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 .
Claims 34 and 35 have been amended.
Claims 34-48 are pending.
Claims 1-33 and 49-72 are cancelled.
Claims 37 and 45-47 are withdrawn.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 34-36, 38-44 and 48 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of U.S. Patent No. 12447464 B2 in view of BASLEY (Properties and suspension stability of dendronized iron oxide nanoparticles for MRI applications. Contrast Media & Molecular Imaging. 2011.).
The patent recites A method for the reduction of inflammation, thrombosis, or rejection or a tissue, a graft, or an organ after transplantation of the tissue, the graft, or the organ into a subject, the method comprising administering an effective amount of a solute-cleared fluid to the tissue, the graft, or the organ, wherein the solute-cleared fluid is prepared from a perfusate, wherein the solute-cleared fluid is prepared by contacting the bodily fluid with the polycationic microfiber of claim 1 (claim 17), which reads a method for the reduction of inflammatory mediators in a bodily fluid of a subject comprising: contacting the bodily fluid with a scavenging apparatus. The polycationic microfiber comprises a high-aspect-ratio polymeric core, the polymeric core consisting of a blend of a first core polymer and a second core polymer; and a polycationic polymer immobilized on the surface of the polymeric core, wherein the first core polymer consists of poly(styrene-alt-maleic anhydride) (claim 1), which reads on a plastic substrate and the polycationic polymer immobilized on the surface of the polymeric core reads on a polycationic polymer immobilized on a substrate.
The patent does not teach the linkage of the substrate occurring at the focal point of the dendron.
Regarding claim 34, BASLEY teaches linking nanoparticles, which are a form of a substrate further discussed below, to dendrons (abstract) via a crosslinker at the focal point (page 134, paragraph 2). This type of linking gave the composition stability (page 134, paragraph 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate having the crosslinking occur at the focal point of the dendron. The person of ordinary skill in the art would have been motivated to make those modifications, because it is an alternate way to attach the substrate and it gives the composition stability, and reasonably would have expected success because the references are in the same field of endeavor such as connecting dendrons to substrates for pharmaceutical purposes.
Claims 34-36, 38-44 and 48 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10066323 B2 in view of BASLEY (Properties and suspension stability of dendronized iron oxide nanoparticles for MRI applications. Contrast Media & Molecular Imaging. 2011.).
The patent recites a method of using a polycationic nanofiber comprising applying the polycationic nanofiber to cells or a tissue at a site of inflammation or infection having a biofilm or microbes capable of forming a biofilm associated therewith in vivo, wherein the polycationic nanofiber reduces the inflammation or infection at the site, wherein the neutral polymer is poly-styrene maleic anhydride, wherein the polycationic nanofiber comprises a neutral polymer nanofiber less than 2 μm in diameter and a second polymer grafted thereon, wherein the second polymer is selected from the group consisting of branched polyethyleneimine (bPEI) and polyamindoamine (PAMAM)…wherein cellular viability of the cells or the tissue after application of the polycationic nanofiber is reduced by less than 50% as compared to untreated control cells (claim 1), which reads on a method for the reduction of inflammatory mediators in a bodily fluid of a subject comprising: contacting the bodily fluid, the wound would inherently have some form of bodily fluid present, with a scavenging apparatus. The neutral polymer reads on substrate comprising an electrospun fiber and the second polymer, PAMAM, reads on cationic polymer.
The patent does not teach the linkage of the substrate occurring at the focal point of the dendron.
Regarding claim 34, BASLEY teaches linking nanoparticles, which are a form of a substrate further discussed below, to dendrons (abstract) via a crosslinker at the focal point (page 134, paragraph 2). This type of linking gave the composition stability (page 134, paragraph 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate having the crosslinking occur at the focal point of the dendron. The person of ordinary skill in the art would have been motivated to make those modifications, because it is an alternate way to attach the substrate and it gives the composition stability, and reasonably would have expected success because the references are in the same field of endeavor such as connecting dendrons to substrates for pharmaceutical purposes.
