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 species (a) pathogen-binding, (b) polylactic acid, (c) virus binding antibody, (d) streptavidin-modified ACE2, (e) DOPS, and (f) DSPC in the reply filed on 5/18/2026 is acknowledged.
Status of Application, Amendments, And/Or Claims
Claims 1-21 are pending and under consideration.
Specification
The disclosure is objected to because of the following informalities: The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, applications, or other information submitted for consideration by the Office, and MPEP § 609.04(a), subsection I. states, ‘the list may not be incorporated into the specification but must be submitted in a separate paper.’ Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 4, 7, 10, 19 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.
Regarding claims 4,7, 10, 19 the phrase "optionally" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
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 1-13 and 20 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.
The written description in this case only sets forth a nanoparticle comprising a core comprising biopolymer polylactic acid, an outer layer encapsulating the core, wherein the outer layer comprises, one or more lipids and wherein outer surface of the outer layer comprises either a SARS-CoV-2 virus neutralizing antibody or streptavidin-modified ACE2 receptor and phosphatidylserine, and therefore the written description is not commensurate in scope with “ any nanoparticle comprising a core comprising any biocompatible polymer having an outer layer encapsulating said core wherein the outer surface of outer layer comprises any pathogen-binding receptor and any pathogen binding antibody and any phagocyte-specific ligand”.
The claims broadly encompass any nanoparticle comprising a core encapsulated by an outer layer, wherein the outer layer comprises outer surface having many lipids and many proteins and the outer surface comprises any number of pathogen-binding receptor and any pathogen binding antibody or any antigen binding fragment thereof; and any phagocyte-specific ligand.
The specification at pg. 53-55 disclose making a functionalized nanoparticle using two step method to make polymer-lipid hybrid nanoparticle, wherein the polymer is polylactic acid (PLA) and lipids comprises phosphotidylserine and DSPE-PEG2000-biotin, so that an streptavidin conjugated ACE2 or an antibody against SARS-CoV spike can be attached to the nanoparticle. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. Some of the factual considerations that are weighed when determining a written description include the level of skill and knowledge in the art, the disclosure of complete or partial structures, the disclosure of physical and or chemical properties, adequate disclosure of the functional characteristics, the correlation between structure and function, and disclosure of methods of making.
Ashley et al. (US Pub. No. 2017/0165375) teaches a mesoporous nanoparticle encapsulated with a lipid bi or multilayer. They teach that the nanoparticle having a core comprising a biocompatible polymer (abstract) provides a novel antibiotic protocells comprising mesoporous nanoparticle comprises comprising lipid and one or more from polylactic acid (PLA) or poly glycolic acid (PGA) [0095]. They teach that the nanoparticle can comprise one or more lipid and/or one or more protein. The outer surface of the nanoparticle comprises a cell binding receptor and/or pathogen-binding antibody or antigen binding fragment thereof (abstract). The outer layer of the nanoparticle comprises pegylated or non-pegylated lipids phospholipids for attaching targeting proteins [0120-0131]. Thus, the nanoparticle is for targeting a bacterial cell.
The specification at pg. 53-55 disclose making a functionalized nanoparticle using two step method to make polymer-lipid hybrid nanoparticle, wherein the polymer is polylactic acid (PLA) and lipids comprises phosphotidylserine and DSPE-PEG2000-biotin, so that an streptavidin conjugated ACE2 or an antibody against SARS-CoV spike can be attached to the nanoparticle. The specification does not disclose representative number of pathogen receptors and pathogen-binding antibodies that includes vast number of genus comprising millions of receptors and pathogen-binding antibodies. The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed.
Applicant is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, 1 "Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.
Vas-Cath Inc. V. Mahurka, 19 USPQ2d 1111, states that 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, for purposes of the written description inquiry, is 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).
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B (1), the court states an adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention.
As discussed above, the skilled artisan cannot envision the detailed genus of “a nanoparticle comprising any pathogen-binding receptor and/or any pathogen-binding antibody or any antigen-binding fragment thereof” and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of making a mutation. The compound itself is required. See Fiers v.Revel, 25USPQ2d 1601 at 1606 (CAFC 1993) and Amgen v.Baird, 30 Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 148 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class.
