Prosecution Insights
Last updated: April 19, 2026
Application No. 17/797,644

METHODS FOR THE TREATMENT OF HUNTER SYNDROME

Non-Final OA §102§103§112§DP
Filed
Aug 04, 2022
Examiner
CHANDRA, GYAN
Art Unit
1674
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Denali Therapeutics Inc.
OA Round
1 (Non-Final)
71%
Grant Probability
Favorable
1-2
OA Rounds
2y 9m
To Grant
99%
With Interview

Examiner Intelligence

Grants 71% — above average
71%
Career Allow Rate
695 granted / 978 resolved
+11.1% vs TC avg
Strong +28% interview lift
Without
With
+27.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
38 currently pending
Career history
1016
Total Applications
across all art units

Statute-Specific Performance

§101
3.6%
-36.4% vs TC avg
§103
29.5%
-10.5% vs TC avg
§102
19.2%
-20.8% vs TC avg
§112
29.5%
-10.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 978 resolved cases

Office Action

§102 §103 §112 §DP
DETAILED ACTION 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 . Election/Restrictions Applicant's election with traverse of Group 4 (claims 1-3,7,8,12,19,27,29,30,36,41,51,59,61,64,74,75,85 ad 89) and the species: Glu at position 380, Ala at position 389, and Asn at position 390 in the reply filed on 10/29/2025 is acknowledged. The traversal is on the ground(s) that the examination of Groups 1-4 would not be serious burden on the Examiner. Upon further search consideration, applicant’s arguments have been found persuasive and therefore, Groups 1-4 are examined together and has been renumbered as Group 1. The following are newly renumbered groups: Group 1, includes claims 1-3,7,8,12,19,27,29,30,36,41,51,59,61,64,74,75,85 and 89. Group 2, includes claim 94. Group 3 , includes claims 97, 100-101, 105, 112, 120, 122, 130, 133, and 135. Status of Application, Amendments, And/Or Claims Claims 1-3,7,8,12,19,27,29,30,36,41,51,59,61,64,74,75,85, 89, 94, 97, 100-101, 105, 112, 120, 122, 130, 133, and 135 are pending. Claims 94, 97, 100-101, 105, 112, 120, 122, 130, 133, and 135 are withdrawn for being drawn to non-elected inventions (i.e., Groups 2-3). Claims 1-3,7,8,12,19,27,29,30,36,41,51,59,61,64,74,75,85 and 89 are under examination. Information Disclosure Statement The Information Disclosure Statement filed on 10/29/2025 has been considered. Priority The instant application is a 371 of PCT/US2021/016913 filed on 2/5/2021. Specification The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. 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. Claim 85 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. Regarding claim 85, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claim(s) 1-3,7-8,12,19,27, 29-30, 51,59,64,74 and 89 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Henry et al. (US 2019/0249155, also published as US Pat. No. 10,870837). The instantly claimed invention is broadly drawn to a method of treating Hunter syndrome in a subject in need thereof comprising administering to the subject a therapeutically effective dose of a pharmaceutical composition comprising a protein, wherein administration of the pharmaceutical composition reduces levels of a glycosaminoglycan (GAG) in the cerebrospinal fluid (CSF) of the subject to a baseline level measured in a healthy subject or a subject that does not have Hunter syndrome, and wherein the protein comprises: a. a first Fc polypeptide linked to an iduronate 2-sulfatase (IDS) amino acid sequence, an IDS variant amino acid sequence, or a catalytically active fragment thereof; and b. a second Fc polypeptide comprising the following amino acid residues, according to EU numbering: i. Trp, Leu, or Glu at position 380; ii. Tyr at position 384; iii. Thr at position 386; iv. Glu at position 387; v. Trp at position 388; vi. Ser or Ala at position 389; vii. Ser or Asn at position 390; viii. Thr at position 413; ix. Glu at position 415; x. Glu at position 416; and xi. Phe at position 421, wherein the therapeutically effective dose is from about 3 mg/kg to about 30 mg/kg of protein (claim 2), wherein the therapeutically effective dose is about 3 mg/kg, 7.5 mg/kg, 15 mg/kg, or 30 mg/kg of protein (claim 3), wherein the pharmaceutical is administered weekly (claim 7), wherein the composition further comprises a pharmaceutically acceptable excipient (claim 8), wherein the first Fc polypeptide linked to the IDS amino acid sequence comprises SEQ ID NO: 175 or 217; and the second Fc polypeptide comprises SEQ ID NO: 169 or 199 (claims 12, 19 and 27), wherein:1) the administration of the pharmaceutical composition reduces