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 .
Status of Claims
Applicant's filing dated 12/23/2025 is acknowledged. Claims 2-4 were previously cancelled. Claims 1 and 5-16 are pending in the instant application and the subject of this final office action.
All of the arguments have been reviewed and considered. Any rejections or objections not reiterated herein have been withdrawn in light of amendments to the claims or as discussed in this office action.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Previous Rejection
Status of Prior Rejections/Objections:
The prior art rejection(s) under 35 USC 103 directed to the following are maintained:
Claims 1 and 5-6 and 15-16 over Lorente-Acosta in view of Harvey, Li, and Desbois
Claims 7-9 and 11-13 over Lorente-Acosta in view of Harvey, Li, Desbois, and Matusewicz
Claim 10 over Lorente-Acosta in view of Acosta in view of Harvey, Li, Desbois, Matusewicz, and Sangha
Claim 14 over Lorente-Acosta in view of Acosta in view of Harvey, Li, Desbois, and Smit
Claim Interpretation
In evaluating the patentability of the claims presented in this application, claim terms have been given their broadest reasonable interpretation (BRI) consistent with the specification, as understood by one of ordinary skill in the art, as outlined in MPEP 2111.
Regarding claim 1, the specification defines “FTA” as a commercially known formulation comprising a weak base, a chelating agent, and an anionic surfactant (para [0028]).
The specification names Whatman 31ETF as a species of suitable untreated filter paper in para [0031]. Whatman 31ET filter paper has been interpreted to be the same or a comparable product to Whatman 31ETF as the examiner can find no differences in the art and they appear to be used interchangeably and for the same purpose.
Regarding claim 14, perforations in filter in cellulose fiber matrices, i.e., paper and filter paper, are interpreted to implicitly limit the wicking of liquids as taught by the specifications in para [0027].
Claim Rejections - 35 USC § 103
Claim(s) 1, 5-6, and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lorente-Acosta (WO 00/76664 A1; published 12/21/2000) in view of Harvey (US 6,168,922 B1; published 01/02/2001), Li (US 2013/0289265 A1; published 10/31/2013), and Desbois (Desbois D, et al. Use of dried serum spots for serological and molecular detection of hepatitis a virus. J Clin Microbiol. 2009 May;47(5):1536-42. Epub 2009 Mar 25.).
Regarding claims 1, 5-6, and 15-16, Lorente-Acosta teaches a biological sample collector comprising a solid support having four chemically differentiated sample receiving areas (Fig. 4; pg. 7, lines 30-32, spanning pg. 9, line 11: “individual patches may be pre-treated with different preparatory substances in dependence on the tests to be carried out on the samples on each patch. Alternatively, individual patches may be of different material depending on the test to be performed”).
Lorente-Acosta teaches that a patch may be made of BFC180, 3MM, or 31ET filter paper [i.e., chemically untreated and cellulosic filter paper; see interpretation] (pg. 4, lines 26-27; instant claims 15-16).
Lorente-Acosta teaches that a patch may be made of FTA filter paper to lyse cells (pg. 4, lines 28-30). As noted in the interpretation, FTA comprises a weak base, a chelating agent, and an anionic surfactant.
Lorente-Acosta fails to teach chemically differentiated areas comprising the formulas of the instant third and fourth areas.
Harvey rectifies this in part by teaching the combination of an absorbent material that does not bind nucleic acids irreversibly impregnated with a chaotropic salt impregnated about the storage medium, wherein a suitable salt is guanidinium thiocyanate (col 3, lines 17-30). Harvey teaches absorbent materials include 3MM and BFC180 (col 4, line 65).
Harvey further teaches that nucleic acids can either be eluted or resolubilized off the absorbent material in a way that enables them to be amplified by conventional techniques (col 1, lines 27-32).
Harvey also teaches that a matrix treated with a combination of weak base, a chelating agent, and an anionic detergent [i.e., surfactant] results in DNA binding to the matrix and protecting the DNA against degradation (col 2, para 1).
Li further rectifies this by teaching a solid matrix wherein a composition comprising a protein denaturant, a reducing agent, and a buffer is present in the solid matrix in a dry state (para [0016]), wherein the composition may further comprise a UV protectant/free-radical trap [i.e., an antioxidant] (para [0019]).
Li teaches that exemplary protein denaturants include guanidinium thiocyanate, guanidinium hydrochloride, arginine, Sodium dodecyl sulfate (SDS), urea, or any combination thereof (para [0019]).