Therefore, only a nanoparticle comprising a core comprising biopolymer polylactic acid, an outer layer encapsulating the core, wherein the outer layer comprises, one or more lipids and wherein outer surface of the outer layer comprises either a SARS-CoV-2 virus neutralizing antibody or streptavidin-modified ACE2 receptor and phosphatidylserine, but not the full breadth of the claim meets the written description provision of 35 U.S.C. §112, first paragraph.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
Claim Rejections - 35 USC § 112
Claims 14-21 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating a SARS-CoV infection in a subject in need thereof comprising administering a nanoparticle comprising a core comprising biopolymer polylactic acid, an outer layer encapsulating the core, wherein the outer layer comprises, one or more lipids and wherein outer surface of the outer layer comprises either a SARS-CoV-2 virus neutralizing antibody or streptavidin-modified ACE2 receptor and phosphatidylserine, does not reasonably provide enablement for a method of preventing or treating any pathogen infection comprising administering a nanoparticle comprising a core comprising biopolymer polylactic acid, an outer layer encapsulating the core, wherein the outer layer comprises, one or more lipids and wherein outer surface of the outer layer comprises either a SARS-CoV-2 virus neutralizing antibody or streptavidin-modified ACE2 receptor and phosphatidylserine. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404, the factors to be considered in determining whether a disclosure would require undue experimentation include: (1) Nature of the invention, (2) the state of the prior art, (3) the predictability or lack thereof in the art, (4) the amount of direction or guidance present, (5) the presence or absence of working examples, (6) the breath of the claims, (7) the quantity of experimentation needed, (8) relative skill of those in the art.
The instant disclosure fails to meet the enablement requirement for the following reasons:
The claims broadly encompass any nanoparticle comprising a core encapsulated by an outer layer, wherein the outer layer comprises outer surface having many lipids and many proteins and the outer surface comprises any number of pathogen-binding receptor and any pathogen binding antibody or any antigen binding fragment thereof; and any phagocyte-specific ligand.
The state of the prior art and the predictability or lack thereof in the art: Ashley et al. (US Pub. No. 2017/0165375) teaches a mesoporous nanoparticle encapsulated with a lipid bi or multilayer. They teach that the nanoparticle having a core comprising a biocompatible polymer (abstract) provides a novel antibiotic protocells comprising mesoporous nanoparticle comprises comprising lipid and one or more from polylactic acid (PLA) or poly glycolic acid (PGA) [0095]. They teach that the nanoparticle can comprise one or more lipid and/or one or more protein. The outer surface of the nanoparticle comprises a cell binding receptor and/or pathogen-binding antibody or antigen binding fragment thereof (abstract). The outer layer of the nanoparticle comprises pegylated or non-pegylated lipids phospholipids for attaching targeting proteins [0120-0131]. Thus, the nanoparticle is for targeting a bacterial cell. CA 2917512 A1 teaches a composition and system for delivery for nanocarriers to cells of the immune system. The invention provides vaccine nanocarriers capable of stimulating an immune response in T cells and/or B cells (abstract). They teach that the nanocarriers are composed of one or more polymers, wherein polymers are biocompatible polymer that is conjugated with PEG or PEO and the biodegradable polymers are PLA, PGA or PLGA (see pg. 5, [0014]). They teach that immune stimulatory agent is on the surface of the nanocarrier (covalently or non-covalently associated) and comprises targeting agent on the surface of the nanocarrier (page 9, [0026]). Neither the prior art nor the specification discloses pathogen-binding receptors or pathogen-binding antibodies that can prevent or even treat any pathogen infection in a subject in need thereof. Therefore, a large amount of experimentation would be required to make and test nanoparticles comprising a genus of pathogen-binding receptors or a genus of pathogen biding and neutralizing antibodies or fragments thereof which can treat any pathogen infection in a subject in need thereof.
The amount of direction and guidance present and the presence or absence of working examples: Given the teachings found in the art, detailed teachings are required to be present in the disclosure in order to enable the skilled artisan to practice the invention as claimed. These teachings are absent. The specification at pg. 53-55 disclose making a functionalized nanoparticle using two step method to make polymer-lipid hybrid nanoparticle, wherein the polymer is polylactic acid (PLA) and lipids comprises phosphotidylserine and DSPE-PEG2000-biotin, so that an streptavidin conjugated ACE2 or an antibody against SARS-CoV spike can be attached to the nanoparticle. The specification does not disclose representative number of pathogen receptors and pathogen-binding antibodies that includes vast number of genus comprising millions of receptors and pathogen-binding antibodies. Therefore, it is unpredictable how one of the skill in the art can practice the instantly claimed invention.
