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 .
Drawings
The drawings were received on 6/13/2023. These drawings are accepted.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-15, in the reply filed on February 18, 2026 is acknowledged. The traversal is on the ground(s) that the previous Office Action did not establish an undue search burden of the claims as specified by MPEP 803. This is not found persuasive because the instant application is a national stage entry filed under 35 U.S.C. 371 and is therefore not subject to US restriction practice but rather subject to lack of unity practice, see MPEP 1893.03(d). It is noted that undue search burden is not a criterion in lack of unity analysis. The test is whether or not special technical features can be established. It is noted that inventions listed as Groups I and II 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 as set forth in previous Office Action mailed December 23, 2025.
Claim 16 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 18, 2026.
Claim Objections
Claims 2-15 are objected to because of the following informalities: Each claim begins with the recitation “A processing cartridge….” However, given that the processing cartridge has already been recited in claim 1, the recitation should instead be “The processing cartridge of claim….” Appropriate correction is required.
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) 1, 2, 3, 6, and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okamoto et al (WO 2020/100987 A1) (provided by applicant in IDS dated June 13, 2023; reference will be made to US 2022/0003643 A1) for the English translation of the document).
With respect to claim 1 Okamoto discloses a processing cartridge (sample analysis substrate 1, See Figs. 3a-3b and Para. 0090) comprising a main cartridge section (base substrate 3) and an actuating cartridge section (cap 2) , the main cartridge section comprises a liquid reservoir chamber (first and second accommodating sections 11, 111, See Fig. 3a and Para.0092), a liquid container (first and second containers 5, 105, See Figs. 3a, 4a-5e, and 8a), a container piercing element (seal breaking nails 14, 114, See Figs. 3a and 7a-c and Para. 0092) and a resilient container holding element (first pusher portion 10 See Figs. 7a-c) having flange portions (flange portion 10b See Paras. 0100 and 0103) capable of elastic deformation (See Para. 0100 and 0103), wherein
- the actuating cartridge section is configured to pivotally dock with the main cartridge section and comprises an actuating member (first drive projection 12 See Figs. 6a-d and Para. 0104 and 0106-0108) configured to interact with the liquid container during docking;
- the liquid container, the piercing element and the container holding element are arranged in the liquid reservoir chamber (See Fig. 7b), the liquid container is filled with a suitable processing liquid (See Para. 0099 for discussion of how a first liquid is held in space 5g of the first container 5) and features a pierceable dispensing side (sealing membrane 9, See Para. 0099), and the container piercing element faces the dispensing side (See Fig, 7a);
- the liquid container is held in a first position by the container holding element, wherein the dispensing side is separated from the container piercing element (see Fig. 7a) ; and
- the actuating member is configured to move the liquid container from the first position to a second position during docking of the cartridge actuating section, and in the second position the dispensing side is pierced by the container piercing element (see Fig. 7a and 9a-10a).
Applicant should note the italicized limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim have been disclosed by Itoh and the apparatus of Okamoto is capable of the recitation of claim 1. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Itoh (see MPEP §2114).
With respect to claim 2 Okamoto disclose that the actuating cartridge section comprises a first end pivotably connected to the main cartridge section (end containing hole 2a and protrusion 2b, See Fig. 3a and Para. 0095), such that the actuating cartridge section may pivot between a non-docking position, in which the liquid container is held in the first position by the container holding element, and a docked position, in which the actuating cartridge section is docked with the main cartridge section and the liquid container is in the second position (See Figs. 3b-c and Figs. 7a-c for depiction of the cap in an open and closed position relative to the base subtrate).
With respect to claim 3 these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Okamoto and the apparatus of Okamoto is capable of providing an elastic force acting on and holding the liquid container in the first position. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Okamoto (see MPEP §2114).
With respect to claim 6 Okamoto discloses a sample collector (injection port 13, See Fig. 3c and Para. 0093), the sample collector being arranged to be accessible for collection of a sample when the actuating cartridge section is separated from the main cartridge section or is in the non-docking position (See Para. 0096).
