DETAILED ACTION
Claims 1-20 are pending and hereby under examination.
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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“handling structure” first recited in claim 7;
The identified structure for the corresponding claim limitations are as follows:
“handling structure” is identified as “The handling structure may comprise a cap defining inner threads, the inner threads engaging outer threads on the transfer container” (Paragraph 0009), “A handling structure, here in the form of a cap 24, is located at the proximal end of stem 20” (Paragraph 0030), and “cap 24 (or other handling structure) preferably has latching features that causes extraction of the collected sample from sponge 22” (Paragraph 0031).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 20 is 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.
Regarding claim 20, the claim states the step of “determining if the sample is sufficient”. The term “sufficient” in claim 20 is a relative term which renders the claim indefinite. The term “sufficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much sample is required to be “sufficient”. For examination purposes, the claim will be interpreted such that any amount of sample being collected will be “sufficient”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Neumaier (DE 102021115185 – English translation provided) and Haupt (US 20230293068).
Regarding claim 1, Neumaier discloses an oral fluid collection assembly, comprising:
a collector having a stem carrying a collection media at a distal end thereof (Fig. 1, handle 20 with sample suction sponge 10 on the distal end);
a transfer container having an extraction surface separating an interior of the transfer container into a first volume and a second volume (Fig. 1, sample receiving vessel 30; Figs. 5A-B, wherein the sample receiving vessel contains a push-out insert 50’ with retaining means 57 and an insert floor 59; Page 12, paragraph 4, the insert floor 59 is grid-like/perforated to hold back impurities and coarser components of the saliva to improve the sample quality. Examiner interprets the push-out insert 50’ insert floor 59 combination to be the extraction surface. The combination of elements 50’/59 divides the sample receiving vessel into two volumes); and
the transfer container and the collector being connectable by latching features that cause engagement of the collection media and the extraction surface to produce an extracted sample (Fig. 5B, the thread 32 engaged with inner thread 41, the sponge 10 fully compressed to create the saliva sample 100).
Neumaier fails to disclose that the sample receiving vessel has an outlet at its distal end so that the saliva sample can be dispensed from the receiving vessel.
Neumaier and Haupt are in the same field of collection devices. Haupt teaches an extraction container that includes an opening with a base cap at the opposing end of the seal (Fig. 1; Paragraph 0062). The user can then break the cap from the lid to dispense an amount of sample for analysis, closing the cap to seal the sample again (Paragraphs 0068 and 0073). The receiving vessel of Neumaier would benefit from the opening with the base cap to dispense a required amount of sample onto a diagnostic device for later analysis. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the receiving vessel of Neumaier with the opening and base cap taught by Haupt, the benefit being able to dispense a required amount of sample for later analysis.
Regarding claim 4, the combination of Neumaier and Haupt disclose the assembly of claim 1. Neumaier further discloses wherein the collection media comprises a sponge mounted to a rigid mounting structure at the distal end of the stem (Fig. 1, sponge 10 mounted to handle 20).
Regarding claim 7, the combination of Neumaier and Haupt disclose the assembly of claim 4. Neumaier further discloses wherein the collector comprises a handling structure at a proximal end thereof (Fig. 1, handle 20 with closure 40 proximal to the sponge 10).
Regarding claim 8, the combination of Neumaier and Haupt disclose the assembly of claim 7. Neumaier further discloses wherein the handling structure comprises a cap defining inner threads, the inner threads engaging outer threads on the transfer container (Figs. 5A-B, inner threads 41 of closure 40 engaging inner threads of sample receiving vessel 32).
Regarding claim 9, the combination of Neumaier and Haupt disclose the assembly of claim 1. Neumaier further discloses wherein the extraction surface comprises a disc situated at a fixed location in the transfer container, the disc defining at least one aperture for passage of the oral fluid (Fig. 5A, wherein the insert floor 59 is disc shaped as it resides in the cylindrical sample receiving vessel 30. The insert floor 59 is positioned in the fixed location directly beneath the push-out insert 50’).
Regarding claim 10, the combination of Neumaier and Haupt disclose the assembly of claim 1. The combination fails to disclose the transfer container being squeezable. However, Haupt discloses that the tubular body dispenses the sample when the user squeezes the exterior surface (Paragraph 0054). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample receiving vessel of Neumaier with the squeezable tubular body as taught by Haupt in order to dispense the sample from the body.
