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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 2, 2026 has been entered.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/30/23 has been considered by the examiner.
Amendment Entered
In response to the amendment filed on April 2, 2026, amended claims 1, 6 and 16 have been entered.
Response to Arguments
Applicant's remarks and amendments with respect to the double patenting rejections are acknowledged. Applicant appears to hold these rejections in abeyance. As such, Examiner maintains the double patenting rejections.
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were fully considered, but are moot in view of the current combination of references that were necessitated by amendment. Please see prior art section below for more detail, updated citations (O’Reilly and Sierra references), and updated obviousness rationale.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5-8, 12-19 are rejected under 35 U.S.C. 1023 as being unpatentable over Palmer
(US Patent Application Document 2016/0022225) and in further view of O’Reilly (US Patent Application Document 2016/0025670), Lenigk (US Patent Application Document 2016/0023209) and Frey (US Patent Application Document 2013/0296664)
Palmer, Lenigk and Frey were applied in the previous office action
Regarding claim 1, Palmer teaches a bodily fluid indicator device comprising: a substrate [fig. 3A,
element 18; par. 69]; and an absorbent material covering a portion of the substrate [fig. 3A, element 16; par. 69], wherein the absorbent material comprises at least one of a graduated scale and/or a reactive feature [par. 77].
However, Palmer does not teach wherein the absorbent material comprises at least one of a sensor, a biosensor, and/or an electrode attached to or printed on the absorbent material; and one or more bendable tabs extending from the substrate, wherein the tabs are independently movable between a first position being substantially coplanar with the substrate and a second position being non-coplanar with the substrate, wherein the tabs, when in the second position are configured to prevent a distal end of the absorbent material from contacting the source of the bodily fluid during collection.
O’Reilly teaches wherein the absorbent material comprises at least one of a sensor, a biosensor,
and/or an electrode attached to or printed on the absorbent material [fig. 2, element 20; par. 126, 127]; and one or more bendable tabs extending from the substrate and wherein the one or more bendable tabs are angled relative to the substrate [fig. 2, element 21; par. 149, 150]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Palmer, to incorporate the absorbent material comprises at least one of a sensor, a biosensor, and/or an electrode attached to or printed on the absorbent material [fig. 2, element 20; par. 126, 127]; and one or more bendable tabs extending from the substrate and wherein the one or more bendable tabs are angled relative to the substrate, for allowing electrical contacts to be exposed, as evidence by O’Reilly [par. 41]
Lenigk teaches wherein the tabs are movable between a first position being substantially coplanar with the substrate and a second position being non-coplanar with the substrate [fig. 5A, 5B; par. 65]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Palmer, to incorporate wherein the tabs are movable between a first position being substantially coplanar with the substrate and a second position being non-coplanar with the substrate, for protection of the substrate, as evidence by Lenigk [par. 65].
Frey teaches and wherein the tabs, when in the second position are configured to prevent a distal end of the absorbent material from contacting the source of the bodily fluid during collection [fig. 3a, 3b; par. 143].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Palmer, to incorporate and wherein the tabs, when in the second position are configured to prevent a distal end of the absorbent material from contacting the source of the bodily fluid during collection, for ensuring the fluid only contacts the electrodes, as evidence by Frey [par. 143].
Regarding claim 2, Palmer further teaches the absorbent material is configured to collect and
evaluate bodily fluid of a subject [par. 52].
Regarding claim 3, Palmer further teaches the bodily fluid indicator device is configured to determine the presence of at least one of pathogens, viruses, enzymes, hormones, metabolites, metals, or microbial contamination in collected bodily fluid of a subject [par. 52].
Regarding claim 5, Palmer further teaches the device is configured to collect bodily fluid from a domestic animal [par. 7, 52]
Regarding claim 7, Palmer further teaches wherein collected bodily fluid of a subject on the absorbent material is exposed to one or more testing materials [par. 66].
Regarding claim 8, Palmer further teaches wherein collected bodily fluid of a subject on the absorbent material exhibits a visible change when exposed to natural, fluorescent, and/or UV illumination [par. 55].
