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
The Examiner notes Applicant’s election of Group II, claims 11-20, as noted in the remarks filed 1/16/2025. Claim 1-10 are withdrawn.
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.
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 19, and thus its dependent claims, 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.
Claim 19 recites the limitations of “when the binding adsorptive reagent reacts, a positive test for respiratory viral pathogens is indicated by the filter material using a first barcode configuration; and when the pathogen binding adsorptive reagent does not react, a negative test for respiratory viral pathogens is indicated by the filter material using a second barcode configuration”, and “an optical scanner positioned to detect the first barcode configuration or the second barcode configuration and transmit an indication of the positive test or the negative test based on the first barcode configuration or the second barcode configuration”. However, there is no description provided in either the Applicant’s specification and/or drawings of the first and second barcode configurations, how they are produced, where they are displayed, or how they function.
Claim 19, and thus its dependent claims, 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 19 recites the limitation of “when the binding adsorptive reagent reacts, a positive test for respiratory viral pathogens is indicated by the filter material using a first barcode configuration; and when the pathogen binding adsorptive reagent does not react, a negative test for respiratory viral pathogens is indicated by the filter material using a second barcode configuration”. As stated above, there is no description provided in either the Applicant’s specification and/or drawings of the first and second barcode configurations, how they are produced, where they are displayed, or how they function. For the purpose of Examination, the examiner will consider this limitation to be met as long as the prior art teaches a system comprising a scanner/optical detector capable of scanning various barcodes related to test samples.
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.
Claim(s) 11is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grieve et al. (US 2013/0334042 A1).
Regarding claim 11, Grieve discloses a standalone detection device for respiratory viral pathogens (pathogen sensor 1 comprising a standalone support structure 2, Paragraph 0066 and Figure 1; pathogen sensor 1 may be used to detect pathogens growing in the human body and used in various application areas such as healthcare settings and environmental monitoring, Paragraph 0208), including: a filter material supported by the standalone detection device (gel layer 8 disposed within support structure 2, Figure 1); wherein the standalone detection device is configured and positioned for detection of proximate exhaled breath particles from a respiratory tract of a mammal without physically contacting the mammal (pathogen sensor 1 is disposed in a standalone support structure 2 not intended to come into physical contact with a user/mammal, Figure 1; however can be used in various application areas such as healthcare settings and environmental monitoring in order to detect various pathogens in the air, Paragraph 0208); wherein at least a portion of the filter material includes a pathogen binding adsorptive reagent (the gel 8 may be a non-water based gel with a growth medium upon which a pathogen will grow, Paragraph 0067); wherein, when the exhaled breath particles pass through the filter material (pathogen sensor 1 fully capable of being used in an environment containing exhaled breath particles, Paragraph 0208), the following occur: when the binding adsorptive reagent reacts, a positive test for respiratory viral pathogens is indicated by the filter material (when a reaction between the pathogen and the gel layer 8 takes place, the event is detected by the electrode 6 and indicates a pathogen is present and growing, wherein the measurement electronics connected to the pathogen sensor and thus the gel layer 8 may provide an output indicating presence of a pathogen, Paragraph 0078; see also Paragraphs 0005-0010; Abstract); and when the pathogen binding adsorptive reagent does not react, a negative test for respiratory viral pathogens is indicated by the filter material (when there is no reaction occurring between the pathogen and the gel layer 8, and thus indicative of no pathogen growth, there is no output signal indicating the presence of a pathogen, therefore the absence of an output signal from the sensor1 indicates no growth/presence of a viral pathogen, Paragraphs 0005-00010).
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.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Grieve et al. (US 2013/0334042 A1) in view of Nassar (KR 20160137918 A).
Regarding claim 12, Grieve teaches the standalone detection device of claim 11, however is silent wherein the pathogen binding adsorptive reagent is heparin sepharose or a sulfated cellulose membrane.
However, Nassar teaches a method of detecting biological agents in a sample, to include viral pathogens (Abstract, Page 3, paragraph 5), comprising a filter (Figure 9) wherein the filter tests the presence of a pathogen (Page 3, paragraphs 4-5), further teaching an example wherein the binding agent being Heparin Sepharose (see Page 9 and Figure 3b describing Heparin-Sepharose being used as the binding agent in “Example 2”).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Grieve’s pathogen sensor such that the binding agent used is Heparin-Sepharose, as taught by Nasser, as using Heparin-Sepharose as a binding reagent for a pathogen provides an effective affinity matrix for binding, capturing, and purifying a wide range of viral pathogens.
Claim(s) 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Grieve et al. (US 2013/0334042 A1) in view of Nassar (KR 20160137918 A) and in further view of Chou (US 2021/0045658 A1).
