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 3/6/26 is acknowledged. Claims 17-18 were canceled. Claims 1-16 and 19-20 are pending and are under examination.
No IDS was filed.
Response to Reply
Drawings
In light of applicant’s claim amendments, the prior drawing objections are withdrawn except for the following below.
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 non-planar structure that enables a directional fluid flow path along said assay (claim 1); non-planar flow path about said assay in a testing position (claim 4); elevated flow path about said assay in a testing position (claim 5); aperture carrier heat block (claim 9); proximity switch (claim 10); directional fluid flow path (claim 14); non-planar flow path (claim 20); and optical strip detector (claim 20) 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 Objections
In light applicant’s claim amendment, the prior objection to claim 20 is withdrawn.
Claim Rejections - 35 USC § 112
In light of applicant’s claim amendments, the prior rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn, except for following below, and a new rejection follows.
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 1-16 and 19-20 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.
The prior rejection of claim 1 is maintained. Claim 1 is rejected because “said assay in an offset position” and “said assay in an operating position” is unclear.
Claim 1 is rejected because “said assay at an elevation” is unclear.
The prior rejection of claim 1 is modified. Claim 1 is rejected because the structural relationship between the assay in an offset position and/or operating position; non-planar structure that enables a directional fluid flow path along said assay; incubator; and optical detector is unclear.
The prior rejection of claim 2 is maintained. Claim 2 is rejected because “an operating position” raises an antecedent basis issue.
The prior rejection of claim 4 is modified. Claim 4 is rejected because “non-planar flow path about said assay in a testing position” is unclear in light of the “offset position” and “operating position” in claim 1. Is this flow path a different structural flow path from the flow path claimed in claim 1?
The prior rejection of claim 5 is modified. Claim 5 is rejected because “elevated flow path about said assay in a testing position” is unclear in light of the “offset position” and “operating position” in claim 1. Is this flow path a different structural flow path from the flow path claimed in claim 1?
The prior rejection of claim 9 is maintained. Claim 9 is rejected because “aperture carrier heat block” is unclear.
The prior rejection of claim 11 is maintained. Claim 11 is rejected because it is unclear whether “optical interrupter” is a structural feature.
The prior rejection of claim 14 is maintained. Claim 14 is rejected because “said non-planar support position” raises an antecedent basis issue.
The prior rejection of claim 15 is maintained. Claim 15 is rejected because “aligns a proximate portion of said assay external of said assembly” is unclear. Claiming “external” of said assembly appears to describe the assay as being beyond the scope of the claimed invention.
The prior rejection of claim 20 is maintained. Claim 20 is rejected because “said distal portion” of said assay raises an antecedent basis issue.
The prior rejection of claim 20 is maintained. Claim 20 is rejected because “an integrated incubator . . . allowing concurrent image acquisition by said camera” is unclear. In light of applicant’s specification, the incubator functions to thermally control said assay while concurrently image acquisition by said camera is performed. The incubator does not appear to control the function of the camera.
Claim Interpretation
The Office asserts that terms and phrases like “to generate” and “wherein” constitute recitations of intended use language for purposes of examination. The Office asserts that in the examined claims reciting such “to generate” 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 rejection by Lochhead is modified, and the following rejections are maintained.
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)(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 1-5 and 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lochhead et al. (“Lochhead,” US Pub. No. 2012/0071342, previously cited).
As to claim 1, Lochhead discloses an apparatus to generate a test result from an assay when contacted with a sample, said apparatus comprising:
a non-planar optics module to align and maintain said assay in an offset position, wherein said non-planar optics module includes an upper tier platform disposed at an angular offset relative to a lower tier platform and positions an upper portion of said assay at an elevation relative to a lower portion of said assay in an operating position, and wherein said angular offset between said upper tier platform and said lower tier platform defines a non-planar structure that enables a directional fluid flow path along said assay between said lower and upper portions of said assay in said operating position and inhibits flooding of a distal testing region of said assay (e.g., figs. 2, 12-18, 26, 46-49; [0079] et seq. recites assay cartridge holder 300 is angled within cartridge holder assembly 1254, which is angled within housing 1202; [0216] et seq. recites cartridge 4500 has fin features 4550 includes a first portion 4552 and a second portion 4554. When cartridge 4500 is resting on second portion 4554, then flow plate 324 within cartridge 4500 lies at a 5-degree angle with respect to the resting surface such that inlet port 4528 is slightly elevated with respect to the outlet port of the flow plate (not visible). The angle of induced tilt may be any angle appropriate for optimum flow of the particular liquids being used in the assay. Optionally, the position of the inlet port and the direction of the tilt may be reversed, i.e., the inlet port may be located near textured grooves 344, and the cartridge may be tilted such that the end with the textured grooves rests higher than a distal end away from the textured grooves);
an incubator incubate said assay (fig. 26, assay system 2600 includes components for incubation to occur as described in [0156] et seq.); and
an optical detector image said assay in said offset position (figs. 2, 12, 18, 46; [0079] et seq. includes reader instrument 100, 1200; laser illumination module 104, 1204; imaging system 124, 1800, a camera or imaging device to image the cartridge).
