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 (i.e., claims 1-13, 42, 58 and 66, drawn to a recombinant carbonic anhydrase polypeptide), and to Species A (i.e., Single and specific recombinant carbonic anhydrase polypeptide indicating ALL variables and including indication of: 1. Single and specific sequence identifier, Applicants’ Election: 65% identity with SEQ ID NO: 5, substitution at position 223, for L or I (i.e., 223L or 223I); 2. Single isoelectric point (pI), Applicants’ Election: lower than 8; 3. Single and specific increase in solubility and/or thermostability and if an increase in solubility then a single and specific time and temperature of exposure and solubility reference point; and if an increase in thermostability, single and specific time and temperature of exposure in an alkaline carbonate solution, Applicants’ Election: a recombinant carbonic anhydrase polypeptide having a solubility of greater than 6 after 24 hours at 80°C in an alkaline carbonate solution 1.45 M K2CO3 with alpha 0.7, and a recombinant carbonic anhydrase polypeptide having increased thermostability after a 72-hour exposure at 85°C, in an alkaline carbonate solution 1.45M K2CO3 with alpha 0.7; 4. Single and specific pH range, Applicants’ Election: pH range 8.5 to 11), in the reply filed on 12/17/2024 is acknowledged.
Claims 6 and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species there being no allowable generic or linking claim. Similarly, claims 24, 29, 31-32, 35-41, 43-57, 59-65 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention there being no allowable generic or linking claim.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 on12/17/2024.
Please note that the Examiner has extended the Species to include substitutions at positions other than 223.
Claim Status
Claims 1-42 were originally filed and amended on 09/24/2021. The amendment cancelled claims 25-28, 30 and 33-34; amended claims 5-14, 17-18, 22-24, 29, 31-32, 35-36 and 38-42; and added new claims 43-66.
The amendment filed on 08/20/2025, cancelled claims 5-7 and 16-18; and amended claims 1-2, 8, 10, 12, 14-15, 19, 22-23 and 45.
Claims 1-4, 8-15, 19-24, 29, 31-32, 35-66 are currently pending, and claims 1-4, 8, 10-15, 19-23, 42, 58 and 66 are under consideration.
Priority
The present application claims status as a 371 (National Stage) of PCT/IB2020/052410 filed March 17th 2020, and claims the benefit under 35 U.S.C 119 (e) to U.S. Provisional Application No. 62/823,744 filed March 26th 2019. 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, or 365 (c ) is acknowledged.
Sequence Interpretation
Regarding claim 1, please note that in light of the transitional word “comprising”, the Examiner is interpreting the scope of a recombinant carbonic anhydrase polypeptide having carbonic anhydrase activity as open-ended, requiring at least 80% identity to SEQ ID NO: 5, with any N-/-C terminal additions and one amino acid difference as compared to SEQ ID NO: 1. Since SEQ ID NO: 5 is 226 residues in length, a sequence that is at least 80% identical would encompass up to 45 modifications including any insertions, substitutions, deletions, etc.; in addition to one amino acid difference at position 223 as compared to SEQ ID NO: 1.
Regarding claim 14, please note that in light of the transitional word “comprising”, the Examiner is interpreting the scope of a recombinant carbonic anhydrase polypeptide having carbonic anhydrase activity as open-ended, requiring at least 81% identity to SEQ ID NO: 5, with any N-/-C terminal additions. Since SEQ ID NO: 5 is 226 residues in length, a sequence that is at least 81% identical would encompass up to 42 modifications including any insertions, substitutions, deletions, etc.
Response to Arguments
1. Applicants’ arguments, see Remarks, filed 08/20/2025, with respect to Duplicate Claim Warning have been fully considered and are persuasive. The Duplicate Claim Warning of claim is moot.
2. Applicants’ arguments, see Remarks, filed 08/20/2025, with respect to the Specification have been fully considered and are persuasive. The Objection to the Specification has been withdrawn.
3. Applicants’ arguments, see Remarks, filed 08/20/2025, with respect to the 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; have been fully considered but are not persuasive. The 35 U.S.C. 112(a) rejection to claims 1-4, 8, 10-15, 19-23, 42, 58 and 66 has been maintained.