Li teaches that tris(2-carboxyethyl)phosphine (TCEP) is an exemplary reducing agent.
Li teaches that the antioxidant hydroquinone monomethyl ether (MEHQ), hydroquinone (HQ), toluhydroquinone (THQ), or ascorbic acid (para [0026]).
Li teaches that 3-(N-morpholino) propanesulfonic acid (MOPS) is an exemplary buffer (para [0025]).
Li further teaches that its compositions permit prolonged dry preservation of nucleic acids, particularly RNA, under ambient conditions (para [0016]), wherein ambient storage of RNA is economically desirable given that RNA is one of the most unstable biomolecules (para [0002]).
Desbois further provides motivation for maintaining the first sample receiving area as a chemically untreated by teaching a use of filter papers other than FTA cards [and, it follows, any treatment with a protein denaturant] and that by denaturing proteins, the cards are not proper for immunoassay (pg. 1541, col 2, lines 3-5). Desbois teaches blotting on to both filter paper and FTA (pg. 137, col 1, (iii) Dried spot preparation; pg. 1536, col 2, (ii) DSS preparation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the four receiving area collectors of Lorente-Acosta with the chemically untreated filter paper and FTA filter paper of Lorente-Acosta, with the elution-friendly substrate and chaotropic salt of Harvey, and with the composition of Li on a suitable substrate. The artisan would have been so motivated as Lorente-Acosta teaches choosing treatment substances/patch materials based on the tests to be performed, wherein Desbois teaches the undifferentiated patch for immunoassays, Harvey teaches the FTA composition for long term DNA storage where the DNA is bound to the matrix, Harvey teaches its composition technique benefiting from elution of DNA, and Li teaches its composition for RNA methods. There would have been a strong expectation of success as all devices/compositions are directed to the storage of biological samples and represent the application of known products to a known device.
Regarding claims 5-6, Lorente-Acosta teaches an envelope and a cover portion for covering the chemically differentiated areas (Fig. 4; pg. 7 para 1: “the sample holder acts as its own, integral envelope”; claim 14: “a first cover section foldable about a first fold line over the sample receiving section”; pg. 7 lines 1-2: “the samples on the absorbent patches are wholly contained and protected against external contamination”; instant claim 5) adhered with a pressure-sensitive adhesive (pg. 7 lines 12-14: “Suitable adhesives include … an acrylic copolymer pressure sensitive adhesive”; pg. 8 para 2: “Lines of pressure-sensitive adhesive 15 are provided along the edges of each flap 14 and along the peripheral edges of the second edge section 6.”; instant claim 6).
Claim(s) 7-9 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lorente-Acosta (WO 00/76664 A1; published 12/21/2000), Harvey (US 6,168,922 B1; published 01/02/2001), Li (US 2013/0289265 A1; published 10/31/2013), and Desbois (Desbois D, et al. Use of dried serum spots for serological and molecular detection of hepatitis a virus. J Clin Microbiol. 2009 May;47(5):1536-42. Epub 2009 Mar 25.) as applied to claim 5 above, and further in view of Matusewicz (US 7488450; granted 02/10/2009).
Regarding claims 7-9 and 11-12, in the sample collector of Lorente-Acosta in view of Harvey, Li, and Desbois, Lorente-Acosta teaches that the cover portion may be made of a plastics material (pg. 4, line 19; instant claim 11) and where the cover flap is folded at a fold line (Fig. 4; instant claim 8).
However, Lorente-Acosta does not explicitly teach a transparent cover potion; a separate card support such that part of the cover portion may be sandwiched between an upper and lower leaf of a card support; or the use of PMMA or unmodified polycarbonate in the flap.
Matusewicz rectifies this by teaching a sample collection and testing device wherein the cover above the samples is transparent (col. 12 lines 31-37: “can be visualized by a user while the cover 150 of the test device 100 is closed. The window 170 can include a sheet of transparent material such as LEXANTM polycarbonate interposed between the chromatographic material 160 and the exterior side 152 of the cover member 150, if the chromatographic material 160 isn't already attached to a transparent material such as polycarbonate.”; col 19 para 2: “The interior side 226 of the window portion 220 is then folded along line 228 until it is brought into contact with and adhered to (with the glue beads) the interior side of center portion 240 to form the base member 230. The placement of the combined sheet of absorbent material 270 and filter material on the center portion 240 is such that the detachment flap 246 and at least a portion of sample tab backing 252 is covered.”; instant claim 7).
