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
This Office Action is in response to Applicant’s Arguments and Amendment filed, 06/15/2025, wherein the Amendment amended claim 8 and added claims 14-16.
Claims 8 and 14-16 are pending.
Priority
The instant application claims priority to provisional application 63/311/849, filed 02/18/2022. See the Filing Receipt dated 10/11/2023.
REJECTIONS MAINTAINED, MODIFIED, & NEW
The Amendment to the claims has resulted in the below new and modified rejections. The same primary reference continues to be relied upon for the rejection of independent claim 8.
Claim Objections
(New) Claim 8 is objected to because of the following informalities: the claim does not end with a period. Each claim must begin with a capital letter and end with a period. Periods may not be used elsewhere in the claims except for abbreviations. See MPEP 608.01(m).
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a), New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
(New) Claims 14-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new matter rejection.
The dosage amounts of oseltamivir recited in claims 14-16 are not supported by the original disclosure. Applicant points to paragraphs [0016], [0038], [0055], and Figures 4A-4C for support. However a careful review of these paragraphs and Figures, and the entirety of the original disclosure, is not sufficient to provide support.
Paragraph [0016] is a description of Fig 3B showing auditory brainstem response threshold shifts; paragraph [0038] is a description of compositions forms; paragraph [0055] is a description of Figs. 4A-C and recites IP injection of 50mg/kg, 10mg/kg, and 50mg/kg dosage amounts of oseltamivir; and Figures 4A-4C are also descriptions of IP injection of 50mg/kg, 10mg/kg, and 50mg/kg dosage amounts of Oseltamivir.
As such, the dosage amounts for oseltamivir recited in claims 14-16 are new matter.
Claim Rejections - 35 USC § 112(b)
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.
(New) Claims 14-16 are 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.
-Claims 14-16 recites the limitation "The pharmaceutical formulation.” There is insufficient antecedent basis for this limitation in the claim.
-Though claims 14-16 recite “The pharmaceutical formulation,” claims 14-16 lack a transition phrase and do not recite any formulation, but recite an effective amount of oseltamivir following “wherein.” As such, it is not clear what pharmaceutical formulation is being claimed since it is not known what is included or excluded from the formulation; the metes and bounds of the claims are unascertainable.
In view of compact prosecution, for the purpose of applying prior art, Claims 14-16 are interpreted as “A pharmaceutical formulation comprising an effective amount of oseltamivir or a pharmaceutically acceptable salt thereof, wherein the effective amount of oseltamivir is a 30/45/75mg unit dose.”
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 (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.
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.
(New) Claims 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Medscape (Oseltamivir, published 02/17/2022, PTO-892).
Medscape teaches 30 mg, 45 mg, and 75 mg capsules of oseltamivir (“Dosage Forms & Strengths”).
Regarding the intended use recitation, “to protect ear cells from death caused by cisplatin,” since the capsules of Medscape are capable of performing the instant intended use, then the capsules of Medscape meet this limitation. See MPEP 2112.01 and 2111.02.
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).
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 non-obviousness.
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.
(Maintained/Modified) Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0064282 to Josefowitz ( published 2015, PTO-892 of 06/25/2024).
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 teaches a composition comprising oseltamivir phosphate and cisplatin, it differs from that of the instantly claimed invention in that it does not teach a composition in an oral unit dosage form.
Josefowitz teaches that its compositions can be in oral unit dosage forms, such as tablets, pills and the like, injection dosage forms, and other forms ([0092], [0147], [0149], [0156]-[0160]). Jones further teaches that its compositions can be administered to a patient in a variety of forms depending on the selected route of administration, as will be understood by those skilled in the art ([0148]).
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 select an oral unit dosage form as the form of the compositions of Josefowitz, to arrive at instant claim 8. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Josefowitz exemplifies a composition comprising oseltamivir and cisplatin that is administered as an injection, and Josefowitz teaches that its compositions can be administered orally or as injections,
-Josefowitz teaches that its orally administered compositions can be unit dosage forms, such as tablets, pills and more, and
-Josefowitz teaches that its compositions can be administered to a patient in a variety of forms depending on the selected route of administration, as will be understood by those skilled in the art.
As such, an ordinary skilled artisan would have been motivated to make such a selection to predictably arrive at a dosage form that is easily self-administered and that administers a consistent dosage amount of oseltamivir and cisplatin.
Regarding the phrase “consisting essentially of,” as discussed in MPEP 2111.03 (III), this phrase limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of "consisting essentially of," applicant has the burden of showing that the introduction of
additional steps or components would materially change the characteristics of the claimed invention. Since the instant specification does not discuss what limitations would “materially affect the basic and novel characteristic(s)” of the claimed invention, the phrase “consisting essentially of” is interpreted no differently than “comprising.”
