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 .
Applicant’s filing of claims 1-33 on 1/10/24 is acknowledged. Claims 1-33 are pending and are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/6/23 was acknowledged. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: the colon after “a base plate having:” should be deleted. Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the sample image area; interior cavity (claim 1); the spacers are attached to at least one interior surface of the opposing cover plate (claim 5); must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 10-13, 24 and 26 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 10 is rejected because the structural relationship between the “plurality of branches” and the subject matter of claim 1 is unclear.
Claim 11 is rejected because the structural relationship between the “plurality of branches”; “lead-in pedestal path”; and “sample port” and the subject matter of claim 1 is unclear.
Claim 12 is rejected because “the surface” in “the surface of the branch” raises an antecedent basis issue.
Regarding claims 12 and 13, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). See claim language in parentheses and beginning with “e.g.”
Claims 24 and 26 are rejected for indefiniteness because the claim merely recites a use, e.g., “using,” without any active, positive steps delimiting how this use is actually practiced. See MPEP 2173.05(q).
Claim 24 is rejected because “a determination of trustworthiness of an assay result by analyzing operational variables displayed in an image of a portion of the liquid sample” is unclear.
Claim Interpretation
The Office asserts that terms and phrases like “for” and “wherein” constitute recitations of intended use language for purposes of examination. The Office asserts that in the examined claims reciting such “for” language, the claim language that follows such recitations does not necessarily denote structure MPEP 2173.05(g). The functional limitation was evaluated and considered, for what it fairly conveys to a person of ordinary skill in the art. Similarly, a “wherein” clause may have a limiting effect on a claim if the language limits the claim to a particular structure. MPEP 2111.04. The determination of whether a “wherein” clause is a limitation in a claim depends on the specific facts of the case. While all words in each claim are considered in judging the patentability of the claim language, including functional claim limitations, not all limitations provide a patentable distinction.
During patent examination, the examined claims must be given their broadest reasonable interpretation consistent with the specification, unless a term has been given a special definition in the specification (“BRI”). See MPEP 2111.
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.
Claims 1-2, 5-9 and 15-33 are rejected under 35 U.S.C. 103 as being unpatentable over Pollock et al. (“Pollock,” US Pub. 2004/0028558) in view of Chou et al. (“US Pub. No. 2020/0363408).
As to claim 1, Pollock discloses a device for liquid sample collection and liquid sample analysis, comprising: a base plate (base 1) having: at least one pedestal area (second channel 18 or read island 7) in at least a portion of a sample image area (see fig. 1); and at least one recessed area (side channels or read channel 8 or collection island 4), wherein at least of a portion of the at least one pedestal area is adjacent to the at least one recessed area (see fig. 1); a cover plate (lid 2) that opposes the base plate, wherein the cover plate covers at least a portion of the pedestal area and at least a portion of the sample image area on the base plate (see fig. 2); and an exterior liquid sample contact area (fluid collection point 3, and fig. 4) on an exterior location of the device; wherein the base plate and the cover plate define an interior cavity (see figs. 1-3), and wherein the interior cavity is in fluid communication with the exterior liquid sample contact area (figs. 1-3).
Regarding claim 1, Pollock does not specifically disclose a plurality of spacers Chou discloses in e.g., fig. 1B, 6 and [0386] et seq., a plurality of spacers attached to at least one interior opposing surface of at least one of the base plate, the cover plate, or both, wherein the plurality of spacers are situated between the opposing plates. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include a plurality of spacers because it helps control the sample thickness between the two plates (e.g., [0387] of Chou).
As to claim 2, Pollock discloses a sample entry orifice (fluid collection point 3, and fig. 4).
As to claim 5, the combination of Pollock and Chou disclose spacers attached to the interior surface of the opposing cover plate (see fig. 1B of Chou).
As to claim 6, the combination of Pollock and Chou disclose spacers attached to the interior surface of the base plate (see fig. 6 of Chou).
As to claim 7, the combination of Pollock and Chou disclose spacers attached to the interior surface of the opposing cover plate and spacers attached to the interior surface of the base plate (see fig. 1B of Chou).
As to claim 8, the combination of Pollock and Chou disclose spacers located in the pedestal area are shorter than the spacers located in the recessed area (see fig. 6 of Chou show spacers of different heights).
As to claim 9, the combination of Pollock and Chou disclose the sample image area on the base plate has an area that fits within a field-of-view of a microscope imager (see [0202] et seq. of Chou).
As to claim 15, Pollock discloses base plate is attached to the cover plate by weld, adhesive or a combination (see [0014] et seq.).
