiner disagrees with Applicant’s contention that no basis for making this objection was provided. As indicated in the prior Office action, the DNase I variant in claims 4, 5, 8, 11, 16, 18, 24 has already been defined in claim 1, claim 7 or claim 10. Therefore, to be consistent with commonly used claim language, which uses “the” when referring to something that has been previously defined, and to avoid any ambiguity, the Examiner stated that the claims should be amended to recite “the DNase I variant of claim 1/7/10” or “the DNase I variant according to claim 1/7/10”. It should also be noted that the same language (i.e., “the” when referring to a DNase I variant previously defined) has been used in U.S. Patent No. 11,993,792. Appropriate correction is required.
Claim 25 remains objected to due to the recitation of “a composition according to claim 24”. Since the composition has been defined in claim 24, the term should be amended to recite “the composition of claim 24” or “the composition according to claim 24”. Appropriate correction is required.
Claim 31 is objected to due to the recitation of “…kit comprising (a) DNase I variant…”. To enhance clarity and to be consistent with commonly used claim language, the term should be amended to recite“…kit comprising (a) a DNase I variant…”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
Claims 1, 4-5, 16, 18, 24, 25, 26, 27 were rejected under 35 U.S.C. 101 because the claimed invention was directed to products of nature without significantly more. In view of Applicant’s amendment of claim 1, which now requires substitutions at any one of the positions corresponding to positions 13, 18, 43, 44, 74, 75, 106, 205, 206 and 207 of the polypeptide of SEQ ID NO: 1, and the fact that neither the goat DNase I disclosed by GenBank accession number XP_005697533 (9/8/2016; cited in the IDS) nor the bison DNase I disclosed by GenBank accession number XP_010838694 (12/31/2014; cited in the IDS) have mutations at the recited positions, this rejection is hereby withdrawn.
Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA )
Claims 4-5, 32-34 remain 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 pre-AIA the applicant regards as the invention. New grounds of rejection are necessitated by amendment.
Claim 4 is indefinite in the recitation of “…variant according to claim 1, wherein the amino acid sequence is identical to positions corresponding to L29… and A224 and wherein the amino acid sequence comprises two or more substitutions at positions selected from E13K..and T207R” for the following reasons. The recitation of numerical positions is meaningless in the absence of the sequence identifier associated with those positions. In addition, “E13K”….and T207R” are not positions but substitutions. Moreover, it is unclear as to how an entire amino acid sequence can be identical to a single position. If the intended limitation is “wherein the amino acid sequence comprises two or more substitutions that correspond to substitutions in SEQ ID NO: 1 selected from E13K…and T207R”, the claim should be amended accordingly. Correction is required.
Claim 5 is indefinite in the recitation of “…variant according to claim 1, wherein the amino acid sequence is further identical to SEQ ID NO: 1 at one or more additional positions…or wherein the amino acid sequence comprises two or more substitutions are selected from E13K…and T207R” for the following reasons. The term “the amino acid sequence comprises two or more substitutions are selected from..” is completely unclear and confusing. In addition, a reference to numerical positions for the substitutions is meaningless without the recitation of the sequence identifier associated with those positions. If the intended limitation is “wherein the amino acid sequence of the variant comprises two or more substitutions that correspond to substitutions in SEQ ID NO: 1 selected from E13K, E13R…and T207R”, the claim should be amended accordingly. Correction is required.
Claim 32 is indefinite in the recitation of “wherein the buffer is a reaction buffer” for the following reasons. Claim 31, from which claim 32 depends, requires the kit to comprise one or more of a dNTP, an rNTP, a primer, a storage buffer and a reaction buffer. There is already a reaction buffer that the kit can have. Therefore, it is unclear as to which is the buffer that is being further limited, or how claim 32 further limits claim 31. If the intended kit is one that comprises a reaction buffer, the claim should be amended accordingly. Correction is required.
Claim 33 is indefinite in the recitation of “wherein the buffer is a storage buffer” for the following reasons. Claim 31, from which claim 33 depends, requires the kit to comprise one or more of a dNTP, an rNTP, a primer, a storage buffer and a reaction buffer. There is already a storage buffer that the kit can have. Therefore, it is unclear as to which is the buffer that is being further limited, or how claim 33 further limits claim 31. If the intended kit is one that comprises a storage buffer, the claim should be amended accordingly. Correction is required.
