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
Claims 1-4, 6, 11, 15-26, 33-36, and 38-42 are pending in the application.
Claims 33-36 and 38-42 are withdrawn.
Claims 1-4, 6, 11, and 15-26 are the subject of this office action.
Election/Restrictions
Claims 33-36 and 38-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1 July 2026.
Priority
The instant application is a 371 National Stage of PCT/US2022/072754, filed 3 June 2022, which claims benefit of 63/196,315, filed 3 June 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7 November 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claims 3, 11 are objected to because of the following informalities:
in claims 3 and 11, a properly formatted Markush grouping should read: “selected from the group consisting of”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
in claim 1: “the first unit is configured to bind to one or more molecules secreted by the cell to which the particle is configured to be bound”
this limitation is interpreted under 112(f) because it requires a recited function without providing structural detail sufficient to support that function. That is, the structure of a “first unit” is unclear and what characteristics or features provide it with the capability of binding to a secreted molecule are not defined. Additionally, the way in which a generic particle is “configured to be bound” to a cell is not defined, and the associated/required structure is unclear. Regarding these functions, the instant specification provides: the first unit may be a protein such as Protein G which binds a secreted antibody or an antibody such as anti-IL-2 or anti-VEGF which binds secreted protein; the particle may be configured to bind a cell via conjugation of an antibody that specifically binds to a cell surface marker such as anti-CD44 antibody (Par. 110, 116, 142, 215, 223)
in claim 11: “the composition is configured for a use selected from…”
this limitations is interpreted under 112(f) because it requires that the composition is “configured for” a particular recited use, but the particular structural or physical features (i.e. the particular configuration) associated with each intended use are unclear. It is unclear whether these are mere recitations of intended use, or whether these require particular structural and physical features of the composition which further limit the physical composition itself over the composition of claim 1. If further physical and structural features are required by the recited uses, it is not clear what these are or what each particular use specifically requires.
in claim 21: “the particle is further configured to: bind to the cell, and; collect one or more of the secreted molecules from the specific cell”
this limitation is interpreted under 112(f) because it requires a recited function without providing structural detail sufficient to support that function. That is, the physical structure or features of a particle that provide it with the capability of binding to a cell are not defined. Regarding this function, the instant specification provides: the particle may be configured to bind a cell via conjugation of an antibody that specifically binds to a cell surface marker such as anti-CD44, anti-CD3 antibody; the first unit may be a protein such as Protein G which binds a secreted antibody or an antibody such as anti-IL-2 or anti-VEGF which binds secreted protein (Par. 110, 116, 142, 215, 223)
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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.
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 6, 11, 18-19, 21-26 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 6 is rejected as indefinite over the following terms: “collector molecule”, “collector antibody”, “collector protein”, “targeting molecule”, “targeting antibody”, “targeting protein”. They appear to limit a molecule/antibody/protein by a particular intended use, but it is not clear what physical structures, characteristics, or features this intended use requires, such that the metes and bounds of these terms are unclear. That is, the physical features or characteristics a molecule must have or not have in order to be considered a collector molecule or a targeting molecule are not clear.
Claim 18 is indefinite because the first half of the claim recites “hydroxyl or carboxyl groups” while the second half of the claim recites only “hydroxyl groups” it is therefore unclear whether or not the particle must comprise hydroxyl groups specifically or whether it may comprise hydroxyl groups or carboxyl groups. Clarification is required.
Claim 21 is rejected as indefinite over the term “specific cell”. The metes and bounds of the term are unclear because it is not clear what exactly makes a cell a specific cell, and what distinguishes a specific cell from any other cell.
