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. Claims 1-88 are canceled. Claims 89-97, 100 are amended. Claims 97-99 are withdrawn. New claims 101-104 are added. Claims 89-96, 101-104 are under consideration.
2. Due to the new rejection below, this Action is a Non-Final Action.
Information Disclosure Statement
3. The information disclosure statement (IDS) was submitted on 11/202025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
4. (previous rejection, withdrawn) Claim 96 was rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Applicant contends: the claim has been amended.
In view of applicant’s amendments, the rejection is withdrawn.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
5. (new, necessitated by amendment as to claims 89, 101; new rejection as to claim 94) Claims 89-96, 101-104 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
See claims 89-96, 101-104 as submitted 10/8/2025.
As to claim 89, as well as new claim 101, it is not clear what “appropriately cleaved” means. The term “appropriately cleaved” is a relative term which renders the claim indefinite. The term “appropriately cleaved” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Further, it is not clear what the difference or relationship between “full-length” and “mature” is in claim 89.
Further, it is not clear what “operatively associated” means in claims 89, 90.
As to claim 94, the claim recites “the lysosomal targeting peptide”. There is insufficient antecedent basis for this limitation in the claim. Claim 89 on which the claim depends does not recite a targeting peptide.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
6. (new, necessitated by amendment) Claim 95 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
See claim 95 as submitted 10/8/2025.
See also the 35 U.S.C. 112(b) rejection above.
It is noted that applicant elected species SEQ ID NO: 73 as recited in claim 95. As to claim 95, the claim recites SEQ ID NO: 73 (elected species), “or a nucleotide sequence at least 85% identical thereto”. Claim 89 on which the claim depends recites “full length” or “mature” lysosomal enzyme, yet claim 95 recites or can read on a fragment thereto (85%). Such a claim thus is not further limiting of the claim on which it depends, rather broadening.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102 / 103
7. (previous rejection, withdrawn) Claims 89, 100 were rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over High et al. (US20180187213A1)(cited in applicant’s IDS submitted 5/13/2021).
Applicant contends: claim 89 has been amended.
In view of applicant’s amendments, the rejection is withdrawn.
Claim Rejections - 35 USC § 103
8. (previous rejection, withdrawn) Claim 95 was rejected under 35 U.S.C. 103 as being unpatentable over High et al. as applied to claims 89, 100 above, and further in view of Fogher et al. (WO2003073839A2; previously cited).
In view of the withdrawal of the rejection over High et al. on which the instant rejection depends, the instant rejection is also withdrawn.
9. (previous rejection, withdrawn) Claims 90, 94 were rejected under 35 U.S.C. 103 as being unpatentable over High et al. as applied to claims 89, 100 above, and further in view of Beverley et al. (W002087510A2; previously cited) and Belfiore et al. (“Insulin Receptor Isoforms in Physiology and Disease: An Updated View,” Endocrine Rev. 3 8(5):379-43 1 (2017))(cited in applicant’s IDS submitted 5/13/2021).
In view of the withdrawal of the rejection over High et al. on which the instant rejection depends, the instant rejection is also withdrawn.
10. (previous rejection, withdrawn) Claims 91-93 were rejected under 35 U.S.C. 103 as being unpatentable over High et al. as applied to claims 89, 100 above, and further in view of Haberman et al. (W003093295A2; previously cited).
In view of the withdrawal of the rejection over High et al. on which the instant rejection depends, the instant rejection is also withdrawn.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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.
11. (previous rejection, maintained; new, necessitated by amendment as to claims 101-104) Claims 89-92, 100-104 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-73 of copending Application No. 17/778175.
See claims 89-92, 100-104 as submitted 10/8/2025.
See also the 35 U.S.C. 112(b) rejection above.
See the rejection as recited in the previous Office Action. As to claims 101-104, it is noted claims 1-73 of copending Application No. 17/778175 already recite AAV vector; AAV8 capsid protein.
Applicant contends: the rejections should be held in abeyance until determination of allowable subject matter.
The rejection is maintained and extended for reasons of record.
12. (previous rejection, maintained) Claim 94 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-73 of copending Application No. 17/778175 as applied to claims 89-92, 100-104 above and further in view of Beverley et al. (W002087510A2)(cited above) and Belfiore et al. (“Insulin Receptor Isoforms in Physiology and Disease: An Updated View,” Endocrine Rev. 38(5):379-43 1 (2017))(cited in applicant’s IDS submitted 5/13/2021).
See claim 94 as submitted 10/8/2025.
Applicant contends: the rejections should be held in abeyance until determination of allowable subject matter.
See the rejection as recited in the previous Office Action.
The rejection is maintained for reasons of record.
13. (previous rejection, maintained) Claim 93 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-73 of copending Application No. 17/778175 as applied to claims 89-92, 100-104 above and further in view of Haberman et al. (W003093295A2)(cited above).
See claim 93 as submitted 10/8/2025.
Applicant contends: the rejections should be held in abeyance until determination of allowable subject matter.
See the rejection as recited in the previous Office Action.
The rejection is maintained for reasons of record.
14. (previous rejection, maintained; new, necessitated by amendment as to claims 101, 102) Claims 89-92, 100-102 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 32-39, 41-45, 49-52, 54, 55, 57, 69 of copending Application No. 17/294074.
See claims 89-92, 100-102 as submitted 10/8/2025.
See also the 35 U.S.C. 112(b) rejection above.
See the rejection as recited in the previous Office Action. As to claims 101-102, it is noted claims 8, 32-39, 41-45, 49-52, 54, 55, 57, 69 of copending Application No. 17/294074 already recite AAV vector.
Applicant contends: the rejections should be held in abeyance until determination of allowable subject matter.
The rejection is maintained and extended for reasons of record.
15. (previous rejection, maintained) Claim 94 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 32-39, 41-45, 49-52, 54, 55,57, 69 of copending Application No. 17/294074 as applied to claims 89-92, 100-102 above and further in view of Beverley et al. (W002087510A2)(cited above) and Belfiore et al. (“Insulin Receptor Isoforms in Physiology and Disease: An Updated View,” Endocrine Rev. 38(5):379-431 (2017))(cited in applicant’s IDS submitted 5/13/2021).
See claim 94 as submitted 10/8/2025.
Applicant contends: the rejections should be held in abeyance until determination of allowable subject matter.
See the rejection as recited in the previous Office Action.
The rejection is maintained for reasons of record.
16. (previous rejection, maintained) Claim 93 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 32-39, 41-45, 49-52, 54, 55,57, 69 of copending Application No. 17/294074 claims as applied to claims 89-92, 100-102 above and further in view of Haberman et al. (WO03093295A2)\(cited above).
See claim 93 as submitted 10/8/2025.
Applicant contends: the rejections should be held in abeyance until determination of allowable subject matter.
See the rejection as recited in the previous Office Action.
The rejection is maintained for reasons of record.
Conclusion
17. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672