Regarding claim 11, the combination of Neumaier and Haupt disclose the assembly of claim 10. Haupt further discloses wherein the outlet of the transfer container comprises a dropper structure (Fig. 4, step 5, wherein the distal end of the opening resembles a dropper; Paragraph 0046, wherein the sample is dispensed “drop-wise”).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Neumaier (DE 102021115185 – English translation provided) and Haupt (US 20230293068) as applied to claim 1 above, and further in view of Slowey (US 20060018800).
Regarding claims 2-3, the combination of Neumaier and Haupt disclose the assembly of claim 1. The combination fails to disclose a plurality of laboratory containers configured to receive portions of the extracted sample from the transfer container. The combination fails to further disclose an adaptor that the transfer container is connectable to at least two of the laboratory containers to define a flow passage from the outlet to the respective inlets of the laboratory containers.
Neumaier, Haupt, and Slowey are in the same field of collection devices. Slowey teaches a sample collection device includes collection tubes 126 that mate to a compression tube 120 having two outlets 122a and 122b (Fig. 8). The additional tube of the tubes 126 provides a sample for supplemental or confirmatory testing or for independent storage or transportation (Paragraph 0082). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample receiving container of Neumaier and Haupt to include more than one outlet for use with more than one collection tube as taught by Slowey, the benefit being having more than one sample for supplemental testing or storage.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Neumaier (DE 102021115185 – English translation provided) and Haupt (US 20230293068) as applied to claim 4 above, and further in view of Bachtel (US 20260182974).
Regarding claims 5 and 6, the combination of Neumaier and Haupt disclose the assembly of claim 4. The combination fails to disclose a wicking strip internal to the stem, viewable through a transparent window in the stem, and providing a visual indication of the presence of oral fluid.
Neumaier, Haupt, and Bachtel are in the same field of collection devices. Bachtel teaches a device for collecting oral fluids and determining a sufficiency of the fluid collected (Abstract). A wick 228 may be installed in a longitudinal channel 240, formed in the inner shaft 214. SVAI windows 224/226 are aligned such that the wick 228 is visible through the SVAI windows. The wick 228 includes a visual indicator 242, such as a dye, that indicates sufficient oral fluid is detected when the color changes in the window (See Figs. 1 and 2B; Paragraph 0056). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stem of Neumaier and Haupt with the wick 228 and SVAI windows 224/226 taught by Bachtel, the benefit being the user seeing a color change when sufficient oral fluid has been collected.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Neumaier (DE 102021115185 – English translation provided) and Haupt (US 20230293068) as applied to claim 1 above, and further in view of Darrigrand (US 20090024060).
Regarding claim 12, the combination of Neumaier and Haupt disclose the assembly of claim 1. The combination fails to disclose wherein the transfer container has volume indicia to facilitate dispensing portions of the extracted sample.
Neumaier, Haupt, and Darrigrand are in the same field of collection devices. Darrigrand teaches an extractor 130 for sample collection that includes indicators 154 that visually show the user how much sample fluid is within the extractor, minimum and maximum amounts appropriate for testing (Fig. 1A and paragraph 0058). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample receiving container disclosed by Neumaier and Haupt with indicators as taught by Darrigrand, the benefit in showing the user how much sample has been collected and what is appropriate for testing.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Neumaier (DE 102021115185 – English translation provided) and Haupt (US 20230293068) as applied to claim 1 above, and further in view of Robbins (US 20230172591).
Regarding claim 13, the combination of Neumaier and Haupt disclose the assembly of claim 1. The combination fails to disclose wherein the outlet of the transfer container is formed by a pierceable membrane.
Neumaier, Haupt, and Robbins are in the same field of collection devices. Robbins teaches a liquid sample collection device. The sealed reagent container includes membranes 84/86 that can be punctured by a protrusion 88 with a sharpened portion to remove the liquid therein (Fig. 7 and paragraph 0092). The substitution of one method of sealing a container, such as the opening disclose by Haupt, for another, such as the pierceable membrane as taught by Robbins, and the result of obtaining the liquid therein would have been predictable to one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the opening as disclosed by Neumaier and Haupt for the pierceable membrane as taught by Robbins, and the result of obtaining the liquid therein would have been predictable to one of ordinary skill in the art.
