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, 101 are canceled. Claims 89, 90, 94, 95 are amended.
Applicant indicates that the status of claims 97-99 as withdrawn claims should be corrected as claim 97 was previously amended to depend on claim 89, which is under examination. Applicant’s arguments are considered and found persuasive, and claims 89-100, 102-104 are herein under examination.
It is noted that claim 93 appears to recite an errant amendment and thus does not have the proper status identifier (See MPEP 714).
Claims 89-100, 102-104 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 6/24/2026. 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 Objections
4. (new objection) Claim 99 is objected to because of the following informalities: Claim 99 appears to need a closing parenthesis after “Hurler-Scheie (MPS IH/S)”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
5. (previous rejection, withdrawn) Claims 89-96, 101-104 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly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.
Applicant contends: the claims have been amended.
In view of applicant’s amendments, the rejection is withdrawn.
6. (previous rejection, withdrawn) Claim 95 was rejected under 35 U.S.C. 112(d) or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In view of applicant’s amendments, the rejection is withdrawn.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.
7. (new, necessitated by amendment) Claims 89-100, 102-104 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 89-100, 102-104 as submitted 6/4/2026.
As to claim 89, the claim recites “native”. The term “native” in claim is a relative term which renders the claim indefinite. The term “native” 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. It is noted [00225] of the apparent specification as pointed to by applicant does not appear to recite the language indicated. Claims 90-100, 102-104 depend on this claim.
Further as to claim 99, it is not clear what “F. Lysosomal Membrane Transport Disorders” refers to; it is not clear what “Infantile Sialic Acid; Storage Disease (ISSD)” refers to or if that is the same disease; is not clear what “Infantile Neuronal” refers to, if that intends to recite “infantile neuroaxonal dystrophy” or not; it is not clear what “Ehlers-Danlos; Syndrome Type VI” refers to, if that intends to recite Ehlers-Danlos Syndrome or not; it is not clear if “Congenital Disorders of Glycosylation” intends to list and limit the subsequent disorders as part of a list or not, or if they are separate recitations or not.
Double Patenting
8. (previous rejection, withdrawn) Claims 89-92, 100-104 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-73 of copending Application No. 17/778175.
Applicant contends: the rejection should be held in abeyance until a determination of allowable subject matter.
In view of applicant’s amendments and upon further consideration, the rejection is withdrawn.
9. (previous rejection, withdrawn) Claim 94 was 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).
In view of the withdrawal of the rejection over claims 1-73 of copending Application No. 17/778175 on which the instant rejection depends, the instant rejection is also withdrawn.
10. (previous rejection, withdrawn) Claim 93 was 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).
In view of the withdrawal of the rejection over claims 1-73 of copending Application No. 17/778175 on which the instant rejection depends, the instant rejection is also withdrawn.
11. (previous rejection, withdrawn) Claims 89-92, 100-102 were 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.
Applicant contends: the rejection should be held in abeyance until a determination of allowable subject matter.
In view of applicant’s amendments and upon further consideration, the rejection is withdrawn.
12. (previous rejection, withdrawn) Claim 94 was 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).
In view of the withdrawal of the rejection over claims 8, 32-39, 41-45, 49-52, 54,
55, 57, 69 of copending Application No. 17/294074 on which the instant rejection depends, the instant rejection is also withdrawn.
13. (previous rejection, withdrawn) Claim 93 was 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).
In view of the withdrawal of the rejection over claims 8, 32-39, 41-45, 49-52, 54,
55, 57, 69 of copending Application No. 17/294074 on which the instant rejection depends, the instant rejection is also withdrawn.
Conclusion
14. 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
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