Detailed Office 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 .
Status of the Claims
Acknowledgement is hereby made of receipt and entry of the communication filed 12 January, 2026. Claims 1, 7, 9, 11, 13, 16-21, 25, and 29-33 are pending in the instant application.
37 C.F.R. § 1.98
The information disclosure statement filed 09 December, 2025, has been placed in the application file and the information referred to therein has been considered.
35 U.S.C. § 112(b)
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.
Claims 1, 7, 9, 11, 13, 16-21, 25, and 29-33 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Two separate requirements are set forth under this statute: (1) the claims must set forth the subject matter that applicants regard as their invention; and (2) the claims must particularly point out and distinctly define the metes and bounds of the subject matter that will be protected by the patent grant.
Amended claim 1 is directed toward an in vitro method for detecting the presence or absence of binding agents in a fluid sample comprising:
a) preincubating host virus-like nanoparticles (HVLNPs) or foreign virus-like nanoparticles (FVLNPs) with the fluid sample;
b) contacting the HVLNPs with FVLNPs following the preincubation; and,
c) detecting or measuring the binding between the HVLNPs and the FVLNPs.
These steps are confusing because step a) indicates the sample may contain HVLNPs or FVLNPs. However, step b) only recites a contacting step wherein the HVLNPs from step a) are contacted with FVLNPs after the preincubation step. This step fails to consider assay steps wherein step a) involves a preincubation step with a FVLNP as opposed to a HVLNP. If step a) begins with a FVLNP, what is it being contacted with in step b)? Appropriate clarification is required.
Claim 13 further references a FVLNP expressing a foreign ligand (SARS-CoV-2 spike (S)protein) that is not expressed on the bacterial cell surface. Claim 1 specifies that the foreign ligand is expressed on the cell surface of microbial cells. The SARS-CoV-2 S protein is viral in origin and is not expressed on the cell surface of microbial cells. Thus, this claim limitation is confusing. Appropriate correction is required.
Claim 32 references a foreign ligand that comprises a viral, fungal, parasitic, or bacterial ligand. The first three items are not microbial in nature. Thus, this claim limitation is confusing. Appropriate correction is required.
35 U.S.C. § 112(d)
The following is a quotation of 35 U.S.C. § 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 13 and 32 are rejected under 35 U.S.C. § 112(d), as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 specifies that the foreign ligand of interest is expressed on the cell surface of microbial cells. However, claim 13 references a FVLNP expressing a foreign ligand (SARS-CoV-2 spike (S)protein) that is not expressed on the bacterial cell surface. Claim 32 references a foreign ligand that comprises a viral, fungal, parasitic, or bacterial ligand. Thus, both claims do not require a bacterial ligand and fail to further limit the claimed subject matter.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
35 U.S.C. § 112(a)
The following is a quotation 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.
Written Description
Claims 1, 7, 9, 11, 13, 16-21, 25, and 29-33 stand rejected under 35 U.S.C. § 112(a), 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, at the time the application was filed, had possession of the claimed invention. Amgen, Inc. v. Sanofi, 872 F.3d 1367, 124 U.S.P.Q.2d 1354 (Fed. Cir. 2017). AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 111 U.S.P.Q.2d 1780 (Fed. Cir. 2014). Univ. of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 920, 69 U.S.P.Q.2d 1886, (Fed. Cir. 2004). Enzo Biochem, Inc. v. Gen-Probe, Inc., 296 F.3d 1316, 63 U.S.P.Q.2d 1609, (Fed. Cir. 2002). Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 U.S.P.Q.2d 1398, (Fed. Cir. 1997). Fiers v. Revel Co., 984 F.2d 1164, 25 U.S.P.Q.2d 1601, (Fed. Cir. 1993). Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 U.S.P.Q.2d 1016, (Fed. Cir. 1991). In re Rasmussen, 650 F.2d 1212, 211 U.S.P.Q. 323 (C.C.P.A. 1981). In re Wertheim, 541 F.2d 257, 191 U.S.P.Q. 90 (C.C.P.A. 1976).