Claim 34 is indefinite in the recitation of “further comprising a reaction buffer, wherein the DNase I variant and the storage buffer are in a first container and the reaction buffer is in a second container” for the following reasons. As written, it appears that the kit of claim 34 already has a storage buffer. However, claim 33 does not require the kit to comprise a storage buffer. Claim 33 simply limits an undefined buffer as a storage buffer. See discussion above regarding the indefiniteness of claim 33. If claim 34 requires both a storage buffer and a reaction buffer, the claim should be amended accordingly. Correction is required.
When amending the claims, applicant is advised to carefully review all examined claims and make the necessary changes to ensure proper antecedent basis and dependency.
Claim Rejections - 35 USC § 102 (AIA )
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, 16, 18, 24, 25, 27 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by GenBank accession number XP_005697533 (9/8/2016; cited in the IDS) as evidenced by Zacchia et al. (Kidney Disease 2(2):72-79, 2016; cited in the IDS). In view of the amendment of claim 1, which now requires substitutions that are not present in the protein disclosed in GenBank accession number XP_005697533, this rejection is hereby withdrawn.
Claims 1, 4-5, 16, 18, 24, 25, 27 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by GenBank accession number XP_010838694 (12/31/2014; cited in the IDS) as evidenced by Zacchia et al. (Kidney Disease 2(2):72-79, 2016; cited in the IDS). In view of the amendment of claim 1, which now requires substitutions that are not present in the protein disclosed in GenBank accession number XP_010838694, this rejection is hereby withdrawn.
Claims 1, 7, 16 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ramaswamy et al. (WO 2010/117901 published 10/14/2010). This rejection is necessitated by amendment.
Claims 1, 7, 16 are directed in part to a protein which is a variant of the polypeptide of SEQ ID NO: 1 that comprises an amino acid sequence having at least 90% identity with SEQ ID NO: 1, wherein said protein comprises one or more of the same amino acids found in the polypeptide of SEQ ID NO: 1 at positions corresponding to positions of the polypeptide of SEQ ID NO: 1 selected from the group consisting of positions 29, 87, 88, 94, 103, 108, 121, 132, 135, 145, 161, 172, 190, 208, and 224, wherein said protein comprises a substitution corresponding to the N74K or N74R substitution in the polypeptide of SEQ ID NO: 1, and wherein said protein has at least 30% of its peak catalytic activity in the presence of a total salt concentration of 0-300 mM.
Ramaswamy et al. teach a consensus DNase I (Figure 1) that comprises an amino acid sequence which is 91% sequence identical to SEQ ID NO: 1 (91% = 236x100/260; SEQ ID NO: 1 has 260 amino acids), comprises the same amino acids found in the polypeptide of SEQ ID NO: 1 at positions corresponding to positions 29, 87, 88, 94, 103, 108, 121, 132, 135, 145, 161, 172, 190, 208, and 224 of the polypeptide of SEQ ID NO: 1, and comprises a substitution at the position corresponding to position 74 of the polypeptide of SEQ ID NO: 1, wherein the amino acid at the position corresponding to position 74 of the polypeptide of SEQ ID NO: 1 is arginine or lysine. See alignment below and Misc-difference 74 entry. Therefore, Ramaswamy et al. teach a variant of the polypeptide of SEQ ID NO: 1 that comprises a substitution that corresponds to the substitution N74K of the polypeptide of SEQ ID NO: 1, and a variant of the polypeptide of SEQ ID NO: 1 that comprises a substitution that corresponds to the substitution N74R of the polypeptide of SEQ ID NO: 1. The specification asserts that a variant of the polypeptide of SEQ ID NO: 1 having the recited structural limitations has at least 30% of its peak catalytic activity in the presence of a salt concentration of 0-300 mM. Thus, it follows that the proteins of Ramaswamy et al. meet this functional limitation by having the recited structural limitations. Therefore, the teachings of Ramaswamy et al. anticipate the instant claims as written/interpreted.
SEQ ID NO: 1
AYK36987
ID AYK36987 standard; protein; 262 AA.
