DETAILED CORRESPONDENCE
Application 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. Applicant’s amendment to the claims filed on 09/05/2025 in response to the Non-Final Rejection mailed on 03/05/2025 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
3. Claims 309, 323-324, and 327 are cancelled.
4. Claims 304-308, 310-322, 325-326 and 328-329 are pending.
5. Applicant’s remarks and declaration filed on 09/05/2025 in response to the Non-Final Rejection mailed on 03/05/2025 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Information Disclosure Statement
The IDS filed on 09/05/2025 has been considered by the examiner and a copy of the Form PTO/SB/08 is attached to the office action.
Claim Rejections - 35 USC § 112(a)
6. The written description rejection of claims 304-329 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of applicants’ amendment to the claims to recite “wherein the adenosine deaminase is a TadA deaminase” and in view of applicants’ remarks and declaration that the methods and working examples in the specification demonstrate that highly divergent TadA enzymes mutated at the corresponding positions confer deoxyadenosine deamination activity.
7. The scope of enablement rejection of claims 304-329 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of applicants’ amendment to the claims to recite “wherein the adenosine deaminase is a TadA deaminase” and in view of applicants’ remarks and declaration that the methods and working examples in the specification demonstrate that highly divergent TadA enzymes mutated at the corresponding positions confer deoxyadenosine deamination activity.
Double Patenting
8. The nonstatutory double patenting rejection of claims 309, 323-324, and 327 over claims 1-32 of U.S. Patent No. 10,113,163 B2 is withdrawn in view of applicants’ amendment to the claims to cancel claims 309, 323-324, and 327.
9. The nonstatutory double patenting rejection of claims 309, 323-324, and 327 over claims 1-23 of U.S. Patent No. 10,947,530 is withdrawn in view of applicants’ amendment to the claims to cancel claims 309, 323-324, and 327.
10. The nonstatutory double patenting rejection of claims 309, 323-324, and 327 over claims 1-21 of U.S. Patent No. 11,999,947 is withdrawn in view of applicants’ amendment to the claims to cancel claims 309, 323-324, and 327.
11. The provisional nonstatutory double patenting rejection of claims 309, 323-324, and 327 over claims 1-3, 5, 7-8, 10-11, 14, 16, 19-20, 22-23, 27-29, 32, 49, 52-53, 56, 62, and 65 of copending Application No. 17/910,552 is withdrawn in view of applicants’ amendment to the claims to cancel claims 309, 323-324, and 327.
12. The provisional nonstatutory double patenting rejection of claims 309, 323-324, and 327 over claims 1-3, 5, 8, 12, 14-15, 21, 23-25, 30-31, 33, 42, 47, 53, 58-59, 62, and 72 of copending Application No. 17/797,700 is withdrawn in view of applicants’ amendment to the claims to cancel claims 309, 323-324, and 327.
13. The provisional nonstatutory double patenting rejection of claims 309, 323-324, and 327 over claims 1-2, 4, 7-8, 11-12, 15-16, 19-20, 27, 45, 47, 56, 65, 70-71, 73, 89, 134-135, 137, and 145 of copending Application No. 17/603,917 is withdrawn in view of applicants’ amendment to the claims to cancel claims 309, 323-324, and 327.
14. The provisional nonstatutory double patenting rejection of claims 309, 323-324, and 327 over claims 1-2, 5, 7, 18-19, 24, 44, 60-63, 88-89, 92, 115-116, 119, 121, 172-173, 176-178, 180-181, 184-186, 194 and 195 of copending Application No. 17/430,298 is withdrawn in view of applicants’ amendment to the claims to cancel claims 309, 323-324, and 327.
