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 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 (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 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.
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.
Claim(s) 1-2, 4-15, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Jenkins”, US Patent 6423550 in view of “Slowey”, US Publication 20110268626, and “Parsons”, US Publication 20180156792.
Regarding claims 1 and 19, Jenkins discloses a sample collection stick having an absorbent cotton pad mounted in a plastic frame/handle with a narrow extension of the pad continuing up the hollow stem of the handle, a window placed in the neck of the stick, and a dye/chemical on the pad underneath the window that changes color when sufficient oral fluid has been taken up by the pad: (col.2, ll.5-17: “A narrow extension of the pad will continue up the central, hollow stem of the handle. A window is placed in the neck of the stick and a chemical is coated on the pad underneath the window…the chemical being chosen so that it will change color when sufficient oral fluid has been taken up by the pad.”). Jenkins also shows a plastic frame/handle structure and describes that the user can see the indicator through the window (col.6, ll.54-65: describing the pad extension, indicator 56 viewed through aperture 36).
Jenkins disclose a variety of candidate indicators (pH indicators spotted on pad, protein-capture schemes, staining transport) (col.4, ll.12-35: “Various schemes have been devised for effecting the color change. pH indicators…”), but does not disclose explicitly that the mechanism is “an insoluble colored spot deposited on a back face of an indicator zone and is only visible when the indicator zone becomes wet, thereby increasing a translucency of the indicator zone.” However, Slowey discloses a “clear window with a small absorbent pad with a colored dot on the inward side, attached on the inside of the window. When the absorbent pad expands against the absorbent paper, the liquid from that pad is transferred to the absorbent paper…the colored dot becomes visible through the absorbent paper and becomes visible in the sample adequacy indicator.” ([0069]: “Alternatively, the sufficiency indicator can be a clear window with a small absorbent pad with a colored dot on the inward side…the colored dot becomes visible through the absorbent paper and becomes visible in the sample adequacy indicator.”). SLOW also lists other suitable indicator approaches (light-pipe, hydrochromic coatings, snap/spring indicators) that show multiple routine options for hidden-until-wet indication ([0068]–[0073]).
Jenkins does not disclose explicitly an “intermediate, hydrophobic region separating the absorbent pad and the color indicator from the handle”. However, Parsons teaches forming hydrophobic barriers and patterned hydrophobic/hydrophilic regions using techniques such as wax printing to define flow paths and to surround an absorbent region with a hydrophobic region to confine fluid flow ([0025]: “the flow path may be defined by a first material surrounded by a second material, the second material being less absorbent than the first material…a wax printing technique may be employed…to form hydrophobic barriers that define the flow path.”). Parsons also enumerates lateral flow media including paper/nitrocellulose [0012].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Jenkins’ collection stick by incorporating Slowey’s colored-dot/translucency indicator technique and to add hydrophobic separation/patterning per Parsons to isolate the pad/indicator region from the handle. Jenkins itself recognizes the need for an indicator that informs users when “sufficient sample has been collected” (col.2, ll.5-17); Slowey discloses such a concealed colored-dot indicator that becomes visible through an absorbent paper when the paper is wetted and becomes translucent [0069] “…a clear window with a small absorbent pad with a colored dot on the inward side…the colored dot becomes visible through the absorbent paper…”). This modification would have been prompted to implement a simple, robust concealed-until-wet indicator that is reliable for untrained users and that integrates with the existing handle/pad/window geometry taught by Jenkins. Transferring a colored dot to the interior of the device so it is revealed only when the indicator zone becomes wet ([0069]) would improve clarity and reduce false positives/false negatives in user perception of sample adequacy. The combination is completed by routine spotting/printing and paper selection techniques and would yield predictable results (the colored dot will be visible when the paper becomes translucent upon wetting). Additionally, Parsons discloses making hydrophobic patterns (wax printing) to isolate pad/indicator regions ([0025]), which would motivate the inclusion of an intermediate hydrophobic region between the pad/indicator and the handle to prevent undesired fluid migration. This too is routine and yields the predictable effect of limiting capillary migration to the intended flow channels.
Regarding claim 2, Jenkins discloses a hydrophilic channel [54] separating the absorbent pad [50] from the color indicator [56] and indicator zone [36] [col. 6, ll.54-65; 54 is hydrophilic as it absorbs the sample].
Regarding claim 4, Jenkins, Slowey and Parsons disclose the indicator zone comprises chromatography paper [Jenkins: e.g., “Whatman#427”; Slowey: 0060+; e.g., cellulose; Parsons: 0012+].
Regarding claim 5, Slowey discloses wherein a thickness of the chromatography paper depends on a type of the application to be collected [0064], and indicated the sample is selected from the group consisting of: blood, sweat, saliva [0067], urine, and tears. Slowey does not state explicitly that the thickness of the paper can also depend on the type of sample.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have the thickness of the chromatography paper depend on a type of the sample selected from the group consisting of: blood, sweat, saliva, urine, and tears. One of ordinary skill in the art would have made such consideration in order to optimize performance [e.g., absorption, wicking] of the chromatography paper with predictable result of absorption based on the type of sample through routine optimization as is well-known in the art [0063+].
