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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 3/20/2026 wherein claims 2, 5, 7-11, 17, 18, 21-23, and 31-40 were canceled and claims 1, 3, and 6 were amended.
Note(s): Claims 1, 3, 4, 6, 12-16, 19, 20, and 24-30 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/20/2026 has been entered.
Priority
This application is a 371 of PCT/US20/42678 filed 7/17/2020 and PCT/US20/42678 claims benefit to PRO of 62/876,379 filed 7/19/2019.
Note(s): The earliest effective filing date is 7/19/2019 as the pending invention is fully supported by the parent applications.
Claim Interpretation
Independent claim 1 is directed to a composition comprising a plurality of particles of one type or a plurality of particles of more than one type, each type comprising a core comprising a tag, a unique compound of interest or a combination of compounds of interest and a unique label, wherein unique compound(s) of interest is/are stably attached to the core wherein each particle type comprises a paramagnetic material and wherein the unique compound of interest or the combination of compounds of interest for each particle type comprises a drug, a biomolecule, or combinations thereof.
Independent claim 24 is directed to a method of measuring gut microbiota functional activity as set forth in claim 24.
Applicant’s Election
Once again, the Examiner acknowledges Applicant’s election of Group I (pending claims 1, 3, 4, 6, 12-16, 19, and 20) in the reply filed on 4/21/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election was treated as an election without traverse (MPEP § 818.01(a)).
Once again, in the response filed 4/21/2025, Applicant elected the species wherein (1) the particle type core comprising a tag is paramagnetic streptavidin-coated silica beads; (2) the unique label is a combination of biotinylated fluorophores PF-505, PF-510LSS, PF-633, and PF-415; (3) the unique combination of compounds of interest is glycan or a glycan derivative; (4) the fiber preparation is pea fiber preparation; and (5) the polysaccharide is a linear or branched polysaccharide. Claims 1, 3, 4, 6, 12-16, 19, and 20 read on the elected species.
Initially, Applicant’s elected species was searched and no prior art was found to reject the claims. The search was expanded to the species found in the cited prior art below. The search was not further extended because prior art was found which could be used to reject one or more claims.
Withdrawn Claims
Claims 24-30 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Response to Applicant’s Amendment and/or Arguments
The Applicant's arguments and/or amendment filed 3/20/2026 to the rejection of claims 1, 3-6, 12-16, 19, and 20 made by the Examiner under 35 USC 102 and/or 112 have been fully considered.
112 Second Paragraph Rejections
All outstanding 112 second paragraph rejections are WITHDRAWN because Applicant amended the claims to overcome the rejections.
102 Rejection
While the claims were amended to overcome the 102 rejection, the amended claims are rejectable under 35 U.S.C. 103 as set forth in detail below.
NEW GROUNDS OF REJECTION
112 Second Paragraph Rejection
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, 3, 4, 6, 12-16, 19, and 20 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.
Claims 1, 3, 4, 6, 12-16, 19, and 20: Independent claim 1 is ambiguous for the following reasons: according to MPEP 2173.05(h), while a Markush grouping may include a large number of alternatives, and not necessarily be indefinite under, in certain circumstances, a Markush group may be so expansive that a skilled artisan cannot determine the metes and bounds of the claimed invention. In the pending claims, the invention is directed to a composition comprising a plurality of particles of one type or a plurality of particles of more than one type; each type of particles comprising a core comprising a tag, a unique compound of interest or a combination of compounds of interest for each particle type comprising a drug, a biomolecule, or combinations thereof.
The term ‘drug’, according to the disclosure (specification, pages 28-29, paragraph [0075]) includes any compound intended for use in diagnosis, cure, mitigation, treatment of disease, or prevention of disease. The drug may be any type of biomolecule such as antibiotics, antidiabetics, antihistamines, anti-inflammatories, antimetabolites, antineoplastic agents, antipsychotics, calcium channel blocker, chemotherapeutics, hormones, proton pump inhibitors, and pscyholeptics.
The term ‘biomolecule’ includes carbohydrates, lipids, nucleic acids, and proteins that are generated synthetically or biologically by a cell or living organism (specification, pages 29-33, paragraphs [0076] - [0083]). In addition, the term may include food particles used as a food ingredient (e.g., glycans). The carbohydrate may be a monosaccharide, disaccharide, oligosaccharide or a polysaccharide.
The term ‘carbohydrate’ encompasses any monosaccharide, disaccharide, oligosaccharide, or polysaccharide.
The term ‘lipid’ encompasses any compound that is soluble in nonpolar solvents, and includes fatty acids, fatty acid derivatives (e.g., monoglycerides, diglycerides, triglycerides, phospholipids, and so forth), sterols, and fat-soluble vitamins (e.g. vitamins, A, D, E, K, and so forth) as well as glycolipids.
The terms ‘nucleic acid’ include any polymeric form of nucleotides of any length, either deoxyribonucleotides or ribonucleotides, or analogs thereof. Polynucleotides may have any three dimensional structure, and may perform any function, known or unknown. The following are non-limiting examples of polynucleotides: coding or non-coding regions of a gene or gene fragment, loci (locus) defined from linkage analysis, exons, introns, messenger RNA (mRNA), transfer RNA, ribosomal RNA, short interfering RNA (siRNA), short-hairpin RNA (shRNA), micro-RNA (miRNA), ribozymes, cDNA, recombinant polynucleotides, branched polynucleotides, plasmids, vectors, isolated DNA of any sequence, isolated RNA of any sequence, nucleic acid probes, and primers. A polynucleotide may comprise one or more modified nucleotides, such as, methylated nucleotides and nucleotide analogs. If present, modifications to the nucleotide structure may be imparted before or after assembly of the polymer. The sequence of nucleotides may be interrupted by non-nucleotide components. A polynucleotide may be further modified after polymerization, such as by conjugation with a labeling component.