15. The nonstatutory double patenting rejection of claims 304-308, 311-317, 319-322, 326 and 329 over claims 1-32 of U.S. Patent No. 10,113,163 B2 is maintained for the reasons of record and the reasons set forth below. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-32 of the ‘163 patent recite an adenosine deaminase comprising an amino acid sequence that is at least 90% identical to the amino acid sequence of SEQ ID Nos: 1, 8, 9, 371, 372, 373, 374, or 375 with the exception of one or more substitutions at positions selected from the group consisting of amino acid residues corresponding to positions 8, 17, 18, 23, 34, 36, 45, 48, 51, 56, 59, 84, 85, 94, 95, 102, 104, 106, 107, 108, 110, 118, 123, 127, 138, 142, 146, 147, 149, 151, 152, 153, 154, 155, 156, and 157 of the amino acid sequence of SEQ ID NO: 1, wherein said adenosine deaminase deaminates adenine in DNA. The dependent claims are further drawn to mutations that encompass the claimed mutations as well as base editors comprising napDNAbp domains and methods for editing nucleotides in DNA.
RESPONSE TO REMARKS: Beginning on p. 9 of applicants’ remarks, applicants in summary contend that the claims have been amended for reasons unrelated to this rejection and request the rejection be withdrawn or reevaluated.
This argument is found to be not persuasive for the reasons of record set forth in the rejection above.
16. The nonstatutory double patenting rejection of claims 304-308, 311-317, 319-322, 326 and 329 over claims 1-23 of U.S. Patent No. 10,947,530 is maintained for the reasons of record and the reasons set forth below. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-23 of the ‘530 patent recite an adenosine deaminase comprising an amino acid sequence that is at least 85% identical to the amino acid sequence of SEQ ID Nos: 1, 8, 9, 371, 372, 373, 374, or 375 with the exception of one or more substitutions at positions selected from the group consisting of amino acid residues corresponding to positions 8, 17, 18, 23, 34, 36, 45, 48, 51, 56, 59, 84, 94, 95, 102, 104, 106, 107, 108, 110, 118, 123, 127, 138, 142, 146, 147, 149, 151, 152, 153, 154, 155, 156 and 157 of the amino acid sequence of SEQ ID NO: 1, wherein the adenosine deaminase deaminates adenine in DNA. The dependent claims are drawn to base editors comprising napDNAbp domains and methods for editing nucleotides in DNA. The specification further defines substitutions at the claimed position to include those that are recited in the claims of the current application. MPEP 804.II.B1. states “[t]he specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) (“[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.”); Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) (“Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings.”). “The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ “ Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. Of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). in re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “It]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.” In AbbVéie Inc. v. Kennedy Institute of Rreumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. V. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008): Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC. 349 F3d 1373. 1385-86. 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).”
RESPONSE TO REMARKS: Beginning on p. 9 of applicants’ remarks, applicants in summary contend that the claims have been amended for reasons unrelated to this rejection and request the rejection be withdrawn or reevaluated.
This argument is found to be not persuasive for the reasons of record set forth in the rejection above.
17. The nonstatutory double patenting rejection of claims 310, 318, 325, and 328 over claims 1-61 of U.S. Patent No. 11,702,651 is maintained for the reasons of record and the reasons set forth below. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-61 of the ‘651 patent recite a nucleic acid molecule encoding an adenosine deaminase comprising an adenosine deaminase comprising an amino acid sequence that is at least 85% identical to the amino acid sequence of SEQ ID Nos: 1, 8, 9, 371, 372, 373, 374, or 375 with the exception of one or more substitutions at positions selected from the group consisting of amino acid residues corresponding to positions 8, 17, 18, 23, 34, 36, 45, 48, 51, 56, 59, 84, 94, 95, 102, 104, 106, 107, 108, 110, 118, 123, 127, 138, 142, 146, 147, 149, 151, 152, 153, 154, 155, 156 and 157 of the amino acid sequence of SEQ ID NO: 1, wherein the adenosine deaminase deaminates adenine in DNA. The dependent claims are further drawn to nucleic acids encoding adenosine deaminase that anticipate the mutations recited in the claims of the current application.
RESPONSE TO REMARKS: Beginning on p. 9 of applicants’ remarks, applicants in summary contend that the claims have been amended for reasons unrelated to this rejection and request the rejection be withdrawn or reevaluated.
