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 .
DETAILED ACTION
Claims 1-4 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Claim 1 recites the recitation “wherein the therapeutically active agent is administered after administration of cisplatin.” This phrase is not supported by the disclosure of Application No. 63/311,849. While [0026] and [0027] of ‘849 provide support for oseltamivir administered prior to cisplatin and the co-administration of cisplatin and oseltamivir, the disclosure of ‘849 does not provide support for administering oseltamivir after cisplatin. This phrase is also not supported by the disclosure of Application No. 18/106,918. While [0044], [0045], and [0055] provides support for oseltamivir administered prior to cisplatin and the co-administration of cisplatin and oseltamivir, the disclosure of ‘849 does not provide support for administering oseltamivir after cisplatin.
Claims 2 and 4 recite a dosage range of oseltamivir. This dosage range is not supported by the disclose of Application No. 63/311,849. ‘849 only provides support for “oral gavage at 100 mg/kg” in [0029] and [0031].
As such, claim 1 is afforded an effective filing date of the instant Application, 09/18/2024, and claim 4 is afforded an effective filing date of Application No. 18/106,918, filed 02/07/2023.
Note: Figures 7A-7G, and their detailed description in [73]-[74], are afforded an effective filing date of the instant Application, 09/18/2024.
Claim Objections
Claims 2 and 4 are objected to because of the following informalities:
-In claims 2 and 4, the phrase “wherein the therapeutically active agent is oseltamivir” should be deleted, as it is superfluous language in view of claims 1 and 3, from which claims 2 and 4 depend.
-In claims 2 and 4, lines 2, the phrase “the dosage range” should be replaced with - -a dosage range- -.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 2015/0064282 to Josefowitz ( published 2015, IDS of 09/18/2024).
Josefowitz teaches the use of Neu1 sialidase inhibitors for the treatment of cancer (abstract).
Josefowitz specifically teaches the following:
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(pgs. 26 and 29, claims 7-8 and 25-26).
Josefowitz further exemplifies a method of treating cancer by administering oseltamivir phosphate and cisplatin ([0172], [0227] and pgs. 17-18, Tables 2-4).
While Josefowitz do not explicitly teach “to protect ear cells,” it is reasonable to assume that the administration of oseltamivir after administration of cisplatin or the co-administration of oseltamivir and cisplatin would have the same properties since the oseltamivir phosphate in the methods of Josefowitz are administered in the same dosage amounts (the instant specification teaches amounts of 2, 10, and 50 mg/kg [74], and Josefowitz teaches dosage amounts of about 0.1mg/kg-50mg/kg [0162]), to the same population (patients undergoing cisplatin therapy), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties.
See also MPEP 2112.02, Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding oseltamivir, the instant specification describes “oseltamivir phosphate” as “oseltamivir” in [43]. As such, “oseltamivir” in the claims is interpreted as “oseltamivir” or “oseltamivir phosphate.”
Regarding “to a subject in need thereof,” since cisplatin treatment causes hearing loss, all patients undergoing cisplatin treatment, are a subject in need of “protecting ear cells.”
Claim Rejections - 35 USC § 103
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 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0064282 to Josefowitz ( published 2015, IDS of 09/18/2024).
Josefowitz is applied to claims 1 and 3, as discussed above, and incorporated herein.
While Josefowitz teaches the limitations of instant claim 1 and 3, it differs from that of claims 2 and 4 in that it does not teach the dosage range of oseltamivir as between 10-50mg/kg in a mouse subject or an equivalent dosage in a human subject.
Josefowitz teaches the administration of about 0.1 to about 50mg/kg of oseltamivir phosphate ([0162]).
Josefowitz teaches its “subjects” as humans or mice or other mammals ([0093]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the dosage range of oseltamivir phosphate of Josefowitz, to arrive at instant claims 2 and 4. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of successful, because:
-Josefowitz teaches that oseltamivir phosphate is administered in an amount of about 0.1-50mg/kg, and
-in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists, MPEP 2144.05.
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Ingersoll (Tamiflu as a Therapeutic Candidate for Noise-Induced Hearing Loss, published 02/05/2022, IDS of 09/18/2024).
Note: It is respectfully requested that Applicant provide a better copy of this reference, wherein the full reference is provided without any parts of the reference cut off, and wherein the text and figures are not blurry.
Ingersoll teaches that oseltamivir phosphate (Tamiflu) protects from cisplatin induced cell death in mouse cochlear explants (Figure 1). Ingersoll specifically exemplifies administration of oseltamivir phosphate before cisplatin (Figure 1).
Regarding claim 1, while Ingersoll teaches a method of protecting cisplatin induced hair cell death in mouse cochlear explants by administering oseltamivir phosphate to cochlear explants treated with cisplatin, it differs from that of instant claim 1 in that it does not teach administration to the subject.