levels of one or more analytes in the CSF of the subject by at least about 10%, 15%, 20%, 25%, or 30%, wherein the reduction is relative to the level of the corresponding one or more analytes in the subject prior to the administration, wherein the one or more analytes are selected from the group consisting of neurofilament light (Nf-L), soluble triggering receptor expressed on myeloid cells 2 (sTREM2), a bis(monoacylglycerol) phosphate (BMP), a ganglioside, and a sphingolipid (claim 29), wherein the administration of the pharmaceutical composition reduces levels of the one or more analytes in the CSF, serum and/or urine of the subject to baseline levels, measured in a healthy subject or in a subject that does not have Hunter syndrome (claim 30), wherein the pharmaceutical composition is administered to the subject intravenously (claim 51), wherein the administration of the pharmaceutical composition: ii reduces levels of a glycosaminoglycan (GAG) in the CSF of the subject by at least 50%, 60%, 70%, 75%, 80%, 85%, or 90% after at least 4, 8 or 12 weekly doses, wherein the reduction is relative to the CSF levels of the GAG in the subject prior to administration (claim 64), wherein administration of the pharmaceutical composition reduces levels of the glycosaminoglycan(GAG) in the urine of the subject to a baseline level measured in a healthy subject or a subject that does not have Hunter syndrome (claim 74), wherein the GAG is heparan sulfate or dermatan sulfate (claim 75), and a method of treating Hunter syndrome in a subject in need thereof, comprising administering to the subject a protein at a weekly dose of about 3 mg/kg, 7.5 mg/kg, 15 mg/kg or 30 mg/kg of the pharmaceutical composition of claim 1 (claim 89). Regarding claim 1, Henry et al. teach a method of treating Hunter syndrome, also known as lysosomal storage disorder (LSD), using a composition comprising enzyme replacement therapy comprising (a) a first Fc polypeptide linked to an ERT enzyme, wherein the ERT is iduronate 2-sulfatase (IDS), an ERT variant, or a catalytically active fragment thereof, and (b) a second Fc polypeptide that forms an Fc dimer with the first Fc polypeptide (see paragraph 0003-0007]). They teach that the Fc polypeptide comprises variants at positions 380 selected from Glu, Trp, Leu, position 384 is Tyr, position 386 is Thr, position 387 is Glu, position 388 is Trp, position 389 is Ser or Ala, position 390 is Ser or Asn, position 413 is Thr, position 415 is Glu, position 416 is Glu and position 421 is Phe (see para [0030]). Regarding claims 2-3, they teach that the composition dose is from 0.1 mg/kg to 50 mg/kg [0316]. Regarding claims 7 and 51, they teach administering the composition in weekly doses intravenously (see [0132]). They teach including a pharmaceutically acceptable excipients to the composition (see [0347]). Regarding claim 12, wherein the IDS sequence comprises SEQ ID NO: 171,175, 213 or 217, they teach IDS sequence having 100% sequence homology (see PE2E search dated Nov. 17, US-17797644-171.rai). Regarding claim 19, they teach the first Fc polypeptide having amino acid sequence with 100% sequence similarity (see PE2E search dated Nov. 17. US-17797644-169.rai). Regarding claims 29-30, 64, they teach that the administration of the pharmaceutical composition reduces analytes in the CSF by at least by 71% and where in the analyte is GAG (see paragraph [0380]). Regarding claim 75, they teach that GAG heparan sulfate or dermatan sulfate (see paragraph [0369]) as measured by LC-MS assay. Therefore, the instantly claimed invention is implicitly or explicitly are taught by the prior art of record. 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claims 1,36,41, 59, 61, 74 and 85 are rejected under 35 U.S.C. 103 as being unpatentable over by Henry et al. (US 2019/0249155, also published as US Pat. No. 10,870837) in view of Hinderer et al. ( IDS, WO 2019060662). The instantly claimed invention is broadly drawn to a method of treating Hunter syndrome in a subject in need thereof comprising administering to the subject a therapeutically effective dose of a pharmaceutical composition comprising a protein, wherein administration of the pharmaceutical composition reduces levels of a glycosaminoglycan (GAG) in the cerebrospinal fluid (CSF) of the subject to a baseline level measured in a healthy subject or a subject that does not have Hunter syndrome, and wherein the protein comprises: a. a first Fc polypeptide linked to an iduronate 2-sulfatase (IDS) amino acid sequence, an IDS variant