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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/09/21 has been considered by the examiner.
Amendment Entered
In response to the amendment filed on September 3, 2025, amended claim 1 has 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 remaining arguments filed with respect to the prior art rejections raised in the previous office action were fully considered, but were not persuasive Applicant argues:
Cunningham does not teach “where the indicator feature is printed directly on the second portion of the absorbent material”
No previously cited references teach the amendment “the one or more bendable tabs are configurable to prevent the stem portion and/or the second portion of the absorbent material from contacting the source of bodily fluid during collection”.
Applicant argues Cunningham does not teach the direct printing of features onto the absorbent material. Examiner interprets the term “printed on” to mean located on the absorbent material, and suggests amending the claim to recite the use of a printing device, if that is what Applicant is implying. Examiner notes Cunningham teaches a reactive feature, which is a reaction product that produces a color, is directly on the absorbent material [par. 23]. Additionally, Cunningham teaches a control region with dried molecules on the absorbent material that produce a color [par. 56]. Therefore, this equates to the indicator feature is printed directly on the second portion of the absorbent material, when taking into consideration broadest reasonable interpretation.
Applicant argues none of the previously cited references teach the amendment. Examiner disagrees, and notes that Frey teaches the tabs are bent in order to prevent the contacting elements from contacting the bodily fluid and only allow the electrodes to contact the bodily fluid (fig. 3a, 3b; par. 143). Therefore, this equates to the one or more bendable tabs are configurable to prevent the stem portion and/or the second portion of the absorbent material from contacting the source of bodily fluid during collection, when taking into consideration broadest reasonable interpretation.
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, 23, 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Pierce
(US Patent Number 9168029) in view of Sangha (US Patent Application Document 2005/0147537), Frey (US Patent Application Document 2013/0296664), and Cunningham (US Patent Application Document 2015/0044714).
Pierce, Sangha, Cunningham and Frey were applied in the previous office action
Regarding claim 1, Pierce teaches a bodily fluid indicator device, the device comprising a
substrate comprising a surface (Fig. 1a, element 100), the substrate comprising a body portion (Fig. 1a, element 112) and a stem portion (Fig. 1a, element 110b), an absorbent material covering at least a portion of the surface of the substrate (Fig. 1a, element 114; Col. 4, lines 47-51), one or more bendable tabs extending from the substrate (Fig. 1b, elements 130) wherein a first portion of the absorbent material is configured to contact a source of the bodily fluid (Col. 4, lines 27-38)
However, Pierce does not teach one or more bendable tabs extending from the body portion of
the substrate on at least one side of the stem portion
Sangha teaches one or more bendable tabs extending from the body portion of the substrate on
at least one side of the stem portion (fig. 20-22, element 412; par. 73)
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 Pierce, to incorporate one or more bendable tabs extending from the body portion of the substrate on at least one side of the stem portion, for exposing the paper for sample collection, as evidence by Sangha (par. 73)
However, Pierce does not teach bodily fluid migrates towards a second portion
the absorbent material 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, wherein the visual reactive feature is configured to determine an absence or presence of a chemical constituent of the bodily fluid, and wherein the one or more bendable tabs are configurable to prevent the stem portion and/or the second portion of the absorbent material from contacting the source of bodily fluid during collection.
Frey teaches bodily fluid migrates towards a second portion the absorbent material [fig. 3a, 3b; par. 16, Examiner notes the substrate may be a paper material; par. 143; Examiner notes the fluid flows from electrodes 5 to contact pads 3 and the body fluid only directly contacts the electrodes in the first portion], the second portion of the absorbent material comprising at least one of a graduated scale and a reactive feature on the second absorbent material [par. 51, 52; Examiner notes the sensor comprises an optical component; par. 78, 79]
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 Pierce, to incorporate bodily fluid migrates towards a second portion the absorbent material the second portion of the absorbent material comprising at least one of a graduated scale and a reactive feature on the second portion of the absorbent material, for determining if an analyte is present using optical means, as evidence by Frey [par. 52]
Frey teaches the one or more bendable tabs are configurable to prevent the stem portion and/or the second portion of the absorbent material from contacting the source of 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 Pierce, to incorporate the one or more bendable tabs are configurable to prevent the stem portion and/or the second portion of the absorbent material from contacting the source of bodily fluid during collection, for ensuring the fluid only contacts the electrodes, as evidence by Frey (par. 143).
Cunningham teaches the absorbent material comprising at least one of a graduated scale and a visual reactive feature printed directly on the second absorbent material [par. 14, 23, 56], wherein the visual reactive feature is configured to determine an absence or presence of a chemical constituent of the bodily fluid [par. 25]
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 Pierce, to incorporate the absorbent material comprising at least one of a graduated scale and a visual reactive feature printed directly on the absorbent material, wherein the visual reactive feature is configured to determine an absence or presence of a chemical constituent of the bodily fluid, for comparing results, as evidence by Cunningham [par. 23, 56]
Regarding claim 23, Sangha further teaches the one or more tabs are located between the first portion of the absorbent material and the second portion of the absorbent material (fig. 3).
