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 .
Remarks
This Office Action fully acknowledges applicant’s remarks filed 01/06/2026. Claims 1-10 are pending. Claims 4, 5, and 8-10 have been withdrawn. Claims 1-10 have been amended.
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.
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.
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.
Claim limitation “image capturing unit” in claim 1 has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “unit” coupled with functional language “image capturing” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. The term “unit” is merely a generic placeholder for the term “means.”
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 1 has/have been interpreted to cover “imaging lenses and an imaging sensor, configured to capture an image of the one or more samples. The imaging sensor may be, for example, a charge-coupled device (CCD) or a complementary metal oxide semiconductor (CMOS), corresponding to structure described in the specification that achieves the claimed function, and equivalents thereof, see applicant’s specification at para. [0032].
Claim limitation “holding unit” in claim 1 has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “unit” coupled with functional language “holding” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. The term “unit” is merely a generic placeholder for the term “means.”
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 1 has/have been interpreted to cover “may be a part of the extendable sample tray” corresponding to structure described in the specification that achieves the claimed function, and equivalents thereof see applicant’s specification at para. [0031].
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 § 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
1. Claims 1, 6, and 7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Application Publication No. 2021/0364536 to Busa et al.
Regarding applicant’s claim 1, Busa et al. discloses an immunoassay test reader that uses test strips 10. (Title and [0005])
Busa et al. teaches that a reader 30 (assembly) includes a housing 1022A,B (enclosure) enclosing electronics and an optics unit configured for reading the one or more test lines and the control line of the test strip (para [0073],[0090]; Figs. 3 and 10) .
Busa et al. further teaches that reader 30 (assembly) is configured with a light source and optics unit 1028 that captures the reflectance of all the test stripes by use of a 2D imaging device (image capturing unit) (para. [0090], [0153]. As such, the imaging device (imaging capturing unit) has a field of view in the reader housing 1022A,B (enclosure).
Busa et al. teaches that the test strips are held in tray 32 as shown in Fig. 3. [0077].
As shown in Fig. 3, the tray 32 protrudes from the reader housing 1022A,B (enclosure). The tray 32 is then retracted inside the reader 30 (assembly) (para. [0077]). Thus, Busa et al. teaches that an end of the tray 20 extends out of the housing 1022A,B (enclosure).
Busa et al. teaches that the tray 32 further includes an area 1008 the area 1008 provided with an optical calibration test pattern 200 (calibration marker) spaced from the test device and positioned in alignment with the axis of the test device (para [0097], Fig. 10).Therefore, the area 1008 corresponds to the claimed holding unit, inasmuch as the area 1008 (holding unit) is coupled to the tray 32 and configured to hold calibration pattern 200 (calibration marker).
II.) Regarding applicant’s claim 6, as noted above Busa et al. anticipates claim 1 from which claim 6 depends.
Claim 6 recited the image capturing unit is spaced away from the at least one sample tray and the at least one holding unit.
Busa et al. illustrates an optical system in Fig. 4 in which when the image capturing device is used as the stated alternative to the array of photodiodes, the image capturing device would be spaced away from the at least one sample tray and the at least one holding unit. [0078]
Therefore Busa et al. anticipates claim 6.
III.) Regarding applicant’s claim 7, as noted above Busa et al. renders claim 1 obvious from which claim 7 depends.
Claim 7 recites a light source, and wherein when the at least one extendable sample tray is brought in the field of view of the image capturing unit, a portion of the extendable sample tray configured to hold the one or more samples is illuminated by the light source.
In Fig. 4 Busa et al. illustrates that tray in the field of view of the image capturing device wherein a portion of the sample tray configured to hold one or more samples is illuminated by the light source 102 for purpose of capturing images of the test strips.
Therefore, Busa et al. anticipates claim 7.
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.
2. Claims 2 and 3 are rejected under 35 USC 103 as being obvious over Busa et al. as applied to claim 1 and further in view of U.S. Patent Application Publication No. 20090155921 to Lu et al.
I.) Regarding applicant’s claim 2, as noted above Busa et al. anticipates claim 1 from which claim 2 depends.
Claim 2 recites assembly according to further comprising a casing unit and wherein the at least one holding unit is rollable into the casing unit.
Busa et al. does not teach a casing unit and wherein the at least one holding unit is rollable into the casing unit.
Lu et al. discloses a method and apparatus for reading test strips. (Abstract).
In Lu et al. teaches that the test strips are placed into a holding cassette 805 [0004], [0064]
In Lu et al. the holding cassette and test strips are rollable into the enclosure in the manner in which gear rack attached to a side of the sliding cassette holder or tray 804. During motion of tray 804, gear rack 1102 actuates rotary damper 1103 through pinion gear 1106, engaged with rack 1102. [0075]
The configuration and function of the gear rack 1102, rotary damper 1103 and pinion gear 1106 reads on a casing unit in that the holding cassette and test strips are rollable into the enclosure in the manner in which gear rack attached to a side of the sliding cassette holder or tray 804 rolls into the surrounding structure that encases the gear rack and holder cassette.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Busa et al. to include the configuration and function of the gear rack 1102, rotary damper 1103 and pinion gear 1106 od Lu et al. for purposes of directing the tray 20 into the reader in a similar manner as taught by Lu et al.
Therefore, Busa et al. in view of Lu et al. renders claim 2 obvious.
I.) Regarding applicant’s claim 3, as noted above Busa et al. in view of Lu et al. renders claim 2 obvious from which claim 3 depends.
Claim 3 recites that the extension of the at least one sample tray coupled to the at least one holding unit causes rolling out of the rollable at least one holding unit from the casing unit.
Lu et al. teaches that in the configuration and function of the gear rack 1102, rotary damper 1103 and pinion gear 1106 that read on a casing unit spring 1104 causes rolling out of the holding unit. [0075]
Therefore, Busa et al. in view of Lu et al. renders claim 3 obvious.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 6 and 7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
International Patent Application Publication No. WO2019045282 to Han teaches a casing unit in which urging member 111 pushes kit K against the inner surface of tray 100 as shown in Fig. 4, illustrating that a casing unit can be interpreted as being merely a case.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL S. GZYBOWSKI whose telephone number is (571)270-3487. The examiner can normally be reached M-F 8:30-5:00.
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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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