With respect to claim 8 Okamoto discloses that the main cartridge section features at least one guide rib (second pusher portion 110, See Para. 0103) configured to interact with a corresponding recess (second drive projection 112, See Para. 0104) in the actuating cartridge section during docking (See Para. 0108 and Fig. 9b).
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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okamoto et al (WO 2020/100987 A1) (provided by applicant in IDS dated June 13, 2023; reference will be made to US 2022/0003643 A1) for the English translation of the document).
Refer above for the disclosure of Okamoto.
With respect to claim 9, although there is no specific teaching of the guide rib having a tapered edge, the courts held In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) that a change in shape is matter of choice in which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed apparatus was significant. Thus, it would have been obvious to one of ordinary skill in the art at the time of filing to taper the guide rib such that it will have a desired fit in the corresponding recess.
Allowable Subject Matter
Claims 4, 5, 7, and 10-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest cited prior art of reference fails to disclose or teach:
that the container holding element comprises a resilient arm in contact with the liquid container (Okamoto discloses a second contact surface 110a provided at the other end of the second pusher portion, which is on the opposite end away from the second container 105) (claim 4);
that the actuating member is configured to enter the liquid reservoir chamber during docking and the liquid container comprise a recess, the actuating member being configured to interact with an edge of the recess when entering the liquid reservoir chamber during docking (claim 5);
that the sample collector is arranged on the actuating cartridge section, such that the sample collector is accommodated in a sample receiving cavity in the main cartridge section when the actuating cartridge section is docked with the main cartridge section or is in the docked position (Okamtoto discloses that the injection port protrudes from the base substrate 3 and covered by the cap 2 when the cap is closed) (claim 7);
that the main cartridge section or the actuating cartridge section features a locking rib having locking recesses arranged on opposite sides thereof, and the corresponding actuating cartridge section or main cartridge section features two opposing resilient hooks, each hook configured for interaction with a respective locking recess on the locking rib, wherein the locking rib has a tapered edge configured to be inserted between the resilient hook during docking (claim 10);
that the container piercing element comprise a comprise a base portion, at least one sided portion, a sharp portion distal to the base portion, and at least one recess arranged in the side portion and extending between the base portion and the sharp portion (Para. 0092 of Okamoto disclose that the seal breaking nails 14 and 114 are projections) (claim 11);
that the container piercing element and the container holder element constitute part of a single unit (Okamoto depicts that these two elements are separate and distinct from each other) (claim 12); claim 13 is dependent upon claim 12 and thus, inherits the same status;
that the actuating cartridge section or the main cartridge section features a first end comprising two opposing pinch arms and a resilient arm arranged between the pinch arms, each of the pinch arms features a pivot knob and the pivot knobs are arranged opposite each other; and the corresponding main cartridge section or actuating cartridge section features a connector hub for insertion between the two pinch arms, the connector hub comprises a bore for accommodating the pivot knobs and has an outer periphery for interaction with the lever; further wherein a first section of the periphery has a shorter distance to a centerline of the bore than a second section of the periphery, the first and second section of the periphery are connected by a third section of the periphery having an increasing distance to the centerline of the bore, the third section of the outer periphery arranged such that a rotary movement of the actuating cartridge section relative to the main cartridge section will face a defined resistance when the resilient arm interacts with the third section (claim 14); and
the actuating cartridge section or the main cartridge section features a first end comprising two opposing pinch arms, each of the pinch arms features a pivot knob and the pivot knobs are arranged opposite each other; and the corresponding main cartridge section or actuating cartridge section feature a connector hub for insertion between the two pinch arms, the connector hub comprises a bore for accommodating the pivot knobs, the bore is defined by a middle section having a circular inner wall, and a first section and a second section arranged on opposite sides of the middle section, each of the first and second section comprises a recess extending between the bore and an outer periphery of the connector hub; each of the pivot hubs has an outer periphery comprising two first sections configured to cooperate with the circular inner wall and two opposing second sections, wherein a distance between the second sections is shorter than a maximum distance between the first sections, and each recess has a width being smaller than the maximum distance between the first sections and larger than a maximum distance between the second section (claim 15).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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/BRITTANY I FISHER/Examiner, Art Unit 1796 March 7, 2026