amino acid sequence, or a catalytically active fragment thereof; and b. a second Fc polypeptide comprising the following amino acid residues, according to EU numbering: i. Trp, Leu, or Glu at position 380; ii. Tyr at position 384; iii. Thr at position 386; iv. Glu at position 387; v. Trp at position 388; vi. Ser or Ala at position 389; vii. Ser or Asn at position 390; viii. Thr at position 413; ix. Glu at position 415; x. Glu at position 416; and xi. Phe at position 421, wherein the administration of the pharmaceutical composition:1) improves or maintains the subject's toileting abilities percentage (TAP) relative to a baseline level measured for the subject prior to administration of the pharmaceutical composition,2) improves or maintains the subject's qualitative individualized educational plan(IEP) trajectories in cognitive categories or behavioral categories relative to a baseline level measured for the subject prior to administration of the pharmaceutical composition;3) improves or maintains the subject's hearing relative to a baseline level measured for the subject prior to administration of the pharmaceutical composition, as assessed by an auditory brainstem response (ABR) assessment or a standard hearing test;4) changes the subject's liver volume relative to a baseline level measured for the subject prior to administration of the pharmaceutical composition, as assessed by MRI or ultrasound; and/or 5) changes the subject's spleen volume relative to a baseline level measured for the subject prior to administration of the pharmaceutical composition, as assessed by MRI or ultrasound (claim 36), wherein the subject is a male subject; wherein the subject is from about 2 to 18 years of age; and/or wherein the subject has neuronopathic Hunter syndrome (nMPSI) or has a same genetic mutation in the IDS gene as a blood relative with confirmed neuronopathic Hunter syndrome (nMPS II) (claim 41), wherein the urine total GAG concentration (normalized to creatinine) decreases relative to a baseline level after administration of the pharmaceutical composition, wherein the baseline level is measured for the subject prior to administration of the pharmaceutical composition (claim 59), wherein the incidence of anti-drug antibodies (ADAs) does not increase relative to a baseline level after administration of the pharmaceutical composition, wherein the baseline level is measured for the subject prior to administration of the pharmaceutical composition (claim 61), wherein administration of the pharmaceutical composition reduces levels of the glycosaminoglycan(GAG) in the urine of the subject to a baseline level measured in a healthy subject or a subject that does not have Hunter syndrome (claim 74), and wherein prior to the administration of the pharmaceutical composition, the subject had received recombinant idursulfase enzyme replacement therapy, and optionally, the subject had pre-existing anti-drug antibodies against IDS prior to administration of the pharmaceutical composition (claim 85). The teachings of Henry et al are set forth above. Henry et al do not teach the limitations of claims 36,41, 59, 61, 74 and 85. Hinderer et al. teach that Hunter syndrome is also known as MPS II and is a rare X-linked recessive genetic disease affecting 1 in 100K individuals, primarily males (page 1). This is caused by a mutation in IDS gene leading to deficiency in IDS enzyme required for the lysosomal catabolism of heparan sulfate and dermatan sulfate (called GAGs, glycosaminoglycan) and they accumulate in various tissues (pg. 1). Regarding claim 41, they teach patients with Hunter syndrome appear normal at birth but the signs and symptoms typically appear at ages 18 months and gets severe by age 4 years and they teach that the subject treated for Hunter syndrome are 12 year old (page 34, last paragraph). These patients do have short stature, macroglossia and hearing loss (second paragraph, pg. 1). Regarding claims 36, they teach that these patients fail in hearing screening tests in the first year and their ability to sit unsupported is weak and half of the children are toilet trained but their ability will lose as the disease progress. (page 2). They teach that patients with MPS II exhibit severe behavioral disturbances continuing to age 8-9 (page 2, 3rd paragraph). Regarding claim 85, they teach the patients are treated for Enzyme replace therapy using recombinant idursulfase (Elaprase®) and is administered weekly by infusion (page 2, paragraph 4). Regarding claim 61, they teach that antibodies to human IDS (i.e., anti-drug antibody) were evaluated by ELISA (see Fig. 8). They teach that MPS II patient are evaluated by MRI, e.g., volumetric analysis of gray and white matter and CSF ventricles (page 43, last paragraph). Regarding claims 59m 74, they teach evaluating serum , CSF and urine of MPS II patient for GAG, heparan sulfate (see page. 43, last paragraph). Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use a subject who is male and has age from about 2 to 18 years or a subject who has gone to ERT as measured by having anti-drug antibodies or a subject who is young and has compromised toileting ability as taught by Hinderer et al to treat Hunter syndrome by administering a composition comprising a. a first Fc polypeptide linked to an iduronate 2-sulfatase (IDS) amino acid sequence, an IDS variant amino acid sequence, or a catalytically active fragment thereof; and b. a second Fc polypeptide comprising the following amino acid residues, according to EU numbering: i. Trp, Leu, or Glu at position 380; ii. Tyr at position 384; iii. Thr at position 386; iv. Glu at position 387; v. Trp at position 388; vi. Ser or Ala at position 389; vii. Ser or Asn at position 390; viii. Thr at position 413; ix. Glu at position 415; x. Glu at position 416; and xi. Phe at position 421 as taught by Henry et al. Additionally, one would have been motivated to do so because Henderer et al teach that a patient starts developing Hunter syndrome as 18 months or older and they are primarily male patients. Henderer et al. also teach that patients with Hunter syndrome and have gone through enzyme replacement therapy (ERT) have anti-drug antibody and they teach that because ERT does not cross the blood brain barrier (BBB), one would benefit with a treatment which crosses the BBB. Further, one would have a reasonable expectation of success in using the instant composition because it crosses the BBB and a patient who has gone through ERT would benefit by the treatment using a pharmaceutical composition comprising: a. a first Fc polypeptide linked to an iduronate 2-sulfatase (IDS) amino acid sequence, an IDS variant amino acid sequence, or a catalytically active fragment thereof; and b. a second Fc polypeptide comprising the following amino acid residues, according to EU numbering: i. Trp, Leu, or Glu at position 380; ii. Tyr at position 384; iii. Thr at position 386; iv. Glu at position 387; v. Trp at position 388; vi. Ser or Ala at position 389; vii. Ser or Asn at position 390; viii. Thr at position 413; ix. Glu at position 415; x. Glu at position 416; and xi. Phe at position 421 as taught by Henry et al. Therefore, the instantly claimed invention would have been obvious over the combined teachings of the prior art. 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 1-3,7-8,12,19,27, 29-30, 51,59,64,74 and 89 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 18-24, 25-43 of U.S. Patent No. 10,870,837 in view of Henry et al. (IDS, WO 2019070577). The instant polypeptide comprising a. a fusion polypeptide comprising a first Fc polypeptide linked to an IDS polypeptide having at least 90% identity to SEQ ID NO: 92, 115, or 235 and b. a second Fc polypeptide comprising a sequence comprising at least 90% to SEQ ID NO: 151 which comprises amino acid sequence of SEQ ID NO: 116, capable of specifically binding to transferrin receptor, wherein the wherein the protein is capable of being transported across BBB or a primate, wherein amino acid sequence of SEQ ID NO: 151 comprises: a. Trp, Glu at position 150, b. Tyr at position 154, c. Thr at position 156, d. Glu at position 157, e. Trp at position 158, f. Ser or Ala at position 159, g. Ser or Asn at position 160, h. Thr at position 183, i. Glu at position 185, j. Glu at position 186, and k. Phe at position 191 wherein these positions correspond to Fc of claim 1, b. according to EU numbering system, unless the evidence to contrary. It is noted that amino acid sequence of SEQ ID NO: 115 is identical to the instantly claimed sequence of SEQ ID NO: 171. Additionally, the Fc of amino acid sequence of SEQ ID NO: 151 is 100% identical to the instantly claimed Fc of SEQ ID NO: 191 (see PE2E search results). Claims 1-12, 18-24, 25-43 of U.S. Patent No. 10,870,837 do not recite treating Hunter syndrome comprising administering the pharmaceutical composition. Henry et al. teach a method of treating Hunter syndrome, also known as lysosomal storage disorder (LSD), using a composition comprising enzyme replacement therapy comprising (a) a first Fc polypeptide