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 1, drawn to a stool sample collection and processing apparatus, Species B1, embodiment drawn to Figure 1C, and Species B2, embodiment drawn to Figures 2F, in the reply filed on 12/23/25 is acknowledged.
Claims 6, 7, and 23-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/23/25.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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:
“a force exertion element” in claims 1 and 27;
“cylindrical insertion member” in claim 9;
“a mixing and dispensing mechanism” in claim 14;
“a mechanism” in claim 20;
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 Objections
Claims 1 and 14 are objected to because of the following informalities: the positive recitation of “a stool sample” in line 2 should apparently read “the stool sample” as it finds antecedent from the preamble in line 1. Appropriate correction is required.
Claims 1 and 27 are objected to because of the following informalities: the positive recitation of “via the at least one nozzle” in line 9 should apparently read “via the at least one fill nozzle” for antecedent clarity. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: the positive recitation of “a spatial arrangement that complements the spatial arrangement of the plurality of capsule portions” in line 2 should apparently read “a nozzle spatial arrangement that complements the spatial arrangement of the plurality of capsule portions” to avoid clarity issues. Similarly, claim 2 could positively recite “a capsule spatial arrangement” also. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: the positive recitation of “the capsule portions” in line 1 should apparently read “the plurality of capsule portions” for antecedent clarity. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: the positive recitation of “cartridge couples to the at one container” in line 6 should apparently read “cartridge couples to the container” to avoid grammatical and/or antecedent issues. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: the positive recitation of “the capsule carrier” in line 1 should apparently read “the capsule carrier assembly” for antecedent clarity. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: the positive recitation of “the portions” in line 6 should apparently read “the first and second capsule portions” for antecedent clarity. Appropriate correction is required.
Claim 27 is objected to because of the following informalities: the positive recitation of “a sample” in line 2 should apparently read “the sample” as it finds antecedent from the preamble in line 1. Appropriate correction is required.
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 2 is 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 2 positively recites “a plurality of capsule portions”, whereas claim 1 introduced “a capsule portion”. The scope of the claim is indeterminate with respect to the relationship(s) amongst the “a plurality of capsule portions” in view of the “a capsule portion”. It would have to be assumed, consistent with the instant Specification, that claim 1’s capsule portion is one of the “a plurality of capsule portions”, however this is not necessarily established nor does it have to be the case, rendering the claim indefinite.
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.
Claim(s) 1-5, 8-22, and 27-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nichols et al. (WO 2020/257542, hereinafter Nichols).
For claim 1, Nichols discloses an apparatus for collection and processing of a stool sample (Figs 15-18) ([0136-0156]), comprising inter alia:
a container (1500) defining a cavity that can contain a stool sample (Figs 15-18) ([0136-0156]);
a capsule carrier assembly (casing around 1810) defining at least one seat (lower support of 1810) that supports a capsule portion (1810) (Figs 15-18) ([0136-0156]);
at least one fill nozzle (1805 and inlets/outlets [0137]) mechanically coupled to the capsule carrier assembly and the container (Figs 15-18) ([0136-0156]), wherein the fill nozzle provides a passageway for a portion of the stool sample to be transferred from the container into the capsule portion (Figs 15-18) ([0136-0156]);
a force exertion element (force [0145]) mechanically coupled to the container such that the force exertion element exerts a force onto the stool sample in the container to move the portion of the stool sample into the capsule portion via the at least one nozzle (Figs 15-18) ([0136-0156]); and
a filter (filter and/or impeller [0139]) positioned relative to the force exertion element (Figs 15-18) ([0136-0156]), wherein the portion of the stool sample passes through the filter prior to being moved into the capsule portion (Figs 15-18) ([0136-0156]).
For claim 2, Nichols discloses the apparatus of claim 1, wherein the capsule carrier assembly supports a plurality of capsule portions (1810) positioned in a spatial arrangement (Figs 15-18) ([0136-0156]).
For claim 3, Nichols discloses the apparatus of claim 2, wherein the at least one fill nozzle includes a plurality of fill nozzles (1805 and inlets/outlets [0137]) arranged in a spatial arrangement that complements the spatial arrangement of the plurality of capsule portions (Figs 15-18) ([0136-0156]).
For claim 4, Nichols discloses the apparatus of claim 3, wherein the capsule portions are positioned in an annular spatial arrangement (individually addressable pre-determined partitions, e.g. vials, tubes [0145]) (Figs 15-18) ([0136-0156]).
For claim 5, Nichols discloses the apparatus of claim 1, wherein the capsule carrier assembly comprises: a capsule carrier (casing around 1810) that supports a plurality of capsule body portions (Figs 15-18) ([0136-0156]); and a capsule capper that supports a plurality of capsule cap portions such that each capsule cap portion aligns with a corresponding capsule body portion when the capsule capper is coupled to the capsule carrier (Figs 15-18) ([0136-0156], especially [0148]).
For claim 8, Nichols discloses the apparatus of claim 1, wherein the capsule carrier assembly is annular (1810 defines a plurality of annular receptables) (Figs 15-18) ([0136-0156]).