Regarding claim 15, Grieve discloses a standalone detection system for respiratory viral pathogens (pathogen sensor 1 comprising a standalone support structure 2, Paragraph 0066 and Figure 1; pathogen sensor 1 may be used to detect pathogens growing in the human body and used in various application areas such as healthcare settings and environmental monitoring, Paragraph 0208), including: a filter material supported by the standalone detection system (gel layer 8 disposed within support structure 2, Figure 1); wherein the standalone detection system is configured and positioned for detection of proximate exhaled breath particles from a respiratory tract of a mammal without physically contacting the mammal (pathogen sensor 1 is disposed in a standalone support structure 2 not intended to come into physical contact with a user/mammal, Figure 1; however can be used in various application areas such as healthcare settings and environmental monitoring in order to detect various pathogens in the air, Paragraph 0208); wherein at least a portion of the filter material includes a pathogen binding adsorptive reagent (the gel 8 may be a non-water based gel with a growth medium upon which a pathogen will grow, Paragraph 0067); wherein, when the exhaled breath particles pass through the filter material (pathogen sensor 1 fully capable of being used in an environment containing exhaled breath particles, Paragraph 0208), the following occur: when the binding adsorptive reagent reacts, a positive test for respiratory viral pathogens is indicated by the filter material (when a reaction between the pathogen and the gel layer 8 takes place, the event is detected by the electrode 6 and indicates a pathogen is present and growing, wherein the measurement electronics connected to the pathogen sensor and thus the gel layer 8 may provide an output indicating presence of a pathogen, Paragraph 0078; see also Paragraphs 0005-0010; Abstract); and when the pathogen binding adsorptive reagent does not react, a negative test for respiratory viral pathogens is indicated by the filter material (when there is no reaction occurring between the pathogen and the gel layer 8, and thus indicative of no pathogen growth, there is no output signal indicating the presence of a pathogen, therefore the absence of an output signal from the sensor1 indicates no growth/presence of a viral pathogen, Paragraphs 0005-00010).
Although Grieve teaches the pathogen sensor device indicating whether or not a pathogen is present (Paragraphs 0005-0010, Abstract), with Grieve further teaching the electrochemical sensing mechanism capable of detecting a color change of the gel layer (Paragraph 0199) Grieve does not explicitly state the filter material indicating a positive test for pathogen using a first color, and a negative test for a pathogen using a second color, and is silent on a photodetector positioned to detect the first color or the second color and transmit an indication of the positive test or the negative test based on the detected first color or second color.
However, Nassar teaches a method of detecting biological agents in a sample, to include viral pathogens (Abstract, Page 3, paragraph 5), comprising a filter (Figure 9) wherein the filter tests the presence of a pathogen (Page 3, paragraphs 4-5), further teaching the filter indicating either a positive or negative test using a first and second color (the color of the aggregate may correlate with the concentration of the particular biological agent, Page 3, paragraph 4; reflected colors may be red, blue, violet, etc., Page 5, second paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Grieve’s pathogen sensor such that the filter detection method includes indicating either a positive or negative test with the use of color, as taught by Nassar, as using color provides a simple and effective visual indication of the presence of a pathogen that allows the user to quickly identify the test results.
Regarding a photodetector, Chou teaches a system for testing pathogens in a sample (Paragraphs 0531-0532) further comprising a photodetector positioned to detect the colors (fluorescent markers may be detected using a photodetector to detect the emitted light, Paragraph 0232).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Grieve’s pathogen sensor by including a photodetector configured to detect emitted colors, as taught by Chou, as providing a photodetector provides a means of monitoring, storing, and transmitting test results from the sensor associated with color changes.
Regarding claim 16, Grieve in view of Nasser and Chou teach the standalone detection system of claim 15, with Nasser further teaching wherein the pathogen binding adsorptive reagent is heparin sepharose or a sulfated cellulose membrane (see Page 9 and Figure 3b describing Heparin-Sepharose being used as the binding agent in “Example 2”).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Grieve’s pathogen sensor such that the binding agent used is Heparin-Sepharose, as taught by Nasser, as using Heparin-Sepharose as a binding reagent for a pathogen provides an effective affinity matrix for binding, capturing, and purifying a wide range of viral pathogens.
Claim(s) 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Grieve et al. (US 2013/0334042 A1) in view of Nassar (KR 20160137918 A) and in further view of Wiles (US 2004/0063168 A1).
