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 .
Claim Objections
Claims 1-2, 18-35 are objected to because of the following informalities:
Claim 1, line 3: “the passage” should read --passage--
Claim 2, line 3: “the hooks” should read --the plurality of hooks--
Claim 18, line 2: “the hooks” should read --the plurality of hooks--
Claim 19, line 1: “the hooks” should read --the plurality of hooks--
Claim 19, line 2: “the forces” should read --forces--
Claim 19, line 3: “the forces” should read --forces--
Claim 20, line 3: “the passage” should read --passage--
Claim 20, line 10: “the inner surface” should read --an inner surface--
Claim 21, line 1: “Device” should read --The device”
Claims 22-35, line 1: “Device” should read --The device”
Claim 22, line 2: “the movement” should read --movement--
Claim 26, line 3: “liquid” should read --the liquid--
Claim 27, line 1: “liquid” should read --the liquid--
Claim 28, line 1: “the volume” should read --a volume--
Claim 28, line 2: “liquid” should read --the liquid--
Claim 30, line 2: the side should read --a side--
Claim 31, line 2: “the at least one biological sample” should read --the one or more biological samples--
Claim 33, line 2: “liquid” should read --the liquid--
Claim 33, lines 2-3: “the at least one biological sample” should read --the one or more biological samples--
Claim 34, line 2: “liquid” should read --the liquid--
Claim 34, line 3: “the at least one biological sample” should read --the one or more biological samples--
Claim 35, line 3: “the at least one biological sample” should read --the one or more biological samples--
Appropriate correction is required.
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.
Claims 21 and 32-35 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 21 recites the limitation "the anchor element" in line 2. There is insufficient antecedent basis for this limitation in the claim. It should read: “an anchor element”
Claim 32 recites the limitation “the mixture of the liquid from the container and of the at least one biological sample” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. It should read: “a mixture of the liquid from the container and of the one or more biological samples.”
Claim 33 recites the limitation “the mixture of the liquid from the container and of the at least one biological sample” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. It should read: “a mixture of the liquid from the container and of the one or more biological samples.”
Claim 34 recites the limitation “the mixture of the liquid from the container and of the at least one biological sample” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. It should read: “a mixture of the liquid from the container and of the one or more biological samples.”
Claim 34 recites the limitation “the element” in line 2. There is insufficient antecedent basis for this limitation in the claim. It should read: “an element”.
Claim 35 recites the limitation “the reagent” in line 3. There is insufficient antecedent basis for this limitation in the claim. It should read: “a reagent”.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 20-22, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rietveld (US 20170023446) (cited by Applicant).
Regarding claim 1, Rietveld teaches a device for collecting one or more biological samples (Fig. 14c) comprising a housing (holder 114) and a collector element (probe 118), wherein the collector element (118) is configured to allow the passage of liquid, and wherein the collector element (118) extends between a first end and a second end (See Fig. 14c), the first end of the collector element (118) protruding out of the housing (114) for collecting the one or more biological samples, the second end of the collector element (118) being arranged within the housing (114), (Fig. 14c), wherein the housing comprises a plurality of hooks for engaging the collector element. (Paragraph [0162]).
Regarding claim 2, Rietveld teaches wherein the front end of the housing (114) has an opening in which the collector element (118) is arranged, wherein the hooks are formed on an inner surface of the opening (recess 190). (Paragraph [0162] mechanical fastening means such as small hooks or deformations of the holder 114 that extend inward toward axis 115 and are located around the opening in the probe-end of the holder 114 could be used to create an interference fit between the tubular tip of the holder and the abutting periphery of the probe 118).
Regarding claim 20, Rietveld teaches a device for collecting one or more biological samples comprising a housing (114) and a collector element (118), wherein the collector element (118) allows the passage of liquid, and wherein the collector element (118) extends between a first end and a second end (See Fig. 14c), the first end of the collector element (118) protruding out of the housing (114) for collecting the one or more biological samples, the second end of the collector element (118) being arranged within the housing (114) (See Fig. 14c), wherein the part of the collector element which is arranged within the housing is glued to the inner surface of the housing. (Paragraph [0162]).
Regarding claim 21, Rietveld teaches wherein the collector element (118) is soft and/or flexible (Paragraph [0118]) such that the anchor element (i.e., hooks) can extend at least partially into the collector element. (Paragraph [0162]).