4. Applicants’ arguments, see Remarks, filed 08/20/2025, with respect to the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement; have been fully considered and are persuasive. The 35 U.S.C. 112(a) rejection to claims 1-4, 8, 10-15, 19-23, 42, 58 and 66 has been withdrawn.
5. Applicants’ arguments, see Remarks, filed 08/20/2025, with respect to the 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; have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejection to claim 2 has been withdrawn.
6. Applicants’ arguments, see Remarks, filed 08/20/2025, with respect to the 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; have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejection to claims 8, 10, 12, 19 and 22 has been withdrawn.
7. Applicants’ arguments, see Remarks, filed 08/20/2025, with respect to the 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; have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejection to claim 15 has been withdrawn.
8. Applicants’ arguments, see Remarks, filed 08/20/2025, with respect to the 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; have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejection to claim 17 is moot.
9. Applicants’ arguments, see Remarks, filed 08/20/2025, with respect to the 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; have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejections to claim 18 are moot.
10. Applicants’ arguments, see Remarks, filed 08/20/2025, with respect to the 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; have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejections to claims 19-23 has been withdrawn.
11. Applicants’ arguments, see Remarks, filed 08/20/2025, with respect to the 35 U.S.C. 101 because the claimed invention is directed to a nature-based product (i.e., a carbonic anhydrase polypeptide having carbonic anhydrase activity) without significantly more; have been fully considered and are persuasive. The 35 U.S.C. 101 rejection to claim 15 has been withdrawn.
12. Applicants’ arguments, see Remarks, filed 08/20/2025, with respect to the 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by US 2016/0222371A1 published on Aug. 4, 2016 (herein after “Cha”), as evidenced by GenCore Sequence alignment of Cha’s SEQ ID NO: 3 vs instant SEQ ID NO: 5 (herein after “GenCore Alignment”); have been fully considered and are persuasive. The 35 U.S.C. 102 rejection to claims 1 and 15 has been withdrawn.
Maintained/Modified Rejections in light of Amendment
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.
1. Claims 1-4, 8, 10-15, 19-23, 42, 58 and 66 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.
MPEP § 2163 states that 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, or by disclosure of relevant, identifying characteristics, i.e., 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 inventor was in possession of the claimed genus.
Independent claim 1 is drawn to “[A] recombinant carbonic anhydrase polypeptide having carbonic anhydrase activity comprising an amino acid sequence having at least 80% identity with SEQ ID NO: 5, and one amino acid difference as compared to SEQ ID NO: 1 at residue position 223; wherein SEQ ID NO: 5 comprises 223L or 223I, and said recombinant carbonic anhydrase polypeptide has increased solubility and/or increased thermostability…” The Examiner interprets the scope of the claimed recombinant carbonic anhydrase polypeptide having carbonic anhydrase activity, as a sequence that would encompass up to 45 modifications including any insertions, substitutions, deletions, etc., where one of the 45 modifications must be one amino acid at position 223 relative to the wild type (i.e., SEQ ID NO: 1). As such, the “recombinant carbonic anhydrase polypeptide” encompasses any amino acid sequence of any carbonic anhydrase that comprises any 45 modifications where one of the modifications is an amino acid difference at position 223 (i.e., Applicant’s Election) compared to SEQ ID NO: 1 and still exhibit carbonic anhydrase activity as well as increased solubility and/or thermostability. Therefore, the scope of claim 1 and dependent claims 2-4, 8, 10-15, 19-23, 42, 58 and 66 encompass a vast array of sequences where the necessary core structure and/or sequence that would be needed for the claimed recombinant carbonic anhydrase to exhibit the claimed functions is to be at least 80% identical to SEQ ID NO: 5 and comprise one amino acid difference relative to a corresponding carbonic anhydrase polypeptide lacking said one amino acid difference.