linked to an ERT enzyme, wherein the ERT is iduronate 2-sulfatase (IDS), an ERT variant, or a catalytically active fragment thereof, and (b) a second Fc polypeptide that forms an Fc dimer with the first Fc polypeptide (see paragraph 0004-0007]). They teach that the Fc polypeptide comprises variants at positions 380 selected from Glu, Trp, Leu, position 384 is Tyr, position 386 is Thr, position 387 is Glu, position 388 is Trp, position 389 is Ser or Ala, position 390 is Ser or Asn, position 413 is Thr, position 415 is Glu, position 416 is Glu and position 421 is Phe (see para [0027]). They teach that the composition dose is from 0.1 mg/kg to 50 mg/kg [0302]. Regarding claims 7 and 51, they teach administering the composition in weekly doses intravenously (see [0119]). They teach including a pharmaceutically acceptable excipients to the composition (see [0333]). Regarding claim 12, wherein the IDS sequence comprises SEQ ID NO: 171,175, 213 or 217, they teach IDS sequence having 100% sequence homology (see PE2E search dated Nov. 17, US-17797644-171.rai). Regarding claim 19, they teach the first Fc polypeptide having amino acid sequence with 100% sequence similarity (see PE2E search dated Nov. 17. US-17797644-169.rai). Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use (a) IDS fusion polypeptide with a first Fc and a second Fc polypeptide that binds to transferrin receptor and crosses the blood brain barrier (BBB) as taught in claims 1-12, 18-24, 25-43 of U.S. Patent No. 10,870,837 to treat Hunter Syndrome as taught by Hendry et al. Additionally, one would have been motivated to do so because Astarita et al. teaches treating Hunter syndrome by administering a pharmaceutical composition comprising: (a) a first Fc polypeptide linked to an ERT enzyme, wherein the ERT is iduronate 2-sulfatase (IDS), an ERT variant, or a catalytically active fragment thereof, and (b) a second Fc polypeptide that forms an Fc dimer with the first Fc polypeptide (see paragraph 0004-0007]). Further, one would have a reasonable expectation of success in treating Hunter syndrome because Henry et al. teach the syndrome by administering a pharmaceutical composition comprising: (a) a first Fc polypeptide linked to an ERT enzyme, wherein the ERT is iduronate 2-sulfatase (IDS), an ERT variant, or a catalytically active fragment thereof, and (b) a second Fc polypeptide that forms an Fc dimer with the first Fc polypeptide. Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36, 47-48 and 52 of copending Application No. 18/290,585 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because a method of providing clinical benefit to a subject with Hunter syndrome the method comprising administration of a protein comprising: (a) a fusion protein comprising a first Fc polypeptide linked to iduronate 2-sulfatase (IDS) amino acid sequence and (b) a second Fc polypeptide comprising SEQ ID NO: 29 or 56, wherein the therapeutically effective dose is from 3 mg/kg to about 30 mg/kg of protein, and wherein the therapeutically effective dose is about 3 mg/kg, 7.5 mg/kg, 15 mg/kg or about 30 mg/kg of protein. The instant claims do not require that the Fc polypeptide comprises SEQ ID NO: 29 or 56 or the fusion polypeptide comprises SEQ ID NO: 35-37 or 67-69. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to GYAN CHANDRA whose telephone number is (571)272-2922. The examiner can normally be reached Mon-Friday 8:30AM-5:00P. 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, Vanessa Ford can be reached at 571-272-0857. 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. /GYAN CHANDRA/Primary Examiner, Art Unit 1674
Read full office action

Prosecution Timeline

Aug 04, 2022
Application Filed
Nov 28, 2025
Non-Final Rejection — §102, §103, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12600758
INTERLEUKIN-2 MUTEINS FOR THE EXPANSION OF T-REGULATORY CELLS
2y 5m to grant Granted Apr 14, 2026
Patent 12600771
ANTIBODY FOR BINDING TO INTERLEUKIN 4 RECEPTOR
2y 5m to grant Granted Apr 14, 2026
Patent 12594323
METHODS OF REDUCING NEUROINFLAMMATION
2y 5m to grant Granted Apr 07, 2026
Patent 12589142
HLA TUMOR ANTIGEN PEPTIDES OF CLASS I AND II FOR TREATING MAMMARY/BREAST CARCINOMAS
2y 5m to grant Granted Mar 31, 2026
Patent 12576136
Insulin Derivative
2y 5m to grant Granted Mar 17, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

1-2
Expected OA Rounds
71%
Grant Probability
99%
With Interview (+27.5%)
2y 9m
Median Time to Grant
Low
PTA Risk
Based on 978 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month