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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/18/25 and 05/13/20 have been considered by the examiner.
Amendment Entered
In response to the amendment filed on March 11, 2026, amended claim 64 has been entered.
Response to Arguments
Applicants remarks and amendments with respect to the rejections under
U.S.C. 112f have been fully considered, but were not persuasive. Applicant argues there is written description for “release unit”. Examiner disagrees and notes this term is further described with more placeholder terms. Each term is not clearly defined with regard to structure nor the interaction with each other. For example, “How is the release unit connected to the holder?”. As such, this term is lacking sufficient written description.
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were fully considered, but are moot in view of the current combination of references that were necessitated by amendment. Please see prior art section below for more detail, updated citations (Lin reference), and updated obviousness rationale.
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.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations 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. Such claim limitations are:
“a release unit configured to release the sample carrier from the holder after a sample of excrement is obtained by the sample carrier” in claim 64
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 (see PG Pub of the instant application, par.230-334+, which appear to set forth corresponding structure for the release unit).
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 § 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 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.
Claims 64, 70 and 78, 84, 85, 88 and 89 are rejected under 35 U.S.C. 103 as being unpatentable over Tsukamura (U.S. Patent Number 5184359 A) and in further view of Spangenberg (U.S. Patent Application Publication 2017/0284925 A1), Lin (CN 106248920) and Tsuruoka (U.S. Patent Application Publication 2019/0293636 A1).
Tsukamura, Spangenberg and Tsuruoka were applied in the previous office action
Regarding claim 64, Tsukamura teaches a device for an on-site analysis of excrements [fig. 1, element 10; col. 6: lines 46-52] comprising: a housing [fig. 1, element 20; col. 6: lines 59-67]; a transport carriage [fig. 2, 3, element 46] disposed in the housing, the transport carriage movable along a guide path part [fig. 4, elements 88, 90] in a feed direction and being configured to transport a sample carrier [fig. 4, element 32; col. ]; a guide part [fig. 4, elements 88, 90] attached to the housing, the guide part including a contamination region having a guide path [fig. 2, 3, element 46], the guide part further including a clean region [fig. 13, element 316] where a new sample carrier can be arranged partially next to the guide path [col. 11: lines 22-45]; the arm element [fig. 2,3, element 50] movable along the guide path in an axial direction [col. 7: lines 23-46], the arm element including a holder [fig. 2, 3, element 54], the holder including a first clamping element [fig. 9, element 146] and a second clamping element [fig. 9, element 82] configured to hold the carrier sample supplied by the transport carriage [col. 9: lines 44-60]; a holder actuation member [fig. 9, element 148] configured to elastically deflect the second clamping element to separate the second clamping element from the first clamping element such that the sample carrier can be inserted between the first and second clamping elements [col. 9: lines 44-60]: a release unit configured to release the sample carrier from the holder after a sample of excrement is obtained by the sample carrier [fig. 19A, 19B; col. 12: lines 7-25]; and an analysis device [fig. 3, element 56], configured to analyze the sample of excrement [col. 9: lines 8-28], wherein the contamination region extends from a guide path opening arranged at a free end of the guide part and a transfer region, in which the new sample carrier is transferred from the transport carriage to-a the holder located on the arm element [col. 11: lines 22-45],
However, Tsukamura does not teach the arm element comprising a material strip that can be unrolled from a coil for extending the arm element and rolled up into the coil for retracting the arm element
Spangenberg teaches the arm element comprising a material strip that can be unrolled from a coil for extending the arm element and rolled up into the coil for retracting the arm element [fig. 8, elements 10, 12; par. 91; Examiner notes the material is unrolled for analysis and then rolled for retracting]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Tsukamura, to incorporate the arm element comprising a material strip that can be unrolled from a coil for extending the arm element and rolled up into the coil for retracting the arm element, for moving the test strips into and out of the detection zone, as evidence by Spangenberg [par. 91].
However, Tsukamura does not teach a holder actuation member configured to elastically and resiliently deflect against an elastic bias, and the second clamping element being elastically biased toward the first clamping element so as to clamp the sample carrier therebetween
Lin teaches a holder actuation member configured to elastically and resiliently deflect against an elastic bias, and the second clamping element being elastically biased toward the first clamping element so as to clamp the sample carrier therebetween [fig. 6, 7, elements 32, 33; par. 14, 16, 66, 68]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Tsukamura, to incorporate a holder actuation member configured to elastically and resiliently deflect against an elastic bias, and the second clamping element being elastically biased toward the first clamping element so as to clamp the sample carrier therebetween, for allowing the clamping frames to elastically extend and retract along the radial direction of the rotating support, as evidence by Lin [par. 66].
