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 .
Amendment Entered
In response to the amendment filed on 06/09/2025 , amended claims 1-10, and newly presented claims 11-13 are entered. Claims 1-13 remain pending in the application.
Response to Amendment
Applicant’s remarks and amendments with respect to the specification and claims have been fully considered and overcome each and every objection and rejection under 35 U.S.C. 112(b) previously set forth in the Non-Final Office Action mailed on 02/12/2025. The objections and rejections are withdrawn in view of amendments to claims.
Examiner acknowledges Applicant’s response to the interpretation under 35 U.S.C. 112(f) of the claimed feature “at least one means for removing the collector” (see page 6 of remarks).
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.
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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over US 7,854,895 B2 to Gallagher et al. (“Gallagher”) in view of US 2019/0128813 A1 to Clarke et al. (“Clarke”).
Regarding independent claim 1, Gallagher discloses a biological fluid test device, in particular a saliva test device (see Figs. 2A-2C and col. 6 lines 41-46, collection device 54), the device comprising:
a sample collector in the form of a membrane (see Figs. 2A-2C and col. 5 lines 49-51, forward portion 64 of absorbent pad 56),
a means for quantity checking, the collector being configured to cause a biological fluid to migrate to the checking means (see Figs. 2A-2C and col. 6 lines 27-38, biological fluid migrates upward along pad 56 toward rear portion 65. Colored dye indicator 63 is visible through window 67 when enough biological sample has been collected)
a means for displaying, on the device (see Figs. 2A-2C, window 67) characterized in that the device comprises, or is associated with, at least one means for removing the collector (see Figs. 2A-2C and col. 5 lines 57-59, separator shaft 62) and a means for storing it for the purpose of more advanced second opinion analysis (see Fig. 4A and col. 5 lines 25-40, vial 12 contains buffer solution 52 for storage of forward portion 64).
However, Gallagher fails to disclose a means for testing for at least one desired substance and displaying a test result for at least one desired substance.
Clarke teaches a device for testing the levels of a given analyte present in saliva (see Figs. 1-5 and [0125], device 10). Clarke further teaches a means for testing for at least one desired substance and a means for displaying a test result for at least one desired substance (see Figs. 1-5 and [0125] - [0127], test strip 16 displays a color change, visible through window 18, in the presence of a given analyte). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the test device disclosed by Gallagher to include the test strip taught by Clarke with a reasonable expectation that it would yield the predictable result of a device that provides preliminary analysis of a test sample to a user, and also allows for storage of the same test sample for further analysis.
Regarding claim 2, the Gallagher/Clarke combination discloses the device as claimed in claim 1 above.
However, Gallagher fails to disclose a means for testing for a desired substance comprises a migration test strip which is in contact with or integral with the collector.
Clarke teaches that the test means comprises a migration which is in contact with or integral with the collector (see Figs. 4-5 and [0127]-[0129], “…pad of absorbent material 13 makes contact with the test strip 16. Upon alignment of the first arm 12 with the second arm 14…pressing the pad of absorbent material 13 onto the test strip 16…the colour change generated by the reaction of saliva with reagents in the strip…”,test strip 16 is in direct contact with absorbent material 13). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the test device disclosed by Gallagher to include the test strip taught by Clarke with a reasonable expectation that it would yield the predictable result of improving the accuracy of the test results.
Regarding claim 3, the Gallagher/Clarke combination discloses the device as claimed in claim 1 above. Gallagher further discloses the means for quantity checking comprises an indicator (see Figs. 2A-2C and col. 6 lines 23-37, colored dye indicator 63 of absorbent pad 56 is visible through window 67 when enough biological sample has been collected) that is sensitive to the pH of a tested biological fluid or to a specific reagent of the tested biological fluid (see col. 10 line 56-col. 11 line 25, solution selected based on the desired interference between the absorbent material and a collected fluid (i.e., sensitive to a pH of a biological fluid)).
Regarding claim 4, the Gallagher/Clarke combination discloses the device as claimed in claim 1 above. Gallagher further discloses a means for displaying comprising a window on the device (see Figs. 2A-2C, window 67) associated with at least one revealing means of the device (see Figs. 2A-2C and col. 6 lines 27-38, dye 63 is visible through window 67).