Claims 34-36, 38-44 and 48 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,468,650 B2 in view of VINOGRADOV (US 2014/0004048 A1) and BASLEY (Properties and suspension stability of dendronized iron oxide nanoparticles for MRI applications. Contrast Media & Molecular Imaging. 2011.).
The patent claims method of inhibiting nucleic acid-induced activation of toll-like receptor 3 (TLR3) or toll-like receptor 9 (TLR9) to treat a TLR3 or TLR9 induced inflammatory or immune response comprising administering to a patient in need of said inhibition of nucleic acid-induced activation of TLR3 or TLR9 an agent that binds a nucleic acid responsible for said induction of activation in an amount and under conditions such that said inhibition of said activation is effected, wherein the agent is poly(amidoamine) (PAMAM) (claim 1). PAMAM reads on polycationic polymer and inhibiting nucleic acid-induced activation of TLR3 and TLR9 reads on reducing inflammatory mediators.
Note, administration of the compound would inherently result in contact of the compound with a body fluid, such as blood/plasma.
The patent does not teach immobilizing the polycationic polymer to a magnetic substrate at the focal point of the dendron.
VINOGRADOV teaches a method of administering (claim 44) PAMAM (claim 14), which is a polycationic polymer, that is conjugated/immobilized to a nanoparticle (claim 1), which reads on a magnetic substrate. The nanoparticles of the invention can be used to find molecules find in a body fluid from a host (page 5, paragraph 0063). The nanoparticles are capable of being used as imaging agents.
Regarding claim 34, BASLEY teaches linking nanoparticles, which are a form of substrate further discussed below, to dendrons (abstract) via a crosslinker at the focal point (page 134, paragraph 2). This type of linking gave the composition stability (page 134, paragraph 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate immobilizing the PAMAM onto a nanoparticle, which reads on substrate. The person of ordinary skill in the art would have been motivated to make those modifications, because it would allow for imaging of an area of interest, and reasonably would have expected success because are in the same field of endeavor, such as PAMAM therapeutic compositions.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate having the crosslinking occur at the focal point of the dendron. The person of ordinary skill in the art would have been motivated to make those modifications, because it is an alternate way to attach the substrate and it gives the composition stability, and reasonably would have expected success because the references are in the same field of endeavor such as connecting dendrons to substrates for pharmaceutical purposes.
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 34-36 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over VINOGRADOV (US 2014/0004048 A1) in view of BASLEY (Properties and suspension stability of dendronized iron oxide nanoparticles for MRI applications. Contrast Media & Molecular Imaging. 2011.).
Regarding claim 34, VINOGRADOV teaches a method of administering (claim 44) PAMAM (claim 14), which is a polycationic polymer, which instant claim 36 defines as a polycationic polymer that has a dendron, the dendron comprising focal point, a plurality of cationic termini and a branched cationic polymer between the focal point and the plurality of cationic termini, that is conjugated/immobilized to a nanoparticle (claim 1), specifically an iron-oxide nanoparticle (claim 8), which reads on a magnetic substrate.
The nanoparticle is crosslinked directly to the polymer via a crosslinker (claim 1 and 20).
Regarding claim 35, VINOGRADOV the nanoparticle/magnetic substrate acts as an imaging agent (page 1, paragraph 0004), which reads on a detectable label (page 6, paragraph 0079).
Regarding claim 36, VINOGRADOV teaches using PAMAM (claim 14).
Regarding claim 48, VINOGRADOV teaches the composition can further include a radionucleotide which can be used as a therapeutic agent for radiation treatment (page 6, paragraph 0078).
VINOGRADOV does not teach the linkage of the nanoparticle/detectable label occurring at the focal point of the dendron.
Regarding claim 34, BASLEY teaches linking nanoparticles to dendrons (abstract) via a crosslinker at the focal point (page 134, paragraph 2). This linking gave the composition stability (page 134, paragraph 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate having the crosslinking occur at the focal point of the dendron. The person of ordinary skill in the art would have been motivated to make those modifications, because it is an alternate way to attach the nanoparticle and it gives the composition stability, and reasonably would have expected success because the references are in the same field of endeavor such as connecting dendrons to nanoparticles for pharmaceutical purposes.
