DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment, filed 07/21/2026, has been entered.
Claims 49, 51-60 and 95 are pending and currently under examination as they read on a method of treating mucopolysaccharidosis type I comprising administering a fusion protein of an anti-human transferrin receptor antibody and human α-L-iduronidase.
This Office Action will be in response to Applicant’s arguments/remarks, filed 07/21/2026.
The Rejections of Record can be found in the previous Office Action, mailed 06/02/2026.
The previous claim objection has been withdrawn in view of Applicant’s amendment, filed 07/21/2026.
The previous rejection under 35 U.S.C. 112(b) has been withdrawn in view of Applicant’s amendment, filed 07/21/2026.
The previous rejection under 35 U.S.C. 112(a) has been withdrawn in view of Applicant’s amendment, filed 07/21/2026.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 49, 51-60 and 95 are rejected under 35 U.S.C. 103 as being unpatentable over Sonoda et al. (US 2019/0338043 A1).
The Rejection of Record can be found in the previous Office Action, mailed 06/02/2026.
Applicant’s arguments have been fully considered but are not persuasive.
Applicant argues that selection of a dose for a blood-brain-barrier (BBB)-penetrating enzyme replacement therapy would not have constituted routine optimization because determination of an effective and safe dose involves multiple factors, including CNS and peripheral tissue exposure, TfR-mediated transcytosis, receptor saturation, receptor binding and dissociation, plasma retention, antibody affinity and avidity, pH sensitivity, and pharmacokinetic/pharmacodynamic considerations. Applicant further argues that Sonoda recognizes that optimal dosage and actual clinical efficacy require accumulated mid- to long-term clinical data and cannot be determined from preclinical or theoretical analysis alone.
These arguments are not persuasive because the claims do not require administration at an optimal dose, nor do they require that the recited dose be predictable from theoretical or preclinical analysis alone. Rather, claim 49 broadly recites administration at a dose of 0.1 to 8 mg/kg body weight, while claim 95 recites a dose of 0.1 to 10 mg/kg body weight.
As discussed in the rejection, Sonoda teaches the same anti-human transferrin receptor/human α-L-iduronidase (hIDUA) fusion protein for the same therapeutic purpose of treating mucopolysaccharidosis type I and teaches intravenous administration of such therapeutic fusion proteins. Thus, the therapeutic agent, disease being treated, and route of administration were known in the prior art. Determination of an appropriate amount of the known therapeutic agent would have involved evaluation of dose-dependent efficacy, tissue exposure, pharmacokinetics, and safety.
Indeed, the factors identified by Applicant do not establish that dosage was not a result-effective variable. Rather, Applicant’s identification of CNS exposure, peripheral tissue exposure, receptor saturation, pharmacokinetics, and safety as considerations in selecting a dose further demonstrates that the amount administered was understood to affect therapeutically relevant results and therefore constituted a parameter that one of ordinary skill in the art would have investigated and optimized. See In re Applied Materials, Inc., 692 F.3d 1289, 1297 (Fed. Cir. 2012); MPEP § 2144.05.
Furthermore, obviousness does not require absolute predictability or certainty of success. A reasonable expectation of success is sufficient. See MPEP § 2143.02. Sonoda’s recognition that accumulated clinical data may be necessary to determine an optimal dosage and actual clinical efficacy does not establish that one of ordinary skill in the art would have lacked a reasonable expectation of determining, through conventional dose-ranging studies, a therapeutically effective dose falling within the broad ranges presently claimed.
Accordingly, Applicant’s arguments do not overcome the prima facie case of obviousness, and the rejection is maintained as it applies to amended and newly added claims.
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 49, 51-60 and 95 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of U.S. Patent No. 10,759,864 and claims 1-47 of U.S. Patent No. 11,111,308 in view of Sonoda et al. (US 2019/0338043 A1).
The patent claims disclosed the same fusion protein comprising (hIDUA) and anti-hTfR antibody and using said fusion protein for the treatment of Hurler syndrome (aka MPS I). Therefore, it would have been obvious to arrive at the claimed method in view of the disclosure by Sonoda et al. as discussed above (see 103).
Applicant’s argument and Examiner’s response are essentially same as above. Therefore, the rejection is maintained.
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 SHARON X WEN whose telephone number is (571)270-3064. The examiner can normally be reached Mon-Fri 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHARON X WEN/Primary Examiner, Art Unit 1641
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