However, Gallagher fails to disclose displaying a test result.
Clarke teaches a device displaying a test result (see Figs. 4-5 and [0127] – [0129], test strip 16 changes color in the presence of a desired substance, the color change visible through window 67). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the test device disclosed by Gallagher to include the test strip taught by Clarke with a reasonable expectation that it would yield the predictable result of making it easier for a user to view a first test result without removing the sample collector.
Regarding claim 5, the Gallagher/Clarke combination discloses the device as claimed in claim 1 above. Gallagher further discloses that the means for removing the collector comprises pincers (see col. 6 lines 17-26, removal of the sample collector with “…tongs or the like”).
Regarding claim 6, the Gallagher/Clarke combination discloses the device as claimed in claim 1 above. Gallagher further discloses that the means for removing the collector comprises an automatic ejection system (see Figs. 2A-2C and col. 5 lines 57-59, separator shaft 62 is slidably mounted on handle to detach front portion 64 from absorbent pad 56, slidable ejection interpreted as automatic ejection).
Regarding claim 7, the Gallagher/Clarke combination discloses the device as claimed in claim 1 above. Gallagher further discloses that the means for removing the collector comprises a scored part of the collector (see Figs. 2A-2C and col. 6 lines 7-9, forward portion 64 detaches from body of absorbent pad 56. Detachment of the absorbent pad into a front and rear portion requiring a separating portion between the forward portion and the body).
Regarding claim 8, the Gallagher/Clarke combination discloses the device as claimed in claim 1 above. Gallagher further discloses that the means for storing the collector comprises a specific preservation solution (see Fig. 4A, buffer solution 52) depending on the biological fluid in question and the desired substance (see Fig. 4A and col. 10 line 56 – col. 11 line 26, buffer solution 52 depends on the material of absorbent pad 56 and the analyte being tested), and/or a specific container of desired compounds (see Fig. 4A and col. 5 lines 25-40, vial 12).
Regarding claim 9, the Gallagher/Clarke combination discloses the device as claimed in claim 1 above. Gallagher further discloses a biological fluid test kit, in particular a saliva test kit (see Fig. 4A and col. 5 lines 25-28, kit 10), the kit comprising:
the test device (device taught by the combination of Gallagher/Clarke as claimed in claim 1)
means for removing the collector (see Figs. 2A-2C and col. 5 lines 57-59, separator shaft 62) and/or means for storing it for the purpose of a second opinion (see Fig. 4A and col. 5 lines 25-40, vial 12 contains buffer solution 52 for storage of forward portion 64).
Regarding claim 10, the Gallagher/Clarke combination discloses the device as claimed in claim 1 above. Gallagher further discloses a method for performing a biological fluid test, (see col. 10 lines 16-30, method for performing a saliva test and storing the sample collector to send for further analysis), the method comprising the steps of:
performing the saliva test using a test device (see col. 10 lines 16-30, sample collection using the device of the Gallagher/Clarke combination),
removing the collector in the form of a membrane (collector (see Figs. 2A-2C and col. 5 lines 57-59, separator shaft 62), and
storing the collector in the form of a membrane and performing more advanced tests using the collector (see Fig. 4A and col. 5 lines 25-40, vial 12 contains buffer solution 52 for storage of absorbent portion 64 to be shipped to a second location for additional testing (i.e., more advanced tests))
However, Gallagher does not disclose indicating a positive or negative test result.
Clarke teaches a device displaying a test result (see Figs. 4-5 and [0127] – [0129], test strip 16 changes color in the presence of a desired substance, the color change visible through window 67). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the test device disclosed by Gallagher to include the test strip taught by Clarke with a reasonable expectation that it would yield the predictable result of making it easier for a user to receive an indication of a first test result, and send the sample for further analysis.