The crux of the statutory requirement governing written description is whether one skilled in the art, familiar with the practice of the art at the time of the filing date, could reasonably have found the later claimed invention in the specification as filed. In re Kaslow, 707 F.2d 1366, 1375, 217 U.S.P.Q. 1089, 1096 (Fed. Cir. 1983). In re Wilder, 736 F.2d 1516, 1520 222 U.S.P.Q. 349, 372 (Fed. Cir. 1984, cert. denied, 469 U.S. 1209 (1985). Texas Instruments, Inc. v. International Trade Comm’n, 871 F.2d 1054, 1063, 10 U.S.P.Q.2d 1257, 1263 (Fed. Cir. 1989). Moreover, the courts have stated that the evaluation of written description is highly fact-specific, and that broadly articulated rules are inappropriate. In re Wertheim, 541 F.2d 257, 263, 191 U.S.P.Q. 90, 97 (C.C.P.A. 1976). In re Driscoll, 562 F.2d 1245, 1250, 195 U.S.P.Q. 434, 438 (C.C.P.A. 1977). It is also important to remember that the true issue in question is not whether the specification enables one of ordinary skill in the art to make the later claimed invention, but whether or not the disclosure is sufficiently clear that those skilled in the art will conclude that the applicant made the invention having the specific claim limitations. Martin v. Mayer, 823 F2d 500, 505, 3 U.S.P.Q.2d 1333, 1337 (Fed. Cir. 1987).
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor has possession of the claimed invention. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 U.S.P.Q.2d at 1116. An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 U.S.P.Q.2d 1961, 1966 (Fed. Cir. 1997). The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 U.S.P.Q.2d 1895, 1905 (Fed. Cir. 1996).
Determination of adequate written description requires the Examiner to read and analyze the specification for compliance with 35 U.S.C. § 112(a). In particular, each claim should be analyzed to determine its broadest reasonable interpretation consistent with written description. Each claim should be evaluated to determine if sufficient structures, acts, or functions are recited to make clear the scope and meaning of the claim, including the weight to be given the preamble. The entire application should be reviewed including the specific embodiments, figures, and sequence listings, to understand how applicant provides support for the various features of the claimed invention. The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated that the inventor was in possession of the claimed invention. Such a review is conducted from the standpoint of one of ordinary skill in the art at the time the application was filed (see, e.g., Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should include a determination of the field of the invention and the level of skill and knowledge in the art. Finally, the Examiner should determine whether there is sufficient written description to inform a skilled artisan that the inventor was in possession of the claimed invention as a whole at the time of filing.
Amended claim 1 is directed toward an in vitro method for detecting the presence or absence of binding agents in a fluid sample comprising:
a) preincubating host virus-like nanoparticles (HVLNPs) or foreign virus-like nanoparticles (FVLNPs) with the fluid sample;
b) contacting the HVLNPs with FVLNPs following the preincubation; and,
c) detecting or measuring the binding between the HVLNPs and the FVLNPs.
The claim further stipulates that said HVLNPs are eukaryotically produced, comprise an envelope (Env), express a surface receptor that binds to a foreign ligand, and comprise a protein containing a late assembly (L) domain that is required for nanoparticle formation (HVLNPEnv+Rec+L+). With respect to the FVLNPs, these may express two different types of particles. One type is produced from eukaryotic producer cells, comprises an Env, expresses a foreign ligand that binds to the HVLNP surface receptor, and comprises a protein containing a late assembly (L) domain that is required for nanoparticle formation (FVLNPEnv+Lig+L+). A second type is also produced from eukaryotic producer cells, does not contain an Env, expresses a foreign ligand that binds to the HVLNP surface receptor, and comprises a viral capsid (CA) protein that is required for nanoparticle formation (FVLNPEnv-Lig+CA+). Finally, the claim stipulates that the foreign ligand of interest comprises a surface ligand originally expressed on microbials cells, although the claims seem to suggest that said ligand may be viral, fungal, parasitic, or bacterial in nature. Claim 30 references a kit comprising the host and foreign virus-like nanoparticles of claim 1.
The claims are still broadly directed toward a large genus of poorly defined HVLNPs and FVLNPs comprising undefined surface receptors, their cognate ligands, and putative binding agents that might inhibit receptor-ligand binding interactions. As previously set forth, these terms are still incredibly broad and encompasses an inordinate number of cellular receptors and their cognate viral, fungal, parasitic, or bacterial ligands. The claims fail to set forth any particular receptors (e.g., ACE2) and their cognate ligands (e.g., S RBD). Putative ligands could include carbohydrates, peptides, proteins, cell penetrating moieties, aptamers, and small ligands (Pereira-Silva et al., 2021). Some limitations simply state that the ligand of interest is present on a microbial cell. Which specific ligands are encompassed by the claim language and what are their cognate receptors? With respect to putative binding agents, the claims encompass an inordinate number of poorly defined species. The claims stipulate that said agents may comprises an antibody, peptide, protein, nucleic acid, aptamer, ribozyme, or a small molecule inhibitor. However, the specification appears to provide a limited number of binding agents, primarily directed at neutralizing antibodies against SARS-CoV-2 S RBD. Additionally, the disclosure also fails to provide a reproducible method for the isolation, purification, and characterization of any given host or foreign nanoparticle. Several factors and challenges still remain in the generation of cell membrane nanoparticles (Liu et al., 2023). The disclosure only appears to provide a limited number of embodiments involving ACE2 host-expressing nanoparticles and SARS-CoV-2 S foreign nanoparticles. It was asserted that these nanoparticles are virus-like particles that were produced by expressing HIV-1 Gag. However, even these examples suffered from a number of limitations, particularly since the precise method of isolation, purification, and characterization was not readily manifest. Considering the claim breadth and unpredictability of the art, multiple examples would be required to support the full genus of host and foreign nanoparticles encompassed by the claim language.