The breadth of the claims and the quantity of experimentation needed: Due to the large quantity of experimentation necessary to any pathogenic infection comprising administering a nanoparticle comprising a core comprising biopolymer polylactic acid, an outer layer encapsulating the core, wherein the outer layer comprises, one or more lipids and wherein outer surface of the outer layer comprises either a neutralizing antibody or streptavidin-modified ACE2 receptor and phosphatidylserine in a subject, the lack of direction/guidance presented in the specification regarding the same, the absence of working examples directed to same, the complex nature of the invention, the state of the prior art which establishes the unpredictability about preventing and/or treating any pathogenic infection comprising said nanoparticles in said subject, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
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.
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.
Claim(s) 1-3,10-11,13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ashley et al (US Pub. No.20170165375) in view of Baker et al. ( US Pub. No. 20150306238).
The instantly claimed invention is broadly drawn to a nanoparticle comprising:(a) a core comprising a biocompatible polymer; and(b) an outer layer encapsulating said core, wherein the outer layer comprises one or more lipids and/or one or more proteins, and wherein an outer surface of the outer layer comprises:(c) a pathogen-binding receptor and/or a pathogen-binding antibody or an antigen-binding fragment thereof; and(d) a phagocyte-specific ligand, wherein the biocompatible polymer is PLA (claim 2), wherein the core as a diameter between 200 and about 1200 nm (claim 3), wherein the outer layer comprises one or more of DOPS, DSPS, POPS, DPPS, and DMPS, optionally about 15% of the one or more DOPS, DSPS, POPS, DPPS, and DMPS, and wherein the phagocyte-specific ligand (d) comprises a moiety targeting a phagocytic cell, optionally wherein the phagocytic cell is selected from the group consisting of a macrophage, a dendritic cell, a neutrophil, a monocyte, and a mast cell (claim 10), wherein the outer layer comprises one or more of the group consisting of 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), cholesterol, and a poly(ethylene glycol) (PEG)-modified lipid, optionally 1,2-distearoyl- sn-glycero-3-phosphoethanolamine (DSPE)-mPEG2ooo (claim 11) and a pharmaceutical formulation comprising a nanoparticle of claim 1 and a pharmaceutically acceptable carrier.
Ashley et al. (IDS, US Pub. No. 2017/0165375) teaches a mesoporous nanoparticle encapsulated with a lipid bi or multilayer. They teach that the nanoparticle having a core comprising a biocompatible polymer (abstract) provides a novel antibiotic protocells comprising mesoporous nanoparticle comprises comprising lipid and one or more from polylactic acid (PLA) or poly glycolic acid (PGA) [0095]. They teach that the nanoparticle can comprise one or more lipid and/or one or more protein. The outer surface of the nanoparticle comprises a cell binding receptor and/or pathogen-binding antibody or antigen binding fragment thereof (abstract). The outer layer of the nanoparticle comprises pegylated or non-pegylated lipids phospholipids for attaching targeting proteins [0120-0131]. Regarding claim 3, they teach that the diameter of particle is about 5 nm to 200 nm or 500 nm (see [0090]) or less than 1,200 nm, less than 100 nm, less than 250nm or less than 200 nm (see [0096]).. Regarding claims 10-11, they teach that the lipid includes 1,2- dioleoyl-sn-glycero-3-[phosphor-L-serine] (DOPS) ([0028]). They teach that phagocytic-specific ligand comprises a moiety targeting phagocytic cell such as macrophages, dendritic cells [0018]. Regarding claim 13, they teach that the composition comprises conventional pharmaceutical carrier or excipient [0155]. Regarding claim 20, they teach that the composition is for treating phagocytic infections (bacterial infection, see abstract, and [0128]). They teach that targeting moieties can include antibodies (see [0098]). Ashley et al do not teach a nanoparticle comprising a pathogen binding receptor and/or antibody on the surface of the nanoparticle.
Baker et al teach a nanoparticle targeting for bacteria (abstract). They teach to include a target binding agent such as antibody or antibody fragment [0111-0114].
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use a binding pathogen binding receptor or antibody as taught by Baker et al in the pathogen targeting nanoparticle comprising a core encapsulated by outer layer of a polymer as taught by Ashley et al. Additionally, one would have been motivated to do so because Baker et al. teach that a nanoparticle can comprise a ligand binding receptor or an antibody or a fragment thereof for binding to a target pathogen. Further, one would have a reasonable expectation of success in using a targeting pathogen using a pathogen binding receptor, or an antibody or a fragment thereof as taught by Baker et al to inhibit pathogen infection or treating other diseases such as cancer by using tumor specific epitopes [0114]. Therefore, the instantly claimed invention would have been obvious to one ordinary skill in the art over the combined teachings of the prior art.
Conclusion
No claim is allowed.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674
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