Regarding the intended use recitation, “to protect ear cells from death caused by cisplatin,” since the composition of Josefowitz is capable of performing the instant intended use, then the composition of Josefowitz meets this limitation. See MPEP 2112.01 and 2111.02.
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).
Response to Arguments
Regarding Applicant’s arguments on pgs. 3-6, Remarks, directed toward the unit dosage form limitation of claim 8, it is respectfully noted that this limitation is addressed in the above modified rejection.
On pg. 6, Remarks, Applicant argues that the instant invention is not obvious because it has unexpected properties. However, Applicant has provided no evidence of unexpected properties, but instead cites Allergan, Inc v. Sandoz Inc, and Ex parte Aarti Rege.
Regarding Allergan, Inc v. Sandoz Inc, while this is referenced in MPEP 2164.02 and 2144.05, it is not clear how the references in MPEP 2164.02 and 2144.05 are applicable to Applicant’s arguments of unexpected properties.
Regarding Ex parte Aarti Rege, it is noted that Ex parte Aarti Rege is not referenced in the MPEP. As such, it is not clear that the facts of Ex parte Aarti Rege align with those of the instant application. The Applicant has only provided a couple of sentences from the case, but has not addressed the fact patterns within the case. And it is further not clear if the cited portion is the opinion of the Board. Moreover, based on the reference to Ex parte Aarti Rege on pg. 6, Remarks, it appears that data was relied upon to show a significant and unexpected result.
Applicant is respectfully reminded that the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. See MPEP 716.01(c).
And MPEP 716.02 states that unexpected results a) are greater than expected results, b) show superiority of a property shared with the prior art, c) exhibit the presence of an unexpected property, and/or d) exhibit the absence of an expected property. MPEP 716.02 additionally states that unexpected results must be commensurate in scope with the claimed invention and provide a comparison with the closest prior art.
On pg. 4, Remarks, Applicant argues that “an effective amount of oseltamivir or a pharmaceutically acceptable salt thereof to protect ear cells from death caused by cisplatin” should be given patentable weight.
This argument has been fully considered, but is not found persuasive. It is respectfully pointed out that the Josefowitz teaches an effective amount of oseltamivir, and as discussed above, regarding the intended use recitation, “to protect ear cells from death caused by cisplatin,” since the composition of Josefowitz is capable of performing the instant intended use, then the composition of Josefowitz meets this limitation. See MPEP 2112.01 and 2111.02.
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).
Moreover, regarding amounts, it is pointed out that the instant specification teaches 10mg/kg, 50mg/kg and 100mg/kg amounts of oseltamivir ([0026]-[0029], [0055]-[0062]) and Josefowitz teaches 2mg/kg, 10mg/kg, 50mg/kg, and 100mg/kg amounts of oseltamivir (Fig. 2a, Fig. 3b, Fig. 7, [0077]-[0080], [0162], [0231], [0239], pg. 20 Tables 8-9, pg. 23 Table 13). Thus, Josefowitz teaches the same effective amounts as those exemplified by the instant specification. As such, Josefowitz teaches “an effective amount of oseltamivir or a pharmaceutically acceptable salt thereof to protect ear cells from death caused by cisplatin.”
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.
(Maintained/Modified) Claim 8 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 18/888,396 (claim set dated 09/18/2024) in view of US PG-PUB 2015/0064282 to Josefowitz ( published 2015, PTO-892 of 06/25/2024).
‘396 claims a method to protect ear cells comprising administering a pharmaceutical composition containing a therapeutically active agent to reduce hearing loss caused by cisplatin treatment, wherein the active agent is oseltamivir and it is co-administered with cisplatin (claim 3).
‘396 claims 10 and 50 mg/kg dosage amounts (claim 2).
While ‘396 claims co-administration of cisplatin and oseltamivir, it differs from that of instant claim 8 in that it does not claim a composition in an oral unit dosage form
Josefowitz is applied as discussed above.
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 select an oral unit dosage form to administer the combination of oseltamivir and cisplatin in ‘396, to arrive at instant claim 8. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because Josefowitz teaches that oseltamivir and cisplatin can be combined together in an oral unit dosage forms for therapeutic use.
As such an ordinarily skilled artisan would have been motivated to make such a selection to predictably arrive at a method of ‘396 that is easily self-administered and that administers a consistent dosage amount of oseltamivir and cisplatin.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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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/L.Q.W./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622