The particles may contain a particle comprising a protein or a combination of proteins. The term ‘protein’ encompasses any polymers of amino acids of any length. The polymer may be linear or branched, it may comprise modified amino acids, and it may be interrupted by non-amino acids. The term also encompass an amino acid polymer that has been modified; non-limiting examples of such modifications include disulfide bond formation, glycosylation, lipidation, acetylation, phosphorylation, or any other manipulation, such as conjugation with a labeling component. Still, the term ‘amino acid’ includes natural and/or unnatural or synthetic amino acids, including glycine and both the D or L optical isomers, and amino acid analogs and peptidomimetics.
The particles may comprise a glycan or a combination of glycans. The term ‘glycan’ encompasses a homo- or heteropolymer of two or more monosaccharides linked glycosidically. As such, the term "glycan" includes disaccharides, oligosaccharides and polysaccharides. The term also encompasses a polymer that has been modified, whether naturally or otherwise; non-limiting examples of such modifications include acetylation, alkylation, esterification, etherification, oxidation, phosphorylation, selenization, sulfonation, or any other manipulation, such as conjugation with a labeling component. Glycans may be linear or branched, may be produced synthetically or obtained from a natural source, and may or may not be purified or processed prior to use.
The particles of the pending invention comprise a unique compound of interest or a combination of compounds of interest and a unique label. The compound of interest includes compounds that are altered, degraded and/or removed from the particle by gut microorganisms during the particles' transit through a subject's gut and compounds that binds to gut microorganisms or that gut microorganisms bind to. Non- limiting examples of suitable compounds of interest include biomolecules and drugs. Particles may be comprised of only one compound of interest (e.g., a specific glycan, lipid, nucleic acid sequence, protein, and so forth). Alternatively, a particle may have multiple compounds of interest of the same type (e.g., multiple glycans, multiple lipids, multiple nucleic acid sequences, multiple proteins, and so forth) or multiple compounds of interest of different types (e.g., one or more glycan and one or more lipid, and so forth). Compounds of interest can be processed into a particle or attached to a core to make a particle by a variety of methods known in the art.
Since claims 3, 4, 6, 12-16, 19, and 20 depend upon independent claim 1 for clarity, those claims are also vague and indefinite.
Thus, independent claim 1 encompasses a subject matter defined by multiple Markush groups and subgroups thereof. As a result, pending claim 1 encompasses a massive number of distinct alternative members such that one skilled in the art cannot determine the metes and bounds of the claim. Hence, due to an inability to envision all of the compounds defined by the Markush groups, the claim is deemed to be vague and indefinite.
103 Rejection
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 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Chandler et al (US Patent No. 6,268,222).
Independent claim 1 is directed to a composition comprising a plurality of particles of one type or a plurality of particles of more than one type, each type comprising a core comprising a tag, a unique compound of interest or a combination of compounds of interest and a unique label, wherein unique compound(s) of interest is/are stably attached to the core wherein each particle type comprises a paramagnetic material and wherein the unique compound of interest or the combination of compounds of interest for each particle type comprises a drug, a biomolecule, or combinations thereof.
Claim 6 is directed to is directed to at least one particle having two or more drugs, two or more biomolecules, or a combination of a drug and a biomolecule.
Chandler et al is directed to microparticles that are attached to nanoparticles labeled with fluorescent dyes. In particular, the compositions of Chandler et al comprise a core particle having on its surface a plurality of smaller polymeric particles which are labeled with different fluorescent dyes (see entire document, especially, abstract; column 3, lines 9-15). The plurality of particles have nanospheres of dyes that are coupled to the microparticles stained with the same or different dyes (columns 2-3, bridging paragraph).
The polymeric microparticles are used as carrier/core particles (column 3 lines 9-12). The nanospheres present as well as carrier particles are made of polymer material which may also incorporate magnetic or magnetically responsive metal oxide such as paramagnetic material (column 3, lines 21-46). In addition, Chandler et al disclose that the series of microparticles with attached nanoparticles having a distinct fluorescent signal and an analytical reactant capable of specifically binding with analytes of interest. Also, Chandler et al disclose that the analytes may be an antigen, an antibody (both monoclonal and polyclonal), a receptor, a hapten, an enzyme, a protein, a peptide, a nucleic acid, a drug, a hormone, a chemical, a polymer, a pathogen, a toxin, or a combination thereof. Hence, Chandler et al disclose that each tagged particle comprising a paramagnetic material may contain a targeting agent (e.g., an antigen, an antibody (both monoclonal and polyclonal), a receptor, a hapten, an enzyme, a protein, a peptide, a nucleic acid, a drug, a hormone, a chemical, a polymer, a pathogen, a toxin, or a combination thereof) as well. Thus, the limitations of claims 1 and 6are met.
APPLICANT’S ASSERTIONS
In response to the previous 102 rejection regarding Chandler et al, it was asserted that the reference does not teach or suggest particles comprising a tag, unique compound of interest attached to the core, tag for each particle in combination with a paramagnetic material and the presence of a drug, a biomolecule, or combinations thereof.
EXAMINER’S RESPONSE
Applicant’s arguments were considered, but deemed non-persuasive for reasons of record. As indicated in the description of Chandler et al, the reference does disclose that one may have paramagnetic material attached to the particle and also that the particles may be conjugated to a targeting agent that includes a drug, a biomolecule, and combinations thereof. Thus, the 103 rejection is deemed proper.
Comments/Notes
The full scope of the pending claims was not searched.
Conclusion
Claims 1, 3, 4, 6, 12-16, 19, and 20 are rejected and claims 24-30 are withdrawn.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G. 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.
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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
August 3, 2026
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