Accordingly, when all the aforementioned factors are considered in toto, the skilled artisan would reasonably conclude that Applicant was not in possession of a sufficient number of receptor-expressing host nanoparticles and ligand-expressing foreign nanoparticles to support the full breadth of protection desired. Submission of a declaration providing a detailed explanation of how the different virus-like particles were produced and isolated would be beneficial.
Applicant is reminded that purpose of the written description requirement is to ensure that the scope of the right to exclude does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification. Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 [54 U.S.P.Q.2d 1915] (Fed. Cir. 2000). To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 U.S.P.Q.2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 U.S.P.Q.2d at 1116. Written description issues may also arise if the knowledge and level of skill in the art would not have permitted the ordinary artisan to immediately envisage the claimed product arising from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 U.S.P.Q.2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not necessarily constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species).
Applicant’s comments with respect to VLNP formation as it applies to viral particle forming proteins expressing a Late assembly (L) domain (e.g., PTAP, PPXY, or YPXnL) are noted. It was pointed out that various retroviral (e.g., HTLV-1, MLV, EIAV, etc.) Gag proteins, Ebola VP40, arenavirus Z proteins, and rabies virus M protein all contain L domains and are capable of forming VLNPs. Additionally, different CA proteins (e.g., HIV-1 CA or norovirus NP-1) are also capable of inducing VLP formation. Applicant’s arguments with respect to this aspect of the claimed invention are persuasive.
It was additionally argued that various surface receptor-ligand binding interactions are well-known in the prior art and could readily be employed. Reference was made to ACE2/SARS-CoV-2 S, ANTXR2/PA63, and FUT2/VP1 binding interactions. However, as previously set forth, the examples set forth in the disclosure fail to provide sufficient guidance with respect to the preparation, isolation, and characterization of any given HVLNP or FVLNP. Example 2 simply states that VSV nanoparticles were employed. It fails to provide a detailed description about the production, isolation, and characterization of these particles. The other examples suffer from the same deficiencies. Example 8 states that the foreign nanoparticles were produced in a manner similar to those described in Example 1. Example 1 simply states that nanoparticles can be induced from producer cells and harvested by centrifugation and filtration. It fails to actually identify the producer cell source and provide a detailed methodology with respect to isolation, purification, and characterization of said nanoparticles. Example 9 appears to describe virus-like particles (VLPs) produced from the norovirus capsid protein VP1. Example 10 simply states that ACE2 host nanoparticles and SARS-CoV-2 spike foreign nanoparticles can be produced in HeLa cells. Once again, this example also fails to provide a detailed methodology with respect to isolation, purification, and characterization of said nanoparticles.
Finally, the claims encompass an inordinate number of binding agents that may include any given antigen-binding fragment, peptide, protein, nucleic acid, aptamer, ribozyme, or small molecule. However, the disclosure is silent with respect to the identification and utilization of suitable binding agents.
Considering the exceedingly broad claim language, the lack of an adequate number of working embodiments, and the lack of adequate support in the disclosure, the skilled artisan would reasonably conclude that Applicant was not in possession of a sufficient number of working embodiments to support the full breadth of the patent protection desired.
Action Is Final
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 C.F.R. § 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 extension fee pursuant to 37 C.F.R. § 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.
Correspondence
Any inquiry concerning this communication should be directed to Jeffrey S. Parkin, Ph.D., whose telephone number is (571) 272-0908. The Examiner can normally be reached Monday through Friday from 10:00 AM to 6:00 PM. A message may be left on the Examiner's voice mail service. 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 are unsuccessful, the Examiner's supervisor, Michael Allen, Ph.D., can be reached at (571) 270-3497. Direct general status inquiries to the Technology Center 1600 receptionist at (571) 272-1600.
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Respectfully,
/JEFFREY S PARKIN/Primary Examiner, Art Unit 1671 24 February, 2026