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 without traverse of Group I, claims 1,2,5,10,13,15-20,23,28,34,36 in the reply filed on 04/03/2026 is acknowledged.
Claims 37,49-50,53 and 59 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/04/2026.
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.
Claims 15-16 remain 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. The rejection of claims 5,10 and 13 is withdrawn.
Claim 15 and dependent claim 16 remain unclear. Claim 15 previously depended from claim 2, which limits the growth factor to a PI3K and Akt pathway. Claim 15 now depends from claim 1 but still refers to the PI3K and Akt pathway, which is not recite3d in claim 1. are also unclear for limiting an optional embodiment of parent claim 2. Claim 2 does not require the growth factor be a stimulator of the PI3K/Akt pathway. It is not clear if claim 15 is intended to require claim 2 include the limitation “stimulator of the PI3K/Akt pathway”. If claim 15 is intended to depend from claim 1, the components in claim 1 are not conditional and claim 15 should not recited “is present”.
Claims 1-2,5,10,13,15-20,23,28,34,36 and 61-68 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 1 is unclear as it recites “at least one…wherein the at least one…is…”. Following this phrase is a single LMP inhibitor, which is closed and defined and doesn’t allow further LMP inhibitors. Claim 1 would be more clear if it read, “at least one…wherein the at least one…comprises…”. Claims 2,5,10,13,15-20,23,28,34,36 and 61-68 are unclear given their dependency from claim 1.
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.
The rejection of claim 36 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form is withdrawn.
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.
A) The rejection of claim(s) 1,2,10,15-16,20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loison (Journal of Clinical Investigation, Volume 124 Number 10 2014 4445-4458) is withdrawn given Applicant’s arguments of significantly higher survival of neutrophils when the components are combined (page 12, Remarks 08/04/2026).
B) The rejection of claim(s) 2,5 under 35 U.S.C. 103 as being unpatentable over Loison (Journal of Clinical Investigation, Volume 124 Number 10 2014 4445-4458 as applied to claims 1,2,10,15-16,20 above, and further in view of Gabet (Cell Death and Differentiation (2011) 18, 678–689) is withdrawn given Applicant’s arguments of significantly higher survival of neutrophils when the components are combined (page 12, Remarks 08/04/2026).
C) The rejection of claim(s) 2,10 under 35 U.S.C. 103 as being unpatentable over Loison (Journal of Clinical Investigation, Volume 124 Number 10 2014 4445-4458 as applied to claims 1,2,10,15-16,20 above, and further in view of Huang (J. Nutr. 132: 2151–2156, 2002) is withdrawn given Applicant’s arguments of significantly higher survival of neutrophils when the components are combined (page 12, Remarks 08/04/2026).
D) The rejection of claim(s) 17-19 and 23 under 35 U.S.C. 103 as being unpatentable over Loison (Journal of Clinical Investigation, Volume 124 Number 10 2014 4445-4458 as applied to claims 1,2,10,15-16,20 above, and further in view of Shlomovitz (The FEBS Journal 286 (2019) 507–522) is withdrawn given Applicant’s arguments of significantly higher survival of neutrophils when the components are combined (page 12, Remarks 08/04/2026).
E) The rejection of claim(s) 28 under 35 U.S.C. 103 as being unpatentable over Loison (Journal of Clinical Investigation, Volume 124 Number 10 2014 4445-4458) in view of Gabet (Cell Death and Differentiation (2011) 18, 678–689), Huang (J. Nutr. 132: 2151–2156, 2002), and Shlomovitz (The FEBS Journal 286 (2019) 507–522) is withdrawn given Applicant’s arguments of significantly higher survival of neutrophils when the components are combined (page 12, Remarks 08/04/2026).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The rejection of claims 1,2,5,10,13,15-19,34,36 under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter is withdrawn given Applicant’s arguments of the combination of components having markedly different characteristics that each individual component by itself (pages 15-16, Remarks 08/04/2026).
Conclusion
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 VALARIE BERTOGLIO whose telephone number is (571)272-0725. The examiner can normally be reached M-F 6AM-2:30PM.
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VALARIE E. BERTOGLIO, Ph.D.
Examiner
Art Unit 1632
/VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632
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