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 .
Application Status
Claims 1, 3-9, 11-20, and 27-28 are pending and examined on the merits herein.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 1, 3-9, 11, 13-20, and 27-28 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.
Regarding claims 1 and 12, the term “derivative” renders these claims indefinite as it includes the possibility of modifications to the structure or sequence of the SPMs, which makes it impossible for one of ordinary skill in the art to determine which modifications would still perform the functions as claimed. The term “derivative” is not defined in the instant specification.
Claims 3-9, 11, 13-20, and 27-28 depend from claims 1 and 12 without resolving the issue identified above. Although claims 4-6, 14-15, and 27-28 are drawn to specific SPM proteins they do not eliminate the inclusion of a “derivative” thereof.
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, 4-6, 12-15, 17-18, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dalli (PLoS One. 2016 Feb 16;11(2):e0149319.; PTO-892).
Regarding claims 1, 4-6, and 27, Dalli teaches administration of MCTR1, MCTR2, and MCTR3 at the peak of inflammation from infection that resolved the infection and reduced exudate neutrophil counts Dalli further teaches that the overall rank order potencies of MCTRs at promoting the resolution of live bacterial infections as MCTR3 ≥ MCTR2 > MCTR1 and that MCTR3 specifically carries potent, unanticipated bioactions governing the cardinal signs of resolution, namely clearance of debris and infections by phagocytes, tissue regeneration, and regulation of pro-inflammatory chemical mediators (discussion, para 1).
Regarding claims 12-18 and 28, Dalli teaches that human macrophages were prepared from peripheral blood leukocytes and incubated with MCTR1, MCTR2, MCTR3 or vehicle at 1pM-10nM for 60 minutes that resulted in anti-inflammatory and pro-resolving human phagocytes (phagocytosis page 3; Fig 4) and that MCTR3 enhanced both human PMN and macrophage responses (discussion, para 2).
Claims 1, 3-4, 8-9, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jin (Ann. Rheum. Dis., 2018, 77: 1644-1652; IDS entered 06/22/2024).
Regarding claims 1, 3-4, 8, Jin teaches that intervention of MaR1 in the CIA model reduced joint inflammation and damage, and improved the imbalanced Treg/Th17 ratio (abstract). Jin further teaches that after MaR1 treatment, the clinical scores and paw swelling decreased, reduced the histological score in a dose dependent manner, decreased pro-inflammatory cytokines (TNF-α, IFN-γ, IL-1β and IL-6), and Treg cell-related cytokines (IL-10 and TGF-β) increased (page 1648, col 2, para 2).
Regarding claims 9 and 11, Jin teaches that after arthritis was induced for 3 weeks, the mice were then treated with MaR1 (0, 20 and 100 ng) by tail vein injection (page 1645, col 1, para 4).
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 7 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dalli (PLoS One. 2016 Feb 16;11(2):e0149319.; PTO-892) as applied to claims 1, 4-6, 12-15, 17-18, and 28 above, and further in view of Poltavets (Cells, 2020; 9(6):1535; PTO-892) and Cui (Front. Cell Dev. Biol. 9:656867;
The teachings of Dalli regarding claims 1, 4-6, 12-15, 17-18, and 28 are detailed above.
Dalli does not teach administration of a monocyte derived macrophage treated with an SPM; a population of cells derived from the method of claim 12, or a pharmaceutical composition comprising the cells.
Regarding claim 7, Poltavets teaches that the controllable activation of macrophages towards desirable phenotypes in vivo and in vitro will provide effective treatments for a number of inflammatory and proliferative diseases (abstract) and further that the switch towards M2 phenotype when macrophages acquire anti-inflammatory properties and start secreting IL-10 and TGF-β to promote regeneration and angiogenesis (section 4.1, para 1). Further in table 2, Poltavets teaches that rheumatoid arthritis is associated with a shift to M1 polarization. Poltavets further teaches existing methods for the transient reprogramming of macrophages with signaling molecules (cytokines, receptor agonists, inhibitory antibodies, etc.) are currently being translated to the clinic (section 5.2, 1st para).