Claims 14-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Neumaier (DE 102021115185 – English translation provided), Haupt (US 20230293068), and Slowey (US 20060018800).
Regarding claim 14, Neumaier discloses an oral fluid collection assembly, comprising:
a collector having a stem carrying a rigid mounting structure at a distal end thereof to which a collection sponge is mounted, the collector further having a cap defining inner threads at a proximal end of the stem (Fig. 1, handle 20 with sample suction sponge 10 on the distal end and a closure 40 on the opposing end);
a transfer container having an extraction surface separating an interior of the transfer container into a first volume and a second volume, the extraction surface defining at least one aperture for passage of an extracted sample of the oral fluid (Fig. 1, sample receiving vessel 30; Figs. 5A-B, wherein the sample receiving vessel contains a push-out insert 50’ with retaining means 57 and an insert floor 59; Page 12, paragraph 4, the insert floor 59 is grid-like/perforated to hold back impurities and coarser components of the saliva to improve the sample quality. Examiner interprets the push-out insert 50’ insert floor 59 combination to be the extraction surface. The combination of elements 50’/59 divides the sample receiving vessel into two volumes); and
the transfer container having outer threads at its proximal end engageable by the inner threads of the cap in a manner that causes engagement of the collection sponge and the extraction surface (Fig. 5B, the thread 32 engaged with inner thread 41, the sponge 10 fully compressed to create the saliva sample 100).
Neumaier fails to disclose that the sample receiving vessel has an outlet at its distal end so that the saliva sample can be dispensed from the receiving vessel, and a plurality of laboratory vessels configured to receive portions of the extracted sample.
Neumaier and Haupt are in the same field of collection devices. Haupt teaches an extraction container that includes an opening with a base cap at the opposing end of the seal (Fig. 1; Paragraph 0062). The user can then break the cap from the lid to dispense an amount of sample for analysis, closing the cap to seal the sample again (Paragraphs 0068 and 0073). The receiving vessel of Neumaier would benefit from the opening with the base cap to dispense a required amount of sample onto a diagnostic device for later analysis. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the receiving vessel of Neumaier with the opening and base cap taught by Haupt, the benefit being able to dispense a required amount of sample for later analysis.
The combination of Neumaier and Haupt fails to disclose a plurality of laboratory containers configured to receive portions of the extracted sample from the transfer container.
Neumaier, Haupt, and Slowey are in the same field of collection devices. Slowey teaches a sample collection device includes collection tubes 126 that mate to a compression tube 120 having two outlets 122a and 122b (Fig. 8). The additional tube provides a sample for supplemental or confirmatory testing or for independent storage or transportation (Paragraph 0082). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample receiving container of Neumaier and Haupt to include more than one outlet for use with more than one collection tube as taught by Slowey, the benefit being having more than one sample for supplemental testing or storage.
Regarding claim 15, the combination of Neumaier, Haupt, and Slowey disclose the assembly of claim 14. Neumaier further discloses wherein the extraction surface comprises a disc situated at a fixed location in the transfer container, the disc defining at least one aperture for passage of the oral fluid (Fig. 5A, wherein the insert floor 59 is disc shaped as it resides in the cylindrical sample receiving vessel 30. The insert floor 59 is positioned in the fixed location directly beneath the push-out insert 50’).
Regarding claim 16, the combination of Neumaier, Haupt, and Slowey disclose the assembly of claim 15. Neumaier further discloses wherein the at least one aperture of the extraction disc comprises a plurality of radial slots (Page 12, paragraph 4, wherein the insert base can be perforated or grid-like, which Examiner interprets as a plurality of slots around the circular insert base).
Regarding claim 18, the combination of Neumaier, Haupt and Slowey disclose the assembly of claim 14. As discussed above, Slowey teaches a sample collection device including collection tubes 126 that mate to a compression tube 120 having two outlets 122a and 122b for split sample collection (Fig. 8).
Regarding claim 19, the combination of Neumaier, Haupt, and Slowey disclose the assembly of claim 14. Haupt further discloses wherein the outlet of the transfer container comprises a dropper structure (Fig. 4, step 5, wherein the distal end of the opening resembles a dropper; Paragraph 0046, wherein the sample is dispensed “drop-wise”).