Matusewicz also teaches a clear “thin plastic sheet stock” such as polycarbonate may be used as a water-resistant, i.e., protective, backing for the sample collection material (col. 13 para 1) and that entire device (“blank”) including the cover may be made of PMMA (“acrylic”) or polycarbonate (col. 4, Detailed Description of the Invention para 1: “ A blank 12 is preferably die-cut or otherwise formed from a piece of rigid material as shown in FIG. 1…. the rigid material can be a plastic that is resistant or impervious to moisture such as … acrylic, or polycarbonate plastic.”)
Matusewicz further teaches multiple locations for sample location on one device (Fig. 9-11; Example 4) including the chemically differentiated zones on the chromatographic material (col. 14 para 4-5), and devices using both sandwich-style (Fig. 9-11) and trifold-style/envelope-style (Fig. 6-8) cover portions, wherein both covers may be folded (col 19 Example 4: “A test device for testing three samples as shown in FIGS. 9-11 is constructed as follows…cover member 350…connected by a hinge (fold line 302)”).
Matusewicz teaches that its cover protects the sample from contamination and protects someone handling the collection device from coming into contact with a sample placed on it (col 9, para 1).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the sample collector of Lorente-Acosta in view of Harvey, Li, and Desbois with the transparent cover portion of Matusewicz, motivated by the desire to improve the protection of both the sample and the device user, as taught by Matusewicz. There would have been a strong expectation for success as all are directed to sample handling devices and represent the application of a known technique to a known device.
It would likewise have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to simplify the structure by using a larger portion of a clear material (i.e., of the clear plastic polycarbonate sheet stock taught) in cases where more of the sample area is beneficial to be visible relative to the device surface area and thus to fold it at the fold line (instant claim 8). In doing so, and taking inspiration from both the sandwich-style of Matusewicz and the trifold-style of Lorente-Acosta and Matusewicz, it would have been obvious to separate the flap of the envelope of the trifold structure from so as to enable an artisan to a different material for the card support according to design constrains. See MPEP 2144.04(V)(C) (instant claim 9). There would have been a strong expectation for success as Matusewicz teaches both sandwich-style and the trifold-style cover portions so an ordinarily skilled artisan could choose elements from each according to the design needs to adapt with the trifold style of Lorente-Acosta and the chromatographic tissue could easily be substituted by one of skill with the filter paper taught by Lorente Acosta.
Therefore, under the above rationales, it would follow that the flap of the cover portion used to cover the samples could be made of PMMA or polycarbonate (instant claim 12)—as taught by Matusewicz as suitable plastics for the blank (including a covering flap) and/or window of that invention—and as no modifiers to the plastics are disclosed that would prevent the passage of UV light in Matusewicz, there would still remain a strong expectation of success for the reasons discussed above.
Regarding claim 13, in the sample collector of Lorente-Acosta in view of Harvey, Li, and Desbois, Lorente-Acosta fails to teach a specific thickness.
Matusewicz partially rectifies this by teaching the use of a “thin plastic sheet stock” (col 13 line 12) but does not explicitly teach 0.25 mm for the cover flap.
However, this is held to be a prima facie obvious variant. The prior art differs from the claimed invention only with respect to a specific thickness of the cover flap. The Court has stated that, generally, such differences amount to mere optimization and will not support patentability unless there is evidence indicating the claimed feature is critical. See MPEP 2144.05(II).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lorente-Acosta (WO 00/76664 A1; published 12/21/2000), Harvey (US 6,168,922 B1; published 01/02/2001), Li (US 2013/0289265 A1; published 10/31/2013), Desbois (Desbois D, et al. Use of dried serum spots for serological and molecular detection of hepatitis a virus. J Clin Microbiol. 2009 May;47(5):1536-42. Epub 2009 Mar 25.), and Matusewicz (US 7488450; granted 02/10/2009) as applied to claim 9 above, and further in view of Sangha (US 2005/0147537 A1; published 07/07/2005).
Regarding claim 10, in the sample collector of Lorente-Acosta in view of Harvey, Li, Desbois, and Matusewicz, Lorente-Acosta and Matusewicz do not teach a lower leaf of the card support with windows.
Sangha rectifies this by teaching a device to hold biological collection device and sample holder where the upper and lower windows align so as to allow a portion of the sample to be removed (para [0058]: “collection paper 110 is visible and accessible through window 54a, b. It will be appreciated that as window 54a is aligned with window 54b that a portion of collection absorbent 110 may be removed by use of a punch to extract a sample of collection paper or absorbent 110 for testing.”).