Claim limitation “configured for a use selected from” in claim 11 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, as discussed in the claim interpretation section above. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The claim requires that a composition is “configured for” a particular intended use, but the particular structural features or changes that are associated with configuring a composition for each intended use, and whether or not a particular intended use requires additional physical or structural limitations beyond what is already recited in claim 1 is unclear. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Dependent claims 19 and 22-26 are rejected as indefinite because they depend from an indefinite claim and fail to remedy its deficiencies.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6, 11, and 15-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (Lee, Ye Lim. Ability of Janus Particle as Single Cell Sensor to Immobilize Plasma Cells and Collect Antibody. Georgia Institute of Technology. Pgs. 1-15. Fall 2018).
Regarding claim 1, Lee teaches a composition comprising:
a cell (Pg. 5, Abstract: a Janus particle binds to a B cell with one hemisphere and collects secreted antibody with another hemisphere; Fig. 2; Pg. 13, Par. 1: the Janus demonstrated the ability to isolate specific hybridoma cells);
a particle comprising a first unit; wherein the first unit is configured to bind one or more molecules secreted by the cell to which the particle is configured to be bound (Abstract; Fig. 2: particle functionalized with anti-CD44 antibody and Protein G, wherein anti-CD44 antibody binds a cell and Protein G binds a secreted antibody; Pg. 9).
Regarding claim 2-4, 6, and 21-26, Lee further teaches the composition wherein:
the first unit is bound to the particle via a first linker, wherein the first linker comprises an agent selected from the group consisting of silanization binding agent, a carbodiimide binding agent, a carboxylic binding agent, a phosphate binding agent, and combinations thereof (Pg. 9, Materials; Pg. 10, Preparation of Janus Particle; Fig. 2; Protein G (i.e. first unit, collector protein, a molecule collection unit that binds a secreted antibody) is bound to a silica particle via APTES (i.e. first linker) or bound to a carboxylated polystyrene particle with EDAC); and
the cell is non-covalently bound to the particle through a second unit affixed to the particle via a second linker, wherein the second linker comprises a thiol-polymer-bioactive molecule complex (Pg. 9, Materials; Pg. 10, Preparation of Janus Particle; Fig. 2; a cell is non-covalently bound by the anti-CD44 antibody (i.e. second unit, targeting antibody, binds a specific cell), which is affixed to the particle via thiol-PEG-biotin (i.e. second linker)).
Regarding claim 11¸it is noted that the only limitation of claim is that the composition is “configured for” a particular use. As discussed in the 112(b) rejection above, it is not clear what structural limitations, if any, these recitations apply to the claimed composition. A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art teaches all structural limitations, it is understood to be capable of the recited intended use, regardless of whether the prior art explicitly teaches the same intended use. As such, Lee is understood to read on claim 11 because it teaches all apparent structural features of the claimed composition.
Lee’s teachings regarding the recited intended use are addressed below for the sake of compact prosecution.
Regarding claim 11¸Lee further teaches the composition wherein the composition is configured for a use such as capturing one or more molecules secreted from the cell (Abstract: the Janus particle can bind to the plasma B cell with one hemisphere and collect antibody with another hemisphere; Fig. 2).
Regarding claim 15-19, Lee further teaches the composition wherein the particle further comprises:
an outer surface comprising one of hydroxyl or carboxyl functional groups such that the first linker is capable of covalently bonding with the outer surface of the particle (Pg. 9, Materials; Pg. 10, Preparation of Janus Particles; Fig. 2; particles may be either carboxylated polystyrene microsphere with EDAC linker or silica beads with APTES linker);
a coating comprising metallic functional groups capable of bonding with the second linker (Pg. 10, Preparation of Janus Particles: gold hemisphere modified with thiol-PEG-biotin; Fig. 2);
wherein the coating is positioned on at least a portion of the outer surface of the particle (Fig. 2);
and wherein the coating comprises a pattern such that the first unit and the second unit are arranged along the particle in a pattern (Fig. 2: coating comprises a hemispheric “Janus pattern”).
Regarding claim 20, Lee further teaches the composition wherein the particle comprises a diameter between 0.01um and 100um (Fig. 2; Pg. 9, Preparation of Janus Particles; 2um and 4um particles).