XX
AC AYK36987;
XX
DT 09-DEC-2010 (first entry)
XX
DE DNase I (Deoxyribonuclease I) consensus protein sequence.
XX
KW DNASE1 protein; Deoxyribonuclease I; dna cleavage; enzyme engineering;
KW enzyme production; genetically engineered microorganism;
KW transgenic animal; transgenic insect; transgenic plant.
XX
OS Synthetic.
OS Equus caballus.
OS Homo sapiens.
OS Mus musculus.
OS Rattus norvegicus.
OS Ovis aries.
OS Bos taurus.
OS Canis lupus familiaris.
OS Oryctolagus cuniculus.
OS Sus scrofa.
XX
FH Key Location/Qualifiers
FT Misc-difference 27
FT /label= Arg, Gln, Lys
FT Misc-difference 54
FT /label= Tyr, Asn, Arg, Asp, Glu, Thr, Lys
FT Misc-difference 74
FT /label= Asn, Ser, Arg, Lys
FT Misc-difference 122
FT /label= Ser, Phe, Leu, Tyr
FT Misc-difference 124
FT /label= Lys, Glu, Gln
FT Misc-difference 138
FT /label= Ser, Gly, Leu, Glu, Thr
FT Misc-difference 159
FT /label= His, Gly, Asp
FT Misc-difference 191
FT /label= Thr, Ala, Pro, Leu
FT Misc-difference 219
FT /label= Ser, Met, Thr, Pro, Ala
FT Misc-difference 223
FT /label= Ser, Gly, Glu, Arg, His, Ala, Asp
FT Misc-difference 228
FT /label= Gly, Asp, Glu, Asn, Ser
FT Misc-difference 231
FT /label= Ala, Leu, Val
FT Misc-difference 245
FT /label= Let, Leu, Thr
FT Misc-difference 247
FT /label= Leu, Gln, Glu
FT Misc-difference 260
FT /label= Thr, Lys, Met, Ala, Arg
FT Misc-difference 261
FT /label= Arg, Lys
FT Misc-difference 262
FT /label= Ala, Ile, Thr
XX
CC PN WO2010117901-A1.
XX
CC PD 14-OCT-2010.
XX
CC PF 02-APR-2010; 2010WO-US029782.
XX
PR 10-APR-2009; 2009US-0168490P.
XX
CC PA (BIRA ) BIO-RAD LAB INC.
XX
CC PI Ramaswamy G, Wang Y;
XX
DR WPI; 2010-N08118/75.
XX
CC PT New isolated polypeptide comprises a DNase I, where the DNase is heat
CC PT liable, useful for removing DNA from a sample, and for transforming a
CC PT cell.
XX
CC PS Disclosure; Fig 1; 49pp; English.
XX
CC The present invention relates to a modified DNase I (Deoxyribonuclease I)
CC polypeptide, where the DNase is heat labile and hyperactive. The
CC invention independently claims for: a method for removing DNA from a
CC sample and a synthetic or isolated nucleic acid encoding the polypeptide.
CC The invention also provides an expression cassette; a cell (selected from
CC yeast, bacterial, insect, plant or animal cells) transformed with the
CC expression cassette; a method of preparing the polypeptide; and a kit
CC comprising the DNase that is heat-labile. The present sequence represents
CC a consensus protein sequence of the DNase I (Deoxyribonuclease I)
CC protein. The sequence is based on SEQ ID Nos. 5-13 (see AYK36972 to
CC AYK36980) of the present invention.
