DETAILED CORRESPONDENCE
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/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 21-27, drawn to a method of testing a test surface, classified in B01L3/5029, B01L2200/082.
II. Claims 28-40, drawn to a system with a collection device, classified in B01L3/5029, C12M1/30.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the process can be practiced by a different apparatus such as an apparatus with a cap or without a image sensor (could be chemical analysis), and the apparatus can be used to practice another process such as sample collection from a user or from a surface without sealing or agitating.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
a. The inventions have acquired a separate status in the art in view of their different classification; and/or
b. The inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
c. The inventions require a different field of search (for example, searching different class/subclasses or electronic resources, or employing different search strategies or search queries); and/or
d. The prior art applicable to one invention would not likely be applicable to another invention; and/or
e. The inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Maria Stout on 4/16/26 a provisional election was made without traverse to prosecute the invention of group II, claims 28-40. Affirmation of this election must be made by applicant in replying to this Office action. Claims 21-27 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4/17/23, 7/21/23, 10/26/23, 3/20/24, 7/3/24, 1/31/25, 5/19/25 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Status
Claims 21-40 are pending with claims 28-40 being examined and claims 21-27 deemed withdrawn.
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 “demarcation guide" in claim 29 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.
Claims 28-40 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 pre-AIA the applicant regards as the invention.
As to claim 28, it is unclear where the buffer that is released from the container in lines 7-8 is initially coming from. Where is the buffer released from? The buffer has not been previously recited, and it is unclear if it is initially in the container or if it comes from somewhere else. The claim also recites in lines 11-12 that the contaminant is on the test strip, and it is unclear how the hazardous contaminant gets to the test strip. How does the contaminant get to the test strip? The contaminant is only related as being on the absorbent material and without clarification it is unclear how the contaminant is now on the test strip without clarification.
Claims 29-40 are rejected based on further claim dependency.
Appropriate correction and/or clarification is required.
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 28-40 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al (US 20050106753; hereinafter “Wu”; already of record) in view of Petruno et al (US 20060240541; hereinafter “Petruno”).
As to claim 28, Wu teaches a system (Wu; Fig. 1-8) comprising:
a collection device comprising: an absorbent material coupled to a handle, the absorbent material configured to contact a test surface to collect a hazardous contaminant, and a container having a first portion shaped to receive the absorbent material and a second portion shaped to receive at least a portion of the handle, the container having a nozzle including an orifice configured to release a volume of buffer solution from the container (Wu teaches an absorbent 280 on handle 282; [36-37]; Fig. 3-5, 7. Wu teaches the device is used to detect drugs, which are hazardous contaminants; [21, 27, 42, 57], claim 22. Wu teaches that container 120 receives the absorbent material and the handle with the respective absorbent and handle being located in different regions; Fig. 1-8, [31]. Wu teaches a nozzle 222 that is on the container; Fig. 7);
an assay test strip configured to receive the volume of the buffer solution released from the container, the assay test strip comprising at least one reaction zone configured to produce an optically-detectable change in appearance in the presence of the hazardous contaminant (Wu teaches a test strip which has a sample reaction zone 730; [42, 45], Fig. 7);
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Although Wu teaches placing the sample on a test strip and appears to teach for various assays to analyze the device (Wu; [21, 22, 42]), Wu does not specifically teach an image sensor configured to receive light reflected from the at least one reaction zone and configured to generate signals representing an intensity of the received light; and control electronics configured to analyze the signals and determine the presence of the hazardous contaminant in the at least one reaction zone. However, Petruno teaches the analogous art of an assay system to detect samples, where the device includes an image sensor configured to receive light reflected from the at least one reaction zone and configured to generate signals representing an intensity of the received light; and control electronics configured to analyze the signals and determine the presence of the hazardous contaminant in the at least one reaction zone (Petruno teaches a test strip that is placed into a reader to determine the intensity of the reflected light, and then makes a determination of the respective concentration; [7-8, 38-40, 44-47], Fig. 3, 5, 8). It would have been obvious to have read the results of the collection device and assay strip of Wu using a reader and control electronics to determine concentration or presence of components as in Petruno because Petruno teaches that a human and an automated reader are obvious variants (Petruno; [9]) and also because providing an automated reader would provide the advantage of reproducible results that eliminated human variability to thereby ensure that the assay device had better quality control for diagnostic purposes.
As to claim 29, Wu teaches the system of claim 28, further comprising a demarcation guide configured to specify an area of the test surface to be tested for contamination by the hazardous contaminant (As best understood, Wu teaches a test window to demarcate the test area; Fig. 7).
As to claim 30, Wu teaches the system of claim 28, wherein the control electronics are configured to determine a concentration of the hazardous contaminant based at least partly on the intensity of the signals and an area of the test surface (The modification of reading the results of the collection device and assay strip of Wu using a reader and control electronics to determine concentration or presence of components as in Petruno has already been discussed above. Petruno teaches determining the concentration; [7-8, 38-40, 44-47]).
