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
In response to applicant’s cancellation of claim 20, the prior restriction requirement is withdrawn. Thus, claims 1-19 will be examined.
Information Disclosure Statement
The information disclosure statement filed 11/16/22 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. The application under examination did not include the 7 cited foreign patent documents listed in the IDS.
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.
Claim 4 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 4 is rejected because it is unclear how the claimed step, e.g., “extending the plunger” structurally further defines the claimed device, which is an apparatus-type of claim.
Claim Interpretation
The Office asserts that terms and phrases like “capable of” constitute recitations of intended use language for purposes of examination. The Office asserts that in the examined claims reciting such “capable of” language, the claim language that follows such recitations does not necessarily denote structure MPEP 2173.05(g). The functional limitation was evaluated and considered, for what it fairly conveys to a person of ordinary skill in the art. While all words in each claim are considered in judging the patentability of the claim language, including functional claim limitations, not all limitations provide a patentable distinction.
During patent examination, the examined claims must be given their broadest reasonable interpretation consistent with the specification, unless a term has been given a special definition in the specification (“BRI”). See MPEP 2111.
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.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Carrano et al. (“Carrano,” US Pub. No. 2018/0217031) in view of Sundvor et al. (“Sundvor,” US Pub. No. 2015/0011020, cited in IDS).
As to claim 1, Carrano discloses testing device in fig. 4A et seq., comprising: a piston (piston cap [0027] et seq.), with a piston chamber (piston 238 [0024] et seq.), an annular lower portion (first macerating surface 244 [0025] et seq.), a pierceable layer spanning the annular lower portion's center (temporary seal 250 [0027] et seq.), a textured surface at a bottom end of the piston ([0030] the first surface 244 and second surface 246 may be textured or include an alternative feature (e.g., a roller, blade, perforation, grate, squeegee, other compressive tool) to grind the sample 264 or facilitate extraction of ground or pulverized specimen from the receiving chamber 206), the piston chamber capable of retaining a fluid ([0028] et seq.), a core (figs. 5-7D), with a first core chamber, a second core chamber, at least one lower drain hole (for chambers and lower drain hole, see [0032] and figs. 5-7D which discloses portions 212 with metering reservoirs and multiple vessels 270-272, and a chamber outlet 210), an annular grinding surface ([0068] et seq.), and a circumferential sealing element (e.g., see seals in figs. 4B-5, which are boxed shaped in the figures).
Regarding claims 1 and 16-19, Carrano does not specifically disclose an assay opening, a piercing element; a plunger, with at least one hole plug protruding from a top portion of the plunger; an assay section, with a test strip, and an indicator window. Sundvor discloses in fig. 2B and 3A, at least one hole plug protruding from a top portion of the plunger. Sundvor discloses in e.g., [0029] et seq., the driving element 120 includes a grinder 122 and a plunger 128, as described below and shown in FIGS. 2A-2B and 3A-3B, however, other variations of the driving element 120 can adapt elements or features of the grinder 122/plunger 128 in enabling processing of the consumable sample, and/or be configured in any other suitable manner. Sundvor discloses in e.g., [0030] et seq., the grinder 122 includes a shaft 123 and a set of protrusions 124 coupled to the shaft 123, and is configured to grind the consumable sample during processing of the consumable sample between the consumable reception opening 112 and the second opening 114 of the first chamber 110. Sundvor also discloses in e.g., [0055] et seq., a detection substrate 150 (“test strip”), and a detection window 142 in [0058] et seq. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include an assay opening, a piercing element; a plunger, with at least one hole plug protruding from a top portion of the plunger, an assay section, with a test strip, and an indicator window because the combination of elements provides an improved system and method for detection of target substances within a consumable (e.g., [0002] of Sundvor).
Furthermore, regarding claims 1 and 16-19, the combination of Carrano and Sundvor disclose “the piston operatively connectable to the core such that pressing the piston into the first core chamber causes the piercing element to pierce the pierceable layer, with the piston capable of rotating inside of the core chamber; the plunger operatively connectable to the core such that extending the plunger relative to the core removes the at least one hole plug from the at least one lower drain hole, and; in which the first core chamber is capable of receiving a test specimen prior to the piston being inserted into the core, to allow the test specimen to be ground between the textured surface and the annular grinding surface” as shown in figs. 4A-8 of Carrano and figs. 2A-6B of Sundvor. Furthermore, because the combination of Carrano and Sundvor disclose the claimed structural features, the combination of Carrano and Sundvor properly read on the claimed intended use and/or functional features. Claims 16-19 are also properly read by the combination of Carrano and Sundvor, in light of MPEP 2112.02.
As to claims 2-6, 8 and 13, these claims are considered intended use and/or functional claim language because they recite the manner of operating the device. See MPEP 2114. Furthermore, the inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims. Thus, the buffer liquid, for example, does not impart patentability to a device claim. See MPEP 2115.
As to claim 7, the combination of Carrano and Sundvor disclose an indicator window (see [0058] et seq. of Sundvor).
As to claim 9, the combination of Carrano and Sundvor disclose a sculpted surface (see [0025] et seq. of Carrano and [0029] et seq. of Sundvor).
As to claim 10, the combination of Carrano and Sundvor disclose a plunger includes a base (see [0029] et seq. of Sundvor).
As to claim 11, the combination of Carrano and Sundvor disclose the textured surface is contained on a texture plate (see [0030] et seq. of Carrano and [0029] et seq. of Sundvor).
As to claim 12, Carrano discloses the pierceable layer (see [0028] et seq. of Carrano).
As to claim 14, the combination of Carrano and Sundvor discloses the piston includes a gripping surface ([0024] and fig. 2 of Carrano), and the plunger includes a gripping hole (fig. 2B and [0029] et seq. of Sundvor).
As to claim 15, the combination of Carrano and Sundvor discloses the plunger retaining element on the assay engages a retaining element on the core (fig. 2A et seq. and [0055] et seq. of Sundvor).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to Friday.
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 by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 571-272-1254.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
11/15/2025