Regarding claim 12, Palmer further teaches the absorbent material comprises a cellulose-based material [par. 69].
Regarding claim 13, Palmer further teaches the absorbent material comprises an inorganic material [par. 69].
Regarding claim 14, Palmer further teaches configured to collect bodily fluid comprising at least one of saliva, sweat, urine, nasal fluid, breast milk, breast discharge, vaginal fluid, and/or rectal fluid [par. 52].
Regarding claim 15, Palmer further teaches the substrate further comprises at least one of a biosensor, sensor, and/or electrode [par. 77].
Regarding claim 16, Palmer further teaches the at least one biosensor, sensor, and/or electrode is in operable communication with the absorbent material [par. 77].
Regarding claim 17, Palmer further teaches the at least one biosensor, sensor, and/or electrode is configured to produce a signal that is colorimetric and/or electronic [par. 77]
Regarding claim 18, Palmer further teaches the signal corresponds to an indication of the presence of at least one of pathogens, viruses, enzymes, hormones, metabolites, metals or microbial contaminates [par. 52].
Regarding claim 19, Palmer further teaches the device is configured to produce a plurality of signals corresponding to a plurality of pathogens, viruses, enzymes, hormones, metabolites, metals or microbial contaminates [par. 14, 52]
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Palmer, O’Reilly, Lenigk
and Frey and in further view of Kobayashi (US Patent Application Document 2017/0122853)
Kobayashi was applied in the previous office action
Regarding claim 4, Palmer, O’Reilly, Lenigk and Frey teach a bodily fluid indicator device, as disclosed above.
However, Palmer, O’Reilly, Lenigk and Frey do not teach the presence of a pharmaceutical contamination is detected in collected bodily fluid of a subject.
Kobayashi teaches the presence of a pharmaceutical contamination is detected in collected bodily fluid of a subject [par. 136, 142]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art
when the invention was filed to modify the method as taught by Palmer, O’Reilly, Lenigk and Frey, to incorporate the presence of a pharmaceutical contamination is detected in collected bodily fluid of a subject, for performing detection of contaminants to ensure the contaminant is decreasing, as evidence by Kobayashi [par. 136, 142]
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Palmer, O’Reilly, Lenigk
and Frey and in further view of Sierra (US Patent Application Document 2018/0259488)
Regarding claim 6, Palmer, O’Reilly, Lenigk and Frey teach a bodily fluid indicator device, as disclosed above.
Lenigk wherein the one or more bendable tabs are configured for placement of the device with respect to a subject [par. 65].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art
when the invention was filed to modify the apparatus as taught by Palmer, to incorporate the one or more bendable tabs are configured for placement of the device with respect to a subject, for exposing the sample substrate, as evidence by Lenigk [par. 65]
Sierra teaches the one or more bendable tabs are configured for placement and stabilization [par. 93 “while in some embodiments, the extended portion may be flexible and configured such that an operator can bend or shape the extended portion into a desired shape for use in contacting a sample”]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art
when the invention was filed to modify the apparatus as taught by Palmer, O’Reilly, Lenigk and Frey, to incorporate the one or more bendable tabs are configured for placement and stabilization, for adequately contacting the sample, as evidence by Sierra [par. 93]
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Palmer, O’Reilly, Lenigk
and Frey and in further view of Hanselle (US Patent Application Document 2010/0317051)
Hanselle was applied in the previous office action
Regarding claim 9, Palmer, O’Reilly, Lenigk and Frey teach a bodily fluid indicator device, as disclosed above.
However, Palmer, O’Reilly, Lenigk and Frey do not teach bodily fluid of a subject is collected from a subject that is not living and/or recently deceased.
Hanselle teaches bodily fluid of a subject is collected from a subject that is not living and/or recently deceased [par. 97]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art
when the invention was filed to modify the apparatus as taught by Palmer, O’Reilly, Lenigk and Frey, to incorporate bodily fluid of a subject is collected from a subject that is not living and/or recently deceased, for detection of dead animals to allow for the determination of cause of death, as evidence by Hanselle [par. 97]
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Palmer, O’Reilly, Lenigk
and Frey and in further view of Everett (US Patent Application Document 2014/0349005)
Everett was applied in the previous office action
Regarding claim 10, Palmer, O’Reilly, Lenigk and Frey teach a bodily fluid indicator device, as disclosed above.