Sangha likewise teaches that this in part permits collection paper to be processed by automated analysis equipment (para [0002]). Sangha further teaches the use of multiple sample portions on a device (para [0066]) intended for samples comprising blood or DNA (para [0003]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adapt the sample collector of Lorente-Acosta in view of Harvey, Li, Desbois, and Matusewicz for more high throughput analyses by mating the windows of the upper leaf with windows in the lower leaf of a card support using the technique of Sangha, motivated by the desire to enable a machine or human using a device to rapidly punch out portions of the sample, as taught by Sangha. There would have been a strong expectation of success as all are directed toward sample collection devices and represent the application of known techniques to known devices.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lorente-Acosta (WO 00/76664 A1; published 12/21/2000), Harvey (US 6,168,922 B1; published 01/02/2001), Li (US 2013/0289265 A1; published 10/31/2013), and Desbois (Desbois D, et al. Use of dried serum spots for serological and molecular detection of hepatitis a virus. J Clin Microbiol. 2009 May;47(5):1536-42. Epub 2009 Mar 25. as applied to claim 1 above, and further in view of Smit (Smit PW, et al. An overview of the clinical use of filter paper in the diagnosis of tropical diseases. Am J Trop Med Hyg. 2014 Feb;90(2):195-210. Epub 2013 Dec 23.).
Regarding claim 14, in the sample collector of Lorente-Acosta in view of Harvey, Li, and Desbois, Lorente-Acosta teaches the delimiting of sample receiving areas wherein the delimitations are represented by dotted lines (Fig. 4; pg. 8 para 1: “Each patch 3 has deliminated on it two separate regions so that each patch defines a row 12 of two separate samples.”). However, Lorente-Acosta does not explicitly teach perforations for delimiting areas.
Smit rectifies this by teaching the availability of commercial filter paper cards with perforations (Contamination risks: “Recently, perforated filter paper cards have become available (Whatman and PerkinElmer), allowing the spots to be removed with a pipette tip, obviating the need for punching machines and reducing contamination risks.”) and the use of FTA paper (Biosafety issues: “FTA paper carries the advantage of inactivating highly pathogenic organisms to allow safe transportation, with reported complete inactivation of highly pathogenic Avian Influenza Virus (AIV) 1 hour after adsorption onto FTA paper.”).
Therefore, it would have been prima obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the perforations taught by Smit in the sample collector of Lorente-Acosta in view of Harvey, Li, and Desbois to utilize perforations for separating sample receiving areas motivated by the desire to enable their separation without the use of a device like a scissors or similar that could carry contamination or itself be contaminated so as to make the device more suitable for use with samples where biosafety is a concern, as taught by Smit. There would have been a strong expectation of success as all are directed toward sample collection and represent the application of known techniques to known devices.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive.
Applicant argues that the artisan would not have had any reason to combine the teachings of Lorente-Acosta, Harvey, Li, and Desbois in the manner described in the Office Action dated 10/01/2025, particularly for the third and fourth sample receiving areas. Applicant alleges that the artisan would not have had a motivation to look outside the bounds of Lorente-Acosta for information regarding chemical compounds present on said sample receiving areas because Lorente-Acosta describes a collection of compounds and mixtures that may be used to treat the sample receiving areas in a way that would facilitate the collection and analysis of the blood samples it is concerned with. Thus, Applicant argues the combination relies on impermissible hindsight.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, while Lorente-Acosta does not explicitly teach the chemical compounds of Harvey and Li, it does teach choosing patches based on the test to be performed. Both Harvey and Li were available to the artisan before the effective filing.
Harvey teaches that its matrix allows for elution off the absorbent material in a way that enables amplification by conventional techniques, as previously cited. Additionally, it teaches application with whole blood (e.g., Example 6, claim 1, claim 8). Likewise, as previously cited, Li teaches the economic desirability of such RNA storage. Further, Li teaches that the samples may be blood (e.g., para [0013]; Fig. 6). Thus, there was the knowledge in the art before the effective filing date of the invention and the motivation to combine such chemically differentiated areas.
For this reason, the arguments are not persuasive.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emma R Hoppe whose telephone number is (703)756-5550. The examiner can normally be reached Mon - Fri 11:00 am - 7:00 pm.
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/EMMA R HOPPE/Examiner, Art Unit 1683
/NANCY J LEITH/Primary Examiner, Art Unit 1636