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 1, claims 1-9 in the reply filed on 17 April 2026 is acknowledged.
Claim 10 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 17 April 2026.
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.
Claims 1-3 and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sieweke et al. (WO 2008/084069A1, IDS ref.) as evidenced by NCBI (Reference sequence NM_001031804.3, first published 2013).
Regarding claims 1 and 2, Sieweke teaches methods for inhibiting the expression or activity of MafB and c-Maf in monocytes, macrophages (claim 2), or dendritic cells and expanding said cells (Abstract). Expanding cells read as proliferating cells. Sieweke teaches the monocytes, macrophages, or dendritic cells may be from any species, preferably murine or human origin (p. 19). Sieweke teaches, preferably the macrophage lacks MafB and c-Maf genes (p. 19). Sieweke teaches MafB/c-Maf deficient monocyte can be obtained by tissue specific deletion of MafB and c-Maf using a loxP/Cre recombinase system (p. 20). The c-Maf of Sieweke is also known as MAF, as evidenced by NCBI, as required by the claim. Sieweke teaches MafB/c-Maf deficient monocytes can be maintained in a M-CSF culture for several months and expanded by more than 1010 fold (p. 33, Results). Sieweke teaches c-Maf/MafB deficient monocytes and macrophages do not develop malignancies in vivo (non-tumorigenic) (p. 34, Results). A macrophage lacking MafB and c-Maf genes reads as a phagocytic cell wherein both alleles of MAFB and MAF have been rendered nonfunctional by deletions of at least 50 base pairs. The teachings of Sieweke do not disclose further transcription factor-encoding gene modifications or deletions, therefore, absent evidence to the contrary, the teachings of Sieweke read on the limitations of the claim.
Regarding claim 3, Sieweke teaches deletion of MafB and c-Maf which would necessarily comprise exonic DNA.
Regarding claims 6-8, the limitations directed to specific number of macrophages increase under suitable cultivation conditions are interpreted as intended results of the collection of human macrophages (a composition). The instant specification defines “’under suitable cultivation conditions’ as used herein are conditions under which the phagocytic cells of the invention are able to grow” (para. [0183]). Since the conditions are not defined by the specification, this is interpreted as a functional property of the cells. Intended results/functions do not result in a structural difference of the composition and thus, do not add any additional structural limitations to the collection of human macrophages. The claims are interpreted as a collection of human macrophages according to claim 2, wherein the human macrophages are non-tumorigenic and are rejected for the same reasons discussed in the rejection of claims 1 and 2.
However, if these limitations were considered to impart a structural change to the composition, Sieweke teaches MafB/c-Maf deficient monocytes can be maintained in a M-CSF culture for several months and expanded by more than 1010 fold (p. 33, Results).
Regarding claim 9, the limitation directed to the human phagocytic cell is configured for use as medicament is an intended use limitation. Intended use limitations do not result in a structural difference composition and thus, do not add any additional structural limitations to the collection of human macrophages. The claim is interpreted as the human phagocytic cell according to claim 1 and is rejected for the same reasons discussed in the rejection of claim 1.
However, if these limitations were considered to impart a structural change to the composition, Sieweke teaches the ability to obtain a large number of in vitro expanded monocytes, macrophages and dendritic cells opens new opportunities for the therapeutic field, wherein, a pharmaceutical composition comprising a monocyte, macrophage, or dendritic cell in combination with a pharmaceutically acceptable carrier (p. 20, Cell therapy). The teachings of Sieweke read as the cell is configured for use as a medicament.
Thus, the reference anticipates the subject matter of claims 1-3 and 6-9.
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 (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 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 nonobviousness.
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.
Claims 1-3, 4, and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Sieweke et al. (WO 2008/084069A1, IDS ref.) as applied to claims 1-3 and 6-9 above, and further in view of Hall et al. (Current Protocols in Cell Biology 19.12.1-19.12.17, September 2009) as evidenced by as evidenced by Wang et al. (Genomics 59, 275-281 (1999)) and NCBI (Reference sequence NM_001031804.3, first published 2013).
Sieweke anticipates the subject matter of claims 1-3 and 6-9, and thus, also render them obvious because Sieweke teaches all of the limitations of the claims. Even if Sieweke did not anticipate the limitations of the claims, the teachings of Sieweke indicates or suggests all of the limitations are suitable for use together and would render the claims obvious.