Regarding claim 19, Grieve discloses a standalone detection system for respiratory viral pathogens (pathogen sensor 1 comprising a standalone support structure 2, Paragraph 0066 and Figure 1; pathogen sensor 1 may be used to detect pathogens growing in the human body and used in various application areas such as healthcare settings and environmental monitoring, Paragraph 0208), including: a filter material supported by the standalone detection system (gel layer 8 disposed within support structure 2, Figure 1); wherein the standalone detection system is configured and positioned for detection of proximate exhaled breath particles from a respiratory tract of a mammal without physically contacting the mammal (pathogen sensor 1 is disposed in a standalone support structure 2 not intended to come into physical contact with a user/mammal, Figure 1; however can be used in various application areas such as healthcare settings and environmental monitoring in order to detect various pathogens in the air, Paragraph 0208); wherein at least a portion of the filter material includes a pathogen binding adsorptive reagent (the gel 8 may be a non-water based gel with a growth medium upon which a pathogen will grow, Paragraph 0067), wherein, when the exhaled breath particles pass through the filter material (pathogen sensor 1 fully capable of being used in an environment containing exhaled breath particles, Paragraph 0208), the following occur: when the binding adsorptive reagent reacts, a positive test for respiratory viral pathogens is indicated by the filter material (when a reaction between the pathogen and the gel layer 8 takes place, the event is detected by the electrode 6 and indicates a pathogen is present and growing, wherein the measurement electronics connected to the pathogen sensor and thus the gel layer 8 may provide an output indicating presence of a pathogen, Paragraph 0078; see also Paragraphs 0005-0010; Abstract) and when the pathogen binding adsorptive reagent does not react, a negative test for respiratory viral pathogens is indicated by the filter material (when there is no reaction occurring between the pathogen and the gel layer 8, and thus indicative of no pathogen growth, there is no output signal indicating the presence of a pathogen, therefore the absence of an output signal from the sensor1 indicates no growth/presence of a viral pathogen, Paragraphs 0005-00010).
However, Grieve is silent on wherein the pathogen binding adsorptive reagent is heparin sepharose or a sulfated cellulose membrane, the positive and negative tests being indicated using a first and second barcode configuration, and using a second barcode configuration; and an optical scanner positioned to detect the first barcode configuration or the second barcode configuration and transmit an indication of the positive test or the negative test based on the first barcode configuration or the second barcode configuration.
Regarding the pathogen binding reagent being Heparin Sepharose or a sulfated cellulose membrane, Nasser teaches a method of detecting biological agents in a sample, to include viral pathogens (Abstract, Page 3, paragraph 5), comprising a filter (Figure 9) wherein the filter tests the presence of a pathogen (Page 3, paragraphs 4-5), further teaching an example wherein the binding agent being Heparin Sepharose (see Page 9 and Figure 3b describing Heparin-Sepharose being used as the binding agent in “Example 2”).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Grieve’s pathogen sensor such that the binding agent used is Heparin-Sepharose, as taught by Nasser, as using Heparin-Sepharose as a binding reagent for a pathogen provides an effective affinity matrix for binding, capturing, and purifying a wide range of viral pathogens.
Regarding the limitations involving a first and second barcode configuration, and an optical scanner positioned to detect the first barcode configuration or the second barcode configuration and transmit an indication of the positive test or the negative test based on the first barcode configuration or the second barcode configuration, the Examiner would first like to note the 112a/b rejections presented above related to these limitations – and for the purpose of Examination, the examiner will consider this limitation to be met as long as the prior art teaches a system comprising a scanner/optical detector capable of scanning various barcodes related to test samples. Therefore, Wiles teaches a system and method for analyzing biological samples (Abstract) comprising a barcode scanner (barcode scanner 121, Paragraph 0055 and Figure 2) configured to scan various barcode configurations related to test samples (barcode scanner 121 used to scan the barcode of each test well, Paragraph 0055).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Grieve’s pathogen sensor device to include a barcode scanner configured to scan various barcode configurations related to the test samples, as taught by Wiles, as providing such a barcode scanning mechanism allows a quick and visual means of identify results related to the test samples.
Regarding claim 20, Nasser further teaches wherein the pathogen binding adsorptive reagent is heparin sepharose or a sulfated cellulose membrane (see Page 9 and Figure 3b describing Heparin-Sepharose being used as the binding agent in “Example 2”). The Examiner notes this limitation does not further limit claim 19 as it repeats a limitation already stated in claim 19.
Allowable Subject Matter
Claims 13-14 and 17-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claims 13-14, and 17-18, these claims are directed towards the quantity of the pathogen binding adsorptive reagent, in this case the quantity of heparin sepharose or sulfated cellulose membrane, as well as a porous sealed packet which the pathogen binding reagent is stored. Although Nasser contemplates the use of heparin-sepharose, Nasser does not teach the quantity of 0.2 ml or greater being impregnated into the filter, nor stored within a porous sealed packet.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 11-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, and 11 of copending Application No. 17/500,126.
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: McCash et al. (US 7,384, 793 B2) and Miller et al. (US 11,129,545 B1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785