However, Tsukamura does not teach wherein the clean region is a region of the guide part which neither the arm element nor a used sample carrier can reach
Tsuruoka teaches the clean region is a region of the guide part which neither the movable arm element nor a used sample carrier can reach [fig. 7B, area in which the sample strips 90 are held before being pushed out by element 273 and transported by the movable arm 264; par. 93, 94]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Tsukamura, to incorporate the arm element comprising a material strip that can be unrolled from a coil for extending the arm element and rolled up into the coil for retracting the arm element, for storing the sample strips and preventing degradation of the reagent, as evidence by Tsuruoka [par. 103].
Regarding claim 70, Tsukamura teaches wherein a sensor unit, as seen looking in an axial retraction direction of the arm element, is arranged axially in front of the release unit for releasing a used sample carrier from the arm element [col. 10: lines 25-53; col. 12: lines 7-25].
Regarding claim 78, Tsukamura further teaches arrangement consisting of a toilet, a urinal [col.6: lines 46-58].
Regarding claim 84, Spangenberg further teaches a refillable magazine containing a roll material, the refillable magazine configured to supply the sample carrier from the roll material to the transport carriage [par. 78].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Tsukamura, to incorporate a refillable magazine containing a roll material, the refillable magazine configured to supply the sample carrier from the roll material to the transport carriage, for moving the test strips into and out of the detection zone, as evidence by Spangenberg [par. 91].
Regarding claim 85, Tsukamura further teaches when the sample carrier is inserted between the first and second clamping elements, the first clamping element is disposed below the sample carrier and the second clamping element is disposed above the sample carrier [fig. 9, elements 146, 82; col. 9: lines 44-60; Examiner notes either clamping element can be the first or second clamping element].
Regarding claim 88, Tsukamura further teaches the analysis device is disposed on an underside of the guide part [fig. 3, element 56]
Regarding claim 89, Tsukamura further teaches the first clamping element and the second clamping element are arranged exerting a pre-stressed spring force against each other [col. 9: lines 44-60].
Claims 71, 86 and 87 are rejected under 35 U.S.C. 103 as being unpatentable over Tsukamura, Spangenberg, Lin and Tsuruoka and in further view of Tsuruoka “Tsuruoka2” (U.S. Patent Application Publication 20190212322 A1).
Regarding claim 71, Tsukamura, Spangenberg, Lin and Tsuruoka teach a device for the on-site analysis of excrements, as disclosed above
However, Tsukamura, Spangenberg, Lin and Tsuruoka do not teach characterized by a sensor unit with a thermal sensor for detecting an excrement temperature, a body temperature, an excrement volume and/or an excrement volume flow.
Tsuruoka2 teaches characterized by a sensor unit with a thermal sensor for detecting an excrement temperature, a body temperature, an excrement volume and/or an excrement volume flow [par. 106, 107].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Tsukamura, Spangenberg, Lin and Tsuruoka, to incorporate characterized by a sensor unit with a thermal sensor for detecting an excrement temperature, a body temperature, an excrement volume and/or an excrement volume flow, for determining start and end times of urine measurement, as evidence by Tsuruoka2 [par. 107].
Regarding claim 86, Tsuruoka2 further teaches the release unit includes a first finger element disposed on an upper side of the arm element and a second finger element disposed on an underside of the arm element [fig. 9A-9C, element 41].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Tsukamura, Spangenberg, Lin and Tsuruoka, to incorporate the release unit includes a first finger element disposed on an upper side of the arm element and a second finger element disposed on an underside of the arm element, for clamping and releasing the sample film, as evidence by Tsuruoka2 [par. 157].
Regarding claim 87, Tsuruoka2 further teaches each of the first finger element and the second finger element include a pair of fingers separated by a gap [fig. 8, element 41] and wherein when the arm element moves in an axial retraction direction through the release unit, the fingers contact the sampler carrier to remove the sample carrier from the holder [par. 157].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Tsukamura, Spangenberg, Lin and Tsuruoka, to incorporate c each of the first finger element and the second finger element include a pair of fingers separated by a gap and wherein when the arm element moves in an axial retraction direction through the release unit, the fingers contact the sampler carrier to remove the sample carrier from the holder, for clamping and releasing the sample film, as evidence by Tsuruoka2 [par. 157].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8 AM - 5 PM.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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