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 .
Claim 34 has been amended.
Claims 34-48 and 69-70 are pending.
Claims 1-33, 49-68 and 71-72 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Claims 37 and 45-47 are withdrawn.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn.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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/14/2024 has been entered.
Claim Interpretation
Merriam-Webster defines substrate as “the base on which an organism lives”. A substrate is not defined as a singular item at which something is immobilized to. Therefor a multitude of things can be considered a singular substrate.
Merriam-Webster defines apparatus as “a group of anatomical or cytological parts functioning together”. Therefore, any group of components working together is defined as an apparatus, such as a composition.
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 34 and 35 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 34 uses the closed language “consisting of”, however claim 35 uses the open language “comprising”. It is unclear whether closed or open language should be used. It is unclear whether the polycationic polymer can contain more things that would have been excluded from the closed language of claim 34.
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, 48, and 69-70 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of U.S. Patent No. 12447464 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
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 (claim 1), the first core polymer and a second core polymer reads on a substrate and the polycationic polymer immobilized on the surface of the polymeric core reads on a polycationic polymer immobilized on a substrate.
The difference between instant application and the patented claims is that the patent claims include additional limitations. Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the claims of the patent and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claims 34-36, 38-44, 48, and 69-70 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10066323 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
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 and the second polymer, PAMAM, reads on cationic polymer.
The difference between instant application and the patented claims is that the patent claims include additional limitations. Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the claims of the patent and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claims 34-36, 38-44, 48 and 69-70 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).
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 substrate.
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 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.
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.
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 34, 36, and 48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WU (Substrate-anchored and degradation-sensitive antiinflammatory coatings for implant materials. Scientific Reports. 2015.).
Regarding claim 34, WU teaches an anti-inflammatory complex comprising a poly(lactic acid)/hydroxyapatite, a alendronate-conjugated poly(amidoamine) dendrimer (ALN-PAMAM-COOH) and HA-anchored alendronate-conjugated poly(amidoamine) dendrimer (ALN-PAMAM-COOH) (page 2, paragraph 2 and figure 2, table b), which reads on substrate, which has a positively charged Indomethacin loaded star-poly[2-(dimethylamino) ethyl methacrylate] immobilized on it (page 2, paragraph 2 and figure 2, table b), which reads on a polycationic polymer immobilized on it.
The complex reduces the concentration of inflammatory cytokines, which read on inflammatory mediators, when in contact with fluid inside of the mice that it was implanted into (page 10, paragraph 1).
Regarding claim 36, the polycationic polymer is PAMAM (page 2, paragraph 2 and figure 2, table b).
Regarding claim 48, the complex reduces inflammation and therefor reads on administering a therapeutic agent to the subject (page 10, paragraph 1).
Claims 34, 36, and 70 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by VINOGRADOV (US 2014/0004048 A1).
Regarding claim 34, 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 substrate. 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.
Regarding claim 36, the polycationic polymer is the dendrimer PAMAM (claim 14).
Regarding claim 70, the dendrimer is covalently linked to the nanoparticle (page 4, paragraph 0053).
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, 42-44, 48 and 70 are rejected under 35 U.S.C. 103 as being unpatentable over VINOGRADOV (US 2014/0004048 A1) in view of LEE (Nucleic acid-binding polymers as anti-inflammatory agents. PNAS. 2011.).
VINOGRADOV teaches Applicant’s invention as discussed above.
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).
Regarding claim 48, the composition is performing a therapeutic effect by acting as an anti-inflammatory agent and therefor reads on administering a therapeutic agent.
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, 42-44, 48 and 69-70 are rejected under 35 U.S.C. 103 as being unpatentable over VINOGRADOV (US 2014/0004048 A1) and LEE (Nucleic acid-binding polymers as anti-inflammatory agents. PNAS. 2011.) in view of KIM (US 2012/0256102 A1).
VINOGRADOV and LEE teach Applicant’s invention as discussed above.
VINOGRADOV and LEE do not teach binding the PAMAM and substrate using a fluorescent label.
Regarding claims 35 and 69, KIM teaches methods of connecting polycation PAMAM dendrimers at their core to detectable labeling functionalities such as dyes, biotin, and alkynes/azides and linkers capable of crosslinking the dendrimer cores to dyes and supports using various linking methods including through two-part linkers such as the the alkyne/azide functionalities (figures 1 and 12, abstract, and paragraphs 0007-0015, 0040, and 0054.) Kim teaches that the particles can be fluorescent labels (page 1, paragraph 0005).
It would have been obvious to the person of ordinary skill in the art bet ore the effective filing date of the claimed invention to connect the PAMAM dendrimers to support structures using detectable functionalities/linkers at the core of the dendrimers taught by KIM such as alkynes/azides in order to both provide for both the ability to bind the materials to support structures and fluorescently detect them. One of ordinary skill in the art would have been motivated to make this combination in order to easily verify the presence of the absorbent dendrimers on the substrates to verify attachment as well as to use common mechanisms of attaching PAMAM dendrimers to substrate materials commonly used in the art at the time of the invention. One of ordinary skill in the art at the time of the invention would have had a predictable expectation of success in making this combination given that all of the prior art is directed towards PAMAM dendrimers.
Claims 34-36, 38-44, 48 and 69-70 are rejected under 35 U.S.C. 103 as being unpatentable over VINOGRADOV (US 2014/0004048 A1), LEE (Nucleic acid-binding polymers as anti-inflammatory agents. PNAS. 2011.) and KIM (US 2012/0256102 A1) in view of DROST (WO 2016/040850 A1).
VINOGRADOV, LEE and KIM teach Applicant’s invention as discussed above.
VINOGRADOV, LEE and KIM 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.
Conclusion
No claims are allowable.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL HARTLEY can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618