Regarding claims 7 and 19-20, Cui teaches that monocytes and macrophages, as a central part of the host immune system, play essential roles in homeostasis and inflammation through polarization into pro- or anti-inflammatory macrophages (introduction, para 1). Cui further teaches that monocytes or macrophages are increasingly explored as possible cellular targets for pharmacological intervention in various diseases and recently, macrophages engineered with chimeric antigen receptors (CARs) have been used as therapeutic cells in solid tumors (discussion, para 1). Cui further teaches that the main source of monocytes or macrophages is primary cells from blood, the variations of which largely depends on the donor individual conditions; the numbers of primary cells usually do not allow large-scale studies or screens, and even much less for cell therapies (discussion, para 1). Cui further teaches an improved method of differentiating hiPSCs under serum-free condition into monocytes, in a large scale, wherein the hematopoietic stem cells or monocytes in the middle step can be further expanded and cryopreserved for future use (introduction, para 3). Cui further teaches this protocol provides a reliable, easily scalable, and gene-editable system for human monocyte and macrophage research (introduction, para 3). Regarding claim 20, administration as a cellular therapy as taught by Cui requires formulation of the cells in a pharmaceutically acceptable composition.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to differentiate macrophages from monocytes as taught by Cui, to polarize the macrophages to an M1 phenotype for RA as taught by Poltavets and to treat the macrophages with MCTR3 to generate an anti-inflammatory (M1) phenotype as taught by Dalli. The ordinary artisan would have been motivated to do so because Dalli teaches that incubation with MCTR3 resulted in anti-inflammatory and pro-resolving macrophages and Poltavets teaches that the controllable activation of macrophages towards desirable phenotypes in vivo and in vitro will provide effective treatments for inflammatory diseases, including rheumatoid arthritis. Cui teaches a protocol of monocyte and macrophage differentiation from iPSC that provides a reliable, easily scalable, and gene-editable system for human monocyte and macrophage research including cellular therapy. The ordinary artisan has a reasonable expectation of success to differentiate macrophages from monocytes, culture the macrophages in the presence of MCTR3 to generate an anti-inflammatory phenotype, and to administer the anti-inflammatory macrophages to treat an inflammatory disorder.
The rationale to apply a technique taught by the prior art as improving the therapeutic and production characteristics of a similar construct is to predictably obtain an improvement to the second construct and is consistent with the exemplary rationales provided by the Supreme Court in KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385, 1395-97 (2007) and discussed in M.P.E.P. § 2143. For these reasons, the invention as a whole would have been prima facie obvious to one ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
Art not relied upon in this rejection:
Lopez Vales ( WO 2018/134230 A1; IDS entered 06/22/2024).
Regarding claims 1, 4-6, Lopez Vales teaches a specialized pro-resolving lipid mediator comprising maresins, D-series resolvins, E- series resolvins, protectins or lipoxins, or a combination thereof, for use in the treatment of neurodegenerative diseases and/or autoimmune diseases (claim 1), method of treatment of neurodegenerative diseases and/or autoimmune diseases, as defined above, in a subject comprising administering to said subject a therapeutically effective amount of a specialized pro- resolving lipid mediator
Regarding claim 3, Lopez Vales teaches a specialized pro-resolving lipid mediator for use, according to any of the preceding claims, wherein said neurodegenerative diseases and/or autoimmune diseases are selected from the group consisting of …rheumatoid arthritis (claim 4).
Regarding claim 11, Lopez Vales teaches wherein said composition is administered by oral, intravenous, subcutaneous, intramuscular, rectal, topical, vaginal, parenteral, transdermal, intraperitoneal, intrapulmonary, intrathecal and intranasal route (claim 13).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER K FAUST whose telephone number is (703)756-1661. The examiner can normally be reached Monday - Thursday 9:00am-6:00pm EST.
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/AMBER K FAUST/Examiner, Art Unit 1643
/GARY B NICKOL/Primary Examiner, Art Unit 1643
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