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 .
Status of Claims
Applicant’s reply filed 12/9/25 is acknowledged. Claims 16-18 were added. Claims 1-18 are pending and are under examination.
Response to Reply
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 open areas allow gas flow therethrough and repel the intrusion of the fluid sample (claims 16-18) 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.
Specification
The disclosure is objected to because of the following informalities: in [0149] of PG Pub., “In some embodiments, the hydrophilic region 426D may also be colored to provide a color zone for reading for reading the results of an assay performed with the sensor stack 480,” the italicized is a repeat.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
In light of applicant’s claim amendments, the prior rejection of claims 13-14 under 35 U.S.C. 101 is modified. See rejection below.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 13-14 and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Amended claim 13 for example recites “to determine the presence or absence of an analyte in the sample”, which is a mental step that can be performed in the human mind by observation, evaluation, judgement, or opinion. This can be performed in the human mind by observation because, in [0010] of PG Pub., “to determine the presence or absence of an analyte in the sample”, the color zone is observed by an observer. This judicial exception is not integrated into a practical application because after the “observing the color zone” step, no action is taken, thus, there is no application, much less a particular practical application. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed sensor stack and the steps involved in performing the claimed assay method are well understood, routine, conventional activity.
Dependent claims 14 and 17 further refine the method step of claim 13, however, the subject matter does not affect the result established above.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-14 and 16-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. For claims 1 and 13, “the hydrophobic regions defining open areas providing at least one uninterrupted path through the panels” does not appear to be supported by the originally filed disclosure because [0011] of PG Pub. shows support for “the open areas between the fibers providing at least one uninterrupted open ink-free path between the first major surface of the web and the second major surface of the web”. For claim 1, “the open areas” does not appear to be supported by the originally filed disclosure.
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 1-14 and 16-18 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.
Claims 1 and 13 are rejected because the scope and structural relationship between the “sample flow path” and “open areas providing at least one uninterrupted path through the panels” is unclear. Is there multiple sample fluid paths in the sensor stack? Is the sample flow path and at least one uninterrupted path referring to the same structural feature? Are the open areas referring to the open areas between the fibers of each panel?
Claims 16-18 are rejected because the open areas are unclear.
Claim Interpretation
The Office asserts that terms and phrases like “configured to” and “wherein” constitute recitations of intended use language for purposes of examination. The Office asserts that in the examined claims reciting such “configured to” 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.
Prior Art Rejections
In light of applicant’s claim amendments, the prior art rejections are withdrawn, and new rejections follow.
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 1, 2, 4, 6-12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Whitesides et al. (“Whitesides,” US Pub. No. 2013/0034869, newly cited) in view of Drewes et al. (“Drewes,” US 7153651, newly cited).
As to claims 1 and 16, Whitesides discloses a diagnostic device in fig. 1, comprising: a sensor stack comprising panels disposed in face-to-face contact with each other, each panel including a hydrophobic region and a hydrophilic region ([0031] et seq. discloses a pair of layers 1 and 2 fabricated from material having designed fluid impermeable or hydrophobic regions and hydrophilic, water adsorbent regions), the hydrophobic regions co-operatively defining a sample flow path (e.g., sample flow path is created when region 4 and test zone 3 are aligned; and/or when region 5 and test zone 3 are aligned) for migration of a fluid sample through the sensor stack, and the hydrophobic regions defining open areas providing at least one uninterrupted path through the panels ([0014] et seq. discloses various combination of hydrophilic and hydrophobic materials that form the layers of the device, which comprise open areas in the paper or cloth layer, and provide at least one uninterrupted path through the panels); and a connective region between at least some of the panels to maintain alignment of the sample flow path ([0031-0032] disclose Layers 1 and 2 in practice preferably are in face-to-face contact, or are separated by a thin, fluid impervious interlayer with perforations defining openings permitting fluid flow therethrough (not shown); [0044] et seq. discloses the devices described herein may optionally include one or more fluid impermeable layers disposed between the plural hydrophilic regions; and the fluid-impermeable layer is typically a planar sheet that is not soluble in the fluid of the microfluidic device and provides a desired level of device stability and flexibility).
