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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/02/2026 has been entered.
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.
Claim 20 recites the limitation "the second adsorbed system" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-15 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. 1-2C and col. 6 lines 41-46, collection device 10 and 54), the device comprising:
a sample collector in the form of a membrane (see Figs. 2A-2C and col. 5 lines 49-51, absorbent pad 56 having forward portion 64);
a migration strip (colored portion 63 and rear portion 65 integrated in pad 56, fig.2) integral or in contact with the sample collector, the migration strip comprising means for quantity checking (see Figs. 2A-2C and col. 6 lines 27-38), the collector being configured to cause a biological fluid to migrate to the means for quality checking, wherein the means for quality checking comprises:
a control line on the migration strip (two control lines defining colored portion 63, as best seen in fig.2B); and
a first adsorbed system which reacts upon contact with the biological fluid to reveal a first colored line (rear portion 65 that adsorbs the colored saliva sample to be displayed at window 67 to confirm that a sufficient quantity of saliva has been collected in the pad 56, fig.2);
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, wherein the means for testing comprises a test revealing system on the migration strip.
Clarke teaches an analogous 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), wherein
means for testing for at least one desired substance, wherein the means for testing comprises a test revealing system on the migration strip (as best seen in fig.1-2, the color change portion 17 is on the same test strip with the test revealing strip 16, par.126-128).
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. And since it has been held that rearranging parts of a device involves only routine skill in the art. In re Japikse, 86 USPQ 70, so it would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to include/arrange the quantity changing system with the testing system on the same test strip as taught by Clarke’s invention.
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 a quantity check on the migration strip of the test device of claim 1 (see Figs. 2A-2C and col. 6 lines 27-38);
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, and wherein the test is performed on the migration strip.
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 kit 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).
Regarding claims 14 and 15, the Gallagher/Clarke combination discloses the test device, wherein the first adsorbed system reacts depending on a pH of a tested biological fluid, wherein the first adsorbed system reacts depending on a specific reagent of the biological fluid (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, 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)) Examiner respectfully notes that th specific reagent is pH.
Claims 16 are rejected under 35 U.S.C. 103 as being unpatentable over US (7,854,895 B2) to Gallagher et al. (“Gallagher”) and (US 2019/0128813 A1) to Clarke et al. (“Clarke”), in further view of Skafidas (US 2019/0150836).
As to claim 16, Gallagher/Clarke combination teaches the invention substantially as claimed above in claim 1 but failed to explicitly teach the specific reagent is amylase.
However, Skafidas teaches an analogous saliva collection testing device (abstract), wherein the collected saliva is tested for amylase (par.11 and par.15).
So, it would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to test the collected saliva for multiple reagents, such as, amylase reagent, in Gallgher’s invention, as taught by Skafidas’s invention, to obtain more accurate and reliable results.
Claims 17 are rejected under 35 U.S.C. 103 as being unpatentable over US (7,854,895 B2) to Gallagher et al. (“Gallagher”) and (US 2019/0128813 A1) to Clarke et al. (“Clarke”), in further view of Goldstein et al (US 5,103,836 A).
As to claim 17, Gallagher/Clarke combination teaches the invention substantially as claimed above in claim 1 but failed to explicitly teach the first adsorbed system reacts depending on a first system of recombinant immunoglobulins.
However, Goldstein teaches an analogous saliva collection testing device (abstract), wherein the first adsorbed system reacts depending on a first system of recombinant immunoglobulins (abstract, col.3, lines 45-65). So, it would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to test the collected saliva for immunoglobulins in Gallgher’s invention, as taught by Goldstein’s invention, for immunological testing and providing more reliable disease testing.
Allowable Subject Matter
Claims 18 and 19 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791