This argument is found to be not persuasive for the reasons of record set forth in the rejection above.
18. The nonstatutory double patenting rejection of claims 304-308, 311-317, 319-322, 326 and 329 over claims 1-21 of U.S. Patent No. 11,999,947 is maintained for the reasons of record and the reasons set forth below. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-21 of the ‘947 patent recite an adenosine deaminase comprising an amino acid sequence having at least 85% amino acid sequence identity to the amino acid sequence of SEQ ID NO: 1, with the exception of one or more of the following substitutions H36L, P48A, L84F, A106V, D108N, S146C, S146R, R152P, E155V, I156F, and K157N in the amino acid sequence of SEQ ID NO: 1, and wherein said adenosine deaminase deaminates adenine in deoxyribonucleic acid (DNA). The dependent claims are further drawn to base editors comprising the adenosine deaminase and the napDNAbp domain and methods for editing a nucleobase for a DNA sequence.
RESPONSE TO REMARKS: Beginning on p. 9 of applicants’ remarks, applicants in summary contend that the claims have been amended for reasons unrelated to this rejection and request the rejection be withdrawn or reevaluated.
This argument is found to be not persuasive for the reasons of record set forth in the rejection above.
19. The provisional nonstatutory double patenting rejection of claims 304-308, 310-322, 325-326 and 328-329 over claims 1-3, 5, 7-8, 10-11, 14, 16, 19-20, 22-23, 27-29, 32, 49, 52-53, 56, 62, and 65 of copending Application No. 17/910,552 is maintained for the reasons of record and the reasons set forth below. The rejection has been modified in view of the amendment filed 12/08/2025 in the ‘552 application to cancel claims 10, 22, 49, 52-53, 56, 62, and 65 of the ‘552 application and to add new claims 71-78 in the ‘552 application.
Claims 304-308, 310-322, 325-326 and 328-329 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 7-8, 11, 14, 16, 19-20, 23, 27-29, 32, and 71-78 of copending Application No. 17/910,552. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-3, 5, 7-8, 11, 14, 16, 19-20, 23, 27-29, 32, and 71-78 of the ‘552 application recite nucleic acids encoding base editors, base editors comprising gRNA, and methods of deaminating an adenosine nucleobase or a cytidine nucleobase in a STAT3 gene, the method comprising contacting the STAT3 gene with a base editor in association with a gRNA, wherein the gRNA comprises a guide sequence that is complementary to a target nucleic acid sequence in the STAT3 gene. The specification further defines the structure of the base editor as comprising an adenosine deaminase that is capable of deaminating DNA with mutations that are encompassed by the present application claims. MPEP 804.II.B1. states “[t]he specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) (“[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.”); Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) (“Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings.”). “The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ “ Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. Of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). in re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “It]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.” In AbbVéie Inc. v. Kennedy Institute of Rreumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. V. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008): Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC. 349 F3d 1373. 1385-86. 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
RESPONSE TO REMARKS: Beginning on p. 10 of applicants’ remarks, applicants contend that the ‘552 has a later filing date than the present application and this rejection should be withdrawn since the remaining rejections being overcome.
This argument is found to be not persuasive for the reasons of record. Briefly, there are still rejections of record that are remaining in the application.