Regarding claim 1, Whitesides discloses in [0031] optionally, a third layer, comprising a hydrophilic, fluid-adsorptive reservoir (not shown), is disposed below layer 2 as a means of drawing fluid through the hydrophilic regions. Also optionally, the device may include, above layer 1, one or more layers defining flow paths, fluid inlets, filters or the like designed as disclosed herein to deliver fluid to the hydrophilic regions in the layers. However, Whitesides does not specifically disclose a wicking layer on the sensor stack. Drewes discloses in col. 6, line 58 et seq., "absorbent material" is meant a material which has a capacity to draw (wick) and retain solution away from a surface that the material is in contact with. The material can surround the optically functional layer and/or be positioned under the support. Use of a combination of material of increasing or decreasing absorbance allows for control of sample movement. 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 wicking layer on the sensor stack because Whitesides recognizes the advantages of having a wicking layer (“hydrophilic, fluid-adsorptive reservoir”) and having a layer(s) on top of the device to deliver fluid to the hydrophilic regions in the layers, and because having a combination of material of increasing or decreasing absorbance allows for control of sample movement (Drewes, col. 6, line 58 et seq.).
As to claim 2, this is considered an intended use and/or functional limitation because it describes the function of the wicking layer. Because Whitesides’ layers slide ([0031]), it would be obvious to have the wicking layer be separable from the sensor stack.
As to claims 4 and 12, Whitesides discloses the device may include, above layer 1, one or more layers defining flow paths, fluid inlets, filters or the like designed as disclosed herein to deliver fluid to the hydrophilic regions in the layers in [0031] et seq., which can serve as a packaging layer.
As to claim 6, the combination of Whitesides and Drewes disclose in col. 14, line 48 et seq. of Drewes, at least one lateral flow restricting pattern.
As to claim 7, the combination of Whitesides and Drewes disclose in col. 3, line 61 et seq. of Drewes, pattern of wicking channels.
As to claim 8, Whitesides discloses in e.g., [0031] et seq., additional layers above the device.
As to claim 9, Whitesides discloses additional layers in [0031] et seq., which can serve as an elastic element.
As to claim 10, Whitesides discloses foam material in [0046] et seq.
As to claim 11, Whitesides discloses additional layers in [0031] et seq., which can serve as a cover layer.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Whitesides in view of Drewes, as applied to claim 1 above, and further in view of Swanson et al. (“Swanson,” US Pub. No. 2013/0316393, previously cited).
See Whitesides above.
As to claims 3 and 5, Whitesides does not specifically disclose a hinge. Swanson discloses a hinge in [0216]. 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 hinge to help keep the layers intact.
Claims 13, 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Whitesides in view of Bjork et al. (“Bjork,” US Pub. No. 2018/0298322, previously cited).
See Whitesides above.
As to claims 13 and 17, Whitesides teaches a method, comprising: applying a sample solution to an assay device in fig. 1 and [0031] et seq., the assay device comprising: a sensor stack, the sensor stack comprising: panels disposed in face-to-face contact with each other, each panel including a hydrophobic region and a hydrophilic region ([0031] et seq. discloses a pair of layers 1 and 2 fabricated from material having designed fluid impermeable or hydrophobic regions and hydrophilic, water adsorbent regions), the hydrophobic regions co-operatively defining a sample flow path (e.g., sample flow path is created when region 4 and test zone 3 are aligned; and/or when region 5 and test zone 3 are aligned) for migration of a fluid sample through the sensor stack, and the hydrophobic regions defining open areas providing at least one uninterrupted path through the panels ([0014] et seq. discloses various combination of hydrophilic and hydrophobic materials that form the layers of the device, which comprise open areas in the paper or cloth layer, and provide at least one uninterrupted path through the panels); and a connective region between at least some of the panels to maintain alignment of the sample flow path ([0031-0032] disclose Layers 1 and 2 in practice preferably are in face-to-face contact, or are separated by a thin, fluid impervious interlayer with perforations defining openings permitting fluid flow therethrough (not shown); [0044] et seq. discloses the devices described herein may optionally include one or more fluid impermeable layers disposed between the plural hydrophilic regions; and the fluid-impermeable layer is typically a planar sheet that is not soluble in the fluid of the microfluidic device and provides a desired level of device stability and flexibility); and
migrating the sample solution through the sample flow path ([0031] et seq.);
separating the wicking layer from the sensor stack to expose the surface of the sensor stack (e.g., [0094] et seq.); and
applying a color solution to a color zone on the surface to determine the presence or absence of an analyte in the sample (e.g., [0045] et seq.).