Regarding claim 22, Rietveld teaches an abutment surface or a stop (juncture 16) for limiting the movement of the collector element into the housing. (Paragraph [0087]; See Fig. 3a).
Regarding claim 30, Rietvald teaches a cap element which can be fitted on the housing on the side on which the collector element is arranged. (Paragraphs [0182], [0184]).
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 18-19 is rejected under 35 U.S.C. 103 as being unpatentable over Rietvald.
Regarding claim 18, Rietvald teaches (Figs. 8, 13-14) wherein the front end of the housing (114) has an opening (Fig. 14) in which the collector element (118) is arranged. (Paragraph [0162]).
Although Rietvald does not specifically teach “wherein the hooks are formed on a separate element”, it would it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Rietvald to teach this feature, as replacing standard attachment methods like hooks with a hook-and-loop fastener (i.e., Velcro) is a predictable use of known elements according to their established functions.
Regarding claim 19, Rietvald does not specifically teach “wherein the hooks are designed such that the forces needed for inserting the collector element into the housing are lower than the forces needed for removing the collector element out of the housing”.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Rietvald to teach this feature, as it merely combines known snap-fit or barb design principles where insertion requires less force than removal is a standard, ubiquitous mechanical design to achieve predictable secure locking without unexpected functional results.
Claims 23-27 are rejected under 35 U.S.C. 103 as being unpatentable over Rietvald in view of Darrigrand (US 20090024060) (cited by Applicant).
Regarding claim 23, Rietvald does not teach “a container for storing liquid”.
Darrigrand, in a related field of endeavor, teaches a sample collector (Fig. 2A) comprising a container (250) for storing liquid (20). (Paragraph [0064]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Rietvald to teach “a container for storing liquid” as taught by Darrigrand. Doing so provides enclosed vessel with a leak-proof barrier to hold fluid, yielding predictable results like containment and prevention of spills.
Regarding claim 24, Rietvald does not teach wherein the liquid is a buffer solution and/or a reagent solution”.
Darrigrand teaches wherein the liquid (20) is a buffer solution and/or a reagent solution. (Paragraph [0064]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Rietvald to teach “wherein the liquid is a buffer solution and/or a reagent solution” as taught by Darrigrand. Doing so enables preservation of the collected sample. (Paragraph [0064]).
Regarding claim 25, Rietvald does not teach “wherein the housing comprises or encloses a channel for guiding the liquid stored in the container to the collector element”.
Darrigrand illustrates (Fig. 9) wherein the housing comprises or encloses a channel (interior cavity 252) for guiding the liquid stored in the container (250) to the collector element (212). (Paragraph [0068]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Rietvald to teach “wherein the housing comprises or encloses a channel for guiding the liquid stored in the container to the collector element” as taught by Darrigrand. Doing so simply provides a standard conduit to move liquid to a collection matrix, which achieves predictable results—namely, smooth fluid transfer from point A to point B.
Regarding claim 26, Rietvald does not teach “a valve and/or release mechanism for opening a passage from the container to the channel so that liquid stored in the container can enter the channel from the container and reach the collector element.”
Darrigrand teaches (Fig. 2A-3B) a valve and/or release mechanism (screen 236) for opening a passage from the container (250) to the channel (252) so that liquid stored in the container can enter the channel from the container and reach the collector element (212). (Paragraphs [0068], [0071]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Rietvald to teach “a valve and/or release mechanism for opening a passage from the container to the channel so that liquid stored in the container can enter the channel from the container and reach the collector element” as taught by Darrigrand. Doing so provides a standard engineering need to control fluid flow, prevent premature mixing, and activate the sample collection at a precise time, yielding no unexpected or surprising technical results.
Regarding claim 27, Rietvald does not specifically teach “wherein liquid stored in the container can reach the collector element through the channel when the valve and/or release mechanism is open, wherein at least part of the liquid can pass through the collector element by gravity acting on the liquid when the container is in a position vertically above the collector element”.
However, it would it would have been obvious to one of ordinary skill in the art before the effective filing date to expect a liquid to fall when a container is upside down and an open valve removes barriers to flow, as using gravity to move a fluid downward by inverting a container is a basic physical principle and does not yield an unexpected result.