Applicants reduced to practice three different Thermovibrio ammonificans carbonic anhydrase (TACA) variants, i.e., SEQ ID NOs: 2-4, chosen as templates for random mutagenesis; with each variant having a different pI (i.e., pI of 8.3 for SEQ ID NO: 2, pI of 7.2 for SEQ ID NO: 3 and pI of 6.1 for SEQ ID NO: 4) in addition to exhibiting carbonic anhydrase activity (see specification, pg. 19, lines 1-5 and Table 1). Figure 1, shows a sequence alignment between wild type TACA (i.e., SEQ ID NO: 1) and the three variants. It is noted that the only difference between SEQ ID NO: 1 and SEQ ID NO: 2 is one non-conservative substitution at R156E. However, SEQ ID NO: 3 comprises two non-conservative substitutions at R156E and at V216T, and thirteen conservative substitutions at K27R, N38D, K88R, K116R, N119D, K128R, E160D, D168E, E192D, E199D, K203R, K206R, and L219I relative to SEQ ID NO: 1; and SEQ ID NO: 4 comprises three non-conservative substitutions at V79E, R156E and V216T, and twelve conservative substitutions at Y77F, K88E, Y105F, K116E, K128E, E137D, E145D, D168E, Y170F, E195D, E199D, and 219I, relative to SEQ ID NO: 1 (see Figure 1).
With respect to SEQ ID NO: 2, the number of positions with improved thermostability and/or solubility over wtTACA (i.e., SEQ ID NO: 1) was identified as 35, out of the 114 positions targeted (see specification, pg. 19, Table 2). The mutagenesis results for each variant are reported in Tables 3-5. Table 3, which depicts mutagenesis results (i.e., mutations other than R156E) for SEQ ID NO: 2, shows scores below 1.0 (i.e., when the mutation is less favorable compared to the parent template enzyme/SEQ ID NO:2), scores of 1.0 (i.e., when the mutation yields a value comparable to parent template enzyme/SEQ ID NO: 2) or scores above 1.0 (i.e., when the mutation is more favorable compared to parent template enzyme/SEQ ID NO: 2), given to each mutation for the solubility score of the variant at all temperatures tested (i.e., RT and 70°C)(see specification, pg. 20, lines 1-10). The stability score was calculated by measuring the residual activity for each variant after 3 days exposure at 85°C in 1.45 M K2CO3 and comparing the ratio of the residual activities over that of the corresponding parent template enzyme/SEQ ID NO: 2 (see specification, pg. 20, lines 11-15). And the fourth column in Table 3, shows the overall score, calculated by multiplying the solubility and stability scores obtained for each mutation (see pg. 20, lines 16-17).
In other words, the results displayed in Table 3, reflect the effect of individual mutations at the 114 positions targeted and their effect on the solubility and stability as well as the overall performance relative to the parent template (i.e., SEQ ID NO: 2, R156E) (see pg. 20, Table 3). Additionally, the specification, in particular Tables 4-5, fails to teach increased solubility and/or increased thermostability for a sequence comprising up to 45 modifications in addition to one ammino acid difference relative to SEQ ID NO: 1 (i.e., at position 223, L or I). For instance Table 4 shows mutagenesis results using SEQ ID NO: 3 as a starting template; however the variant with the most mutations comprises only two mutations and none of the mutations is at position 223 (see instant specification, pg. 25, Table 4). Similarly, Table 5, shows mutagenesis results of variants derived from SEQ ID NO: 4; where the variant that comprises the most mutations in addition to a mutation at position 223, comprises a total of 5 mutations, i.e., SEQ ID NO:11: S39I+G130A+T154P+D195E+K223I with a solubility score of 1.0 and a stability score of 3.81; SEQ IDNO: 7: S39I+G130A+T154P+D195E+K223L with a solubility score of 1.4 and a stability score of 9.21. However, the amino acid/mutation causing the increase in stability or solubility was impossible to determine. The same is observed for variants with 4 mutations, such as SEQ ID NOs: 8-10, which comprise 223I or 223L, had a solubility score of 1.0 (for SEQ ID NO: 8) or 1.5 (for SEQ ID NOs: 9-10) and a stability score of 4.74, 5.88, 8.26 for SEQ ID NOs: 8-10 (see instant specification, pg. 26, Table 5). It is noted that variants comprising only two mutations, with one of the mutations being 223I or 223L such as SEQ ID NO: 6, mutated at S39I+K223L had a solubility score of 1.5 attributed to the 39I mutation, and a stability score of 4.17 attributed to the 223I mutation (see instant specification, pg. 26, Table 5). Other variants derived from SEQ ID NO: 4 comprising a mutation at 223 are S39L+K223I with solubility score of 1.5 attributed to 39L and stability score of 3.17 with no attribution to any mutations; S39L+K223L with solubility score of 1.3 attributed to 39L and stability score of 4.16 attributed to the 223L mutation; D195E+K223I with solubility score of 1.3 and stability score of 2.94 attributed to the 195E mutation (see instant specification, pg. 27, Table 5). The one and only variant of parent SEQ ID NO: 4 with a solubility score of 1.3 and a stability score of 2.41, where both scores are attributed to mutation 223I comprises a total of 16 mutations (i.e., SEQ ID NO: 4 comprises three non-conservative substitutions at V79E, R156E and V216T, and twelve conservative substitutions at Y77F, K88E, Y105F, K116E, K128E, E137D, E145D, D168E, Y170F, E195D, E199D, and 219I, relative to SEQ ID NO: 1 see instant specification, Figure 1) (see instant specification, pg. 27, Table 5).
