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 .
DETAILED ACTION
1. Applicant’s prior election of Group I (claims 1-5, species sequence of SEQ ID Nos. 5 & 6) in the reply filed on 12/18/25 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)).
2. Applicants’ amendment filed 7/20/26 in response to Office Action mailed 1/20/26 is acknowledged.
3. Claims 1-3 filed 7/20/26 are under consideration in this examination.
4. Claims withdrawn:
Claims 6-15 (including non-elected sequences) remain withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
5. Applicant's amendment and arguments filed 7/20/26 have been fully considered but they are not deemed to be persuasive. The reasons are discussed following the rejection(s).
6. Any objection or rejection of record which is not expressly repeated in this Office Action has been overcome by Applicant’s response and withdrawn.
7. New Matter Rejection
35 U.S.C. § 112, first paragraph (Written Description)
Claims 1-3 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph - written description requirement, 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(s), at the time the application was filed, had possession of the claimed invention.
The amendments filed 7/20/26 are objected under 35 U.S.C. 132 because it introduces new matter into the disclosure (claims 1-3). 35 U.S.C. 132 states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
Claim 1, recites “(Currently amended) A non-naturally occurring carbonic anhydrase comprising at least one mutation that results in the substitution of at least one cysteine for at least one amino acid in a naturally occurring carbonic anhydrase; and wherein the nucleotide sequence encoding the non-naturally occurring carbonic anhydrase comprises a sequence that is greater than 98.6 percent identical to SEQ ID NO: 6; and wherein the amino acid sequence of the non- naturally occurring carbonic anhydrase comprises a sequence that is greater than 98.4 percent identical to SEQ ID NO: 5; and wherein the non-naturally occurring carbonic anhydrase has increased activity at a temperature of greater than about 60 degrees Celsius when compared to the naturally occurring carbonic anhydrase. Claims 2 & 3 are included in the rejection for being dependent on claim 1.
The claimed sequence homologies pertaining to SEQ ID NO: 6 (98.6%) and SEQ ID NO: 5 (98.4%) is not part of the original specification as filed. Applicants argue that - Support for these amendments can be found throughout the application as originally filed. No new matter has been added by these amendments. However, this is not the case.
Applicant is required to cancel the new matter in the reply to this Office Action.
8. 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 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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US 2015/0191711 A1.
[0002] Carbonic anhydrases (CA, EC 4.2.2.1) is a group of enzymes that catalyzes the reversible reaction of carbon dioxide and water into bicarbonate and proton according to:
CO.sub.2+H.sub.2O.revreaction.HCO.sub.3.sup.-+H.sup.+
[0072] "Carbonic anhydrase" and the abbreviation "CA" is used interchangeably to refer to a polypeptide having enzymatic E.0 4.2.1.1 activity and that is capable of catalyzing the inter-conversion of carbon dioxide and water to bicarbonate and a proton.
[0073] "Human carbonic anhydrase II" and "HCA II" is used interchangeably to denote the iso-form 2 variant of human carbonic anhydrase II.
In [0024] & [0025], US 2015/0191711 A1 teaches a carbonic anhydrase which is simple and economical to produce, has a high catalytic activity, a high physical stability as determined by thermodynamic, thermal and kinetic stability and a long life time under various conditions. The reference further teaches way to achieve invention by means of the isolated polypeptide having carbonic anhydrase activity, the sequence of which is modified human carbonic anhydrase II, wherein the polypeptide comprises the mutations A23C, S99C, L202C, C205S and V241C, has increased physical stability, high enzyme activity compared to wild type carbonic anhydrase II and further comprises disulfide bridges between C23 and C202 and/or between C99 and C241. [0101] The increased thermal, thermodynamic and kinetic stability of the double disulfide bridge variant of SEQ ID NO: 8 should render it a high life time at elevated temperatures.
"The esterase activity of the three disulfide variants (SEQIDNO: 4, 6 and 8) at the conditions of measurement (approx.21C.) was found to be 99, 86 and 78 percent respectively, compared to the activity of the HCAII pwt variant; para [0096]. See tables 3-5 and Example 10.
Regarding claim 2, the reference discloses the non-naturally occurring carbonic anhydrase of claim1, and further discloses wherein the increased activity is for more than about 30 minutes, 1hour, 2hours, 3hours, 4hours, 5hours, 6hours, 24hours, 44hours, 48hours, and 92hours(para[0096];Tables3-4; para [0101]-[0102]- "The increased thermal, thermodynamic and kinetic stability of the doubled disulfide bridge variant of SEQ ID NO: 8 should render it a high life time at elevated temperatures....the half-life (1/2) of each enzyme variant a teach temperature can be calculated by t1/2=In2/k. The results of the life time experiments are presented in table 7-9 and FIG.7."; Table7-“Percent remaining esterase activity after 15 min incubation...Variant...Temperature...SEQIDNO: 2...60[C]...1[%]...SEQIDNO:8...60[C]...99[%]";Table 8-"Percent remaining esterase activity after 2h incubation...Variant...Temperature...SEQIDNO:2...60 [C]...O[%]...SEQIDNO:8...6O[C]...106[%]";Table 9-"Inactivation rate constants (ku) inactivation, halftime (t1/2) and t/10 of enzyme variants at 60-70C...Variant...Temperature.. .t1/2...SEQIDNO: 8...60[C]...2057 (86days)"; Note, as wild-type equivalent variant SEQIDNO: 2 displays 0% activity after 2h at 6OC and half-life of variant SEQIDNO:8 at 60C is~86days, the latter variant exhibits increased activity at all time points in between). Regarding claim 3, the reference discloses the non-naturally occurring carbonic anhydrase of claim 1, and the reference further discloses wherein the increased activity is at a temperature greater than 65, 70, 75, 80, 85 or 90 degrees Celsius (para[0096];Tables 3-4).
Applicants’ arguments: Applicant has amended the claims to recite that the non-naturally occurring amino acid and genetic sequences claimed are greater than 98.6 percent identical to SEQ ID NO: 6; and 98.4 percent identical to SEQ ID NO: 5. US 2015/0191711 does not disclose or teach non-naturally occurring amino acid and genetic sequences claimed are greater than 98.6 percent identical to SEQ ID NO: 6; and 98.4 percent identical to SEQ ID NO: 5 as Applicant currently claims.
Accordingly, since US 2015/0191711 does not disclose or teach the claimed subject matter of Applicant's claimed invention, US 2015/0191711 cannot anticipate or obviate Applicant's invention as currently claimed. Applicant requests that this rejection be withdrawn.
As noted above the homologies claimed are not part of the original disclosure. Hence, the rejection is maintained.
9. No claim is allowed.
10. THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TEKCHAND SAIDHA whose telephone number is (571)272-0940. The examiner can normally be reached on M-F 8.00-5.30. 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, Robert B 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TEKCHAND SAIDHA/
Primary Examiner, Art Unit 1652
Recombinant Enzymes, Hoteling
Telephone: (571) 272-0940
Fax: (571) 273-0940
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