DETAILED ACTION
The amendment submitted on July 14, 2026 has been entered. Claims 1-13 are pending in the application. Claims 3-4 and 6-7 are withdrawn. Claims 1-2, 5, and 8-13 are rejected for the reasons set forth below. No claim is allowed.
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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election without traverse of “medulloblastoma” (see claim 5) as the species for initial examination in the reply filed on July 14, 2026 is acknowledged. Claims 3-4 and 6-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Applicant’s request for rejoinder is acknowledged.
Claim Rejections – 35 USC § 102/103
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.
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 explained in MPEP1 2141 et seq. They 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 1-2, 5, and 10-13 are 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 Freyer (“ACCL0431: A Randomized Phase III Study of Sodium Thiosulfate (STS) for Prevention of cisplatin-induced Hearing Loss in Children,” consisting of 18 pages, presented at the 2014 ASCO Annual Meeting).
Freyer (cited in applicant’s IDS2) discloses using sodium thiosulfate (STS) for the preven-tion of cisplatin-induced hearing loss in children (p. 1) with localized or disseminated medullo-blastoma (p. 9), among other types of cancer. The treatment protocol is generally outlined in the Study Schema at p. 5. The STS is administered six hours after each administration of cisplatin in a treatment cycle (p. 5). The patients are 1-18 years old (p. 6), i.e., pediatric patients, it being a matter of common sense that they are human. It appears that all of the patients have at least some risk for developing cisplatin-induced nephrotoxicity. The average cumulative cisplatin dose (“Cum. CDDP dose” at p. 9) was 393 mg/m², which suggests the limitations of claims 10-11. Hearing is measured, i.e., audiometry, four weeks after treatment and is compared to a baseline measured beforehand (p. 5), which suggests the subject matter of claim 13.
The instant claims appear to be identical to the disclosure of Freyer, except for the “wherein” clauses listed below. They appear to represent applicant’s discovery of a mechanism of action or therapeutic outcome of the treatment outlined in the preceding paragraph, including at least the following claim limitations:
… wherein the administration of sodium thiosulfate does not lead to a significant reduction in glomerular filtration rate compared to a human pediatric patient less than about 2 years of age adminis-tered cisplatin to treat a localized and non-metastatic cancer but not administered sodium thiosulfate about six hours after complet-ing the administration of cisplatin (claim 1)
… wherein the administration of sodium thiosulfate does not lead to a reduction in glomerular filtration rate of grade 3 or higher as determined by National Institutes of Health (NIH) Common Termi-nology Criteria for Adverse Events version 3.0 (CTCAE) (claim 2)
… wherein the administration of sodium thiosulfate does not result in a significant increase in serum creatinine compared to a human pediatric patient less than about 2 years of age administered cisplatin to treat a localized and non-metastatic cancer but not administered sodium thiosulfate about six hours after completing the administration of cisplatin (claim 12)
Note that these “wherein” clauses do not require the artisan to perform any specific step, manipulation, selection, process, transformation, etc., other than what it already recited else-where in the claims, in order to effectuate these outcomes. Applicant is reminded that such a “wherein” clause “in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” See MPEP 2111.04. The mere discovery of such previously unappreciated properties of a known therapy, or of a scientific explanation for the prior art’s functioning, does not render it patentably new to the discoverer. The claiming of a new use, new function, or unknown property that is inherently present in the prior art, although not necessarily specifically disclosed therein, does not make the instant claims patentably novel. See MPEP 2112. Furthermore, the mere recognition of latent properties like these “wherein” clauses in the prior art does not render an otherwise known invention non-obvious. Granting a patent on the discovery of an unknown but inherent function “would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art.” The fact that applicant has apparently recognized other advantages that would flow naturally from following the suggestion of the Freyer cannot be the basis for patentability when the differ-ences would otherwise be obvious. See MPEP 2145(II).
Freyer discloses using the same drug (STS), in the same patients (pediatric cancer patients), for the same purpose (preventing cisplatin-induced hearing loss), so it is a reasonable inference that the therapeutic outcome would be the same, i.e., the “wherein” clauses listed above would necessarily follow from performing the method as taught by Freyer. The examiner therefore concludes that the “wherein” clauses listed above are inherent in the method of Freyer. In cases like this, where the prior art seems to be identical except that the prior art is silent as to an inherent characteristic, it is Office policy to make a rejection under both § 102 and § 103. “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant” to show a patentable difference between the claimed inven-tion and the teachings of Freyer. See MPEP 2112(V).
Claim Rejections – 35 USC § 103
The statutory basis for rejections under this section is set forth above.
Claims 1-2, 5, and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Freyer as applied above to claims 1-2, 5, and 10-13, and further in view of Neuwelt (Pediatr. Blood Cancer 2006;47:174-82).
The disclosure of Freyer is relied upon as set forth above. The difference between the prior art and the claims at issue is that Freyer does not specifically disclose that the patient has a serum sodium concentration of less than 145 mEq/L prior to administration or the claimed frequency and timing of administration. Neuwelt (cited in applicant’s IDS3), however, discloses that it is prudent to delay treatment of children with hypernatremia, i.e., sodium values above the normal maximum of 145 mEq/L (see the footnotes to Table II at p. 176, as well as the “Discussion” at p. 181, which states that serum sodium has a “normal range of 136-145 meq/L”). Optimizing the frequency and timing of dosage in the manner recited in claims 8-9 would have been viewed as a matter of routine experimentation well known to the skilled artisan. See MPEP 2144.05(II)(A) (Optimization Within Prior Art Conditions or Through Routine Experimentation). Indeed, applicant’s own specification acknowledges that “modifications and adaptations” (p. 21, ll. 20-21) of each patient’s “cancer treatment plan” (p. 23, l. 21) is “determined by the treating physician” (p. 16, l. 2) in the ordinary practice of clinical medicine. The examiner therefore concludes that the subject matter of claims 8-9 would have been prima facie obvious.
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 possi-ble 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 provi-sions 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 accompa-nied 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 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/195,296 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 2 of the ‘296 Application claims subject matter that is within the scope of at least instant claims 1 and 13. The examiner therefore concludes that the instant claims are prima facie obvious over the subject matter claimed in the ‘296 Application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). 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, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
September 22, 2026
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]
2 See the Information Disclosure Statement (IDS) submitted on February 2, 2024. A duplicate copy of Freyer is included with this communication for convenience.
3 See the IDS submitted on February 2, 2024.
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