DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group I with the election of species of atorvastatin as the compound with one or more pharmacological activities/pharmacokinetic parameters similar to atorvastatin, the species of nonsteroidal antiinflammatory agent as the drug inducing hearing loss, and the dosage form is a tablet in the reply filed on 09/03/2025 is acknowledged. The traversal is on the ground(s) that it is not appropriate to raise lack of unity on a national phase entry, that the groups are linked as to form a single general inventive concept, and do not cause a serious or undue burden to the Office. Applicant also asserts that there is no burden on the species and that there is no evidence in the way of distinctness citing MPEP 806, 808, and 803.02. This is not found persuasive because the application is the national stage entry of PCT/US2021/014918 wherein contrary to Applicant’s assertion that it is not appropriate to raise lack of unity at national stage entry, if the examiner finds that the national stage entry lacks unity of invention, the examiner may require the application to elect the invention to which the claims shall be restricted (MPEP 1893.03(d)), wherein the lack of unity and restriction is appropriate. The assertion that the groups are linked as to form a single general inventive concept is not persuasive as addressed in the previous presented restriction as the technical feature linking the groups does not constitute a special technical feature as demonstrated by Nakagawa and does not define a contribution over the prior art. As for the traversal on the grounds for meeting burden, this is not persuasive because the instant case is submitted under 35 U.S.C. 371, the Unity of Invention practice in MPEP §1850 and MPEP §1893.03(d) was followed, not restriction practice. This is also the case with regards to Applicant’s arguments for the election of species Thus the criteria for burden stated in MPEP §803 (and MPEP 806, 808 as cited by Applicant) for national applications filed under 35 U.S.C. 111(a) does not apply (MPEP §801). The lack of unity has been addressed in the previous action. As the technical feature did not contribute over the art, the restriction was applied appropriately; and the species are not unified as addressed in the prior action, the election of species was applied appropriately.
The requirement is still deemed proper and is therefore made FINAL.
Upon review, the election of species for the compound with one or more pharmacological activities/pharmacokinetic parameters similar to atorvastatin is expanded to the group of statins (HMG-CoA reductase inhibitors), the species of the drug inducing hearing loss is expanded to include chemotherapeutic platinum based drugs like cisplatin and carboplatin, the dosage form is expanded to include capsules and oral liquid forms.
Status of Application
Applicant has elected Group I in response to restriction requirement and elected the species atorvastatin as the compound with one or more pharmacological activities/pharmacokinetic parameters similar to atorvastatin, the species of nonsteroidal antiinflammatory agent as the drug inducing hearing loss, and the dosage form is a tablet for the examination.
Upon review, the election of species for the compound with one or more pharmacological activities/pharmacokinetic parameters similar to atorvastatin is expanded to the group of statins (HMG-CoA reductase inhibitors), the species of the drug inducing hearing loss is expanded to include chemotherapeutic platinum based drugs like cisplatin and carboplatin, the dosage form is expanded to include capsules and oral liquid forms.
Due to restriction, based on election of Group I and the elected/expanded species addressed above, claims 19, 34 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-6, 8-19, 34, 48, 53-55 are pending.
Claims 1-6, 8-18, 48, 53-55 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement filed 11/14/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Rejections - 35 USC § 102
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.
Claims 1-6, 8-9, 12-13, 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sherman et al. (U.S. Pat. Pub. 2016/0235782).
Rejection:
Sherman et al. teaches and specifically claims treating platinum-induced ototoxicity (Sherman established that ototoxicity from platinum-containing chemotherapeutic agents is known in the art [3], ototoxicity is hearing loss and damage to the inner ear from a medication/active agent) with the administration of sodium thiosulfate pentahydrate in combination with a HMG CoA reductase inhibitor (statin) like atorvastatin and lovastatin (claim 21, 23, 26, 44); which is claimed and immediately envisioned (see full document specifically claims cited). The properties of crossing blood barrier separating the inner ear from peripheral blood and reducing the threshold shift when reducing hearing loss are inherently present as the same statin actives are being administered wherein the same permeability (crossing blood barrier) properties must be present and the properties/effects such as the reduction in threshold shift is inherently present as there is a reduction of hearing loss - and a reduction in threshold shift is simply a reflection of a reduction of hearing loss which necessarily flows from the teaching/claims of the prior art where the same active is being administered to the patient for the same purpose and there is a reduction of hearing loss (you can’t have a reduction in threshold shift without a reduction of hearing loss as it is a reflection of the reduction of hearing loss). It is noted that the claimed breath does not recite “a patient in need thereof” wherein the administration of the statin for any purpose would inherently address any drug induced hearing loss present.
All the critical elements are taught by the cited reference and thus the claims are anticipated.
In the alternative, even if one would assert that one could not immediately envision the method as claimed by Sherman et al., it would be implicit if not prima facie obvious as addressed below.
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.
Claims 1-6, 8-9, 12-13, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Sherman et al. (U.S. Pat. Pub. 2016/0235782).
Rejection:
Sherman et al. teaches and specifically claims treating platinum-induced ototoxicity (Sherman established that ototoxicity from platinum-containing chemotherapeutic agents is known in the art [3], ototoxicity is hearing loss and damage to the inner ear from a medication/active agent) with the administration of sodium thiosulfate pentahydrate in combination with a HMG CoA reductase inhibitor (statin) like atorvastatin and lovastatin (claim 21, 23, 26, 44); which is claimed and implicit if not prima facie obvious to one of ordinary skill in the art (see full document specifically claims cited). The properties of crossing blood barrier separating the inner ear from peripheral blood and reducing the threshold shift when reducing hearing loss are intrinsically present as the same statin actives are being administered wherein the same permeability (crossing blood barrier) properties must be present and the properties/effects such as the reduction in threshold shift is intrinsically present as there is a reduction of hearing loss – and a reduction in threshold shift is simply a reflection of that reduction of hearing loss which necessarily flows from the teaching/claims of the prior art where the same active is being administered to the patient for the same purpose and there is a reduction of hearing loss (you can’t have a reduction in threshold shift without a reduction of hearing loss as it is a reflection of the reduction of hearing loss). It is noted that the claimed breath does not recite “a patient in need thereof” wherein the administration of the statin for any purpose would address any drug induced hearing loss present in the patient.