As to claim 31, Wu teaches the system of claim 28, wherein the assay test strip comprises: a sample receiving zone for receiving the volume of the buffer solution released through the orifice of the nozzle; and a length of material extending between the sample receiving zone and the at least one reaction zone and configured to wick at least the received buffer solution from the sample receiving zone to the at least one reaction zone (Wu teaches a test strip which has a sample receiving zone 720 and a sample reaction zone 730; [42, 45], Fig. 7).
As to claim 32, Wu teaches the system of claim 28, wherein at least a portion of the container is flexible such that an interior volume of the container can be compressed to expel the volume of the buffer solution from the interior volume through the orifice of the nozzle (Wu teaches that the container can be squeezed; Fig. 7, [31, 41, 52]).
As to claim 33, Wu teaches the system of claim 28, further comprising a network connection interface, and wherein the control electronics are configured to send data representing whether the hazardous contaminant is present in the at least one reaction zone to at least one remote computing device over a network via the network interface (The modification of reading the results of the collection device and assay strip of Wu using a reader and control electronics to determine concentration or presence of components as in Petruno has already been discussed above. Petruno teaches communication off results using a wired or wireless connection; [40]).
As to claim 34, Wu teaches the system of claim 28, wherein at least a portion the absorbent material is wrapped around one or more sides of the handle (Wu teaches the absorbent 280 around end of handle 282; Fig. 3-5, 7).
As to claim 35, Wu teaches the system of claim 28, wherein the absorbent material is mechanically fastened to the handle (Wu teaches the absorbent 280 attached to handle 282; Fig. 3-5, 7).
As to claim 36, Wu teaches the system of claim 28, wherein the absorbent material is adhered to the handle (Wu teaches the absorbent 280 attached to handle 282; Fig. 3-5, 7).
As to claim 37, Wu teaches the system of claim 28, wherein the container comprises: an open end having an aperture into the interior volume; and a releasable portion of the container including: an attachment mechanism configured to releasably couple to the container over the open end to provide a fluid-tight seal with the interior volume of the container with the handle and the absorbent material and the buffer solution sealed within the interior volume, the nozzle, and a cap releasably coupled to the nozzle (Wu teaches an open end 274 of the container, and an attachment mechanism that attaches to seal such that the handle and absorbent and buffer are in the container; [33], Fig. 1-7. Wu teaches a cap releasably attached to the nozzle; [30, 40, 52]).
As to claim 38, Wu teaches the system of claim 28, wherein the length of the handle exceeds a width of the handle (Wu teaches that the handle 282 is longer than the width; Fig. 3-5, 7).
As to claim 39, Wu teaches the system of claim 38, wherein the width of the absorbent material exceeds the width of the handle (Wu teaches that the absorbent width 280 is larger than the handle width 282; Fig. 3-5, 7).
As to claim 40, Wu teaches the system of claim 28, wherein the absorbent material extends generally perpendicular to at least a portion of the handle (Wu teaches that the absorbent 280 extends horizontally and perpendicular to the vertical orientation of handle 282; Fig. 3-5, 7).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Mitra et al (US 20190083975; hereinafter “Mitra”) teaches a cap 205 a handle 212 with an absorbent 213 and a container 202 where the sample and buffer mix and are then output through 309 to a cartridge and the optical properties of the cartridge are determined; Fig. 1-7, [113, 119-121, 137, 184-187]. Although the cartridge is not a test strip, it would be obvious to use a test strip instead as an obvious variant.
Dimov et al (US 20180293350; hereinafter “Dimov”) teaches testing via a test strip and sending to remote devices; Fig. 1-6.
Bishop et al (US 20170036205; hereinafter “Bishop”; already of record) teaches a swab in a container with a nozzle in the cap, and where the container is squeezable to release the sample fluid from the nozzle; Fig. 1-10.
Wan, J (US 20120264229; hereinafter “Wan”; already of record) teaches multiple outlets and squeezing the container to expel sample out of either outlet, and it would be obvious to have made the sample collector a swab; Fig. 1-8.
Tung et al (US 20090117665; hereinafter “Tung”) teaches an absorbent for drugs where the absorbent can be any known absorbent and where the sample is passed through a nozzle to a test strip for reading; [15-16].
Wu et al (US 7114403; hereinafter “Wu II”; already of record) teaches absorbent for drugs which is output to a test strip.
Eguchi et al (US 20060074347; hereinafter “Eguchi”; already of record) teaches a swab on a handle that closes a container and a tip 15 that can be removed to form a nozzle where there is a test strip 11 with fibers and a window for reading assay results.
Nason, F (US 5078968; hereinafter “Nason”) teaches a handle that moves into container 30 which has outlet nozzle for dropping solution for further analysis; Fig. 13-16.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN R WHATLEY whose telephone number is (571) 272-9892. The examiner can normally be reached Mon- Fri 8am-5pm.
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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/Benjamin R Whatley/Primary Examiner, Art Unit 1798
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