Regarding claim 13, Whitesides discloses in [0031] optionally, a third layer, comprising a hydrophilic, fluid-adsorptive reservoir (not shown), is disposed below layer 2 as a means of drawing fluid through the hydrophilic regions. Also optionally, the device may include, above layer 1, one or more layers defining flow paths, fluid inlets, filters or the like designed as disclosed herein to deliver fluid to the hydrophilic regions in the layers. However, Whitesides does not specifically disclose a wicking layer on the sensor stack. Drewes discloses in col. 6, line 58 et seq., "absorbent material" is meant a material which has a capacity to draw (wick) and retain solution away from a surface that the material is in contact with. The material can surround the optically functional layer and/or be positioned under the support. Use of a combination of material of increasing or decreasing absorbance allows for control of sample movement. 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 wicking layer on the sensor stack because Whitesides recognizes the advantages of having a wicking layer (“hydrophilic, fluid-adsorptive reservoir”) and having a layer(s) on top of the device to deliver fluid to the hydrophilic regions in the layers, and because having a combination of material of increasing or decreasing absorbance allows for control of sample movement (Drewes, col. 6, line 58 et seq.).
As to claim 14, Whitesides does not specifically disclose a hinge. Bjork discloses a hinge in [0042]. 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 hinge to help keep the layers intact.
Claims 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Whitesides in view of Whitesides et al. (“Whitesides’191,” US Pub. No. 2009/0298191, newly cited).
See Whitesides above.
As to claims 15 and 18, Whitesides teaches a method of making a diagnostic device using an elongate web of a fibrous material comprising a first major surface and a second major surface, wherein the web has a thickness t extending from the first major surface to the second major surface, and a first edge and a second edge, the web comprising a plurality of adjacent web regions extending from the first edge to the second edge, wherein at least a portion of the web regions are separated from adjacent web regions by border regions (e.g., [0014] et seq.), the method comprising:
applying a first portion of a hydrophobic polymeric ink composition ([0040] et seq.) to the first major surface of the web in at least one web region, wherein the first portion of the ink composition wicks a distance less than t from the first major surface of the web toward the second major surface of the web; and
applying a second portion of the hydrophobic polymeric ink composition ([0040] et seq.) to the at least one web region on the second major surface of the web, wherein the second portion of the ink composition wicks from the second major surface of the web toward the first major surface of the web, wherein the first portion of the hydrophobic polymeric ink composition meets the second portion of the hydrophobic polymeric ink composition to form a hydrophobic area comprising the hydrophobic polymeric ink composition and a hydrophilic area substantially free of the hydrophobic polymeric ink composition;
at least partially hardening the hardenable polymeric ink composition in the hydrophobic areas of the at least one web region to provide a hydrophobic ink on fibers of the fibrous material and open areas between the fibers ([0014] et seq.), the open areas between the fibers providing at least one uninterrupted open ink-free path between the first major surface of the web and the second major surface of the web;
each of the panels including registered hydrophilic areas that define a sample flow path therebetween ([0031] et seq.) and maintaining alignment of the sample flow path with at least one connective region ([0031-0032] disclose Layers 1 and 2 in practice preferably are in face-to-face contact, or are separated by a thin, fluid impervious interlayer with perforations defining openings permitting fluid flow therethrough (not shown); [0044] et seq. discloses the devices described herein may optionally include one or more fluid impermeable layers disposed between the plural hydrophilic regions; and the fluid-impermeable layer is typically a planar sheet that is not soluble in the fluid of the microfluidic device and provides a desired level of device stability and flexibility).
Regarding claim 15, Whitesides does not specifically teach folding the web along the border regions to form a stack of panels. Whitesides’191 teaches in [0124] et seq., FIG. 10 illustrates an exemplary procedure for assembling the lateral flow device of FIGS. 9A-9B. First, the bioassay layer and filter are prepared 1010. In one example, the bioassay layer is a porous medium having patterned barriers and assays spotted in regions defined by the barriers. The protective layer, e.g., adhesive, is provided 1030. In one example, a 7-mm diameter hole is punched out of clear adhesive tape (e.g., Scotch tape)) (7.times.1.9 cm).about.7 mm from one end of the tape. The filter is then adhered to the bioassay layer 1040 using the adhesive. The adhesive is then folded a series of times 1050 to secure the filter to the bioassay layer, with the hole in the adhesive placed over the glass fiber filter, and the excess length of the tape wrapped around the bioassay layer to seal the device. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to fold the device to form a stack of panels because it would be desirable to make the device more compact.
Response to Arguments
Applicant’s arguments with respect to claims 1-18 have been considered but are moot because of the new grounds of rejections.
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 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 LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 571-272-1254.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
1/9/2026