XX
SQ Sequence 262 AA;
Query Match 91.8%; Score 1238; Length 262;
Best Local Similarity 91.1%;
Matches 236; Conservative 7; Mismatches 16; Indels 0; Gaps 0;
Qy 1 LKIAAFNIRTFGETKMSNATLASYIVRILRRYDIALIQEVRDSHLVAVGKLLDYLNQDDP 60
|:|||||||||||||||||||:|||| || ||||||||||||||| ||||||| ||||||
Db 1 LRIAAFNIRTFGETKMSNATLSSYIVXILSRYDIALIQEVRDSHLTAVGKLLDXLNQDDP 60
Qy 61 NTYHYVVSEPLGRNSYKERYLFLFRPDQVSVLDSYQYDDGCEPCGNDTFSREPAVVKFSS 120
||||||||||||| ||||||||:|||||||||||||||||||||||||||||||:|||||
Db 61 NTYHYVVSEPLGRXSYKERYLFVFRPDQVSVLDSYQYDDGCEPCGNDTFSREPAIVKFSS 120
Qy 121 PSTKVKEFAIVPLHAAPSDAVAEIDSLYDVYLDVQQKWHLEDVMLMGDFNAGCSYVTSSQ 180
| | ||||||||||||| |||||||:|||||||||||| |||:|||||||||||||||||
Db 121 PXTXVKEFAIVPLHAAPXDAVAEIDALYDVYLDVQQKWXLEDIMLMGDFNAGCSYVTSSQ 180
Qy 181 WSSIRLRTSPTFQWLIPDSADTTATSTHCAYDRIVVAGSLLQSAVVPGSAAPFDFQAAYG 240
|||||||||| ||||||||||||||||||||||||||| ||| |||| || |||||||||
Db 181 WSSIRLRTSPXFQWLIPDSADTTATSTHCAYDRIVVAGXLLQXAVVPXSAXPFDFQAAYG 240
Qy 241 LSNEMALAISDHYPVEVTL 259
|||: | ||||||||||||
Db 241 LSNQXAXAISDHYPVEVTL 259
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 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.
Claim Rejections - 35 USC § 103 (AIA )
Claim 26 was rejected under 35 U.S.C. 103 as being unpatentable over GenBank accession number XP_005697533 (9/8/2016; cited in the IDS) in view of Horikoshi et al. (U.S. Patent No. 3,956,064 issued 5/11/1976). In view of the amendment of claim 1, which now requires substitutions that are not present in the protein disclosed in GenBank accession number XP_005697533, this rejection is hereby withdrawn.
Claim 26 was rejected under 35 U.S.C. 103 as being unpatentable over GenBank accession number XP_010838694 (12/31/2014; cited in the IDS) in view of Horikoshi et al. (U.S. Patent No. 3,956,064 issued 5/11/1976). In view of the amendment of claim 1, which now requires substitutions that are not present in the protein disclosed in GenBank accession number XP_010838694, this rejection is hereby withdrawn.
Claims 18, 25 are rejected under 35 U.S.C. 103 as being unpatentable over Ramaswamy et al. (WO 2010/117901 published 10/14/2010). This rejection is necessitated by amendment.
In addition to disclosing DNase 1 variants that have the recited substitutions, Ramaswamy et al. also teach recombinant methods to produce DNase mutants, wherein said DNase mutants are linked to His-tags for purification (page 32, paragraph [0144]) and signal peptides for secretion (page 5, paragraph [0026]). In addition, Ramaswamy et al. teach compositions that comprise DNase I mutants and reverse transcriptase (RTase; page 30, paragraph [0138], Kit 2 and 3) and methods to detect or purify RNA in a sample for reverse transcription (page 28, paragraph [0127]).
Claims 18 and 25 are directed in part to (i) a fusion protein that comprises the DNase I variant of claim 1 as described above, and an affinity tag and/or a secretion signal, and (ii) a composition comprising the DNase I variant of claim 1 as described above and one or more enzymes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to recombinantly produce the consensus DNase 1 variants of Ramaswamy et al. linked to a His tag and/or a secretion signal, and use them in a method that requires reverse transcriptase. A person of ordinary skill in the art is motivated to recombinantly produce a fusion protein that comprises a consensus DNase 1 variant of Ramaswamy et al. and a His-tag and/or a secretion signal for the benefit of being able to further purify the DNase I variant by (a) directing the DNase I variant to the extracellular medium, thus avoiding purification from intracellular components, and (b) use the His tag for increased purity. A person of ordinary skill in the art is motivated to use the consensus DNase I variants in a method that requires a reverse transcriptase for the benefit of further characterization of these variants.
