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 .
Response to Arguments
Applicant’s arguments and amendments, filed 2/27/2026, with respect to the rejection(s) of claim(s) 1 – 3, 8 – 10, 12 and 14 – 16 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Stave et al. (US 6,663,833 B1), have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Engebretson (US 2004/0089079 A1).
The previous rejection of claims 3, 4 and 8 – 10 and 12 – 18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, has been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 – 10 and 12 – 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1 and 8, the specification does not provide support for the newly added amendment reciting “wherein the porous matrix has a pore diameter of at least 50 µm.”
Regarding newly added dependent claims 19 and 20, these claims do not appear to be support in the specification.
Claims 19 and 20 are 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 19 recites the limitation "the interior volume of the microfluidic liquid gathering capillary" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the elements of the single continuous pathway” interior volume of the microfluidic liquid gathering capillary" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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.
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 – 5, 8 – 10, 12, 14 – 16 and 18 – 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stave et al. (US 6,663,833 B1; hereinafter “Stave”) in view of Engebretson (US 2004/0089079 A1; hereinafter “Engebretson”).
Regarding claim 1, Stave teaches a sample collection system (Assay devices for the detection of analyte in a sample; col. 2, line 61; figures 1 – 3) comprising:
a porous matrix (flowthrough or separating membrane 175 (col. 22, lines 63 – 67; figure 2);
a microfluidic liquid gathering capillary (sample capillary tube 180; col. 22, lines 63 – 67; figure 2);
at least one analyte detection microwell (immunochromatographic strip 210; col. 23, lines 27 – 32; figure 2), the at least one analyte detection microwell having a porous surface; and
a filtration well (capillary sink 220; figure 2; col. 23, lines 36 – 65; immunochromatographic strip 210 is in fluid communication with capillary sink 220 that attracts fluids from the strip 210).
Stave does not specifically teach wherein the porous matrix has a pore diameter of at least 50 µm.
However, Stave does teach that their disclosed sample collection system can be used to detect analytes in other types of samples other than blood samples, including environmental samples, and subjecting these samples to an immunoassay (col 2, lines 7 – 17; col. 4, lines 16 – 27).
Engebretson teaches an apparatus for collecting environmental samples for immunoassay analysis (paragraph 24). The Engebretson apparatus can use a porous membrane having a pore diameter of about or greater than 50 µm (paragraph 33). Consequently, as evidenced by Engebretson, utilizing a porous membrane or matrix wherein the porous matrix has a pore diameter of at least 50 µm would have been considered to be suitable and predictable to a person of ordinary skill in the art for use in sampling and analyzing environmental samples. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the porous matrix has a pore diameter of at least 50 µm.
Regarding claim 2, Stave teaches the sample collection system of claim 1, further comprising a reaction well (mixing chamber 380; col. 24, lines 1 – 14; figure 3).
Regarding claim 3, Stave teaches the sample collection system of claim 1, wherein the sample well connects to the reagent well (as shown in figure 2, filtration membrane 210 is connected to porous matrix 175 via intervening capillary segment 180 and second reagent channel reservoir 205; col. 23, line 18, col. 24, line 7) with at least one analyte detection microwell and is attached to an upper portion of the reaction well (as shown in figure 3, filtration membrane 410 is attached to an upper portion of the reaction well 400).
Regarding claim 4, Stave does not specifically teach the sample collection system of claim 3, wherein the filtration well (capillary sink 220; figure 2; col. 23, lines 36 – 65; immunochromatographic strip 210 is in fluid communication with capillary sink 220 that attracts fluids from the strip 210) comprises a liquid gathering capillary that allows fluid connection to a waste chamber and vacuum. However, sample sink 185 functions essentially as an overflow or waste chamber for the apparatus collecting excess sample fluid during operation (col. 22, line 63 – col. 23, line 26; figure 2). Stave also does teach the use of a vacuum to facilitate transfer of fluid through the apparatus (col. 10, lines 56 – 67). The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). Furthermore, the prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the filtration well comprises a liquid gathering capillary that allows fluid connection to a waste chamber and vacuum.
Regarding claim 5, Stave does not specifically teach the sample collection system of claim 1, wherein the microfluidic liquid gathering capillary (sample capillary tube 180; col. 22, lines 63 – 67; figure 2) comprises at least two capillaries, wherein a first and a second capillary of the liquid gathering capillary are the same in diameter. However, the mere duplication of parts, without any new or unexpected results, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.04). Furthermore, the combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the microfluidic liquid gathering capillary (sample capillary tube 180; col. 22, lines 63 – 67; figure 2) comprises at least two capillaries, wherein a first and a second capillary of the liquid gathering capillary are the same in diameter.
