DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendments of 10/04/2024 have been entered in full. Claims 1-18 are cancelled. Claims 19-32 are pending.
All prior objection/rejections not specifically maintained in this Office action are hereby withdrawn in view of Applicants’ amendment and/or arguments filed 10/04/2024.
Claim Rejections - 35 USC § 112
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 24 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 24 includes ruxolitinib in a group from which the tyrosine kinase inhibitor of claim 23 is to be selected. Claim 23 recites “wherein the tyrosine kinase inhibitor inhibits ABL and/or BCR-ABL”. Ruxolitinib inhibits JAK1 /JAK2, not ABL and/or BCR-ABL (see [0093] in publication US 20210324092]. Therefore, the ruxolitinib embodiment of claim 24 is outside the scope of claim 23.
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.
Claims 20 and 21 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.
Claim 20 recites that “the Philadelphia chromosome positive ALL is resistant to treatment with ABL kinase inhibitors.” This wording implies that the ALL is resistant to all ABL kinase inhibitors, which would include the imatinib recited in claim 21. Thus, it is unclear whether claim 21 actually further limits claim 20. Interpreting claim 21 as further limiting claim 20 raises uncertainty as to the scope of “ABL kinase inhibitors” in claim 20. Should claim 20 recite ““ABL kinase inhibitors, except sometimes not imatinib”?
Clarity would be improved if claim 20 were amended to recite “the Philadelphia chromosome positive ALL is resistant to treatment with an ABL kinase inhibitor.”
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 19-21, 26, and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over US 20180251561 (Durum; of record), taken together with US 20150246975 (Doshi; of record) and US 20150301032 (De).
Durum teaches a method of treating ALL by administering a monoclonal antibody that binds the extracellular domain of IL-7Ra, as in pending claim 19. Durum teaches embodiments wherein the antibody is administered in combination with a CXCR4 antagonist, such as AMD3100, as in claims 19 and 29-32 [0007][0026][0078]. AMD3100 and anti- IL-7Ra work synergistically to deplete leukemia cells from bone marrow [0362].
The treatment taught in Durum is generally directed to all IL-7R+ ALL patients without regard to the presence or absence of the Philadelphia chromosome or whether the patient may have been treated with a kinase inhibitor. Consequently, Durum does not particularly point out leukemia that is that is Philadelphia chromosome positive, as in claim 19, nor leukemia that is resistant to ABL kinase inhibitors as the subject of treatment, as in claim 20.
The prior art teaches that the Ph chromosome is present in about 20% of adults with ALL and that patients with Ph+ positive ALL on a tyrosine kinase inhibitor regimen may become resistant to the inhibitor and subsequently relapse (Doshi [0079]). When this occurs, it is desirable to use a therapy directed to a target other than the ABL kinase. Doshi provides an example wherein the alternative target is CD38, which is expressed on the surface of leukemic cells. As noted above, Durum teaches that ALL can be treated by administering a monoclonal antibody that binds IL-7R alone, or in combination with AMD3100. Therefore, one of skill in the art would expect that a monoclonal antibody that binds IL-7R would be successfully used in a manner analogous to the anti-CD38 antibody in Doshi for targeting leukemic cells that are resistant to kinase inhibitors. This expectation is further supported by the suggestion in De that IL7R+ could represent a biomarker for residual/relapsed disease in Ph+ leukemias [0080].
While one of skill in the art would have no reason to expect that treatment with a monoclonal antibody that binds the extracellular domain of IL-7R, alone or in combination with AMD3100, as in Durum, would fail in any particular subset of IL-7R+ ALL patients, the combined teachings of Durum, Doshi, and De favor the use of a monoclonal antibody that binds the extracellular domain of IL-7R in patients with Ph+ leukemias that have become resistant to ABL kinase inhibitors. Therefore, the method of claim 20, and claims dependent therefrom, is prima facie obvious in view of the combined teachings of Durum, Doshi, and De.
Conclusion
Claims 19-21, 24, 26, and 29-32 are rejected.
Claims 22, 23, 25, 27, and 28 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL C GAMETT, Ph.D., whose telephone number is (571)272-1853. The examiner can normally be reached on M-W. Please note the examiner’s part-time schedule. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached on 5712722911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL C GAMETT/Primary Examiner
Art Unit 1647