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 .
Response to Arguments
The Applicant has provided a response, dated 1/30/2026, wherein the Applicant has included arguments directed towards the previous Office Action, and amendments to the claims, specification, and drawings. The amended specification and drawings are accepted, and the objections to the specification and the drawings is withdrawn.
On page 15 of the Applicant’s Arguments, the Applicant points to the amendment to claim 6, and suggests that this should be appropriate to withdraw the 35 USC 112(b) rejection. When considering the claim limitation, it still has the same fundamental issue, wherein it is unclear if the claim is drawn to any expression vector, if there is a particular sequence that must be used. A “recombinant expression vector” suggests that the sequence might not be a conventionally used sequence, and it should be clear in order to ensure that the claimed material is clear and enabled. By including the limitation in amended claim 1, this claim is also considered indefinite.
On page 16 of the Applicant’s Arguments, the Applicant notes that the previous rejections do not show the newly claimed limitations. This is correct, and the claims previously rejected under 35 USC 102(a)(1) are now rejected under 35 USC 103. All changes to rejection rationale will be provided in the updated rejections.
On page 16 of the Applicant’s Arguments, the Applicant states that the non-statutory double patenting rejections should be withdrawn in light of the new claim amendments. Since the previous patents continue to encompass the currently claimed method, and there is no evidence provided that the currently claimed material provides for non-obvious improvements, the non-statutory double patenting rejections are maintained; while the newly added dosing limitation is considered, it is noted that many of both patents’ claims do not include dosing limitations, and as such, would necessarily encompass the claimed method. As stated above, the Applicant must show that the currently claimed dosage provides for some non-obvious improvement.
The Applicant has amended and canceled a number of claims, as well as adding new claims 104-127. These will be discussed in the rejections below.
Claim Objections
Claims 105-107 objected to because of the following informalities: these claims utilize tables to provide limitations. See MPEP 2173.05(s). Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1, 6, 7, 16, 18, 20, 22, 26, 29, 30, 75 and 104-124 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.
Claims 1, 6, 7, 16, 18, 20, 22, 26, 29, 30, 75 and 104-124 either include a limitation drawn to “a recombinant expression vector,” or are dependent on a claim that claims “a nucleotide sequence.” Since no nucleotide sequence is claimed, these claims are indefinite, as it is unclear what nucleotide sequence the Applicant is trying to claim. Please provide claimed sequences in the form of a SEQ ID No. For the sake of examining these claims on their merit, it will be assumed that any sequence that codes for human iduronate-2-sulfatase applies.
Claims 108-110 are indefinite because they are dependent on claim that states that brain mass is determined by transgene PCR; based upon the wording of claims 108-110, they appear to suggest that the brain mass is measured by MRI, and not transgene PCR. It is unclear if brain mass must be measured by two separate methodologies, or if the claim should be drawn to only one methodology.
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Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 6, 7, 16, 18, 20, 22, 26, 29, 30, 75 and 104-124 are rejected under 35 U.S.C. 103 as being unpatentable over Yoo, et al (PGPub 2020/0149019 [IDS Reference]) and Hinderer (WO 2017/181113). Yoo teaches methods of treating mucopolysaccharidosis type II (MPS II or Hunter Syndrome) by providing human iduronate-2-sulfatase (hIDS) to the central nervous system of a subject. See paragraph [0003]. Yoo notes that hepatosplenomegaly is a pathology consistent with MPS II. See paragraph [0005]. As such, it stands to reason that Yoo’s treatment of MPS II necessarily results in a treatment of hepatosplenomegaly. Finally, although Yoo does provide the method in the form of an expression vector, Yoo does not teach the claimed dosage. See paragraph [0012].
Hinderer teaches a method of treating MPS II by providing rAAV, that includes a sequence for hIDS, to a subject’s central nervous system. See page 3, lines 1-11. Hinderer also teaches dosages that are within the claimed level. See page 3, lines 16 and 17. Hinderer also suggests modifications to dosing ranges based upon the age of the subject. See page 19, 1st paragraph. Although Hinderer does describe administration in terms of “brain mass,” Hinderer does not provide for any specific methods of determining brain mass.