Therefore, Table 5 show solubility and stability scores above 1.0 for only one variant that includes one mutation at one amino acid position as compared to a corresponding carbonic anhydrase polypeptide lacking said one amino acid difference (i.e., position 223). Thus, the instant specification fails to demonstrate a recombinant carbonic anhydrase polypeptide having carbonic anhydrase activity comprising an amino acid sequence having at least 80% identity with SEQ ID NO: 5 and one amino acid difference as compared to SEQ ID NO: 1 at residue position 223, wherein SEQ ID NO: 5 comprises 223L or 223I, and said recombinant carbonic anhydrase polypeptide has increased solubility and/or increased thermostability as compared to a corresponding carbonic anhydrase polypeptide lacking said one amino acid difference.
An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. See MPEP 2163 (I)(A). In the instant case, the sequences reduced to practice (i.e., SEQ ID NOs: 2-4) do not share a common core structure; without an indication of a core structure, sequence or residues that would be necessary in order for a recombinant carbonic anhydrase polypeptide to exhibit the claimed functions (i.e., increased solubility and/or increased thermostability), it would be difficult for a skilled artisan to envision the correlation between structure and function for the whole genus and/or to predict what would be covered by the functionally claimed genus because Applicants have failed to provide a representative number of species to support the scope of the whole genus. Since Applicants have reduced to practice SEQ ID NOs: 3-5, and since the sequence with the most modifications only encompasses 16 modifications including a mutation at position 223 where the position is mutate to L or I, as compared to SEQ ID NO: 1; an ordinary skilled artisan would not be able to determine the additional 29 modifications that can be made to the sequence in order for it to be at least 80% identical to SEQ ID NO: 5 and still exhibit the function of increased solubility and/or increased thermostability as compared to a corresponding carbonic anhydrase polypeptide lacking said mutation at position 223. An adequate written description would encompass at least 93% identity to SEQ ID NO: 5 with any N-/-C terminal additions and one amino acid difference as compared to SEQ ID NO: 1. Support for 93% identity can be found in the instant specification at pg. 11, lines 23-28.
As such, claims 1-4, 8, 10-15, 19-23, 42, 58 and 66 do not meet the written description requirement, because “[t]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant [inventor] has invented the subject matter which is claimed.” In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). See MPEP 2163.I.
Applicants’ Arguments
Applicants assert that the focused amendment limits the scope to variants that are explicitly described and tested, and that the positions are supported by working examples, Tables 1-5, Figures, and description of variants showing improved properties such as thermostability and solubility (see Remarks, filed 08/20/2025, pg. 20, paragraphs 3-4).
Response to Arguments
Applicant's arguments filed 08/20/2025 have been fully considered but they are not persuasive for the following reasons:
MPEP §2163 states that 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, or by disclosure of relevant, identifying characteristics, i.e., 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.