Claims 10, 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sherman et al. (U.S. Pat. Pub. 2016/0235782) as applied to claims 1-6, 8-9, 12-13, 18 above.
Rejection:
The teachings of Sherman et al. are addressed above. Sherman established that ototoxicity from platinum-containing chemotherapeutic agents is known in the art wherein the patients implicitly have cancer (being treated with chemotherapy) and that the platinum agents include cisplatin (claim 21, 23, 26, 44, [3,13, 241]) and administration can be oral (claim 21). Sherman et al. also teaches that the combination therapy can have more than one therapy as claimed with HMG CoA reductase inhibitors (statins), and triple therapy is also contemplated and that the order of therapies are not restricted such as where the first can be administered prior or be administered concomitantly or subsequent to another therapy which also includes platinum complexes like cisplatin and carboplatin ([252-253], see full document specifically areas cited).
Wherein while Sherman et al. does not exemplify administering the statin and sodium thiosulfate pentahydrate prior to the platinum agents or during administration of the platinum agents, Sherman et al. does expressly teach that order of therapies are not restricted such as where the first can be administered prior or be administered concomitantly or subsequent to another therapy which also includes platinum complexes like cisplatin and carboplatin, it would be prima facie obvious to exemplify the teachings of Sherman to administer the actives like the statin as taught (prior to or during/concomitantly) with the platinum agents to treat the platinum-induced ototoxicity with a reasonable expectation of success.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Sherman et al. (U.S. Pat. Pub. 2016/0235782) as applied to claims 10, 14-17 above, in view of Noronha et al. (Once-a-Week Versus Once-Every-3-Weeks Cisplatin Chemoradiation for Locally Advanced Head and Neck Cancer: A Phase III Randomized Noninferiority Trial-Abstract only).
Rejection:
The teachings of Sherman et al. are addressed above including treating ototoxicity from platinum-containing chemotherapeutic agents known in the art including cisplatin (patients implicitly have cancer being treated with the chemotherapeutic platinum-containing agent).
Sherman does not expressly recite that the cancer is head or neck cancer but is directed to platinum-containing chemotherapeutic agents like cisplatin.
Noronha et al. teaches that cisplatin 100mg/m2 once every 3 week is the standard of care in locally advanced head and neck squamous cell cancer (first sentence).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the cancer using cisplatin to be head and neck cancer as suggested by Noronha et al. and produce the claimed invention; as it is prima facie obvious for the cancer to be the one for which the cisplatin is the standard of care with a reasonable expectation of success.
Claims 48, 53-54 are rejected under 35 U.S.C. 103 as being unpatentable over Sherman et al. (U.S. Pat. Pub. 2016/0235782) as applied to claims 1-6, 8-9, 12-13, 18 above, in view of Choung et al. (WO 2018/164526).
U.S. Pat. Pub. 2020/0022954 is the national stage of Choung et al. (WO 2018/164526) and used as the translation. All references are to the translation.
Rejection:
The teachings of Sherman et al. are addressed above.
Sherman et al. does not expressly teach the dose of HMG CoA reductase inhibitors (statins) but does teach their inclusion.
Choung et al. teaches that hearing loss can be caused by medications such as anticancer drugs and certain health conditions like diabetes [2-3]. Choung et al. teaches HMG-CoA reductase inhibitors like atorvastatin and lovastatin for treating or preventing hearing loss (claim 1-4, 6-7, 13; [11-14, 28, 30, 40-41]) and the dose to be more preferably 0.01-10mg/kg (standard man is 70kg= 0.7-700mg) which can be administered once to several times a day [37], which can be increased or decreased depending the various factors including disease severity, body weight, age and the like [38]. The dosage forms include a tablet and capsule [14, 32].
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate HMG CoA reductase inhibitors (statins) at their known dose range/frequency and forms and produce the claimed invention; as it is prima facie obvious to incorporate the statins at its known dosage range and frequence in their known forms like tablets and capsules, useful for hearing loss with a reasonable expectation of success. It would also be prima facie obvious to optimize within the known dose range and arrive at the claimed values as a means of attain the desired therapeutic profile depending on disease severity and other factors with a reasonable expectation of success absent evidence of criticality for the claimed values.
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Sherman et al. (U.S. Pat. Pub. 2016/0235782) in view of Choung et al. (WO 2018/164526) as applied to claims 48, 53-54 above, further in view of Beringer et al. (Capsules).
Rejection:
The teachings of Sherman et al. in view of Choung et al. are addressed above.
Sherman et al. in view of Choung et al. do not recite the capsule to be a gelatin capsule but does teach a capsule dosage form.
Beringer et al. teaches that capsules are either a hard or soft container/shell of a suitable form of gelatin (capsules are gelatin capsules/containers that are either hard or soft, first sentence).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the capsules containing the HMG CoA reductase inhibitors (statins) would be gelatin capsules as suggested by Beringer et al. and produce the claimed invention; as Beringer et al. establishes that capsules are known to be gelatin capsules that are either hard or soft wherein it is implicit if not prima facie obvious that the taught capsules would be gelatin with a reasonable expectation of success.
Conclusion
Claims 1-6, 8-18, 48, 53-55 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613