DETAILED ACTION
Claims 1-12, submitted on June 11, 2026 are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
Notice of Pre-AIA or AIA Status
This application, filed on or after March 16, 2013, is being examined under the first-to-file provisions of the Leahy-Smith America Invents Act (AIA ), Pub. L. No. 112-29, 125 Stat. 284 (2011). In the event that 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 statu-tory basis 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.
Related Proceedings
See re-examination control no. 96/000,390 and inter partes review no. IPR2022-00123, both of which concern US Patent No. 10,596,190 B2. On July 5, 2023, an Inter Partes Review Certificate was issued in the ‘190 Patent in which all of the claims were cancelled.
Withdrawn Rejections
The provisional rejection of claims 1-10 on the ground of nonstatutory double patenting over copending Application No. 18/236,836 is withdrawn in view of the terminal disclaimer submitted on June 11, 2026.
Response to Arguments
Applicant argues that “Freyer and Berg fail to disclose every limitation of the claims.” See applicant’s Remarks, submitted June 11, 2026, at p. 4. In particular, applicant asserts that it improper for the examiner to conclude that “the wherein clauses in the claims are not limiting and therefore afforded no patentable weight.” Remarks at p. 5. This is because “these efficacy elements in the claim are limiting and explicitly reflect the claims’ entire purpose for the method-to clinically and significantly reduce cisplatin-induced ototoxicity in young patients with medul-loblastoma or PNET without substantively affecting relapse free survival or overall survival.” Remarks at p. 5. The examiner recognizes and appreciates the scientific merit of these observa-tions, but Office policy remains that the discovery of such “latent properties” in the prior art does not entitle applicant to a patent. See MPEP 2145(II). Applicant’s arguments in this regard are therefore not persuasive.
Applicant further argues that “[n]either Freyer nor Berg disclose any data or information sufficient to allow a person of skill to reasonably expect that the efficacy limitations provided in the wherein clauses as provided in the claims would be met.” Remarks at p. 4. According to applicant, Freyer only discloses limited data for some tumors, and it does not provide data for the reduction in cisplatin-induced hearing loss between the sodium thiosulfate group and the observation group by specific tumor-type. Applicant further asserts that Berg also discloses no such data. Remarks at p. 4. According to applicant, the claimed invention is only possible with the critical “missing data [that] is provided in the instant specification (see, e.g., Figs. 9, 23, 24B, and 24B).” Remarks at pp. 4-5. It remains the examiner’s position, however, that the cited references disclose all of the operative or manipulative steps of the claimed invention, including selecting pediatric cancer patients with particular types of cancers and administering sodium thiosulfate to these patients for the prevention of cisplatin-induced hearing loss. The therapeutic outcomes or results of this treatment do not advance the useful arts as discussed in MPEP 2112 and 2145(II). This argument is therefore not persuasive.
Applicant asserts that the rejections under § 103 as being obvious over Freyer, Berg, Dickey, and Neuwelt should likewise be withdrawn. Applicant does not provide separate arguments concerning Dickey or Neuwelt, so the rejection is maintained for the reasons set forth above. Applicant’s arguments have been fully considered but are not persuasive, and the rejec-tions are therefore maintained.
Maintained Rejections 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 explained in MPEP 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 1-6, 10, and 12 remain rejected under 35 U.S.C. 103 as being prima facie obvious over Freyer (“ACCL0431: A Randomized Phase III Study of Sodium Thiosulfate (STS) for Preven-tion of cisplatin-induced Hearing Loss in Children,” consisting of 18 pages, presented at the 2014 ASCO Annual Meeting) in view of Berg et al., Laryngoscope 1999;109(11):1806-14.
Freyer (cited in the prior action) discloses using sodium thiosulfate (STS) for the preven-tion of cisplatin-induced hearing loss in children (p. 1) with medulloblastoma (p. 9), among other types of cancer. The treatment protocol is generally outlined in the Study Schema at p. 5. The STS is administered “IV” (i.e., intravenously) six hours after each administration of cisplatin in a treatment cycle (p. 5). Hearing is measured by standard audiometry four weeks after treatment and is compared to a baseline measured beforehand (p. 5). Hearing loss is determined, for example, as “> 20 dB loss at 1 frequency or > 10 dB at 2 consecutive frequencies” (p. 7), which meets the limitation of 2. The patients are 1-18 years old (p. 6), i.e., pediatric patients, including children “<5 years old” (p. 17), it being implicit that they are human, which meets the limitations of claims 3-4. The average cumulative cisplatin dose (“Cum. CDDP dose” at p. 9) was 393 mg/m², which suggests the limitations of claims 5-6. In some cases, the children had prior cranial irradi-ation (pp. 6 and 9), which meets the limitations of claim 12.
