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 .
DETAILED ACTION
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1, 2, 3-8, 10, 12-17, and 20-22, drawn to an assembly.
Group II, claim(s) 23, 24, and 27, drawn to a system.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because the groups do not share the same or corresponding technical feature, wherein the special technical feature of Group I is drawn to a homogenization accelerator, which is secured in a pocket bound by the cap and a seal on the lid that is not found in Group II.
During a telephone conversation with Peter Flynn on January 13th, 2026 a provisional election was made without traverse to prosecute the invention of Group II, claims 23, 24, and 27. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1, 2, 3-8, 10, 12-17, and 20-22 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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).
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:
1) Sampler for collecting a sample…as in cl. 23
2) Detection device configured for measuring, operating, and measuring/visualizing as in cl. 23.
3) Measurement device capable of detecting and measuring weight, mass, or volume as in cl. 27
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.
1) Food corer, hollow tube, or equivalents thereof as in pars.[0007] of Applicant’s pre-grant publication US 2024/0299940, original cl. 22.
2) An optical detector as in at least one photodiode and a detection sensor, as in pars. [0142,0148,0174], and equivalents thereof. *further clarification is required.
3) A scale or sensor for measuring weight, mass or volume within the and equivalents thereof as in par.[0214].
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
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 23, 24, and 27 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 23 recites the limitation "the detection test". There is insufficient antecedent basis for this limitation in the claim.
The recitation itself is drawn to a process recitation wherein the claims are drawn to a device and there is no prior discussion of such a “detection test” to clearly provide the functionality of the detection device therewith.
Further, Applicant’s specification at par.[0210] discloses that the detection device may comprise a motor for rotating the rotor of the homogenizer, however, it is noted that these elements are not a part of independent claim 23.
Clarification is required as this pertains to the above-discussed claim interpretation section with respect to the metes and bounds of the structure(s) afforded to the detection device for its recited functionalities.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 23, as best understood, is/are rejected under 35 U.S.C. 102a1 as being anticipated by Gilboa-Geffen et al. (WO 2019/165014), hereafter Gilboa-Geffen
With regard to claim 23, Gilboa-Geffen discloses a system for detecting as claimed, comprising a sampler for collecting a sample as claimed (par.[0021] a food corer including a hollow tube with a cutting edge), a disposable analytical cartridge configured for processing the sample as claimed (pars.[0021,0030,0047], and a detection device 100 configured for measuring the sample, operating the detection test (as best understood herein; see above rejection under 35 USC 112 b/2nd), and measuring and visualizing a signal as claimed (pars.[0040,0045,0097,0098], fig 1, for example).
Claim Rejections - 35 USC § 103
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.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gilboa-Geffen in view of Kayyem et al. (US 2015/0323555), hereafter Kayyem.
Gilboa-Geffen has been discussed above.
Further, with regard to claim 24, Gilboa-Geffen discloses that the disposable analytical cartridge comprises a lid 103 (par.[0098] and a movable cap (pars.[0106,0167,0225], fig. 5G), a filter system configured as claimed (filter for filtering off larger particles; par.[0108], cl. 6), a separate transparent substrate comprising a plurality of fluidic channels and a detection area with the detection agent immobilized thereon (pars.[0013,0184]), a detection chamber with an optical window (pars.[0009,0012,0013]), waste chamber for accepting and storing outflow contents as claimed (par.[0011]), a rotary valve system and conduits configured as claimed (pars.[0012,0022]), and an air flow system configured to regulate air as claimed (pars.[0022], cl. 22).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gilboa-Geffen in view of Kantrowitz et al. (US 2007/0014693), hereafter Kantrowitz.
Gilbert-Geffen has been discussed above.
With regard to claim 27, Gilbert-Geffen does not specifically the cover comprises a measurement device capable of detecting and measuring the weight, mass, or volume of the sample as claimed.
With regard to claim 27, Gilbert-Geffen discloses the detection device comprises a frame attachable to the housing, a base attached to the frame and a cover connected to the frame (see fig. 1 wherein the detection device is fully enclosed by wall connected wall portions constituting said frame, base and cover as claimed).
Kantrowitz discloses a modular hospital cart wherein the specimen sensor is adapted to measure the quantity of a specimen in a specimen container and the specimen sensor is a weight sensor adapted to sense the weight of the sample container and to transmit the weight sensor signal to the processing and memory circuitry in order to determine if the sensed weight is sufficient to comply with the specimen for its analysis (par.[0039], figs. 1-3).
It would have been obvious to one of ordinary skill in the art to modify Gilboa-Geffen to provide a measurement device adjacent to the detection device adapted for measuring the weight, mass, or volume of the sample (and wherein it is noted that the recitation “…when the sample is placed…” is drawn to a conditional process recitation not afforded patentable weight in a device claim) such as taught by the analogous prior art of Kantrowitz to a biological sample collection and analysis system wherein an adjacent measurement device for measuring weight, mass, or volume provides the ability to ascertain if the received sample is sufficient in order to carry out a proper analysis thereof.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEIL N TURK/Primary Examiner, Art Unit 1798