As to claim 2, see portion of cartridge 110 overhang in fig. 17; and portion of cartridge 4500 overhang the fin features 4550 in [0216] et seq.
As to claims 3-5, see fig. 26, [0132] et seq. discloses cartridge having a planar surface adjacent assay surface 2620 and angled parts with ports. Also see e.g., fig. 47, [0218] et seq.
As to claim 10, see [0079] et seq., which discloses reader instrument 100 may include an interlock switch that electrically disengages light emitting circuitry when cartridge is not inserted or only partially inserted.
As to claims 11 and 12, see [0079] for proximity switch, and [0079, [0108] and [0164] for the functional claim language (e.g., breaks a path . . ., and performs at least two image detections).
As to claim 13, [0110] discloses safety interlock switch 1258 (FIGS. 13 and 15) monitors when a cartridge is properly inserted into reader instrument 1200, thereby enabling laser illumination to occur.
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 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Lochhead in view of Dunn et al. (“Dunn,” US Pub. No. 2013/0244313, previously cited).
See Lochhead above.
As to claims 6-7, while Lochhead discloses in [0216], when cartridge 4500 is resting on second portion 4554, then flow plate 324 within cartridge 4500 lies at a 5-degree angle with respect to the resting surface such that inlet port 4528 is slightly elevated with respect to the outlet port of the flow plate (not visible), and in [0218], one side of tilt rack 4700 is designed to be higher than an opposing end such that the top surface of tilt rack 4700 is at an angle 4752 with respect to the surface on which the tilt rack rests, Lochhead does not specifically disclose the distal portion is about ten degrees to about thirty degrees, or about 20 degrees, offset from said proximate portion.
Dunn discloses in e.g., [0294], the cartridge may have an internal tilt relative to a level orientation, which is sufficient to drive flow of the liquid sample from the inlet port to the outlet port. In another aspect, one, two, and/or three of the factors, namely, the tilt, the capillary action, and the wicking pad, may contribute to driving the flow of the liquid sample from the inlet port to the outlet port. In another aspect, the tilt is at an angle between 2 and 45 degrees relative to a level orientation. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lochhead’s angle to have the distal portion is about ten degrees to about thirty degrees, or about 20 degrees, offset from said proximate portion because Lochhead discloses the angle 4752 may be, for example, 5 degrees or any suitable angle to optimize the fluid flow for the particular assay being run (e.g., [0218] of Lochhead).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lochhead in view of Miller (US Pub. No. 2012/0142020, previously cited).
See Lochhead above.
As to claim 8, while Lochhead discloses in fig. 26, [0138] et seq., cartridge has a planar surface adjacent assay surface and has angled part with ports that align with illumination beam by integrated lens, Lochhead does not specifically disclose a bend aligned between a proximate portion and an opposing distal portion. Miller discloses in e.g., [0036] et seq., as shown in FIG. 1A, the cover 1 of the cartridge is made of a rigid material, preferably plastic, capable of repetitive deformation without cracking at flexible hinge region 10. The cover 1 further comprises a paddle 7 (“bend”), which is moveable relative to the body of the cover 1, and which is attached to the body by flexible hinge region 10. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lochhead’s planar surface with a bend because it would be desirable to design the cartridge for rapid determination of analytes in liquid samples by various assay techniques including immunoassays.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lochhead in view of Markovsky et al. (“Markovsky,” US Pub. No. 2018/0238809, previously cited).
See Lochhead above.
As to claim 9, while Lochhead discloses an aperture carrier in figs. 1-2, Lochhead does not specifically disclose a heat block. In [0078] et seq., Markovsky discloses an incubator 102 that may heat assay 21 to provide the proper incubation environment for a corresponding assay and diagnostic test. Incubator 102 is in communication to the cavity 3 and is capable of maintaining a consistent temperature within cavity 3 by heating at a pre-defined rate. Incubator 102 may include a heater. The heater may be a ceramic heater, a resister heater element and the like. Typically, cavity 3 is designed to be small so that the heater need only draw minimum current. In that way, heating only essential areas and providing insulation around those areas minimizes power requirements. 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 heat block because it would provide the proper incubation environment for an assay and diagnostic test.
Claims 14-16, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Markovsky in view of Lochhead.
See Markovsky and Lochhead above.
As to claims 14-15, Markovsky discloses in e.g., [0106] et seq., an assembly to generate a test result from an assay, an optics module comprising: a. an offset frame (e.g., bottom face of window 108 in fig. 14) to receive and maintain said assay, wherein said frame includes an upper tier platform portion (e.g., engagement lip 106) and a lower tier platform portion (lower half of window 108) to create a non-planar support for said assay; and b. an imaging detector in [0048] et seq. See also [0106] et seq.