Note, administration of the compound would inherently result in contact of the compound with a body fluid, such as blood/plasma. Furthermore, the nanoparticles of the invention can be used to find molecules find in a body fluid from a host (page 5, paragraph 0063).
Although the reference is silent about reducing the concentration of the inflammatory mediators in the bodily fluid, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. /n re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being administered the same active agent, the polycationic polymer, by the same mode of administration in the same amount in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method.
Thus, the references teaches, either expressly or inherently, each and every limitation of the instant claims.
Claims 34-36, 42-44 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over VINOGRADOV (US 2014/0004048 A1) and BASLEY (Properties and suspension stability of dendronized iron oxide nanoparticles for MRI applications. Contrast Media & Molecular Imaging. 2011.) in view of LEE (Nucleic acid-binding polymers as anti-inflammatory agents. PNAS. 2011.).
VINOGRADOV and BASLEY teach Applicant’s invention as discussed above.
Regarding claims 42-44, VINOGRADOV does not teach specifically treating inflammatory/autoimmune diseases, such as lupus.
Regarding claims 42-44, LEE teaches that nucleic acid-binding polymers can act as anti-inflammatory agents (abstract), such as PAMAM-G3 which is a polycationic polymer (page 14056, paragraph 1). PAMAM-G3 can act as a molecular scavenger and inhibit the ability of circulating immune stimulatory nucleic acids (page 14058, paragraph 3), which reads on inflammatory mediators. The composition can be used to treat various inflammatory/autoimmune diseases, including lupus (page 14055, paragraph 1).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate treating conditions such as lupus. The person of ordinary skill in the art would have been motivated to make those modifications, because it is utilizing the PAMAM for therapeutic purposes, and reasonably would have expected success because the references are in the same field of endeavor, such as PAMAM compositions.
Claims 34-36, 38-44 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over VINOGRADOV (US 2014/0004048 A1) and BASLEY (Properties and suspension stability of dendronized iron oxide nanoparticles for MRI applications. Contrast Media & Molecular Imaging. 2011.) and LEE (Nucleic acid-binding polymers as anti-inflammatory agents. PNAS. 2011.) in view of DROST (WO 2016/040850 A1).
VINOGRADOV, BASLEY, and LEE teach Applicant’s invention as discussed above.
Regarding claims 38-41, VINOGRADOV, BASLEY, and LEE do not teach utilizing the composition out of the body.
Regarding claims 38-41, DROST teaches that medical conditions can be treated by passing blood or plasma through a device that scavenges specific blood constituents (page 1, paragraph 4), such as inflammatory cytokines (page 15, paragraph 2), which reads on inflammatory mediators. The process involves removing blood/plasma from the body, filtering the blood/plasma and then passing the blood/plasma back into the body (page 26, paragraph 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate utilizing the composition outside of the body. The person of ordinary skill in the art would have been motivated to make those modifications, because it allows an alternate treatment for inflammatory diseases, and reasonably would have expected success because the references are in the same field of endeavor, such as treatments for inflammatory conditions utilizing scavenging inflammatory mediators from the body.
Response to Arguments
Applicant argues, VINOGRADOV does not teach a polycationic polymer immobilized to a substrate by its focal point.
Examiner does not find the argument persuasive because as discussed above, although VINOGRADOV does not teach the linkage of the nanoparticle/detectable label occurring at the focal point of the dendron. BASLEY teaches linking nanoparticles to dendrons (abstract) via a crosslinker at the focal point (page 134, paragraph 2). This linking gave the composition stability (page 134, paragraph 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate having the crosslinking occur at the focal point of the dendron. The person of ordinary skill in the art would have been motivated to make those modifications, because it is an alternate way to attach the nanoparticle and it gives the composition stability, and reasonably would have expected success because the references are in the same field of endeavor such as connecting dendrons to nanoparticles for pharmaceutical purposes.
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 SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618
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