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 .
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.
Priority
The present application is a continuation-in-part of application 16/408,621, filed 05/10/2029 (US Patent 11,913,960), which claims benefit under 35 U.S.C. 119(e) to provisional application No. 16/408,621, filed 05/11/2018.
Information Disclosure Statement
The information disclosure statement (IDS) filed 01/18/2024 is considered, initialed and is attached hereto.
Specification
The use of the term "Tween" (TWEEN®), which is a trade name or a mark used in commerce, has been noted in this application (see e.g., page 13, paras [000102]-[000105] of the specification). The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as TM, SM , or R following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1, 7 and 11-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,913,960 B2 (hereinafter referred to as ‘960).
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘960 (see at claim 1) similarly recites A method for conducting an enzyme linked immunosorbent assay (ELISA) for detecting the activity of properdin, the method comprising: i) coating a surface with a non-inhibitory anti-properdin antibody, and incubating for a first desired time and at a first desired temperature; ii) adding a blocking agent to prevent non-specific binding and to block any remaining active sites, and incubating for a second desired time and at a second desired temperature; iii) adding a normal human serum sample (i.e., a biological sample) that contains properdin to the surface of step ii), wherein the normal human serum that contains properdin is added in ethylenediaminetetraacetic acid (EDTA), and incubating for a third desired time and at a third desired temperature; iv) adding a properdin-depleted serum sample to the surface of step iii), wherein the properdin-depleted serum sample provides complement proteins including C3(H.sub.2O), Factor B, and Factor D, and, wherein C3(H.sub.2O) and Factor B bind to properdin, and wherein Factor D cleaves Factor B to form C3(H.sub.2O)Bb that, in turn, cleaves C3 and deposits C3b covalently on the blocking agent on the surface; and v) adding an anti-C3b antibody to detect the C3b on the blocking agent on the surface.
Regarding claim 7, see ‘960, claim 1 similarly recites sample that is serum.
Regarding claim 11, see ‘960 at claim 2, further comprising removing nonphysiological forms of properdin (Pns) from the normal human serum sample by size exclusion chromatography prior to adding the normal human serum sample to the surface of step ii).
Regarding claim 12, see ‘960 at claim 3, anti-properdin antibody comprises monoclonal antibody.
Regarding claim 13, see ‘960 at claim 5, wherein the properdin-depleted serum sample is diluted 1/20 or 1/18-fold in 5 mM magnesium ethylene glycol tetraacetic acid (MgEGTA).
Regarding claim 14, see ‘960 at claim 6, wherein C3b deposition is measured by adding biotinylated anti-C3b antibody and streptavidin-horseradish peroxidase.
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of US Patent 11,913,960 B2 (hereinafter referred to as ‘960) in view of Camous et al., Complement alternative pathway acts as a positive feedback amplification of neutrophil activation, Phagocytes, granulocytes, and myelopoiesis, Blood, 117(4), (2011), p. 1340-1349.
Camous et al. teach complement alternative pathway plays an important role in neutrophil mediated diseases, that neutrophils activate complement when stimulated by cytokines or coagulation-derived factors (abstract). Camous et al. teach assaying for properdin in neutrophil supernatant samples (see page 1341, col. 1, para 5).
It would have been prima facie obvious to one having ordinary skill in the art to have performed the properdin activity assay of ‘960 on samples comprising neutrophil supernatants in the interest of investigating the role of properdin in neutrophil mediated diseases (see Camous), the modification would be applying a known method (the based method of ‘960) to samples known to contain properdin in relation to neutrophil related diseases (Camous)). One having ordinary skill in the art would have a reasonable expectation of success performing the assay intended for measuring activity of properdin on a sample known to detect properdin.
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of US Patent 11,913,960 B2 (hereinafter referred to as ‘960) in view of Camous et al., as applied to claim 2 above, and further in view of Kuhns et al., Isolation and Functional Analysis of Human Neutrophils, Curr. Protoc. Immunol., 111, (2016), 18 pages.
‘960 recite a method substantially as claimed, however fails to teach neutrophil supernatant having a neutral pH (claim 3).
Kuhns et al. teach neutrophils (polymorphonuclear neutrophils) are sensitive to commonly occurring contaminants of media and labware, that unless otherwise indicated, blood and cells should be maintained at physiologic pH, room temperature and in the absence of divalent cations to help limit activation (see page 2, para 2). Kuhns teach providing freshly prepared neutrophils (PMN) in buffer at pH 7.2 (i.e., neutral pH), see page 6, bottom of page, at “1.”.
It would have been obvious to have provided the neutrophil supernatant at a neutral pH (as in Kuhns) due to the knowledge that neurophiles are sensitive to their environment (Kuhns). Providing at the pH described in Kuhns is considered an obvious matter of a known technique applied to a known method, i.e., it was known to maintain sample containing neutrophils at a pH considered to be physiological pH, more specifically 7.2 (neutral pH). One having ordinary skill in the art would have a reasonable expectation of success employ art recognized conditions for maintaining neutrophils in a sample.