The difference between the prior art and the claims at issue is that Freyer does not specifically disclose that the cisplatin is administered over a period of six hours or less (see instant claim 1).
Berg (also cited in the prior action), however, discloses that “a 6-hour period” was known in the prior art as the chemotherapy protocol for administering cisplatin to children (see “Chem-otherapy protocol” at p. 1809).
It would have been prima facie obvious to one of skill in the art to administer the cisplatin over a six-hour period as taught by Berg when practicing the therapy of Freyer and thereby arrive at subject matter within the scope of the instant claims. Note that Freyer is silent regarding the administration protocol, including the amount of time for IV administration of cisplatin, because it would have been within the ordinary skill of the artisan to look up this information. Berg provides an answer to the question of how to administer the cisplatin.
The “wherein” clauses at the end of claim 1 appear to represent applicant’s discovery of a mechanism of action or therapeutic outcome of the treatment outlined above, including the following claim limitations:
… wherein the medulloblastoma or PNET pediatric patient is at least about 50% less likely to experience cisplatin-induced hearing loss than a medulloblastoma or PNET pediatric patient adminis-tered cisplatin to treat a medulloblastoma or PNET tumor but not administered sodium thiosulfate about six hours after completing the administration of cisplatin (claim 1)
… wherein the administration of sodium thiosulfate does not result in a significant difference in relapse free survival or overall survival in the medulloblastoma or PNET pediatric patient compared to a medulloblastoma or PNET pediatric patient administered cisplatin but not administered sodium thiosulfate (claim 1)
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/Berg.
Claims 1-12 remain rejected under 35 U.S.C. 103 as being prima facie obvious over Freyer and Berg as applied to claims 1-6 and 12 above, and further in view of Dickey et al., J. Pharmacol. Exp. Ther. 2005;314(3):1052-58 and Neuwelt et al., Pediatr. Blood Cancer 2006;47(2):174-82.
The disclosures of Freyer and Berg are relied upon as set forth above.
With respect to claims 7-9, the difference between the prior art and the claims at issue are that Freyer and Berg do not specifically disclose the claimed dosage amounts of STS. Dickey (cited in the prior action), however, discloses that 8 g/m² STS was known to be otoprotective against platinum-caused hearing loss (see Abstract). Note that Dickey is footnote 2 cited in Freyer at p. 3. Neuwelt (also cited the prior action) discloses that 10-16 g/m² STS was also known to be otoprotective against platinum-caused hearing loss in children (see Abstract). Neuwelt also discloses “high dose STS (20 mg/m²)” (p. 175, right col.). Note that Neuwelt is footnote 5 cited in Freyer at p. 3. Dickey and Neuwelt are evidence that the dosage amounts referred to in claims 7-9 were generally known in the prior art. In situations like this, where the general conditions of a claim are disclosed in the prior art, “it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP 2144.06. The examiner therefore concludes that the subject matter of claims 7-9 would have been viewed as the result of routine optimization within the general teachings of the prior art and accordingly are prima facie obvious.
With respect to claim 11, Neuwelt discloses that treatment of PNET tumors with platinum-containing chemotherapies also have the undesirable side effect of hearing loss (see Table II at p. 176 and the discussion thereof). It would have been desirable, and therefore prima facie obvious, to one of skill in the art to prevent cisplatin-induced hearing loss in pediatric patients (Freyer/Berg), including patients with PNET tumors (Neuwelt). One would have had a reasonable expectation of success because the implicit disclosure of Freyer (see, e.g., p. 4) is that the use of STS would be expect to be useful in the prevention of hearing loss from cisplatin chemotherapy, regardless of the particular type of cancer being treated.
Conclusion
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 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 16, 2026
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