Regarding claim 4, Sieweke teaches, preferably the macrophage lacks MafB and c-Maf genes (p. 19), however, Sieweke is silent to the deletions being from 200-3000 base pairs.
However, the MAFB gene is a single exon gene that is approximately 3000 base pairs long, as evidenced by Wang (Abstract). Since Sieweke teaches the macrophages preferably lack this gene, this reads as a deletion of 3,000 base pairs.
The sequence of MAF was known to comprise 6900 base pairs and the CDS for MAF is from nucleotides 836-1957 (1121 base pairs), as evidenced by NCBI reference sequence NM_001031804.3. Thus, since the exonic DNA of exon 1 was known, this would have been an obvious choice to delete these nucleotides in order to effectively prevent the gene from being expressed because exon 1 comprises the DNA binding domain and the translation/transcription start, since this exon serves a critical function it would be considered an obvious target for deletion. Additionally, absent evidence of criticality, MAF only comprises 2 exons and one of ordinary skill would immediately envision the choice of targeting exon 1, exon 2, or both. MPEP 2144.08.II.4(a) states that a genus may be so small that, when considered in light of the totality of the circumstances, it would anticipate the claimed species or subgenus. For example, it has been held that a prior art genus containing only 20 compounds and a limited number of variations in the generic chemical formula inherently anticipated a claimed species within the genus because “one skilled in [the] art would... envisage each member” of the genus.
In re Petering, 301 F.2d 676, 681, 133 USPQ 275, 280 (CCPA 1962) (emphasis in original).
Furthermore, MPEP 2144.05.II.A. states "[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). Therefore, it would have been obvious to one of ordinary skill in the art to have recognized that the size of the deletion was a result effective variable because Hall teaches when designing a targeting construct, a few factors should be considered that could result in an incomplete knockout to help avoid an incomplete knockout of the gene function (p. 19.12.5). Since the number of base pairs to delete to form a non-functional transcription factor is recognized as a result effective variable, one of ordinary skill would be motivated to optimized by routine experimentation to determine the optimal effective range of base pairs to delete. Absent evidence of criticality, the claimed range of 200-3000 base pairs would be obvious.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claims 1-3, 5, 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Sieweke et al. (WO 2008/084069A1, IDS ref.) as applied to claims 1-3 and 6-9 above, and further in view of Yanagimachi et al. (PLoS One, Vol. 8, No. 4, 03 April 2013, IDS ref.).
Sieweke anticipates the subject matter of claims 1-3 and 6-9, and thus, also render them obvious because Sieweke teaches all of the limitations of the claims. Even if Sieweke did not anticipate the limitations of the claims, the teachings of Sieweke indicates or suggests all of the limitations are suitable for use together and would render the claims obvious.
Regarding claim 5, Sieweke does not teach the human phagocytic cell is derived from an iPS cell.
However, Yanagimachi teaches development of monocytic cells from induced pluripotent stem cells (iPSCs) is of interest because it provides an unlimited source of cells for clinical application and basic research of disease pathology (Abstract). Yanagimachi teaches methods to differentiate functional macrophages from iPSCs under serum and feeder cell-free conditions (Abstract). Yanagimachi teaches pluripotent cell-derived macrophages expressed monocytic lineage-specific genes and sufficient numbers of monocytic cell lineage cells can be obtained from a small number of human ESCs/iPSCs (p. 7, Results). Yanagimachi teaches pluripotent cell-derived monocytic lineage cells are functionally comparable to primary monocytes and the pluripotent derived macrophages were also functionally comparable to their primary counterparts (p. 8, Discussion).
Therefore, it would have been obvious to one of ordinary skill in the art to utilize iPS cells to differentiate macrophages of Yanagimachi in the method of Sieweke with a reasonable expectation of success because Sieweke teaches MafB/c-Maf deficient monocytes can be maintained in a M-CSF culture for several months and expanded by more than 1010 fold and Yanagimachi teaches iPS cell derived macrophages maintain monocytic specific genes and maintain function similar to primary monocytes. One would be motivated to utilize iPS cells to differentiate macrophages of Yanagimachi in the method of Sieweke because Yanagimachi teaches iPS cells provide an unlimited source of cell for clinical applications or disease research.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
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/N.A.H./Examiner, Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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