DETAILED ACTION
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 .
Election/Restrictions
Applicant's election with traverse of the specie of cancer associated with Epstein-Barr virus, in the reply filed on 3/23/2026 is acknowledged. The traversal is on the ground(s) that no undue burden would be imposed to the examiner. This is not found persuasive because the species encompassed by the claims (i.e., various disorders) have different etiologies, treatments, pathophysiology, and involved in different medical technologies. Therefore, searching for all of the species encompassed by the claims would impose undue burden to the examiner.
The requirement is still deemed proper and is therefore made FINAL.
Claims 4-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected specie, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/23/2026.
Claim Rejections - 35 USC § 112
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.
Claim 14 is 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.
Claim 14 recites the limitation "a dose of about 1.0 to about 1000mg/day" in line 1. There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 14 recited the dosage that is broader than the claim it depends from. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-3, 10-17, 20-21, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2011/113013 (‘013) in view of von Tresckow et al., J Clin Oncol 32, 8559-8559(2014). ‘013 is of record in the parent application.
‘013 teaches a method of treating herpes virus-induced condition including lymphoma by using a HDAC inhibitor, in a dosage of 0.01-1mg/kg, and an antiviral agent (see claims 1, 2, 4, 8, 16). ‘013 teaches the antiviral agent can be valganciclovir (see claim 79). ‘013 teaches the HDAC inhibitor as being administered orally (see claim 15). ‘013 also teaches the herpes virus include Epstein-Barr virus (see claim 13). ‘013 teaches various dosing/administration schedule such as pulse administration in various dosing regimen including twice daily, and sometimes, the antiviral agent is administered when no inducing agent is administered (see [00201]-[00208], also page 61, line 11-12).
‘013 does not expressly teach 4SC-202 as the HDAC inhibitor. ‘013 does not expressly teach the dosing schedule as recited.
Von Tresckow et al. teaches 4SC-202, a HDAC inhibitor, as effective in treating lymphoma, in a 25/50/100/200/400 mg QD or 200mg BID (once daily or twice daily dosing regimen (see the abstract).
It would have been obvious to one of skilled in the art to employ 4SC-202 in the method of ‘013 to treat lymphoma. It would have been obvious to one of ordinary skill in the art to employ the herein claimed dosing schedule and regimen in the method of ‘013 to treat lymphoma.
One of ordinary skill in the art would have been motivated to employ 4SC-202 in the method of ‘013 to treat lymphoma because 4SC-202 is a well-known HDAC inhibitor and it is also well-known to be effective in inhibiting lymphoma cell line and promote cell apoptosis. Employing 4SC-202 in the method of ‘013 to treat lymphoma would be reasonably expected to be effective.
Furthermore, one of ordinary skill in the art would have been motivated to employ the herein claimed dosing schedule and regimen in the method of treating lymphoma. The optimization of result effect parameters (e.g., dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The herein claimed dosage and dosing regimen are encompassed by the teachings of the cited prior art, especially von Tresckow et al., therefore, the case of obviousness exists.
The mechanism of action of the agent is considered inherently present in 4SC-202.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
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