Claims 4 and 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of US Patent 11,913,960 B2 (hereinafter referred to as ‘960) in view of Song et al., US2010/0263061A1 and Ruddy et al., Depressed synovial fluid levels of properdin and properdin factor b in patients with rheumatoid arthritis, Arthritis & Rheumatology, 18(4), (1975), (abstract).
‘960 recites a method substantially as claimed, however, fails to recite sample that is synovial fluid (claim 4); and fail to teach subjects having rheumatoid arthritis (claim 5).
Song et al. teach that properdin is the only known positive regulator of the complement activation cascade (para [0004]), Song et al. teach inhibiting activity or properdin to treat AP-mediated pathology, including arthritis (see para [0055]).
Ruddy et al. (abstract), also indicate measurement of properdin in synovial fluid of patients with rheumatoid arthritis (the reference also correlating this protein in relation to RA, and present in samples that are synovial fluid samples).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to have further modified ‘960 in order to have performed the properdin activity assay on samples from subjects with RA as an obvious matter of applying a known technique to a known method one motivated in the interest of investigating the correlation between properdin and RA (as in Song and Ruddy), in particular the prior art recognized the correlation of properdin/properdin activity with RA, and further demonstrate it was known to monitor properdin in RA patients comprising samples that are synovial fluid samples. One having ordinary skill in the art could have modified the assay of ‘960 and determined activity in synovial fluid samples from subjects with RA and the results would have been predictable, based on Ruddy et al. (who demonstrate measurement of this target in the same sample in subjects with RA, thereby providing a reasonable expectation of success).
Claims 4 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of US Patent 11,913,960 B2 (hereinafter referred to as ‘960) in view of Bansal et al., US PG Pub No. 2013/0039925A1 and Struglics et al., The complement system is activated in synovial fluid from subjects with knee injury and from patients with osteoarthritis, Arthritis Research & Therapy, 18, (2016), p. 1-11.
Bansal et al. suggest properdin levels and the involvement of the alternate complement pathway in osteoarthritis (osteoarthritis as an alternate complement pathway condition), see para [0023].
Struglics also teach complement system is activated in synovial fluid from subjects with osteoarthritis (see abstract, involved in pathogenesis of OA). See for example, page 3, col. 2, para 2, capture antibody against properdin, samples comprising synovial fluid.
It would have been further prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to have further modified ‘960 in order to have performed the properdin activity assay on samples from subjects with OA as an obvious matter of applying a known technique to a known method one motivated in the interest of investigating the correlation/relation between properdin and OA (as in suggested by Bansal et al. and Struglics), in particular the prior art recognized the correlation of properdin/properdin activity with OA, and further demonstrate it was known to monitor properdin in OA patients comprising samples that are synovial fluid samples. One having ordinary skill in the art could have modified the assay of ‘960 and determined activity in synovial fluid samples from subjects with OA and the results would have been predictable, based on Struglics et al. (who demonstrate measurement of this target in the same sample in subject’s with OA, thereby providing a reasonable expectation of success).
Claims 8 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of US Patent 11,913,960 B2 (hereinafter referred to as ‘960) in view of Schwaeble et al., WO2013033518A1 and Tani et al., EP 0230247A2.
Schwaeble et al. teach cancer is considered a properdin related disease (see 2, lines 9-12).
See also, Tani et al. suggest complement component proteins are detectable in samples including ascites (ascitic fluid, see abstract, and page 2, lines 41-48).
It would also have been prima facie obvious to one having ordinary skill in the art to have modified the method as taught by ‘960 in order to perform the method using samples that are ascite fluid samples from a subject having cancer as an obvious matter to try, one specifically motivated to try because cancer is considered a properdin related disease (Schwaeble et al.), and further because it was expected that properdin is detectable in samples including ascites fluid samples (see Tani et al.). One having ordinary skill in the art would have a reasonable expectation of success applying the method of ‘960 to this sample and subject population given that the assay of ‘960 is detecting properdin, and properdin was already recognized in the art as related to cancer and detectable/present in biological fluid samples such as ascites.
Claims 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of US Patent 11,913,960 B2 (hereinafter referred to as ‘960) in view of Kirschfink et al., Modern Complement Analysis, Clinical and Diagnostic Laboratory Immunology, 10(6), (2003), p. 982-989.
Kirschfink et al. teach complement activation products are usually present in only trace amounts in vivo, but rapidly generate in vitro, and as such it is crucial that sample are collected and stored to properly avoid in vitro activation, Kirschfink et al. teach blood should be drawn directly in EDTA-containing tubes (final concentration of 10mM) (see page 986, col. 2, first full paragraph).
It would have been prima facie obvious to one having ordinary skill in the art to have modified the methods taught by ‘960 in order to provide samples in EDTA (ethylenediaminetetraacetic acid) in order to prevent in vitro activation products (Kirschfink et al.). One having ordinary skill in the art would have a reasonable expectation of success because in in vitro activation products are recognized as an issue to be addressed in the prior art (Kirschfink).
This is a provisional nonstatutory double patenting rejection.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN J MARCSISIN whose telephone number is (571)272-6001. The examiner can normally be reached M-F 8:00am-4:30pm.
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/ELLEN J MARCSISIN/ Primary Examiner, Art Unit 1677
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