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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-18 and 20 in the reply filed on 11/14/2025 is acknowledged.
Claim 19 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (method), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/14/25.
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 4 and 8 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.
Claim 4 recites the limitation "the optical layer”. There is insufficient antecedent basis for this limitation in the claim. The examiner interprets this to be “the optical filter layer”.
Claim 8 recites “some light”. The term “some” renders the limitation indefinite since the term “some” is a term of degree related to the amount of light that is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. See MPEP 2173.05(b). For the purpose of examination, the limitation will be interpreted as "a portion of light".
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, 2, 3, 5, 6, 7, 8, 10, 11, 12, 13, 14, 15, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eltoukhy (US Pub 2018/0341649).
Regarding Claim 1, Eltoukhy teaches an apparatus (Fig. 7, biosensor 400), comprising:
a flow cell body defining a channel to receive fluid (flow cell 402 defines a channel),
the channel having a floor extending along a length of the flow cell body (shaped so that a flow channel 418 exists between the flow cover 410);
a plurality of reaction sites positioned along the floor of the channel, the plurality of reaction sites forming an array along a length of the floor of the channel ([0098] a plurality of reaction sites 414);
an optical filter layer positioned under the floor of the channel, the optical filter including at least a portion spanning uninterruptedly along a length corresponding to the length of the array of reaction sites ([0104] a filter or light-management layer 433); and
a plurality of imaging regions positioned under the optical filter layer, each imaging region of the plurality of imaging regions being positioned directly under a corresponding reaction site, such that each reaction site and corresponding imaging region cooperate to form a sensing pair ([0107] a light detector 436, plurality of imaging regions with reaction site 414’);
the optical filter layer permits one or more selected wavelengths of light to pass from each reaction site to the imaging region forming a sensing pair with the reaction site ([0104] a filter or light-management layer 433. [0106] The filter layer 433 may include various features that affect the transmission of light. In some embodiments, the filter layer 433 can perform multiple functions.);
the optical filter layer reduces transmission of excitation light directed toward the plurality of reaction sites, the optical filter layer reduces transmission of light emitted from each reaction site to imaging regions not forming a sensing pair with the reaction site ([0106] The filter layer 433 may include various features that affect the transmission of light. In some embodiments, the filter layer 433 can perform multiple functions. For instance, the filter layer 433 may be configured to (a) filter unwanted light signals, such as light signals from an excitation light source; (b) direct emission signals from the reaction sites 414 toward corresponding light detectors 436 that are configured to detect the emission signals from the reaction sites; or (c) block or prevent detection of unwanted emission signals from adjacent reaction sites. As such, the filter layer 433 may also be referred to as a light-management layer.).
Regarding Claim 2, Eltoukhy teaches the apparatus of claim 1, the floor of the channel defining a plurality of wells, the plurality of wells providing the plurality of reaction sites ([0047] The flow cell may include at least one flow channel that is in fluid communication with the reaction sites.).
Regarding Claim 3, Eltoukhy teaches the apparatus of claim 1, the flow cell body defining a plurality of channels, the channels being oriented parallel with each other, each channel of the plurality of channels having a floor with a plurality of reaction sites ([0034] the cartridges and biosensors may include one or more microfluidic channels that deliver reagents or other reaction components to a reaction site.).
Regarding Claim 4, Eltoukhy teaches the apparatus of claim 3, the plurality of channels forming an array along a width of the flow cell body ([0059] The flow cell may include one or more flow channels that receive a solution from the bioassay system 100 and direct the solution toward the reaction sites.), the optical layer including at least a portion spanning uninterruptedly along a width corresponding to the width of the array of channels.
Regarding Claim 5, Eltoukhy teaches the apparatus of claim 1, further comprising a plurality of imaging sensors, each imaging sensor forming a corresponding imaging region of the plurality of imaging regions ([0111] The solid-state imager 432 may include a dense array of light detectors 436 that are configured to detect activity indicative of a desired reaction from within or along the flow channel 418).
Regarding Claim 6, Eltoukhy teaches the apparatus of claim 1, the optical filter layer reduces transmission of light from each reaction site to imaging regions not forming a sensing pair with the reaction site by inducing loss in light transmitted from the reaction sites ([0107] In some embodiments, the filter layer 433 may include a plurality of filter walls 440. The filter walls 440 may be configured to at least one of (a) reflect emission signals or (b) block or prevent unwanted emissions signals from adjacent reaction sites.).