Claims 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Rietvald in view of Darrigrand, further in view of Cobb (WO 2021209228).
Regarding claim 28, Rietvald as modified does not teach “wherein the volume of the container can be reduced to squeeze liquid from the container into the channel”.
Cobb, in a related field of endeavor, teaches wherein the volume of the container (bulb 28) can be reduced to squeeze liquid from the container into the channel (26). (Page 4, lines 13-15; Page 9, lines 26-27).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Rietvald as modified to teach “wherein the volume of the container can be reduced to squeeze liquid from the container into the channel” as taught by Cobb. Doing so enables release of the liquid for analysis. (Page 4, line 15).
Regarding claim 29, Rietvald as modified does not teach “wherein the volume of the container can be reduced such that liquid is released from the container into the channel and passes through the collector element”.
Cobb teaches wherein the volume of the container (28) can be reduced such that liquid is released from the container into the channel (26) and passes through the collector element (nib 12). (Page 4, lines 13-15).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Rietvald as modified to teach “wherein the volume of the container can be reduced such that liquid is released from the container into the channel and passes through the collector element” as taught by Cobb. Doing so enables release of the liquid for analysis. (Page 4, line 15).
Claims 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over Rietvald in view of Cobb.
Regarding claim 31, Rietvald does not teach “wherein an element for indicating and/or measuring a reaction between a reagent and the at least one biological sample is arranged within or on the cap element”.
Cobb teaches wherein an element (i.e., transparent polycarbonate window) for indicating and/or measuring a reaction between a reagent and the at least one biological sample is arranged within or on the cap element. (Page 14, lines 19-21).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Rietvald to teach “wherein an element for indicating and/or measuring a reaction between a reagent and the at least one biological sample is arranged within or on the cap element” as taught by Cobb. Doing so enables the test signal to be visualized and measured. (Page 14, lines 10-12).
Regarding claim 32, Rietvald does not teach “wherein the element is indicating the pH value of the mixture of the liquid from the container and of the at least one biological sample”.
Cobb contemplates wherein the element is indicating the pH value of the mixture of the liquid from the container and of the at least one biological sample. (Page 22, lines 8-20).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Rietvald to teach “wherein the element is indicating the pH value of the mixture of the liquid from the container and of the at least one biological sample” as taught by Cobb. Doing so allows visual determination of pH. (Page 14, lines 19-21; Page 22, lines 18-20).
Regarding claim 33, Rietvald does not teach “wherein the cap element comprises a reagent which is released to the mixture of liquid from the container and of the at least one biological sample”.
Cobb teaches wherein the cap element comprises a reagent which is released to the mixture of liquid from the container and of the at least one biological sample. (Page 14, lines 10-19).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Rietvald to teach “wherein the cap element comprises a reagent which is released to the mixture of liquid from the container and of the at least one biological sample”, as taught by Cobb. Doing so enables specific tests to be performed on the sample. (Page 14, lines 10-12).
Regarding claim 34, Rietvald does not teach “wherein the cap element comprises an element comprising a reagent which is released to the mixture of liquid from the container and of the at least one biological sample”.
Cobb teaches wherein the cap element comprises an element (i.e., seal) comprising a reagent which is released to the mixture of liquid from the container and of the at least one biological sample. (Page 14, lines 10-19).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Rietvald to teach “wherein the cap element comprises an element comprising a reagent which is released to the mixture of liquid from the container and of the at least one biological sample”, as taught by Cobb. Doing so enables specific tests to be performed on the sample. (Page 14, lines 10-12).
Regarding claim 35, Rietvald does not teach “wherein the cap element comprises a window which is arranged such that a user can at least partially see the element for indicating and/or measuring a reaction between the reagent and the at least one biological sample”.
Cobb teaches wherein the cap element comprises a window which is arranged such that a user can at least partially see the element for indicating and/or measuring a reaction between the reagent and the at least one biological sample. (Page 14, lines 19-21).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Rietvald to teach “wherein the cap element comprises a window which is arranged such that a user can at least partially see the element for indicating and/or measuring a reaction between the reagent and the at least one biological sample”, as taught by Cobb. Doing so enables the test signal to be visualized. (Page 14, lines 10-12).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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/OM PATEL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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