Additionally, although Gallagher/Clarke combination fails to explicitly disclose ending the method if the test is negative and removing the collector in the form of a membrane if the test is positive, such modification would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, since it has been held that a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding claim 11, the Gallagher/Clarke combination discloses the device as claimed in claim 1 above. The Gallagher/Clarke combination further discloses a visual means for quantity checking (see Gallagher col. 6 lines 27-38, dye indicator 63 is visible through window 67 when enough biological sample has been collected).
However, the Gallagher/Clarke combination fails to disclose the test device characterized in that the means for quantity checking comprises a control line.
Clarke further teaches a color control icon visible in a window of a test strip (see [0044], “…there is a window, or the second arm is translucent or transparent, the colour calibration icon can be seen… include the colour newly generated from the test next to the colour calibration icon…”), but fails to explicitly disclose that the color control icon is a line.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the means for quantity checking of the Gallagher/Clarke combination (to include a control indicator) for the purpose of confirming a sufficient sample amount of collected saliva, as evidence by Gallagher (col. 6, lines 27-38).
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the Gallagher/Clarke combination (to include a control line), as such modification would involve a mere change in configuration of a control icon disclosed by the Gallagher/Clarke combination, and it has been held that a change in configuration of shape of a device is obvious, absent persuasive evidence that a particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 12, the Gallagher/Clarke combination discloses the biological fluid test ki as claimed in claim 9/1 above. Gallagher further discloses a container (see Fig. 4A and col. 5 lines 25-40, vial 12 (i.e., container) contains buffer solution 52 for storage of forward portion 64).
Regarding claim 13, the Gallagher/Clarke combination discloses the biological fluid test ki as claimed in claim 9/1 above. Gallagher further discloses a preservation solution, or means for producing the preservation solution (see Fig. 4A and col. 5 lines 25-40, vial 12 (i.e., container) contains buffer solution 52 (i.e., a preservation solution) for storage of forward portion 64).
Response to Arguments
Applicant’s arguments filed on 06/09/2025 with respect to the rejection of claims 1-10 under 35 U.S.C. 103 have been fully considered, but they are not persuasive.
In particular, on page 7 of the remarks, Applicant argues that Gallagher and Clarke, taken individually or in combination, fail to teach “…means for testing at least one desired substance…means for displaying, on the device, a test result for at least one desired substance…” as recited in claim 1 because Gallagher does not teach testing a substance on a device, or displaying the test result thereon.
MPEP §2145 (IV) states one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s argument that Gallagher does not teach or suggest “means for testing at least one substance”, Examiner relies on the teachings of Clarke (i.e., device 10 and test strip 16) to teach this limitation, and further relies on the teachings of Clarke (i.e., test strip 16 displays a color change, visible through window 18, in the presence of a given analyte) to teach “means for displaying, on the device, a test result for at least one desired substance…”, as recited in independent claim 1. Therefore, this line of argument is considered not persuasive in view of the treatment of claim 1 above.
Applicant further argues, on page 7 of the remarks, that the rejection of record is improper because Gallagher is not analogous art to the instant application. In particular, applicant argues that the technical problem to be solved by Gallagher is not the same as that of the claimed invention. Applicant further cites several portions of the specification to provide examples of technical advantages of the claimed invention.
MPEP § 2141.01(a) states that in order for a reference to be used in an obviousness rejection, it must be analogous art to the claimed invention. A reference is analogous art to the claimed invention when it is either from the same field of endeavor as the claimed invention, or is reasonably pertinent to the problem faced by the inventor. A reference is “reasonably pertinent” when it “logically commended itself to an inventor’s attention in considering his problem.” In re ICON Health and Fitness, Inc., 496 F.3d 1374, 1379-80 (Fed. Cir. 2007) (quoting In re Clay, 966 F.2d 656, 658, 23 USPQ2d 1058, 1061 (Fed. Cir. 1992)). Additionally, MPEP §2145 (IV) states one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Examiner respectfully disagrees that Gallagher is non-analogous prior art for several reasons. First, Gallagher is in the same field of endeavor as the claimed invention. Both are in the field of devices for sampling body fluids. Second, even if it could be argued that Gallagher is not in the same field of endeavor as the claimed invention, Gallagher is an analogous art because it is reasonably pertinent to the problem faced by the inventor of the claimed invention. Gallagher teaches a fluid sample collection system for collecting and transporting a fluid sample to address the problem of compromised sample analysis seen in traditional sample collection systems, thereby decreasing the cost, complexity, and sample contamination risk (see col. 1, lines 45-63). Furthermore, the rejection of record relies on both Gallagher and Clarke to teach the limitations of the claimed invention as recited in claim 1, and Applicant has made no argument regarding Clarke being non-analogous art. Regarding Applicant’s citations of portions of the specification describing technical advantages of the claimed invention, MPEP § 2145 (II) states that the fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious, see Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant further argues, on page 8 of the remarks, that he rejection of record is improper because the devices of Gallagher and Clarke, when combined, would change the principal operation of Gallagher. In particular, Applicant argues that combining the devices of Clarke and Gallagher would not allow for additional sample collection on absorbent material 13 of Clarke, and further argues that the combination would make it difficult to cut out absorbent material 13.