Regarding Claim 7, Eltoukhy teaches the apparatus of claim 1, further comprising a plurality of shields, each shield of the plurality of shields to block optical rays between a corresponding reaction site and an imaging region of the plurality of imaging regions that does not form a sensing pair with the corresponding reaction site ([0104] Moreover, each of the substrate layers 431-434 may include a plurality of sub-layers. [0105] The passivation layer 434 is configured to shield the filter layer 433 from the fluidic environment of the flow channel 418.).
Regarding Claim 8, Eltoukhy teaches the apparatus of claim 1, the optical filter layer substantially prevents transmission of light at wavelengths less than approximately 500 nm, the optical filter layer absorbs some light at wavelengths between approximately 500 nm and approximately 600 nm while permitting transmission of some light at wavelengths between approximately 500 nm and approximately 600 nm ([0108] The light-absorbing material 446 may include, for example, a material that is configured to absorb the excitation light and permit the fluorescent emissions (i.e., emission light, emission signals) to pass therethrough. In the illustrated embodiment, the light-absorbing material 446 may comprise a resist-based absorption material that is configured to block, for example, 532 nm excitation light. However, other light-absorbing materials 446 may be used.).
Regarding Claim 11, Eltoukhy teaches the apparatus of claim 1, the optical filter layer and floor cooperating to define a height dimension ([0100] The height H1 and other dimensions of the flow channel 418 may be configured to maintain a substantially even flow of a fluid along the detector surface 412.), the height dimension corresponding to a distance between a top of the floor and a bottom of the optical filter layer ([0177] The filter walls 840 may be similar to the filter walls 550 (FIG. 29). For example, the filter walls 840 have a height H4 and a light-absorbing material 846 has a thickness T4 that is greater than the height H4 of the filter walls 840.), the plurality of reaction sites defining a pitch dimension, the pitch dimension corresponding to a distance between a center of one reaction site of the plurality of reaction sites to a center of an adjacent reaction site of the plurality of reaction sites, the height dimension and pitch dimension providing a height-to-pitch ratio ranging from approximately 3 to approximately 5 ([0137] As noted above, various layouts may be envisaged for the sites of the microarray. Moreover, the density, location, pitch, and sizes of the sites may vary depending upon such factors as the array design, the type of processing and imaging equipment used for analyzing the arrays, and the molecules to be processed. Typical pitches may include at most about 5 micron, 2 micron 1 micron, 850 nm or an even lower maximum value.).
Regarding Claim 12, Eltoukhy teaches the apparatus of claim 1, the apparatus lacking any shields between the plurality of reaction sites and the plurality of imaging regions ([0105] The passivation layer 434 is configured to shield the filter layer 433 from the fluidic environment of the flow channel 418. [0107] In some embodiments, the filter layer 433 may include a plurality of filter walls 440. The filter walls 440 may be configured to at least one of (a) reflect emission signals or (b) block or prevent unwanted emissions signals from adjacent reaction sites.).
Regarding Claim 13, Eltoukhy teaches the apparatus of claim 1, the optical filter layer having a thickness ranging from approximately 500 nm to approximately 5 µm ([0106] the filter layer 433 has a thickness that is about 1-5 μm and, more particularly, about 3-4 μm.).
Regarding Claim 14, Eltoukhy teaches the apparatus of any of claim 1, the imaging regions being separated from each other by a pitch distance ranging from approximately 0.5 µm to approximately 25 µm ([0137] While the particular pitch of the sites may vary, depending, for example, upon their size and the density desired, typical pitches may include at most about 5 micron, 2 micron 1 micron, 850 nm or an even lower maximum value.).
Regarding Claim 15, Eltoukhy teaches the apparatus of claim 1, the optical filter layer comprising a first sub-layer of filter material and a second sub-layer of filter material ([0104] each of the substrate layers 431-434 may include a plurality of sub-layers.).