Claims 1-4, 6, 11, and 15-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ramirez et al (Isolation of antigen-specific plasma cells using Janus particles. Biomaterials, Abstracts. 2018).
Regarding claim 1, Ramirez teaches a composition comprising:
a cell (see Figure showing a composition comprising Janus particles bound to cells);
a particle comprising a first unit; wherein the first unit is configured to bind one or more molecules secreted by the cell to which the particle is configured to be bound (Statement of Purpose: The Janus particles attach directly to antibody secreting cells on one surface through a common marker, while the second surface collects secreted IgG antibody through Protein G, a high affinity binder of IgG molecules).
Regarding claim 2-4, 6, and 21-26, Ramirez further teaches the composition wherein:
the first unit is bound to the particle via a first linker, wherein the first linker comprises an agent selected from the group consisting of silanization binding agent, a carbodiimide binding agent, a carboxylic binding agent, a phosphate binding agent, and combinations thereof (Statement of Purpose; Col. 1, Methods: Protein G (i.e. first unit, collector portion, a molecule collection unit that binds a secreted antibody) is bound to silica particles via APTES (i.e. first linker) or bound to carboxylated styrene particles via EDC (i.e. first linker)); and
the cell is non-covalently bound to the particle through a second unit affixed to the particle via a second linker, wherein the second linker comprises a thiol-polymer-bioactive molecule complex (Methods, Col. 1: a gold hemisphere of the particle was modified via thiol-PEG-biotin (i.e. second linker) where targeting antibodies (i.e. second unit, binds a specific cell) labeled with streptavidin selectively bind to the biotin, for example, the antibody may be anti-CD44).
Regarding claim 11¸it is noted that the only limitation of claim is that the composition is “configured for” a particular use. As discussed in the 112(b) rejection above, it is not clear what structural limitations, if any, these recitations apply to the claimed composition. A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art teaches all structural limitations, it is understood to be capable of the recited intended use, regardless of whether the prior art explicitly teaches the same intended use. As such, Ramirez is understood to read on claim 11 because it teaches all apparent structural features of the claimed composition.
Ramirez’s teachings regarding the recited intended use are addressed below for the sake of compact prosecution.
Regarding claim 11¸Ramirez further teaches the composition wherein the composition is configured for a use such as capturing one or more molecules secreted from the cell (see, e.g. the Figure).
Regarding claim 15-19, Ramirez further teaches the composition wherein the particle further comprises:
an outer surface comprising one of hydroxyl or carboxyl functional groups such that the first linker is capable of covalently bonding with the outer surface of the particle (see Methods, Col. 1: the particle may be a silica bead with an APTES linker or a carboxylated polysterene with an EDC linker);
a coating comprising metallic functional groups capable of bonding with the second linker (see Methods, Col. 1: beads were coated with a layer of gold and titanium. The gold hemisphere was modified with thiol-PEG-biotin);
wherein the coating is positioned on at least a portion of the outer surface of the particle (Methods, Col. 1: coating is present in a hemispheric Janus pattern);
Regarding claim 20, Ramirez further teaches the composition wherein the particle comprises a diameter between 0.01um and 100um (Figure shows that the particles have a diameter of about 4um).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fitzgerald et al (A universal nanoparticle cell secretion capture assay. Cytometry A. 2013 Feb;83(2):205-11.; previously cited): which discloses heterofunctional nanoparticles coupled to a cell surface specific antibody and to a secreted protein-specific antibody, which capture the secreted protein on the surface of the producing cell
Tang et al (Bifunctional Janus microparticles with spatially segregated proteins. Langmuir. 2012 Jul 3;28(26):10033-9. Epub 2012 Jun 18.): which discloses fabrication of bifunctional janus microparticles with spatially segregated proteins
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIS LUSI whose telephone number is (571)270-0694. The examiner can normally be reached M-Th 8am-6pm ET.
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/ELLIS FOLLETT LUSI/Examiner, Art Unit 1677
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
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