Regarding claim 6, Slowey discloses the insoluble colored spot is visible through the thickness of the indicator zone [0069], but does not disclose explicitly the insoluble colored spot penetrates through half of the thickness of the indicator zone. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have the insoluble colored spot penetrate through half of the thickness of the indicator zone. One of ordinary skill in the art would have made such consideration in order to optimize performance [e.g., translucency] with predictable result of translucency through absorption based on placement/penetration in thickness via routine optimization.
Regarding claim 7, Jenkins and Slowey disclose the mechanism is a hydrochromic dye that changes color upon interacting with water [Jenkins: col. 4, ll. 12-28; Slowey: 0070].
Regarding claim 8, Jenkins discloses the mechanism is a soluble dye that dissolves into the sample and moves with the sample as it wicks up a zone adjacent the color indicator [col. 4, ll. 20-35].
Regarding claim 9, Jenkins discloses the absorbent pad is shaped to resemble a surface of a conical portion of the tube or other collection vessel so as to substantially cover said portion when placed therein [fig. 13; 50 fits into 60 which is conical from side view].
Regarding claim 10, Jenkins discloses a spacer [e.g., 38] to separate the handle [30, 40] from the absorbent pad [50] [fig. 6-10; col. 50-53; spacer between handle halves 30 and 40 that separates from the pad 50].
Regarding claim 11, Jenkins discloses a method of using the metered liquid sample collection device of claim 1 comprising:
collecting the sample with the metered liquid sample collection device or the tube [col. 6, ll. 30-34];
subsequently placing the metered liquid sample collection device into the tube or other collection vessel [e.g., 60] [col. 6, ll. 34-38]; and
(i) drying the sample on the absorbent pad for long term storage or (ii) extracting and processing the sample using a buffer [col. 5, ll. 15-17; col. 5, l. 26].
Regarding claim 12, Jenkins discloses the handle [e.g., 24] remains outside of the tube or other collection vessel [e.g., 60] when the metered liquid sample collection device is placed and capped therewithin [e.g., fig.3-4; col. 7, ll. 20-41; handle 24 is held by collar 70 to remain above/outside of 60].
Regarding claim 13, Jenkins discloses the metered liquid sample collection device can be removed from the tube or other collection vessel without contaminating the sample in the tube or other collection vessel [col. 7, ll. 31-35].
Regarding claim 14, Jenkins discloses a kit [e.g., fig. 1] comprising the metered liquid sample collection device of claim 1, said kit comprising a tube or other collection vessel [e.g., 60] not integrally formed with the metered liquid sample collection device [col. 6, ll. 34-41].
Regarding claim 15, Jenkins discloses instructions can be provided with the kit (col. 8, Il. 24-25), but does not disclose explicitly the instructions for use of the metered liquid sample collection device are printed on the metered liquid sample collection device. However, it would have been obvious to one of ordinary skill in the art to print the instructions on the metered liquid sample collection device in order to save paper that otherwise can be misplaced.
Regarding claim 20, Slowey discloses the mechanism comprises an electrical circuit that is completed when an indicator zone associated with the indicator becomes wet; and completion of the electrical circuit turns on a light, makes a sound, or otherwise produces a signal [e.g, darken] [0071].
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Jenkins”, US Patent 6423550 in view of “Parsons”, US Publication 20180156792.
Regarding claim 16, Jenkins discloses a metered liquid sample collection device comprising:
an absorbent pad [e.g., 50] located at a first end [e.g., fig. 3] of the metered liquid sample collection device [col. 3, ll. 49-50];
an indicator [e.g., 56] that operatively indicates when the predetermined volume of a sample has been collected [col. 3, ll. 42-46];
a handle [e.g., 24, 26] for manipulating the metered liquid sample collection device located at a second end of the metered liquid sample collection device opposite the first end [e.g., fig. 6, 8, 10].
Jenkins does not explicitly disclose an intermediate hydrophobic region. Parsons discloses hydrophobic barrier techniques (wax printing) and partitioning of hydrophilic/hydrophobic regions to define flow paths [0025].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Jenkins’ collection stick by incorporating the hydrophobic separation/patterning per Parsons to isolate the pad/indicator region from the handle. Combining these references would improve Jenkins’ device with the inclusion of an intermediate hydrophobic region between the pad/indicator and the handle to confine fluid migration toward the indicator. These changes are routine wax/hydrophobic patterning methods well known in the art and would produce predictable results (i.e., hydrophobic barriers confine flow and prevent migration to undesired areas).
Regarding claim 17, Parsons discloses wherein the intermediate hydrophobic region is patterned with wax [0025+].
Response to Arguments
Applicant’s arguments, with respect to the rejection(s) of the hydrophobic region under Jenkins [i.e., plastic] have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Applicant's arguments, with respect to the rejection(s) under Slowey [pp.11-12] have been fully considered but they are not persuasive. Examiner submits that Slowey clearly discloses the indicator spot that becomes translucent when wet [0069]. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments, with respect to the rejection(s) under Parsons [pg.14] have been fully considered but they are not persuasive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the hydrophobic region actively prevents or reduces an amount of liquid sample from traveling at all [no flow]) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. Additionally, examiner submits that the control of flow sample does not exclude the containment or prevention of flows.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. “Siegel”, US Patent 8921118, teaches patterned hydrophobic barriers / wax-printed hydrophobic regions in paper microfluidics.
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/TSE W CHEN/ Supervisory Patent Examiner, Art Unit 3791