DETAILED ACTION
The Art Unit location of your application in the USPTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Art Unit 1799.
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 .
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.
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.
Claims 1-4, 7 and 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hudak et al. (US 2002/0173047) (Attached PTO-892).
With respect to claim 1, the reference of Hudak et al. discloses:
A cassette device for lateral flow immunoassay testing (Figs. 1-4), comprising:
a housing (20) disposed around an interior space configured to accommodate a test strip (3);
a receptacle (1) located above the interior space and on an exterior of the housing portion, the receptacle configured to contain a fluid; and
a gating device (20) (Figs. 1, 2 and 4) movable between a first position and a second position, wherein, when the fluid is present in the receptacle:
in the first position the gating device is positioned at an opening (22) of the receptacle to prevent the fluid from moving through the opening and reaching the interior space; and
in the second position the gating device is positioned to enable the fluid to move through the opening and reach the interior space.
With respect to claim 2, the gating device includes a sealing portion (twist, slide or stopcock)(Fig. 4) such that when the gating device is in the first position, a seal is formed between the sealing portion and the opening substantially prevent the fluid from flowing out of the receptacle through the opening.
With respect to claim 3, when the gating device is in the second position and when fluid is present in the receptacle and when the test strip (3) is disposed in the interior space, the fluid is capable of flowing through the opening (22) onto a portion of the test strip (3) positioned beneath the receptacle.
With respect to claim 4, wherein the receptacle (1) and the interior space configured to accommodate the test strip (3) are positioned with respect to each other such that the fluid flows through the opening (22) onto a sample portion of the test strip when the gating device is in the second position and the test strip is disposed within the interior space.
With respect to claim 7, the housing include a viewing window (10).
With respect to claims 10-13, in the absence of further positively recited structure, the device of the reference of Hudak et al. is structurally capable of being used with and/or configured to be used for the samples and/or tests of claims 10-13. Note: The claims do not positively recite any samples, reagents or test strips as part of the claimed structure.
Claim Rejections - 35 USC § 103
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 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hudak et al. (US 2002/0173047) (Attached PTO-892) in view of Sundvor et al. (US 2017/0097342) (Attached PTO-892).
The reference of Hudak et al. has been discussed above with respect to claim 1.
Claims 8 and 9 differ by reciting that the gating device is biased in the first position using a spring.
The reference of Sundvor et al. discloses (Fig. 2) that it is known in the art to control the flow between a receptacle (105) and a chamber (140) for holding a test strip (150) using a valve (138) with opening (136), wherein the valve can be a biased valve (¶[0062]), such as a solenoid valve which would include a spring.
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to employ a spring biased valve in the device of the primary reference for the known and expected result of using an alternative means recognized in the art to achieve the same result, control the flow from a sample chamber into a detection chamber.
Allowable Subject Matter
Claims 18 and 19 are allowed.
Claims 14-17 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:
Claims 14-17 would be allowable because the prior art of record fails to teach or suggest a cassette device, in the claimed environment or scope of claim, that includes a fluid reservoir located on the housing adjacent to the receptacle; and a channel between the fluid reservoir and the receptacle.
Claim 18 would be allowable because the prior art of record fails to teach or suggest a cassette device, in the claimed environment or scope of claim, wherein the gating device include a post having an outer diameter that corresponds to an inner diameter of the receptable opening.
Claim 19 would be allowable because the prior art of record fails to teach or suggest a cassette device, in the claimed environment or scope of claim, wherein the gating device include a button that is spaced away from the receptacle and protrudes through the housing.
Response to Arguments
Objection to Drawings
The objection to the drawings has been withdrawn in view of the corrected drawings and corresponding comments on page 10 of the response dated 11/13/2025.
112 Claim Rejections
The rejections of claims 1-17 under 35 USC 112(b) have been withdrawn in view of the amendments to the claims and related comments on pages 10-11 of the response dated 11/13/2025.
102 Claim Rejections
Applicant’s arguments, see pages 11-14, filed 11/13/2025, with respect to the rejection of claim 1 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hudak et al. (US 2002/0173047) (Attached PTO-892).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H BEISNER whose telephone number is (571)272-1269. The examiner can normally be reached on Mon-Fri from 8am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL A MARCHESCHI, can be reached at telephone number (571)272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB
Prosecution Insights