Regarding claims 8, 15 and 16, as indicated above, Stave teaches all of the positively recited structure of the sample collection system as claimed, wherein the claim merely recites the convention operation of the claimed sample collection system. Stave does teach the use of a vacuum to facilitate transfer of fluid through the apparatus (col. 10, lines 56 – 67). Stave therefore implicitly anticipates the method as claimed.
Regarding claim 9, Stave does teach the use of a vacuum to facilitate transfer of fluid through the apparatus (col. 10, lines 56 – 67). Stave implicitly teaches the method of claim 8, wherein applying the vacuum to the vacuum connection removes the liquid to the waste chamber.
Regarding claim 10, Stave teaches the method of claim 8, wherein an affinity capture reagent is added to the porous matrix and/or porous surface (col. 11, line 6 – col. 13, line 44).
Regarding claim 12, Stave teaches the method of claim 8, wherein the high affinity capture reagent comprises a microparticle with a diameter greater than the pore size of the porous surface (col. 12, line 65 – col. 13, line 44).
Regarding claim 14, Stave does teach the use of a vacuum to facilitate transfer of fluid through the apparatus (col. 10, lines 56 – 67). Stave implicitly anticipates the method of claim 8, wherein the vacuum connection is attached to the filtration well.
Regarding claim 18, Stave does not specifically teach the sample collection system of claim 1, wherein the microfluidic liquid gathering capillary (sample capillary tube 180; col. 22, lines 63 – 67; figure 2) comprises at least two capillaries, wherein a first and a second capillary are different in diameter.
However, the mere duplication of parts, without any new or unexpected results, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.04). Furthermore, the combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). The mere change in diameter between the two capillaries can be due to design choice. The size of an article is not a matter of invention (see MPEP § 2144.04). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the microfluidic liquid gathering capillary (sample capillary tube 180; col. 22, lines 63 – 67; figure 2) comprises at least two capillaries, wherein a first and a second capillary of the liquid gathering capillary are different in in diameter.
Regarding claim 19, Stave teaches the sample collection system of claim 1, wherein the porous matrix occupies at least a portion of the interior volume of the microfluidic liquid gathering capillary (e.g., the porous membrane can be included in the liquid flow channel downstream of the reagent reservoir; col. 16, lines 1 – 20).
Regarding claim 20, Stave teaches the sample collection system of claim 1, wherein the sample collection system comprises a single continuous pathway (the device is a continuous liquid flow channel; col. 3, lines 15 – 29; figures 1 – 6), and wherein the elements of the single continuous pathway are fixed in their positions (figures 1 – 6); and wherein the movement of a liquid introduced to the sample collection system is driven by a difference in pressure between the two ends of the single continuous pathway (e.g., the sample delivery means can be facilitated by a syringe containing the sample that is depressed to provide sample delivery; col. 15, lines 5 – 8).
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stave and Engebretson, and further in view of Douglas (US 2001/0001034 A1; hereinafter “Douglas”).
Regarding claim 6, modified Stave does not specifically teach the sample collection system of claim 1, wherein the liquid gathering capillary is greater than 300 µm in diameter.
Regarding claim 7, modified Stave does not specifically teach the sample collection system of claim 1, wherein the liquid gathering capillary is greater than 1,000 µm in diameter.
Douglas teaches assay apparatus using a conventional capillary tube inside diameter between 0.001 inches (25.4 microns) to 0.1 inches (2,540 microns) (claim 2). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the liquid gathering capillary is greater than 300 µm or 1,000 µm in diameter depending on design choice.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stave and Engebretson, and further in view of Wang (US 2008/0148873 A1; hereinafter “Wang”).
Regarding claim 13, modified Stave does not specifically teach the method of claim 8, further comprising sensing of liquid movement by an electrode placed in the microwell or sample well.
Wang teaches the use of fill electrodes for sensing the presence or movement of liquid samples in a sample chamber in a microfluidic apparatus (paragraph 53). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the step of sensing of liquid movement by an electrode placed in the microwell or sample well.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stave and Engebretson, and further in view of Salsman (US 2015/0300957 A1; hereinafter “Salsman”).
Regarding claim 17, modified Stave does not specifically teach the method of claim 8, wherein the lancet is used to collect the sample into porous matrix prior to adding the sample to the reaction well or sample well.
However, the incorporation and use of a lancet to draw in and collect sample fluid, such as blood, for testing with a diagnostic microfluidic device is well known in the art as evidenced by Salsman (paragraph 53). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the lancet is used to collect the sample into porous matrix prior to adding the sample to the reaction well or sample well.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth A Robinson can be reached at (571) 272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796