MPEP 2145 (III) states that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Additionally, MPEP §2145 (IV) states one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Examiner respectfully disagrees that the combination of Gallagher and Clarke would change the principal operation of Gallagher for several reasons. First, Gallagher is relied on to teach “a sample collector in the form of a membrane” (i.e., absorbent pad 56 of Gallagher). Clarke is relied on to teach “a means for testing for at least one desired substance” (i.e., test strip 16 of Clarke), and “a means for displaying a test result for at least one desired substance” (i.e., a window 18 of Clarke), as described above. Second, when combined with the device of Gallagher, the resulting device would still perform the operation of sample collection disclosed by Gallagher (see col. 6, lines 41-46).
Applicant further argues, on page 8 of the remarks, that the rejection of record is improper because there is no teaching, suggestion, or motivation to combine Gallagher and Clarke. In particular, Applicant argues that Gallagher does not suggest adding testing on a device, and further argues that Clarke does not suggest a removable sample part.
Examiner respectfully disagrees. 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 the instant case, one of ordinary skill in the art would have been motivated to combine the teachings of Gallagher (a fluid collection system for sample collection and transportation) with the teachings of Clarke (biological fluid sample collection and testing device) for the purpose of providing a means for collection and analysis of a biological fluid sample, as evidence by Clarke (see [0011], “…saliva testing device that is simple, sensitive, inexpensive and provides a means for both collection and analysis of saliva in the home…”).
Applicant argues, on page 9 of the remarks, that Gallagher and Clarke, taken individually or in combination, fail to teach the claimed limitation “…the test means comprises a migration test strip” as recited in claim 2. In particular, Applicant argues that Gallagher teaches an absorbent material that is not a test strip, and further argues that Clarke teaches an absorbent material put against a test strip.
Examiner respectfully disagrees. Clarke teaches a test strip (test strip 16) which when pressed into an absorbent material (i.e., direct contact with the collector) saliva migrates from the collector to the test strip to cause a color changing reaction (i.e., a migration test strip) indicating a test result (see Figs. 4-5 and [0127]-[0129], “…pad of absorbent material 13 makes contact with the test strip 16. Upon alignment of the first arm 12 with the second arm 14…pressing the pad of absorbent material 13 onto the test strip 16…the colour change generated by the reaction of saliva with reagents in the strip…”).
Applicant further argues, on page 10 of the remarks, that Gallagher and Clarke, taken individually or in combination, fail to teach the claimed limitation “the means for quantity checking comprises an indicator that is sensitive to the pH of a tested biological fluid or to a specific reagent of the tested biological fluid” as recited in amended claim 3. In particular, Applicant argues that Gallagher teaches using a colored dye not specific to the fluid being tested, and further argues that Clarke teaches use of an absorbent material, but not use of a quantity checking means. This line of argument is considered not persuasive in view of the treatment of claim 3 above.
Applicant further argues, on page 10 of the remarks, that Gallagher fails to disclose “the means for quantity checking comprises a control line”, as recited in newly presented claim 11. This line of argument is considered not persuasive in view of the treatment of claim 11 above.
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 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.
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/ALYSSA PAIGE NOVAK/Examiner, Art Unit 3791
/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791
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