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 .
Election/Restrictions
Applicant’s election without traverse of Group I and the following species, bolded in applicant’s reply:
Species A: "pathogen-mimicking particle": polymeric nanoparticles;
Species B: "pathogen-targeting particle": liposome;
Species C: "Biomarker": E protein;
Species D: "Marker": Fluorescent marker;
Species E: "Complement Activating Agent": a protein;
Species F: "method of detecting": fluorescent detection; and
Species G: "Goal of claim 10": detecting a pathogen-neutralizing antibody of a patient to a pathogen
in the reply filed on April 29, 2026 is acknowledged. Applicant is correct that an election of species is required for facilitating search and expediting prosecution, and that, upon allowance of a generic claim, additional species will be considered in the order listed in applicant’s election.
Claims 1-14 and 16-21 are pending; claims 5, 10-12, 14, 19, 20, and 21 are withdrawn due to non-elected inventions and species; and elected claims and species corresponding to 1-4, 6-9, 13, and 16-18 are under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/24/2023 has been considered by the examiner.
Specification
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. The preliminary amendment received 6/22/2023 incorporates European Patent Application No. 20217081.7, filed December 23, 2020 by reference. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
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 1-4, 6-9, 13, and 16-18 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.
Claim 1 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of pathogen-mimicking particles recited in claim 1 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: The instant “pathogen-mimicking particle” is selected from, “a pathogen-like particle, a fusion protein, a protein aggregate, and/or a nanoparticle selected from silica nanoparticles, polymeric nanoparticles, dendritic particles, organic nanoparticles, and inorganic nanoparticles”. It is not evident what structural and/or functional attributes characterize these materials listed as “pathogen-mimicking”, as required. There is no unifying structure conserved between any of the alternatives. For example, polymeric nanoparticles could be characterized as organic and inorganic (both separately recited) and silica, dendritic, fusion, and protein aggregate nanoparticles are all assembled from completely different building blocks.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. This rejection affects all dependent claims.
Claim Rejections - 35 USC § 112
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.
Claims 1-4, 6-9, 13, and 16-18 are 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.
The instant claims require a "pathogen-mimicking particle" and a "pathogen-targeting particle". There is no corresponding structures corresponding to the recited requisite functions. While the instant application provides support for biotinylated ACE2 bound to streptavidin-liposomes loaded with luminol (depicted in Figure 1), the broad genus of materials encompassed by a "pathogen-mimicking particle" and a "pathogen-targeting particle" are not adequately described. The instant specification does not reasonably convey possession of these materials.
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, the only representative species described is biotinylated ACE2 bound to streptavidin-liposomes loaded with luminol, depicted in Figure 1 and described in the working examples.
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 "pathogen-mimicking particle" and the "pathogen-targeting particle" claimed to allow persons of ordinary skill in the art to recognize that applicants were in possession of the exponential quantity of materials 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, 2, 4, 6-9, 13, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Jou et al. (CA 1,309,344) and Dave et al. (Journal of Microbiological Methods. 2019; 160 :130–142),
Jou et al. teach a fluorophore-loaded liposome (pathogen targeting molecule, recited in instant claims 1, 4, and 16) comprising an antibody (recited in instant claim 7) presented on the surface for quantitative detection of a polyvalent antigen in a sample by complement-mediated lysis (recited in instant claims 8 and 17) of the fluorescent (recited in instant claim 6) marker-encapsulated liposome. See page 7, lines 11-25 and claims 1 and 2.
Jou et al. do not mention a polymeric nanoparticle, required as a pathogen-mimicking particle, recited in instant claims 1, 2, and 9.
Dave et al. teach liposome-polymeric hybrid nanoparticles (LPHNs) in the abstract and Figures 1B, 2, 3A, 3B, and 3D.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have used the LPHNs of Dave et al. as the fluorophore-loaded vehicle for quantitative detection of a polyvalent antigen in a sample by complement-mediated lysis, as taught by Jou et al., because Dave et al. teach LPHNs are structurally reliable and cargo-stable, with high loading efficiency, see the abstract, Introduction, and section 5.1. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have used the LPHNs of Dave et al. as the fluorophore-loaded vehicle for quantitative detection of a polyvalent antigen in a sample by complement-mediated lysis, as taught by Jou et al., because Dave et al. teach fluorescent-dye-loaded LPHNs for diagnostic imagery, see section 6.3 and Jou et al. teach other liposomes made with other lipid conjugates are encompassed on page 29, lines 10-20.
Neither Jou et al. nor Dave et al. mention the components assembled in a kit, as required in instant claim 13.
However, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have incorporated these materials and auxiliary agents required for imaging into a kit for ease of transport, storage, and preparation.
Jou et al. do not the pathogen-targeting molecule diameter size ranging between 1-600 nm, recited in instant claim 4.
In the first sentence of the Introduction of Dave et al., it states:, “nanoparticles mainly in the size range between 10 and 1000 mm.” The millimeter (mm) metric unit is clearly a typo by Dave et al. since the lipid-hybrid particles discussed are nano-sized, as evidenced by the title and recitation of “nanoparticle(s)” approximately 175 times throughout the article. Therefore, it is reasoned that the LPHNs of Dave et al. range in size between 10 and 1000 nm, overlapping with the size range recited. Absent evidence of criticality, the size of the LPHNs with respect to the claimed composition are adjustable, as evidenced by the range claimed. Therefore, it would have been prima facie obvious for a person having ordinary skill in the art prior to the effective filing date to optimize the LPHN size. 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.”
Claims 3 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Jou et al. and Dave et al. as applied to claims 1, 2, 4, 6-9, 13, 16, and 17 above, and further in view of Mukherjee et al. (International Journal of Nanomedicine 2019:14 1937–1952) and Banerjee et al. (Virus Diseases. January–March 2016; 27 (1): 1–11).
See the teachings of Jou et al. and Dave et al. above. On page 29, lines 10-20, Jou et al. mention antigen-conjugated liposomes, but do not teach the requisite biomarker as an envelope protein.
Banerjee et al. review viral glycoproteins of influenza, SARS, hepatitis C, HIV, Ebola, Dengue, and Chikungunya viruses as diagnostic agents, see title, abstract, Figure 1, and “Application of viral glycoproteins in diagnostics”.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have expressed one of the viral envelope proteins on the surface of the LPHNs of Jou et al. and Dave et al. to diagnose virus infection, as taught by Banerjee 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 expressed one of the viral envelope proteins of Banerjee et al. on the surface of the LPHNs of Jou et al. and Dave et al. because Mukherjee et al. depict LPHNs comprising a variety of targeting agents, i.e., biomarkers, including a glycoprotein, transferrin, in Figure 1 and Banerjee et al. teach virus envelopes are glycoproteins in “Viral glycoproteins” and “Viral glycoproteins and their biological role”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tausk et al. (US 5,919,633) teach a guaiac-loaded liposome decorated, i.e., sensitized with an antigen or antibody. The liposome guaiac contents rupture by complement-mediated lysis in a subject’s blood sample in a detection assay, see Figure 1, column 2, lines 28-49; column 4, lines 4-31; column 5, lines 9-34; column 7, lines 18-45; and claims 1-5.
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.
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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.
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/Shanon A. Foley/ Primary Examiner, Art Unit 1671
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