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 .
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.
Claim 10 is 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 10 requires that the silane-polyethylene glycol-carboxyl polymer “inhibits non-specific binding” of the porous silica nanoparticles to molecules “other than viruses”. The quoted provision attempts to exclude what is not invented rather than distinctly and particularly pointing out what is invented, as required under of 35 USC § 112(b). See MPEP 2173.05(i) discussing
In re Schechter, 205 F.2d 185, 98 USPQ 144 (CCPA 1953)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 10 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claim 10 requires that the silane-polyethylene glycol-carboxyl polymer “inhibits non-specific binding” of the porous silica nanoparticles to molecules “other than viruses”. Paragraph [0024] of the instant published disclosure, USPgPub 2024/0230648, states:
[0024] The amphipathic polymer is a biofriendly, surface-reactive derivative, which may specifically detect viruses by inhibiting nonspecific binding with other molecules.
However, there is no teaching in the instant disclosure that any of the broad genus of virus antibodies bound to the amphipathic polymer do not bind molecules other than viruses, as instantly required. The skilled artisan would not predict that the instant amphipathic polymer-bound virus antibodies are specific to binding to viruses and non-specific to any other molecule, as evidenced by the teachings of Labombarde et al. (Cell Reports. 2022 Mar 8; 38 (10)). In the paragraph bridging pages 3-4, Labombarde et al. describe polyreactive influenza hemagglutinin (HA) antibodies binding to “insulin, lipopolysaccharide (LPS), and double-stranded DNA (dsDNA)” in Figures 1I–1M and broadly reactive monoclonal influenza antibody contributions to autoimmunity, see the “Graphical Abstract” on page 2. Labombarde et al. illustrate the capricious and arbitrary nature of antibodies binding to specifically to viruses or “other molecules”. There is inadequate written description of virus antibodies that do not non-specifically bind to molecules other than viruses, as claimed.
The applicable standard for the written description requirement can be found in MPEP 2163; University of California V. Eli Lilly, 43 USPQ2d 1398 at 1407; PTO Written Description Guidelines; Enzo Biochem Inc. V. Gen-Probe Inc., 63 USPQ2d 1609; Vas- Cath Inc. V. Mahurkar, 19 USPQ2d 1111; and University of Rochester V. G.D. Searle & Co., 69 USPQ2d 1886 (CAFC 2004). To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, there is no structure identified correlating with amphipathic-polymer-antibody-binding to viruses, but not binding to molecules other than viruses. Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
Vas-Cath Inc. V. Mahurkar, 19USPQ2d 1111, clearly states "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116). Conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers V. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
There is no disclosure of sufficient characteristics of the amphipathic-polymer-antibodies binding to viruses, but not binding to molecules other than viruses, as claimed, to allow persons of ordinary skill in the art to recognize that applicants were in possession of the exponential quantity of amphipathic-polymer-virus-antibodies encompassed by claims. The specification does not clearly allow persons of ordinary skill in the art to recognize that the inventors invented what is claimed. The claims do not meet the written description provision of 35 U.S.C. 112, first paragraph.
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 1, 3, 4, 6, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (Nano Convergence. 2021 Aug 16; 8 (1): 24, of record), Brinker et al. (USPgPub 2018/0344641), and Bamrungsap et al. (Microchimica Acta. 2014; 181 (1): 223-30, of record).
Lee et al. teach covalent conjugation and linkage of full length antibodies to PLGA-poly(ethylene glycol)-carboxylic acid (PLGA-PEG-COOH) nanoparticles through carbodiimide (EDC/NHS) coupling reactions. See the abstract, Introduction, the second paragraphs under sections 2.1 and 2.2, respectively, section 3.1, Tables 1 and 2, and Scheme 1. These teachings correspond to the amphipathic polymer, PEG-COOH-antibody components recited in lines 3, 5-8, 11, and 12 of claim 1..
Lee et al. do not mention porous silica nanoparticles with diameters ranging between 100-200 nm or silane groups bound to the surface of the nanoparticles, required in instant claims 1, 6, and 9, and non-specific binding recited in claim 10.
Paragraphs [0029 and 0033] of Brinker et al. teaches a mesoporous silica nanoparticle coated with silane groups on its surface with an average size ranging between 1- 500 nm, see paragraphs [0012, 0143] and Figure 85A-B, depicting an average size of 50 nm.
Regarding the diameter of the mesoporous nanoparticle nm range, absent evidence of criticality, the diameters of the claimed porous silica nanoparticles are adjustable. Therefore, it would have been prima facie obvious for a person having ordinary skill in the art prior to the effective filing date to routinely optimize diameter of the mesoporous silica nanoparticles of Brinker et al, absent evidence to the contrary. MPEP 2144.05 states, “where 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 optimization.”
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have replaced the PLGA nanoparticle of Lee et al. with the silane-surface-coated mesoporous silica nanoparticles of Brinker et al. because mesoporous silica nanoparticles have a controlled size and shape, with high surface area networks of uniformly sized pores that accommodate high payloads. In addition, mesoporous silica is biodegradable and generally recognized as safe (GRAS) by the FDA. The silane coating on the surface of the mesoporous silica nanoparticles of Brinker et al. shield surface silanols and deprotonated silanols that are highly lipophilic and known to promote non-specific binding, as required by instant claim 10. See paragraph [0474, toward the bottom]. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have replaced the PLGA nanoparticle of Lee et al. with the silane-surface-coated mesoporous silica nanoparticles of Brinker et al. because both Brinker et al and Lee et al. teach nanoparticle-PEG-COOH-antibody covalent conjugation. See the abstract, Introduction, the second paragraphs under sections 2.1 and 2.2, respectively, section 3.1, Tables 1 and 2, and Scheme 1 of Lee et al. and paragraphs [0029, 0031, 0033, 0307, 0345-0347, 0472, 0551-0557], Figures 80-83, 89-92B, and claims 1-3 and 5 of Brinker et al.
Neither Lee et al. nor Brinker et al. teach the antibody bound to the -PEG-COOH- is an H1N1 virus antibody used to detect infection, as required by instant claims 1, 3, and 4.
Bamrungsap et al. teach a monoclonal antibody specific to influenza virus A (H1N1) nucleoprotein, see “Monoclonal antibody specific to influenza A nucleoprotein (Mab)”, “Source of recombinant nucleoprotein (rNP)…”, and “rNP used in this study…”, in the second column on page 224.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have conjugated the H1N1 nucleoprotein Mab of Bamrungsap et al. to the mesoporous silica nanoparticle- silane-coated -PEG-COOH- of Lee et al. and Brinker et al. to detect H1N1 in a sample, see the abstract, “Detection of the NP antigen in the infected allantoic fluid”, in the second column on page 225, “Detection of the NP in infected allantoic fluid”, in the second column on page 228, and Figures 5 and 6 of Bamrungsap et al. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have conjugated the H1N1 nucleoprotein Mab of Bamrungsap et al. to the mesoporous silica nanoparticle- silane-coated -PEG-COOH- of Lee et al. and Brinker et al. because Bamrungsap et al. conjugate the H1N1 nucleoprotein Mab to silica nanoparticles by a carboxyl group (-COOH), see “Surface modification of Cy5-doped silica nanoparticles”, beginning on page 224, “Conjugation of antibodies on carboxyl-modified particles”, in the first column on page 225, and Figure 2.
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 SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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 Allen can be reached at 571-270-3497. 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.
/Shanon A. Foley/ Primary Examiner, Art Unit 1671
Prosecution Insights