The combination fails to disclose the transfer container being squeezable. However, Haupt discloses that the tubular body dispenses the sample when the user squeezes the exterior surface (Paragraph 0054). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample receiving vessel of Neumaier with the squeezable tubular body as taught by Haupt in order to dispense the sample from the body.
Regarding claim 20, Neumaier discloses a method of collecting a saliva sample from a user, the method comprising steps of:
obtaining an oral fluid collector having an elongate stem with a collection sponge located at its distal end (Fig. 1, handle 20 with sample suction sponge 10 on the distal end and a closure 40 on the opposing end);
collecting a sample with the collection sponge (Page 9, paragraph 6, “This means that the sample suction sponge 10 can suck up this volume of liquid, ie the saliva sample”;
determining if the sample is sufficient (Page 5, paragraph 4, “According to one embodiment, the sample suction sponge is designed to be sufficiently absorbent to absorb a saliva sample of at least about 0.5 ml, in particular at least about 1 ml, preferably at least about 2 ml. This volume is sufficient for the saliva sample in the sample receptacle without adding an additional dilution solution to investigate”; and
if the sample is sufficient, compressing the sponge to produce an extracted sample into a transfer container (Page 12, paragraph 5, “The sample suction sponge 10 is not only compressed laterally in the constriction 54, but also axially from below by the insert base 59. Even the lowest sponge section of the sample suction sponge 10 can be compressed and squeezed out in the squeezing insert 50'. As a result, the saliva sample 100 can be squeezed out of the sample suction sponge 10 more effectively”).
Neumaier fails to disclose the transfer container having a dropper structure and squeezing the transfer container so as to dispense respective portions of the extracted sample into at least two separate laboratory containers.
Neumaier and Haupt are in the same field of collection devices. Haupt teaches an extraction container that includes an opening with a base cap at the opposing end of the seal (Fig. 1; Paragraph 0062; Fig. 4, step 5, wherein the distal end of the opening resembles a dropper; Paragraph 0046, wherein the sample is dispensed “drop-wise”). The user can then break the cap from the lid to dispense an amount of sample for analysis when the user squeezes the exterior surface (Paragraph 0054), closing the cap to seal the sample again (Paragraphs 0068 and 0073). The receiving vessel of Neumaier would benefit from the opening with the base cap to dispense a required amount of sample onto a diagnostic device for later analysis. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the receiving vessel of Neumaier with the opening and base cap taught by Haupt, the benefit being able to dispense a required amount of sample for later analysis.
The combination of Neumaier and Haupt fails to disclose a plurality of laboratory containers configured to receive portions of the extracted sample from the transfer container.
Neumaier, Haupt, and Slowey are in the same field of collection devices. Slowey teaches a sample collection device includes collection tubes 126 that mate to a compression tube 120 having two outlets 122a and 122b (Fig. 8). The additional tube provides a sample for supplemental or confirmatory testing or for independent storage or transportation (Paragraph 0082). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample receiving container of Neumaier and Haupt to include more than one outlet for use with more than one collection tube as taught by Slowey, the benefit being having more than one sample for supplemental testing or storage.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Neumaier (DE 102021115185 – English translation provided), Haupt (US 20230293068), and Slowey (US 20060018800) as applied to claim 14 above, and further in view of Bachtel (US 20260182974).
Regarding claim 17, the combination of Neumaier, Haupt, and Slowey disclose the assembly of claim 14. The combination fails to disclose a wicking strip providing a visual indication of the presence of oral fluid.
Neumaier, Haupt, Slowey, and Bachtel are in the same field of collection devices. Bachtel teaches a device for collecting oral fluids and determining a sufficiency of the fluid collected (Abstract). A wick 228 may be installed in a longitudinal channel 240, formed in the inner shaft 214. SVAI windows 224/226 are aligned such that the wick 228 is visible through the SVAI windows. The wick 228 includes a visual indicator 242, such as a dye, that indicates sufficient oral fluid is detected when the color changes in the window (See Figs. 1 and 2B; Paragraph 0056). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stem of Neumaier and Haupt with the wick 228 and SVAI windows 224/226 taught by Bachtel, the benefit being the user seeing a color change when sufficient oral fluid has been collected.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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