As to claims 16-17, Pollock discloses in figs. 1-4 having the interior cavity comprise a horizontal channel having no vertical walls, wherein the horizontal channel is situated between the pedestal area and the cover plate, wherein the horizontal channel channels a liquid sample from the exterior liquid sample contact area on the exterior location of the device; and a chamber area having a ceiling, a floor, and walls, defined by the opposable plates, the at least one pedestal area, and the at least one recessed area. As to the leak-resistant claim language in claim 17, this is considered intended use and/or functional claim language.
As to claim 18, Pollock discloses a vent from the interior cavity to the exterior of the device ([0009] et seq.).
As to claim 19, the combination of Pollock and Chou disclose a plurality of pedestals (fig. 6 of Chou discloses a plurality of protrusions).
As to claims 20 and 27-29, the combination of Pollock and Chou disclose a liquid sample (see [0001] et seq. of Pollock and [0058] et seq. of Chou).
As to claim 21, the combination of Pollock and Chou disclose a method of making the device of claim 1, comprising: contacting a first plate with a negative imprint mold to form the base plate having one or more pedestals and one or more recessed areas; contacting a second plate with a negative imprint mold to form the cover plate having one or more spacers; and combining the two plates into a closed configuration. See [0887] et seq. of Chou.
As to claims 22-23, while Pollock teaches a method for analyzing a liquid sample for an analyte, comprising: contacting the device of claim 1 with a liquid sample in the vicinity of the exterior sample contact area; waiting for a period of time for the contacted sample to imbibe into the interior cavity and spread on the pedestal area of the device and equilibrate to form an equilibrated sample; and analyzing the equilibrated sample for a predetermined analyte in the device by the colour change (e.g., colorimetric assay) or electrical current in [0039] et seq., Pollock does not specifically teach analyzing with an optical analyzer apparatus. Chou teaches an optical analyzer apparatus in [0213] et seq. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include an optical analyzer apparatus because it would allow for high sensitivity in identifying the analyte.
As to claim 24, the combination of Pollock and Chou teach the step of analyzing the sample further comprises executing a non-transitory computer medium having an instruction that, when executed, performs, using an algorithm, a determination of trustworthiness of an assay result by analyzing operational variables displayed in an image of a portion of the liquid sample. See [0096] et seq. of Chou.
As to claims 25-26, the combination of Pollock and Chou teach the algorithm is machine learning, artificial intelligence, statistical methods, or a combination thereof. See [0160] et seq. of Chou.
As to claims 30 and 31, the combination of Pollock and Chou teach the analyte comprises a e.g., tissue; and the molecule is a protein in [0059] et seq. of Chou.
As to claim 32, the combination of Pollock and Chou disclose a system for analyzing a sample, comprising: the device of claim 1; a mobile communication device comprising: one or a plurality of cameras ([0083] et seq. of Chou) for detecting, imaging, or detecting and imaging, the sample; electronics, signal processors, hardware and software ([0096] et seq. of Chou) for receiving, processing, or both, the detected signal, the image of the sample, or both, and for remote communication; and a light source ([0213] et seq. of Chou) from the mobile communication device or from an external source.
As to claim 33, the combination of Pollock and Chou disclose the base plate is attached to the cover plate at the ends of spacers on the base plate, the cover plate, or both (fig. 1B et seq. of Chou).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Pollock in view of Chou, as applied to claim 1 above, and further in view of Chou et al. (“Chou’543,“ WO2020/055543, cited in IDS).
See Pollock and Chou above.
As to claim 3, Pollock does not specifically disclose spacers attached in the pedestal area. Chou’543 discloses in fig. 2C and 2E spacers attached in the pedestal area. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have spacers attached to the pedestal area because it helps determine a property of an analyte in sample in an image-based assay (e.g., p. 4 in Figs. 2D and 2E paragraph of Chou’543).
As to claim 4, the combination of Pollock, Chou and Chou’543 disclose spacers attached in the pedestal area (see figs. 2C and 2E of Chou’543), and spacers in the recessed area (see monitoring marks in fig. 2A of Chou’543). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have spacers attached to the pedestal area and in the recessed area because it helps determine a property of an analyte in sample in an image-based assay (e.g., p. 4 in Figs. 2D and 2E paragraph of Chou’543).
Claims 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Pollock in view of Chou, as applied to claim 1 above, and further in view of Chou et al. (“Chou’401,“ US Pub. No. 2020/0103401).
See Pollock and Chou above.
As to claims 10-14, Pollock does not specifically disclose a plurality of branches coated with reagent; and lead-in path. Chou’401 discloses in fig. 24-25 and [0029] et seq., a plurality of branches coated with reagent (see branched channels in reaction chamber). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have a plurality of branches coated with reagent because it allow for control over reactions conditions throughout the branched channels. As to the types of reagents, this is considered intended use and/or functional claim language.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to Friday.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
1/24/2026