DETAILED ACTION
Claims 1-12, submitted on May 9, 2023 are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
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.
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. See MPEP 2141 et seq.
Claims 1-6, 10, and 12 are 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 Prevention 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 applicant’s IDS1) 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 irradiation (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 applicant’s IDS2), however, discloses that “a 6-hour period” was known in the prior art as the chemotherapy protocol for administering cisplatin to children (see “Chemotherapy protocol” at p. 1809).
It would have been prima facie obvious to one of skill in the are 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 administered 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 are 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 applicant’s IDS3), 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 in the IDS4) 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.
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 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 10-13 of copending Application No. 18/236,836 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the ‘836 Application are directed to a method of reducing the risk of cisplatin-induced hearing loss in a pediatric patient with medulloblastoma comprising administering STS. See, e.g., claims 1 and 5 submitted on August 22, 2023 in the ‘836 Application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
November 21, 2025
1 See the Information Disclosure Statement (IDS) submitted on February 2, 2024. A copy of this reference may be found in the file for 16/384,153.
2 For convenience, a copy of this reference is included herewith.
3 For convenience, a copy of this reference is included herewith.
4 A copy of this reference is also attached.