However, Palmer, O’Reilly, Lenigk and Frey do not teach the bodily fluid of a subject is collected from the central nervous system of the subject.
Everett teaches the bodily fluid of a subject is collected from the central nervous system of the subject [par. 36]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art
when the invention was filed to modify the method as taught by Palmer, Esfandiari, O’Reilly and Frey, to incorporate the bodily fluid of a subject is collected from the central nervous system of the subject, for detection of central nervous system injury, as evidence by Everett [par. 36]
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Palmer, O’Reilly, Lenigk
and Frey and in further view of Goldstein (US Patent Application Document 2015/0216471)
Goldstein was applied in the previous office action
Regarding claim 11, Palmer, O’Reilly, Lenigk and Frey teach a bodily fluid indicator device, as disclosed above.
However, Palmer, O’Reilly, Lenigk and Frey do not teach the absorbent material comprises one or more nanoparticle reactive agents.
Goldstein teaches the absorbent material comprises one or more nanoparticle reactive agents [par. 91]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art
when the invention was filed to modify the method as taught by Palmer, O’Reilly, Lenigk and Frey, to incorporate the absorbent material comprises one or more nanoparticle reactive agents, for allowing for colorization to indicate the amount of analyte, as evidence by Goldstein [par. 93]
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Palmer and in further
view of Lenigk and Frey
Regarding claim 21, Palmer teaches a bodily fluid indicator device comprising: a substrate [[fig. 3A, element 18; par. 69]; an absorbent material covering a portion of the substrate [fig. 3A, element 16; par. 69], wherein the absorbent material is configured to contact a source of bodily fluid so that bodily fluid migrates toward a distal end of the absorbent material [par. 52]; and at least one fluid characterization feature attached to or printed onto the substrate [par. 66].
However, Palmer does not teach one or more bendable tabs extending from the substrate, wherein the tabs are movable between a first position being substantially coplanar with the substrate and a second position being non-coplanar with the substrate, and wherein the tabs, when in the second position are configured to prevent a distal end of the absorbent material from contacting the source of the bodily fluid during collection
Lenigk teaches one or more bendable tabs extending from the substrate, wherein the tabs are movable between a first position being substantially coplanar with the substrate and a second position being non-coplanar with the substrate [fig. 5A, 5B; par. 65]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Palmer, to incorporate one or more bendable tabs extending from the substrate, wherein the tabs are movable between a first position being substantially coplanar with the substrate and a second position being non-coplanar with the substrate, for protection of the substrate, as evidence by Lenigk [par. 65].
Frey teaches the tabs, when in the second position are configured to prevent a distal end of the absorbent material from contacting the source of the bodily fluid during collection [fig. 3a, 3b; par. 143].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Palmer, to incorporate the tabs, when in the second position are configured to prevent a distal end of the absorbent material from contacting the source of the bodily fluid during collection, for ensuring the fluid only contacts the electrodes, as evidence by Frey [par. 143]
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 21-39 of US Patent No. 17/934,087. Although the claims at issue are not identical, they are not patentably distinct from each other as they are understood to be obvious variants of one another.
Claim 1 of the reference claim states a bodily fluid indicator device, the device comprising: a substrate comprising a surface; an absorbent material covering at least a portion of the surface of the substrate; the second portion of the absorbent material comprising at least one of a graduated scale and a visual reactive feature printed directly on the second portion of the absorbent material. This falls entirely within the scope of the limitations of pending claim 1 which states a bodily fluid indicator device comprising: a substrate; and an absorbent material covering a portion of the substrate, wherein the absorbent material comprises at least one of a graduated scale and/or a reactive feature.
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the device as claimed in the pending claim, to incorporate the second portion of the absorbent material comprising at least one of a graduated scale and a visual reactive feature printed directly on the second portion of the absorbent material, as the limitation in the pending claim is encompassed by the limitation in the reference claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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