One of ordinary skill in the art has a reasonable expectation of success at recombinantly producing fusions that comprise a His-tag and/or a secretion signal because the molecular biology techniques required are well known in the art as evidenced by Ramaswamy et al. One of ordinary skill in the art has a reasonable expectation of success at using the consensus DNase I variants in combination with reverse transcriptase because all that is required is the replacement of one functional equivalent with another. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Ramaswamy et al. (WO 2010/117901 published 10/14/2010) in view of Horikoshi et al. (U.S. Patent No. 3,956,064 issued 5/11/1976; previously cited). This rejection is necessitated by amendment.
The teachings of Ramaswamy et al. have been discussed above. Ramaswamy et al. do not teach a lyophilized DNase I variant. Horikoshi et al. teach drying a composition comprising a DNase (column 6, lines 40-43 to obtain a powder. Horikoshi et al. also teach the lyophilization of a DNase composition to form a purified powder comprising the DNase (column 6, lines 44-57). Horikoshi et al. teach that purified DNase that is lyophilized is stable at 5 °C for more than 6 months and is stable for more than a year at 20 °C (column 7, lines 30-33). Horikoshi et al. do not teach the DNase I variants of Ramaswamy et al.
Claim 26 is directed in part to a composition that comprises a variant of the polypeptide of SEQ ID NO: 1 that comprises an amino acid sequence having at least 90% identity with SEQ ID NO: 1, wherein said protein comprises one or more of the same amino acids found in the polypeptide of SEQ ID NO: 1 at positions corresponding to positions of the polypeptide of SEQ ID NO: 1 selected from the group consisting of positions 29, 87, 88, 94, 103, 108, 121, 132, 135, 145, 161, 172, 190, 208, and 224, wherein said protein comprises a substitution corresponding to the N74K or N74R substitution in the polypeptide of SEQ ID NO: 1, and wherein said composition is dried or lyophilized.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to lyophilize or dry a composition comprising the DNase I of Ramaswamy et al. A person of ordinary skill in the art is motivated to dry or lyophilize a composition comprising the DNase I of Ramaswamy et al. for the benefit of preserving the DNase I for further use and/or characterization since Horikoshi et al. teach that drying or lyophilizing an enzyme will extend its shelf life. One of ordinary skill in the art has a reasonable expectation of success at drying or lyophilizing a composition that comprises a DNase I because the techniques required to dry or lyophilize proteins are well known and widely used in the art as evidenced by Horikoshi et al. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Double Patenting
Claims 12 and 17 remain rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 12 and 17 of U.S. Patent No. 11,993,792, respectively. This is a statutory double patenting rejection.
Applicant refers to this rejection as an obviousness type double patenting rejection and requests this rejection be held in abeyance until one or more claims are deemed to be otherwise in condition for allowance.
Applicant’s arguments have been fully considered. It is noted, however, that the instant rejection is not an obviousness-type double patenting rejection but a 101 statutory double patenting rejection. Therefore, since claims 12 and 17 have not been amended or canceled, this rejection is maintained for the reasons of record.
Claims 1, 4-5, 7-8, 10-11, 16, 18, 24-27, 31-35 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15, 21-24 of U.S. Patent No. 11,993,792.
This rejection has been discussed at length in the prior Office action. It is maintained for the reasons of record.
Applicant requests that this rejection be held in abeyance until one or more claims are deemed to be otherwise in condition for allowance. In view of the fact that there are no arguments traversing the Examiner’s position and there is no submission of a terminal disclaimer, this rejection is maintained.
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Conclusion
No claim is in condition for allowance.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Applicant is advised that any Internet email communication by the Examiner has to be authorized by Applicant in written form. See MPEP § 502.03 (II). Without a written authorization by Applicant in place, the USPTO will not respond via Internet email to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Sample written authorization language can be found in MPEP § 502.03 (II). An Authorization for Internet Communications in a Patent Application or Request to Withdraw Authorization for Internet Communications form (SB/439) can be found at https://www.uspto.gov/patent/forms/ forms-patent-applications-filed-or-after-september-16-2012, which can be electronically filed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to DELIA M RAMIREZ, Ph.D., whose telephone number is (571) 272-0938. The examiner can normally be reached on Monday-Friday from 8:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert B. Mondesi, can be reached at (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/DELIA M RAMIREZ/Primary Examiner, Art Unit 1652
DR
December 4, 2025
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