20. The provisional nonstatutory double patenting rejection of claims 304-308, 310-322, 325-326 and 328-329 over claims 1-3, 5, 8, 12, 14-15, 21, 23-25, 30-31, 33, 42, 47, 53, 58-59, 62, and 72 of copending Application No. 17/797,700 is maintained for the reasons of record and the reasons set forth below. The rejection has been modified in view of the amendment filed 11/21/2025 in the ‘700 application to cancel claims 2-3, 15, 53, 58-59, 62, and 72. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 5, 8, 12, 14, 21, 23-25, 30-31, 33, 42, and 47 of the ‘700 application recite nucleic acids encoding base editors, base editors comprising gRNA, and methods of deaminating an adenosine nucleobase in an SMN2 gene, the method comprising contacting the SMN2 gene with a base editor in association with a guide RNA, wherein the gRNA comprises a guide sequence that is complementary to a target nucleic acid sequence in the SMN2 gene. The specification further defines the structure of the base editor as comprising an adenosine deaminase that is capable of deaminating DNA with mutations that are encompassed by the present application claims. MPEP 804.II.B1. states “[t]he specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) (“[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.”); Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) (“Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings.”). “The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ “ Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. Of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). in re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “It]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.” In AbbVéie Inc. v. Kennedy Institute of Rreumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. V. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008): Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC. 349 F3d 1373. 1385-86. 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
RESPONSE TO REMARKS: Beginning on p. 10 of applicants’ remarks, applicants contend that the ‘700 has a later filing date than the present application and this rejection should be withdrawn since the remaining rejections being overcome.
This argument is found to be not persuasive for the reasons of record. Briefly, there are still rejections of record that are remaining in the application.
21. The provisional nonstatutory double patenting rejection of claims 320 and 321 over claims 65, 93-102, 108-115, 117, and 124-127 of copending Application No. 18/460,178 is maintained for the reasons of record and the reasons set forth below. The rejection has been modified in view of the amendment filed on 06/10/2025 in the ‘178 application to cancel claim 65 and to add new claims 273-275.
Claims 320 and 321 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 93-102, 108-115, 117, 124-127, and 273-275 of copending Application No. 18/460,178. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 93-102, 108-115, 117, 124-127 and 273-275 of the ‘178 application are drawn to a method for deaminating an adenosine nucleobase in a sense or antisense strand of an HFE or F8 gene, the method comprising contacting the HFE or F8 gene with a base editor and gRNA bound to the base editor, wherein the gRNA bound to the base editor, wherein the gRNA comprises a guide sequence that is complementary to a target nucleic acid sequence in the HFE or F8 gene. . The specification further defines the structure of the base editor as comprising an adenosine deaminase that is capable of deaminating DNA with mutations that are encompassed by the present application claims. MPEP 804.II.B1. states “[t]he specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) (“[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.”); Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) (“Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings.”). “The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ “ Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. Of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). in re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “It]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.” In AbbVéie Inc. v. Kennedy Institute of Rreumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. V. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008): Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC. 349 F3d 1373. 1385-86. 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
RESPONSE TO REMARKS: Beginning on p. 11 of applicants’ remarks, applicants contend that the ‘178 application has a later filing date than the present application and this rejection should be withdrawn since the remaining rejections being overcome.
This argument is found to be not persuasive for the reasons of record. Briefly, there are still rejections of record that are remaining in the application.
22. The nonstatutory double patenting rejection of claims 320 and 321 over claims 1-39 of U.S. Patent No. 11,795,443 is maintained for the reasons of record and the reasons set forth below. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-39 of the ‘443 patent recite a method for deaminating an adenosine nucleobase in a sense or antisense strand of a promoter of an HBG1 or HBG2 gene, the method comprising contacting the promoter with a base editor and a guide RNA bound to the base editor, wherein the gRNA comprises a guide sequence that is complementary to a target nucleic acid sequence in the promoter of at least one of the HBG1 and HBG2 gene, wherein the base editor comprises a fusion protein comprising (i) a nucleic acid programmable DNA binding protein (napDNAbp) domain and (ii) an adenosine deaminase, wherein the adenosine deaminase comprises an amino acid sequence that is at least 85% identical to the amino acid sequence of a wild-type adenosine deaminase, with the exception of substitutions at one or more of W23, H36, N37, P48, I49, R51, N72, L84, S97, A106, D108, H123, G125, A142, S146, D147, R152, E155, I156, K157, and K161 of the amino acid sequence of SEQ ID NO: 1, or corresponding substitutions in another wild-type adenosine deaminase, wherein the step of contacting the promoter results in a T-A base pair in the promoter being mutated to C-G base pair in the promoter. The dependent claims further recite mutations that encompass the claimed mutations of the present application.