It would be obvious to combine Yoo and Hinderer because they both describe similar methods of treating MPS II with hIDS expression vectors. Although Yoo does not teach the claimed dosing, Hinderer does. This would suggest to the ordinary artisan that the dosing can be predictably optimized to a level that is consistent with that claimed. Furthermore, although neither reference teaches methods of acquiring brain mass, there does not appear to be a rationale as to why the claimed method is unexpectedly better than any other method. The fact that both references note the relevance of brain mass would suggest to the ordinary artisan that this should be measured in order to optimize the correct dosage. Since all methods of finding brain mass result in finding the mass of a brain, all of the methods can be considered obvious variants of each other, and as such, are entirely interchangeable.
With respect to claims 1, 6, and 104-107, Yoo and Hinderer teach the claimed method, wherein Hinderer provides for the claimed dosage.
With respect to claims 7 and 16, although it is unclear if Yoo or Hinderer report the claimed size change, both references describe each step in a manner to suggest that the claimed changes would be inherent to the method. As such, even if Yoo or Hinderer does not explicitly report the size change, it would be reasonable to suggest that this size change would have been inherent to the method. See MPEP 2112(I) and 2112(II).
With respect to claim 18, Yoo teaches that MPS II is treated by delivering a recombinant adeno-associated viral vector (rAAV), which comprises a sequence that encodes hIDS, into the cerebrospinal fluid of a human subject. See paragraph [0018] [0019].
With respect to claim 20, Yoo teaches the claimed age range. See paragraph [0280].
With respect to claim 22, Yoo teaches that the claimed method can be performed after enzyme replacement therapy. See paragraph [0042].
With respect to claims 26, 117 and 118, Yoo teaches intracisternal and intracerebroventricular administration. See paragraph [0021].
With respect to claims 29 and 111-114, Yoo teaches rAAV serotypes 9 and rh10. See paragraph [0018].
With respect to claim 30 and 115-116, Yoo teaches chicken β-actin (CB7) promoter and a CMV enhancer. See paragraph [0017].
With respect to claim 74, Yoo teaches Elliots B solution for the administration of the rAAV. See paragraph [0284]. The claimed values are consistent with this widely-used carrier.
With respect to claims 108-110, as discussed above, all methods of finding brain mass are considered obvious variants. Since both references highlight the importance of brain mass when dosing, any method of finding brain mass would be obvious to the ordinary artisan.
With respect to claims 119-121, Yoo provides for a single administration. See paragraph [0286].
With respect to claims 122-124, Yoo indicates that the method can be performed by also administering immunosuppressive therapies before or concurrently to the method. See paragraph [0041].
With respect to claims 125-127, Hinderer teaches a sequence with 100% homology to the claimed sequence. Specifically, Hinderer’s SEQ ID No 3 is the same as the claimed sequence.
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.
Claims 1, 6, 7, 16, 18, 20, 22, 26, 29, 30, 75 and 104-124 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, and 10-16 of U.S. Patent No. 11,613,739. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent and the pending claims provide for inventions with overlapping scope. The patent provides for methods of treating MPS II by providing an rAAV with an hIDS sequence, to the cerebrospinal fluid.
The patent provides for a method of treating MPS II and disorders that occur because of MPS II by providing hIDS to the central nervous system. The hIDS can be administered via rAAV and the central nervous system administration results in cerebrospinal fluid administration. The primary difference between the patent and the instant claim-set is that the instant claim-set provides for a dosing limitation, whereas the cited claims of the patent do not include any dosing. The broadest claims of the patent provide for a scope that is greater than that of the instant claim-set. Since there is no evidence to suggest that the claimed dosing range provides for any non-obvious improving, the claims of the instant application are anticipated by those of the patent.
Claims 1, 6, 7, 16, 18, 20, 22, 26, 29, 30, 75 and 104-124 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,986,515. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent provides for a method of treating MPS II by testing for the presence of heparan sulfate in a human sample, diagnosing MPS II, and administering hIDS to the central nervous system of the subject. Narrower claims provide for the administration with an rAAV.
The patent provides for a method of treating MPS II and disorders that occur because of MPS II by providing hIDS to the central nervous system. The hIDS can be administered via rAAV and the central nervous system administration results in cerebrospinal fluid administration. The broadest claims of the instant invention provide for a scope that is greater than that of the patent, whereas some of the narrower independent claims and dependent claims directly read upon the patent scope.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
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