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 Pierce, Cunningham, and Frey, to incorporate the one or more tabs are located between the first portion of the absorbent material and the second portion of the absorbent material, for protection of the collection paper, as evidence by Sangha (par. 70).
Regarding claim 27, Pierce further teaches a substrate that is planar (Fig. 1a,
element 100).
Regarding claim 28, Pierce further teaches the substrate is flexible (Col. 9, lines
34-47).
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Pierce, Sangha,
Cunningham, and Frey and in further view of Lenigk (US Patent Application Document 2016/0023209)
Lenigk was applied in the previous office action
Regarding claim 21, Pierce, Sangha, Cunningham, and Frey teach a bodily fluid indicator device, as disclosed above.
However, Pierce, Sangha, Cunningham, and Frey do not teach tab of the one or more bendable tabs is movable between a first position being coplanar with the substrate and a second position being non-coplanar with the substrate.
Lenigk teaches tab of the one or more bendable tabs is movable between a first position being 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 Pierce, Sangha, Cunningham, and Frey, to incorporate tab of the one or more bendable tabs is movable between a first position being 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).
Regarding claim 22, Frey teaches the one or more bendable tabs, when in the second position, prevents the second portion of the absorbent material from contacting the source of bodily fluid (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 Pierce, Sangha, Cunningham, and Lenigk, to incorporate the one or more bendable tabs, when in the second position, prevents the second portion of the absorbent material from contacting the source of bodily fluid, for ensuring the fluid only contacts the electrodes, as evidence by Frey (par. 143).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Pierce, Sangha,
Cunningham, and Frey and in further view of Geiger (US Patent Application Document 2010/0203578).
Geiger was applied in the previous office action
Regarding claim 24, Pierce, Sangha, Cunningham, and Frey teach a bodily fluid indicator
device, as disclosed above
However, Pierce, Sangha, Cunningham, and Frey do not teach the graduated scale is
configured to determine an amount of bodily fluid being produced based on a proportion of the graduated scale over which the bodily fluid has migrated.
Geiger further teaches the graduated scale is configured to determine an amount of bodily fluid being produced based on a proportion of the graduated scale over which the bodily fluid has migrated (par. 47).
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 Pierce, Sangha, Cunningham , and Frey, to incorporate the graduated scale is configured to determine an amount of bodily fluid being produced based on a proportion of the graduated scale over which the bodily fluid has migrated, for visual indication of fluid migration, as evidence by Geiger (par. 47).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Pierce, Sangha,
Cunningham, and Frey and in further view of Brock (US Patent Application Document 2002/0001818)
Brock was applied in the previous office action
Regarding claim 25, Pierce, Sangha, Cunningham, and Frey teach a bodily fluid indicator device, as disclosed above.
However, Pierce, Sangha, Cunningham, and Frey do not teach the reactive feature is configured to determine an absence or presence of a chemical constituent of the bodily fluid based on a reaction of the reactive feature over which the bodily fluid has migrated.
Brock teaches the reactive feature is configured to determine an absence or presence of a chemical constituent of the bodily fluid based on a reaction of the reactive feature over which the bodily fluid has migrated (par. 18).
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 Pierce, Sangha, Cunningham, and Frey, to incorporate the reactive feature is configured to determine an absence or presence of a chemical constituent of the bodily fluid based on a reaction of the reactive feature over which the bodily fluid has migrated, for determining an amount of analyte present, as evidence by Brock (par. 18).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Pierce, Sangha,
Cunningham, and Frey and in further view of Bahl (US Patent Number 5609160).
Bahl was applied in the previous office action
Regarding claim 29, Pierce, Sangha, Cunningham, and Frey teach a bodily fluid indicator device, as disclosed above
However, Pierce, Sangha, Cunningham, and Frey do not teach the first portion of the absorbent material is disposed on the body portion of the substrate and the second portion of the absorbent material is disposed on the stem portion of the substrate.