RESPONSE TO REMARKS: Beginning on p. 10 of applicants’ remarks, applicants in summary contend that the claims have been amended for reasons unrelated to this rejection and request the rejection be withdrawn or reevaluated.
This argument is found to be not persuasive for the reasons of record set forth in the rejection above.
23. The provisional nonstatutory double patenting rejection of claims 304-308, 310-322, 325-326 and 328-329 over claims 1-2, 4, 7-8, 11-12, 15-16, 19-20, 27, 45, 47, 56, 65, 70-71, 73, 89, 134-135, 137, and 145 of copending Application No. 17/603,917. The rejection has been modified in view of the amendment filed 06/20/2025 in the ‘917 application to cancel claims 7-8, and 11 and to add new claim 146.
Claims 304-308, 310-322, 325-326 and 328-329 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 12, 15-16, 19-20, 27, 45, 47, 56, 65, 70-71, 73, 89, 134-135, 137 and 145-146 of copending Application No. 17/603,917. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2, 4, 12, 15-16, 19-20, 27, 45, 47, 56, 65, 70-71, 73, 89, 134-135, 137 and 145-146 of the ‘917 application recite a fusion protein a first adenosine deaminase and a second adenosine deaminase wherein the first and/or second adenosine deaminase is capable of deaminating adenine of a deoxyadenosinde in DNA. The dependent claims further recite methods of targeting a nucleic acid with said fusion protein and polynucleotides encoding the fusion protein. Additionally, the dependent claims are further drawn to mutations that encompass the presently claimed adenosine deaminases.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
RESPONSE TO REMARKS: Beginning on p. 11 of applicants’ remarks, applicants contend that the ‘917 application has a later filing date than the present application and this rejection should be withdrawn since the remaining rejections being overcome.
This argument is found to be not persuasive for the reasons of record. Briefly, there are still rejections of record that are remaining in the application.
24. The provisional nonstatutory double patenting rejection of claims 304-308, 311-317, 319-322, 326, and 329 over claims 1-2, 5, 7, 18-19, 24, 44, 60-63, 88-89, 92, 115-116, 119, 121, 172-173, 176-178, 180-181, 184-186, 194 and 195 of copending Application No. 17/430,298 is maintained for the reasons of record and the reasons set forth below. The rejection has been modified in view of the Notice of Allowance mailed on 07/30/2025 in the ‘298 application to allow claims 1-2, 5, 7, 18-19, 24, 44, 60-62, 92, 172-173, 178, 184, and 186. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2, 5, 7, 18-19, 24, 44, 60-62, 92, 172-173, 178, 184, and 186 of the ‘298 application are drawn to base editors and methods of editing a HBB polynucleotide comprising a SNP associated with a sickle cell disease, the method comprising contacting a beta globin polynucleotide with one or more gRNAs and a fusion protein comprising a polynucleotide programmable DNA binding domain and at least one base editor domain that is an adenosine deaminase variant comprises T166R alteration in the following amino acid sequence having at least 85% sequence identity to the following amino acid sequence SEQ ID NO: 2, wherein said gRNA targets said base editor domain to effect an alteration of the SNP associated with sickle cell disease. The dependent claims further limit the adenosine deaminase to encompass variants of the presently claimed application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. It is noted that this application has been allowed and upon issuance the provisional nature of the rejection will become “nonstatutory”.
RESPONSE TO REMARKS: Beginning on p. 11 of applicants’ remarks, applicants contend that the ‘298 application has a later filing date than the present application and this rejection should be withdrawn since the remaining rejections being overcome.
This argument is found to be not persuasive for the reasons of record. Briefly, there are still rejections of record that are remaining in the application.
Conclusion
25. Status of the claims:
Claims 304-308, 310-322, 325-326 and 328-329 are pending.
Claims 304-308, 310-322, 325-326 and 328-329 are rejected.
No claims are in condition for an allowance.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
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/PAUL J HOLLAND/Primary Examiner, Art Unit 1656
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