With regard to claims 14-15, Markovsky does not specifically disclose that the upper tier platform portion is disposed at an angular offset relative to the lower tier platform portion, and wherein said angular offset adapted to induce a directional fluid flow path and inhibit flooding of said assay. Lochhead discloses figs. 2, 12-18, 26, 46-49; [0079] et seq. recites assay cartridge holder 300 is angled within cartridge holder assembly 1254, which is angled within housing 1202; [0216] et seq. recites cartridge 4500 has fin features 4550 includes a first portion 4552 and a second portion 4554. When cartridge 4500 is resting on second portion 4554, then flow plate 324 within cartridge 4500 lies at a 5-degree angle with respect to the resting surface such that inlet port 4528 is slightly elevated with respect to the outlet port of the flow plate (not visible). The angle of induced tilt may be any angle appropriate for optimum flow of the particular liquids being used in the assay. Optionally, the position of the inlet port and the direction of the tilt may be reversed, i.e., the inlet port may be located near textured grooves 344, and the cartridge may be tilted such that the end with the textured grooves rests higher than a distal end away from the textured grooves. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have the upper tier platform portion disposed at an angular offset relative to the lower tier platform portion because it may be advantageous to place the assay cartridge at a tilt so as to assist with the fluid flow (e.g., [0216] of Lochhead).
Furthermore, with regard to claims 14-15, while Markovsky disclosers an imaging detector in [0048], Markovsky does not specifically disclose a camera. Lochhead discloses in e.g., [0163], a camera or another suitable imaging device, e.g., sensor 128 of fig. 2 is connected within reader instrument 100 and brought online in step 3110) aligned about said frame. Lockhead’s camera is adapted to (e.g., “adapted to” is intended use and/or functional claim language) acquire at least one image of the assay in the non-planar support position during incubation to detect analyte presence or absence based on reflectance or transmission values. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to specifically have a camera because it would be advantageous to utilize a commonly known imaging device.
As to claim 16, see angled portion of engagement lip in fig. 14 of Markovsky.
As to claim 19, see fig. 14 and [0105] et seq. of Markovsky.
As to claim 20, Markovsky discloses an apparatus to generate a test result from an assay, a modular interface comprising: a. a housing (fig. 1 et seq.) adapted to align and maintain said assay in an offset position; c. an optical strip detector (e.g., [0077] et seq.); d. a light level detector (e.g., [0088] et seq.; “adapted to” is intended use and/or functional claim language); e. an imaging device adapted to monitor illumination and maintain imaging conditions (e.g., image sensor, [0089] et seq.); f. a light source (e.g., [0054] et seq.; the combination of Markovsky and Lochhead disclose a light source aligned to illuminate said assay in said offset position); and g. an integrated incubator adapted to thermally control said assay while image acquisition by said camera is concurrently being performed (e.g., incubator 102, [0049] et seq.; “adapted to” is intended use and/or functional claim language).
Regarding claim 20, Markovsky does not specifically disclose an offset frame, and wherein said distal portion of said assay is disposed at an angular elevation relative to a proximate portion, thereby defining a non-planar flow path for sample migration along said assay. Lochhead discloses figs. 2, 12-18, 26, 46-49; [0079] et seq. recites assay cartridge holder 300 is angled within cartridge holder assembly 1254, which is angled within housing 1202; [0216] et seq. recites cartridge 4500 has fin features 4550 includes a first portion 4552 and a second portion 4554. When cartridge 4500 is resting on second portion 4554, then flow plate 324 within cartridge 4500 lies at a 5-degree angle with respect to the resting surface such that inlet port 4528 is slightly elevated with respect to the outlet port of the flow plate (not visible). The angle of induced tilt may be any angle appropriate for optimum flow of the particular liquids being used in the assay. Optionally, the position of the inlet port and the direction of the tilt may be reversed, i.e., the inlet port may be located near textured grooves 344, and the cartridge may be tilted such that the end with the textured grooves rests higher than a distal end away from the textured grooves. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have the upper tier platform portion disposed at an angular offset relative to the lower tier platform portion because it may be advantageous to place the assay cartridge at a tilt so as to assist with the fluid flow (e.g., [0216] of Lochhead).
Furthermore, with regard to claim 20, while Markovsky disclosers an imaging detector in [0048], Markovsky does not specifically disclose a camera. Lochhead discloses in e.g., [0163], a camera or another suitable imaging device, e.g., sensor 128 of fig. 2 is connected within reader instrument 100 and brought online in step 3110) aligned about said frame. Lochhead’s camera is optically aligned with said assay in said offset position and adapted to capture at least one image indicative of analyte presence or absence during incubation (e.g., “adapted to” is intended use and/or functional claim language). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to specifically have a camera because it would be advantageous to utilize a commonly known imaging device.
Response to Remarks
Applicant's arguments filed 3/6/23 have been fully considered but they are not persuasive. Also, applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
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.
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, Lyle Alexander can be reached on 571-272-1254.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
5/30/2026
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