Bahl teaches the first portion of the absorbent material is disposed on the body portion of the substrate and the second portion of the absorbent material is disposed on the stem portion of the substrate (fig. 10, element 50)
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 Pierce, Sangha, Cunningham , and Frey, to incorporate the first portion of the absorbent material is disposed on the body portion of the substrate and the second portion of the absorbent material is disposed on the stem portion of the substrate, for controlling the amount of fluid collected from the user for biological testing, as evidence by Bahl (Col. 5, lines 3-10; Col. 5, lines 24-30)
Claim 30 and 34-39 is rejected under 35 U.S.C. 103 as being unpatentable over Pierce and in
further view of Bahl and Brock
Regarding claim 30, Pierce teaches method of using a bodily fluid indicator device (Fig. 1a),
However, Pierce does not teach the method comprising: providing a bodily fluid indicator device of claim 1; contacting a bodily fluid with the indicator device for a period of time sufficient to allow the bodily fluid to migrate from the first portion of the absorbent material to the second portion of the absorbent material
Bahl teaches the method comprising: providing a bodily fluid indicator device of claim 1; contacting a bodily fluid with the indicator device for a period of time sufficient to allow the bodily fluid to migrate from the first portion of the absorbent material to the second portion of the absorbent material (fig. 10, element 50; Col. 4, lines 20-21; Col. 5, lines 3-10; Col. 5, lines 24-30 “effects a color change when a sufficient amount of fluid has been collected)
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 Pierce, to incorporate the method comprising: providing a bodily fluid indicator device of claim 1; contacting a bodily fluid with the indicator device for a period of time sufficient to allow the bodily fluid to migrate from the first portion of the absorbent material to the second portion of the absorbent material, for controlling the amount of fluid collected from the user for biological testing, as evidence by Bahl (Col. 5, lines 3-10; Col. 5, lines 24-30).
However, Pierce does not teach determining at least one of a measurable amount of bodily fluid being produced and an absence or presence of a chemical constituent of the bodily fluid.
Brock teaches determining at least one of a measurable amount of bodily fluid
being produced and an absence or presence of a chemical constituent of the bodily fluid (par. 18)
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 Pierce, to incorporate determining at least one of a measurable amount of bodily fluid being produced and an absence or presence of a chemical constituent of the bodily fluid, for determining an amount of analyte present, as evidence by Brock (par. 18).
Regarding claim 34, Brock further teaches the bodily fluid migrates over at least a portion of the one or more reactive features (par. 18).
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 Pierce, Bahl, and Frey, to incorporate the bodily fluid migrates over at least a portion of the one or more reactive features, for determining an amount of analyte present, as evidence by Brock (par. 18).
Regarding claim 35, Brock further teaches the absence or presence of a chemical constituent of the bodily fluid is determined based on a reaction of the one or more reactive features over which the bodily fluid has migrated (par. 18)
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 Pierce, Bahl, and Frey, to incorporate the absence or presence of a chemical constituent of the bodily fluid is determined based on a reaction of the one or more reactive features over which the bodily fluid has migrated, for determining an amount of analyte present, as evidence by Brock (par. 18).
Regarding claim 36, Pierce further teaches bending one more of the bendable tabs to prevent a portion of the device from contacting the bodily fluid (Col. 5, lines 33-48: the locks can be activated after fluid collection in order to prevent the absorbent material from contacting the user's mouth)
Regarding claim 37, Pierce the bodily fluid comprises saliva, sweat, nasal fluid,
breast milk, breast discharge, or vaginal fluid (Col. 9, lines 48-50)
Regarding claim 38, Brock further teaches the reaction includes at least one of a change in color, intensity, visibility, size, and/or shape of the one or more reactive features (par. 18).
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 Pierce, Bahl, and Frey, to incorporate the reaction includes at least one of a change in color, intensity, visibility, size, and/or shape of the one or more reactive features, for determining an amount of analyte present, as evidence by Brock (par. 18).
Regarding claim 39, Pierce further teaches wherein a first portion of the absorbent material is configured to contact a source of the bodily fluid (Col. 4, lines 27-38.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Pierce,
Bahl and Brock and in further view of Kamei (US Patent Application Document 2015/0253320)
Kamei was applied in the previous office action
Regarding claim 31, Pierce, Bahl, and Brock teach a bodily fluid indicator device, as disclosed above.
However, Pierce, Bahl, and Brock do not teach the period of time is less than one minute.
Kamei teaches the period of time is less than one minute (par. 123)
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 Pierce, Bahl, and Brock, to incorporate the period of time is less than one minute, for providing faster results, as evidence by Kamei (par. 123).
Claims 32 and 33 rejected under 35 U.S.C. 103 as being unpatentable over
Pierce, Bahl and Brock and in further view of Geiger
Regarding claim 32, Pierce, Bahl and Brock teach a bodily fluid indicator device, as disclosed above.
Pierce, Bahl and Brock do not teach the bodily fluid migrates over at least a portion of the graduated scale.
Geiger teaches the bodily fluid migrates over at least a portion of the graduated scale (par. 47)
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 Pierce, Bahl and Brock, to incorporate the bodily fluid migrates over at least a portion of the graduated scale, for visual indication of fluid migration, as evidence by Geiger (par. 47).
Regarding claim 33, Geiger further teaches the measurable amount of bodily fluid being produced is determined based on a proportion of the graduated scale over which the bodily fluid has migrated (par. 47).
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 Pierce, Bahl and Brock, to incorporate the measurable amount of bodily fluid being produced is determined based on a proportion of the graduated scale over which the bodily fluid has migrated, for controlling the amount of fluid collected from the user for biological testing, for visual indication of fluid migration, as evidence by Geiger (par. 47).
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 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-13, 21, 23, and 24 of US Patent No. 10058307. 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.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8 AM - 5 PM.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791