The importance of structure/function correlations was highlighted by the courts (Abbvie Deutschland v. Janssen Biotech and Centorcor Biologics, App. No. 2013-1338, -1346 (Fed. Cir., July 1, 2014)). The Abbvie case involved antibodies and written description. The court stated: “We have held that “a sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Id. at 1350 (quoting Eli Lilly, 119 F.3d at 1568– 69).”. The courts then further stated: “With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus.” (emphasis added) and then state: " Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Ariad, 598 F.3d at 1351 (“[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.”); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1352 (Fed. Cir. 2011) (noting the technical challenges in developing fully human antibodies of a known human protein). It is true that functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date. Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002). However, the record here does not indicate such an established correlation. Instead, Abbvie used a trial and error approach to modify individual amino acids in order to improve the IL-12 binding affinity. Moreover, the ’128 and ’485 patents do not describe any common structural features of the claimed antibodies. The asserted claims attempt to claim every fully human IL-12 antibody that would achieve a desired result, i.e., high binding affinity and neutralizing activity, and cover an antibody as different as Stelara, whereas the patents do not describe representative examples to support the full scope of the claims.”
In the instant case, the details provided in the instant specification pertaining to the recombinant carbonic anhydrase polypeptide having carbonic anhydrase activity comprising an amino acid sequence having at least 80% identity with SEQ ID NO: 5 and one amino acid difference as compared to SEQ ID NO: 1 at residue position 223, wherein SEQ ID NO: 5 comprises 223L or 223I, and said recombinant carbonic anhydrase polypeptide has increased solubility and/or increased thermostability as compared to a corresponding carbonic anhydrase polypeptide lacking said one amino acid difference, fail to convey with reasonable clarity that the inventor had possession of the recombinant carbonic anhydrase polypeptide that yield the increased solubility and/or increased thermostability. The evidence provided in the specification is not sufficient to satisfy the written description of a genus because the “identifying characteristics” described in the instant specification, in particular requiring at least 80% identity to SEQ IDNO: 5 in addition to one amino acid difference at position 223 as compared to SEQ ID NO: 1, refer to a recombinant carbonic anhydrase with at least 45 modifications including any insertions, substitutions, deletions, etc.; in addition to one amino acid difference at position 223 as compared to SEQ ID NO: 1. However, Applicants have reduced to practice only three sequences and none of the sequences reduced to practice encompass 45 modifications. Therefore, there is no core structure/sequence associated with the increased solubility and/or increased thermostability as compared to a corresponding carbonic anhydrase polypeptide lacking said one amino acid difference.
Additionally, a "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Thus, the limited recombinant carbonic anhydrase polypeptide having carbonic anhydrase activity, in addition to one amino acid difference as compared to SEQ ID NO: 1 having increased solubility and/or increased thermostability as compared to a corresponding carbonic anhydrase polypeptide lacking said one amino acid difference do not constitute a representative number of recombinant carbonic anhydrase polypeptides that an ordinary skilled artisan can reasonably extrapolate which recombinant polypeptides would exhibit the claimed function.
Furthermore, the evidence provided the instant specification in particular Tables 1 and 3-5, is also not sufficient to satisfy the written description requirement because the variants do not encompass up to 45 modifications (i.e., 80% identity to SEQ ID NO: 5) and still exhibit the function increased solubility and/or increased thermostability. Therefore, the “identifying characteristics” recited in the instant specification are not sufficient to distinguish the claimed recombinant carbonic anhydrase polypeptide from other known carbonic anhydrase polypeptides lacking said one amino acid difference. As such, the details disclosed in the instant specification pertaining to the 80% identity with SEQ ID NO: 5 are not sufficient to show that Applicants were in possession of the claimed genus (i.e., recombinant carbonic anhydrase polypeptide), and are also not sufficient to claim that the Applicants’ were in possession of the claimed species (i.e., recombinant anhydrase polypeptide having 80% identity with SEQ ID NO: 5 and one amino acid difference at position 223 as compared to SEQ ID NO: 1).
Accordingly, the 35 U.S.C. 112(a) rejection of claims 1-4, 8, 10-15, 19-23, 42, 58 and 66 is maintained.
Conclusion
No claims are allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/CLAUDIA ESPINOSA/Patent Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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