Regarding Claim 20, Eltoukhy teaches an apparatus, comprising:
a flow cell body defining a channel to receive fluid (flow cell 402 defines a channel),
the channel having a floor extending along a length of the flow cell body (shaped so that a flow channel 418 exists between the flow cover 410);
a plurality of reaction sites positioned along the floor of the channel, the plurality of reaction sites forming an array along a length of the floor of the channel ([0098] a plurality of reaction sites 414);
an optical filter layer positioned under the floor of the channel, the optical filter including at least a portion spanning uninterruptedly along a length corresponding to the length of the array of reaction sites ([0104] a filter or light-management layer 433. [0106] The filter layer 433 may include various features that affect the transmission of light. In some embodiments, the filter layer 433 can perform multiple functions.); and
a plurality of imaging regions positioned under the optical filter layer, each imaging region of the plurality of imaging regions being positioned directly under at least one corresponding reaction site of the plurality of reaction sites, such that each reaction site and corresponding imaging region cooperate to form a sensing relationship ([0107] a light detector 436, plurality of imaging regions with reaction site 414’);
the optical filter layer being configured to permit one or more selected wavelengths of light to pass from each reaction site to the imaging region forming a sensing relationship with the reaction site; the optical filter layer being configured to reduce transmission of excitation light directed toward the plurality of reaction sites, the optical filter layer being further configured to reduce transmission of light emitted from each reaction site to imaging regions not forming a sensing relationship with the reaction site ([0106] The filter layer 433 may include various features that affect the transmission of light. In some embodiments, the filter layer 433 can perform multiple functions. For instance, the filter layer 433 may be configured to (a) filter unwanted light signals, such as light signals from an excitation light source; (b) direct emission signals from the reaction sites 414 toward corresponding light detectors 436 that are configured to detect the emission signals from the reaction sites; or (c) block or prevent detection of unwanted emission signals from adjacent reaction sites. As such, the filter layer 433 may also be referred to as a light-management layer.).
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.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Eltoukhy (US Pub 2018/0341649).
Regarding Claim 9, Eltoukhy teaches the apparatus of claim 1, the optical filter layer comprises dyes ([0164] Alternatively, methods and systems can also be utilized wherein one dye, or a plurality of dyes with similar detection characteristics, are used when detecting and differentiating multiple different analytes.).
Eltoukhy is silent to a combination of an orange dye and a black dye
An orange dye and a black dye would shield light from passing through. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a combination of an orange dye and a black dye to the optical filter layer in the apparatus, as taught by Eltoukhy, to allow for reduced transmission of light.
Regarding Claim 10, Eltoukhy teaches the apparatus of claim 1.
Eltoukhy is silent to the optical filter layer having a transmittance coefficient ranging from approximately 0.1 to approximately 0.5.
A particular parameter can be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, and the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation (see MPEP 2144.05.II.B.). There is no evidence indicating that a transmittance coefficient is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the optical filter layer having a transmittance coefficient ranging from approximately 0.1 to approximately 0.5 so that the filter layer blocks at least half of the light or less going through.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Eltoukhy (US Pub 2018/0341649), in view of Lauer (US Pub 2007/0041089).
Regarding Claims 16 and 17, Eltoukhy teaches the apparatus of claim 15.
Eltoukhy is silent to further comprising a plurality of rings, the plurality of rings being positioned adjacent to one or both of the first sub-layer of filter material or the second sub-layer of filter material, the plurality of rings including a first array of rings and a second array of rings, the first array of rings being located at a first vertical position between the reaction sites and the plurality of imaging regions, the second array of rings being located at a second vertical position between the reaction sites and the plurality of imaging regions.
Lauer teaches in the related art of an imaging device. [0063] As mentioned above, the mask may consist of the superposition of a first array of disks and of a second array comprising disks and rings, the means for modifying the features of the mask consisting of a means for moving the second array in translation with respect to the first array, so that the disks of the first array alternately select the rings or the disks of the second array.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a plurality of rings, the plurality of rings being positioned adjacent to one or both of the first sub-layer of filter material or the second sub-layer of filter material, the plurality of rings including a first array of rings and a second array of rings, the first array of rings being located at a first vertical position between the reaction sites and the plurality of imaging regions, the second array of rings being located at a second vertical position between the reaction sites and the plurality of imaging regions, as taught by Lauer, to the apparatus, as taught by Eltoukhy, to allow for modifying the detection zone while leaving the illumination zone unchanged or for modifying the illumination zone while leaving the detection zone unchanged, as taught by Lauer, in [0061].
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Eltoukhy (US Pub 2018/0341649), in view of Misawa (US Pub 2007/0040194
Regarding Claim 18, Eltoukhy teaches the apparatus of claim 1.
Eltoukhy is silent to the optical filter layer including ferric oxide.
Misawa teaches in the related art of an imaging device. [0009] For the light absorbing layer, the inorganic fine particle is preferably ferric oxide, or a barium sulfate with iron oxide coating.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added ferric oxide, as taught by Misawa, in the optical filter layer in the apparatus, as taught by Eltoukhy, to allow for a light absorbing layer, in [0009].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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