Ingersoll additionally teaches oseltamivir phosphate for use in humans or other mammals. Ingesoll teaches reducing hearing loss in military-service personnel during training or combat (Background). Ingersoll teaches methods wherein oseltamivir phosphate is administered to mice to protect against hearing loss (Figures 2-3, Methods).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the mouse cochlear explants with mice or humans, to arrive at instant claims 1 and 3. One of ordinary skill in the art would have been motivated to make such modifications, with a reasonable expectation of success, because:
-Ingersoll exemplifies other methods of protecting against hearing loss by administering oseltamivir phosphate to mice,
-Ingersoll teaches its methods for use, for example, in military-service personnel, and
-Ingersoll teaches “Our studies aim to characterize Tamiflu properties and measure the lowest in vivo dose required for protection against various levels of noise-exposure in the aim of repurposing and fast-tracking the drug for use in humans” (Summary, “4.”).
As such, it is clear that Ingersoll’s methods are directed toward use in mammals, such as humans and mice, and that Ingersoll’s methods would reasonably be expected to treat hearing loss in a mouse or human.
Regarding the sequence of administration recited in claims 1 and 3, while Ingersoll does not teach administration of oseltamivir phosphate after cisplatin or co-administration of oseltamivir phosphate and cisplatin, Ingersoll does teach administration of oseltamivir phosphate after noise-induced hearing loss (Figure 3) and teaches administration of oseltamivir phosphate with noise exposure (Figure 3). As such, an ordinary skilled artisan would have been motivated to modify the sequence of administration of cisplatin and oseltamivir phosphate to arrive at a method that is optimized for protecting a subject against cisplatin-induced cell death, and hence, hearing loss, and optimized for therapeutic effectiveness of cisplatin on the subject; "[W]here 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," MPEP 2144.05(II).
Regarding oseltamivir, the instant specification describes “oseltamivir phosphate” as “oseltamivir” in [43]. As such, “oseltamivir” in the claims is interpreted as “oseltamivir” and “oseltamivir phosphate.”
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Ingersoll (Tamiflu as a Therapeutic Candidate for Noise-Induced Hearing Loss, published 02/05/2022, IDS of 09/18/2024), as applied to claims 1 and 3, and further in view of US 2015/0064282 to Josefowitz ( published 2015, IDS of 09/18/2024).
Ingersoll is applied as discussed above and incorporated herein.
While Ingersoll teaches the limitations of instant claim 1 and 3, it differs from that of claims 2 and 4 in that it does not teach the dosage range of oseltamivir phosphate as between 10-50mg/kg in a mouse subject or an equivalent dosage in a human subject.
Josefowitz is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the dosage range of oseltamivir phosphate of Ingersoll, to arrive at instant claims 2 and 4. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of successful, because:
-Josefowitz teaches that oseltamivir phosphate can be administered to patients undergoing cisplatin treating in an amount of about 0.1-50mg/kg,
-Ingersoll teaches administration of 100mg/kg oseltamivir phosphate by oral lavage, to mice for noise induced hearing loss, and
-"[W]here 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," MPEP 2144.05(II).
As such, an ordinary skilled artisan would have been motivated to modify the amount of oseltamivir phosphate administered to a human subject by different modes of administration, to predictably arrive at an amount that optimizes the protection of hearing loss and optimizes efficacy of the cancer treatment.
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,053,446 (PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1 and 3, ‘446 claims a method to protect ear cells from death caused by cisplatin treatment comprising administering to a subject in need thereof, a pharmaceutical composition containing oseltamivir, wherein the composition is administered prior to cisplatin treatment (claims 2-3).
Regarding the sequence of administration recited in claims 1 and 3, while ‘446 does not teach administration of oseltamivir phosphate after cisplatin or co-administration of oseltamivir phosphate and cisplatin, ‘446 does teach administration of oseltamivir prior to or after acoustic overexposure (claims 1 and 4). As such, an ordinary skilled artisan would have been motivated to modify the sequence of administration of cisplatin and oseltamivir phosphate to arrive at a method that is optimized for protecting a subject against cisplatin-induced cell death, and hence, hearing loss, and optimized for therapeutic effectiveness of cisplatin on the subject; "[W]here 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," MPEP 2144.05(II).
Regarding oseltamivir, the instant specification describes “oseltamivir phosphate” as “oseltamivir” in [43]. As such, “oseltamivir” in the claims is interpreted as “oseltamivir” and “oseltamivir phosphate.”
Regarding claims 2 and 4, ‘446 claims a dosage range of between 10mg/kg and 100mg/kg in a mouse subject or an equivalent dosage in a human (claim 3); in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Examiner, Art Unit 1622
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