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 .
Applicant’s filing of claims 1-20 on 8/16/23 is acknowledged. Claims 1-20 are pending and are under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/16/23, 1/11/24, 6/7/24, 10/18/24, 2/16/25, 6/9/25 and 11/14/25 were acknowledged. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, at least one container overlapped the second end of the first quantification chamber in a vertical direction” (claim 1); and “wherein one of the containers is overlapped the second end of the first quantification chamber in a vertical direction” (claim 11) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-20 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 and 11 are rejected because the claim language, “the at least one container overlapped the second end of the first quantification chamber in a vertical direction” (claim 1) and “wherein one of the containers is overlapped the second end of the first quantification chamber in a vertical direction” (claim 11) is unclear.
Claim 11 is rejected because “froze-dry sample” is unclear.
Claim Interpretation
Functional limitations are evaluated and considered, for what it fairly conveys to a person of ordinary skill in the art. See MPEP 2173.05(g). Similarly, a “wherein” clause may have a limiting effect on a claim if the language limits the claim to a particular structure. MPEP 2111.04. The determination of whether a “wherein” clause is a limitation in a claim depends on the specific facts of the case. 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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sabounchi et al. (“Sabounchi,” US Pub. No. 2017/0016060) in view of Andreyev et al. (“Andreyev,” US Pub. No. 2016/0186240).
As to claim 1, Sabounchi discloses an analysis cartridge (e.g., 1100, [0105] et seq.), comprising: a main cover (e.g., 200 or 1212; [0086] et seq.), having a first surface and a second surface opposite with each other (figs. 11-46B), the first surface comprising a first quantification chamber (any of the channels in e.g., 11 can serve as the first quantitation chamber under BRI), a first fluid tunnel (any of the channels can serve as a fluid tunnel under BRI in fig. 11), a first gas tunnel (any of the channels can serve as a gas tunnel under BRI in fig. 11) and a storage chamber extending along horizontal directions (any of the channels can serve as a storage chamber under BRI in fig. 11), wherein a first end of the first quantification chamber is connected to the first fluid tunnel, a first end of the storage chamber is connected to the first gas tunnel, and a second end of the first quantification chamber is connected to a second end of the storage chamber (see channels/chambers connected to different channels/chambers in fig. 11); at least one container (e.g., reagent reservoirs 1216; [0113] et seq.) disposed on the second surface of the main cover, the at least one container overlapped the second end of the first quantification chamber in a vertical direction (see fig. 12 et seq.); a first pipette, disposed on the main cover and protruded from the second surface of the main cover (see 1246 in fig. 30 et seq.; [0127] et seq.)), wherein the first pipette is connected to the second end of the first quantification chamber and disposed within the at least one container (see fig. 11 et seq.); and a rotary valve (1410 in [0120] et seq.), rotably disposed on the main cover.
Regarding claims 1 and 11, Sabounchi does not specifically disclose a rotary valve (1410 in [0120] et seq.), rotably disposed on the second surface of the main cover. Andreyev discloses in figs. 50-54, a rotary venting valve on the second surface of the main cover in [0167] 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 reconfigure the rotary valve to be on the second surface of the main cover to allow for a more compact design.
Furthermore, regarding claims 1 and 11, Sabounchi does not specifically disclose a froze-dry sample disposed in the container. Andreyev discloses different forms of a sample in [0114] et seq., which may include a froze-dry sample. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have a froze-dry sample because it would allow for the sample to be stable for a longer period of time.
As to claim 2, the combination of Sabounchi and Andreyev disclose the at least one container comprises a second quantification chamber disposed therein, the second quantification chamber is disposed between a top and a bottom of the at least one container, and a bottom surface of the second quantification chamber and a bottom of the first pipette are in a same plane in e.g., [0105] et seq. of Sabounchi.
As to claim 3, the combination of Sabounchi and Andreyev disclose the second quantification chamber comprises an inclined sidewall in e.g., [0105] et seq. of Sabounchi.
As to claim 4, the combination of Sabounchi and Andreyev disclose the rotary valve further comprises a flow channel and an opening, the flow channel and the opening are aligned with the first fluid tunnel and the first gas tunnel respectively in e.g., [0107] et seq. of Sabounchi.
As to claim 5, the combination of Sabounchi and Andreyev disclose the first surface of the main cover further comprises: a second gas tunnel connected to the first fluid tunnel, wherein the opening is aligned with the second gas tunnel in e.g., [0105] et seq. of Sabounchi.
As to claim 6, the combination of Sabounchi and Andreyev disclose the main cover further comprises: a second fluid tunnel extending on the first surface of the main cover, wherein the flow channel is aligned with the second fluid tunnel; and a second pipette disposed on the main cover and protruded from the second surface of the main cover, wherein the second pipette is connected to the second fluid tunnel and disposed within the at least one container in e.g., [0105] et seq. of Sabounchi.
As to claim 7, the combination of Sabounchi and Andreyev disclose a sealing layer, disposed on the first surface of the main cover; and a package cover, disposed on the sealing layer in e.g., [0114] et seq. of Sabounchi.
As to claims 8 and 9, the combination of Sabounchi and Andreyev disclose the package cover further comprises: an airtight ring, disposed on a first surface of the package cover and aligned with the at least one container; a container cover, disposed on the airtight ring and covering the at least one container; and at least one pin, disposed on a second surface of the package cover in e.g., [0093] et seq.
As to claim 10, the combination of Sabounchi and Andreyev disclose a plurality of fluid tunnels and a plurality of gas tunnels, disposed on the first surface of the main cover and extended along different horizontal directions respectively; a plurality of pipettes and a plurality of air pipes, disposed on the main cover and respectively protruded from the second surface of the main cover in the vertical direction, wherein each of the pipettes is connected to each of the fluid tunnels, and each of the air pipes is connected to each of the gas tunnels; and a plurality of the containers, respectively disposed on the second surface of the main cover, wherein each one of the air pipes and each one of the pipettes are disposed within one of the containers in e.g., [0105] et seq. of Sabounchi.
As to claim 12-20, see steps in [0085] et seq. of Sabounchi. Also see e.g., MPEP 2112.01.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,878,301. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims and the patented claims comprise substantially the same subject matter. For example, examined claim 1 and patented claim 1 comprise an analysis cartridge, comprising; a first cover (“main cover”); a second cover, attached to the first cover, the second cover comprising two opposite surfaces and a plurality of first through holes and one second through hole disposed thereon, the first through holes and the second through hole individually penetrating through the two surfaces; a plurality of containers, sandwiched between the first cover and the second cover, the containers individually being in alignment with the first through holes; a plurality of fluid tunnels disposed on the first cover, each of the fluid tunnels being connected to a first pipette; a plurality of gas tunnels disposed on the first cover, wherein each of the gas tunnels has a gas hole aligned with and extended into each of the containers; and a rotary valve, rotatably disposed between the first cover and the second cover to in alignment with the second through hole, the rotary valve comprising a flow channel disposed thereon to connect to the containers individually.
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.
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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
2/21/2026