For claim 9, Nichols discloses the apparatus of claim 1, further comprising a cartridge (force [0145]) having a cylindrical insertion member (force [0145]) that fits into the cavity of the container (Figs 15-18) ([0136-0156]).
For claim 10, Nichols discloses the apparatus of claim 1, wherein the force exertion element is a piston (force [0145]) (Figs 15-18) ([0136-0156]).
For claim 11, Nichols discloses the apparatus of claim 9, wherein the force exertion element is a piston (magnetic piston via magnetic beads [0145]) positioned inside the cylindrical insertion member of the cartridge (Figs 15-18) ([0136-0156]).
For claim 12, Nichols discloses the apparatus of claim 9, wherein the force exertion element is the cylindrical insertion member (force [0145]) (Figs 15-18) ([0136-0156]).
For claim 13, Nichols discloses the apparatus of claim 1, wherein the container rotates relative to at least an auger portion of the device to mix the stool sample (mixer for homogenization [0137]) (Figs 15-18) ([0136-0156]).
For claim 14, Nichols discloses an apparatus for collection and processing of a stool sample (Figs 15-18) ([0136-0156]), comprising inter alia:
a container (1500) defining a space that can contain a stool sample (Figs 15-18) ([0136-0156]);
at least one capsule carrier assembly (casing around 1810) configured to support at least one capsule (1810) (Figs 15-18) ([0136-0156]);
a cartridge (1550) including a piston (force [0145]), a filter (filter [0151]), a mixing and dispensing mechanism (mixer for homogenization [0137]), and one or more fill nozzles (1805) configured to align with an opening of the at least one capsule (Figs 15-18) ([0136-0156]),
wherein the cartridge couples to the at one container (Figs 15-18) ([0136-0156]); and
an actuator (PCB 1580) that can be actuated to rotate the cartridge (1580 controls contents of 1550) (Figs 15-18) ([0136-0156]).
For claim 15, Nichols discloses the apparatus of claim 14, wherein at least a portion of the container can achieve rotational movement relative to the cartridge to mix the stool sample (mixing homogenization [0137]) (Figs 15-18) ([0136-0156]).
For claim 16, Nichols discloses the apparatus of claim 14, where the piston is configured to displace the stool sample through the filter (force [0145]) (Figs 15-18) ([0136-0156]).
For claim 17, Nichols discloses the apparatus of claim 14, where the mixing and dispensing mechanism comprises at least one auger (mixer for homogenization [0137]) (Figs 15-18) ([0136-0156]).
For claim 18, Nichols discloses the apparatus of claim 17, wherein the at least one auger is a first auger on an exterior surface of the cartridge (one side of mixer) (Figs 15-18) ([0136-0156]).
For claim 19, Nichols discloses the apparatus of claim 17, wherein the at least one augur is a second auger on an interior surface of the container (other side of mixer) (Figs 15-18) ([0136-0156]).
For claim 20, Nichols discloses the apparatus of claim 14, wherein the capsule carrier comprises: a first capsule portion and a second capsule portion arranged in offset positions relative to one another (Figs 15-18) ([0136-0156]); a mechanism (moveable stage [0145])) configured to align the first capsule portion with the second capsule portion (Figs 15-18) ([0136-0156]); and a guide to axially displace the portions to mate the first capsule portion and a second capsule portion to form a closed capsule (Figs 15-18) ([0136-0156], especially [0148]).
For claim 21, Nichols discloses the apparatus of claim 14, wherein the actuator is a hand crank configured to cause sample mixing in one direction and sample dispensing in a second direction (hand actuates electronics of mixer for homogenization) ((Figs 15-18) ([0136-0156]).
For claim 22, Nichols discloses the apparatus of claim 14, wherein the at least capsule carrier assembly is annular (Figs 15-18) ([0136-0156]).
For claim 27, Nichols discloses an apparatus for collection and processing of a sample (Figs 15-18) ([0136-0156]), comprising, inter alia:
a container (1800) defining a cavity that can contain a sample (Figs 15-18) ([0136-0156]);
a capsule carrier assembly (casing around 1810) defining at least one seat that supports a capsule portion (1810) (Figs 15-18) ([0136-0156]);
at least one fill nozzle (1805) mechanically coupled to the capsule carrier assembly and the container (Figs 15-18) ([0136-0156]),
wherein the fill nozzle provides a passageway for a portion of the sample to be transferred from the container into the capsule portion (Figs 15-18) ([0136-0156]);
a force exertion element (force [0145])) mechanically coupled to the container such that the force exertion element exerts a force onto the sample in the container to move the portion of the sample into the capsule portion via the at least one nozzle (Figs 15-18) ([0136-0156]); and
a filter (filter and/or impeller [0139)) positioned relative to the force exertion element (Figs 15-18) ([0136-0156]),
wherein the portion of the sample passes through the filter prior to being moved into the capsule portion (Figs 15-18) ([0136-0156]).
For claim 28, Nichols discloses the apparatus of claim 27, wherein the sample is a stool sample (Figs 15-18) ([0136-0156]).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for configuring stool sample collection and processing
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791