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
Claim 2 is objected to because of the following informalities: The examiner suggests amending “bistable” (see lines 6 and 8) to “bi-stable”. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: The examiner suggests amending “bistable” (see lines 7 and 9) to “bi-stable”, amend “the first stable state” (see lines 11-12) to “the first state”, and “the second stable state” (see lines 15-16) to “the second state”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: The examiner suggests amending “bistable” (see lines 6 and 8) to “bi-stable”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: The examiner suggests amending “bistable” (see lines 7 and 9) to “bi-stable”. Appropriate correction is required.
Claim 49 is objected to because of the following informalities: The examiner suggests amending “bistable” (see line 13) to “bi-stable”. 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 9-10, 13, 15 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 9 recites the limitation "the first sub-container" in lines 10 and 14. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the first sub-container" in lines 5, 10-12, 14-16, and 18-19. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the first sub-container" in lines 3, 6, 8-9, 12, 16 and 20. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the first sub-container" in lines 3, 5, 7-9, 11-13, and 15-16. 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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Irmscher et al. (US 2019/0344263 A1) in view of Nolan et al. (US 2010/0099074 A1) and Skiffington et al. (US 5,965,453).
Regarding claim 1, Irmscher et al. discloses an assay assembly (analysis device, 300), the assembly (see figures 1-7 and 12 and paragraphs 0144-0185) comprising:
a. a sample collection tube comprising:
a first chamber (container, 100);
a breakable seal or valve (a seal, e.g. a pierceable membrane, see paragraph 0172); and
a test cartridge (200) comprising a sample inlet and one or more reaction chambers, since a swab (400) is placed more or less in a central portion forming a receiving chamber, see figure 4 and paragraph 0173).
Irmscher et al. fails to disclose an assembly comprising:
b. a base unit comprising:
a heating element; and
a power supply; and
c. a sample collector comprising:
a handle comprising a cap that is operatively coupleable with the sample collection tube; and
a sample collection portion.
Nolan et al. discloses an assembly (apparatus, 50) comprising:
b. a base unit comprising:
a heating element; and
a power supply (power source, 56) (see figures 5-7 and paragraphs 0068-0070).
Nolan et al. fails to disclose an assembly comprising:
c. a sample collector comprising:
a handle comprising a cap that is operatively coupleable with the sample collection tube; and
a sample collection portion.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Irmscher et al. with the teachings of Nolan et al. resulting in an assembly comprising:
b. a base unit comprising:
a heating element; and
a power supply in order to heat a sample when desired.
Skiffington et al. discloses an assembly (see figures 1- and column 9, line 66 through column10, line 34) comprising:
c. a sample collector comprising:
a handle (15) comprising a cap (cover, 12); and
a sample collection portion, since the applicant’s specification discloses a swab can be a sample collection and handle (see applicant’s specification, 0011).
Shiffington et al. fails to disclose an assembly comprising:
c. a sample collector comprising:
a handle comprising a cap that is operatively coupleable with the sample collection tube.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Irmscher et al. wit the teachings of Skiffington et al. resulting in an assembly comprising:
c. a sample collector comprising:
a handle comprising a cap; and
a sample collection portion for easier insertion of the sample into the sample collection tube.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to a handle comprising a cap that is operatively coupleable with the sample collection tube, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves routine skill in the art (see MPEP 2144.04 (V-A)) and to ensure the sample is secure within the sample collection tube.
Allowable Subject Matter
Claims 2 and 8 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.
Regarding claim 2, the prior art references fail to disclose or suggest an assembly further comprising:
a. a bi-stable locking mechanism having at least one first state and at least one second state; wherein the first state of the bi-stable locking mechanism comprises the first chamber and the test cartridge coupled in the first stable state, and wherein the at least one second state of the bistable locking mechanism is responsive to the sample collector being operatively coupled with the sample collection tube and wherein the at least one second state of the bistable locking mechanism comprises the first chamber being operatively coupled to the test cartridge in the second stable state; and
b. a fluidic coupling mechanism, wherein responsive to the sample collector operatively coupling the first chamber and the test cartridge in the second stable state, the fluidic coupling mechanism is configured to place the first chamber of the sample collection tube in fluidic communication with the test cartridge.
Claim 8 depends on claim 2.
The following is a statement of reasons for the indication of allowable subject matter:
Claims 49, 72, 135, 139, 146, 187, 189-190, 202, 206, 215, 265, and 298 are allowed.
The prior art references are Irmscher et al. (US 2019/0344263 A1), Nolan et al. (US 2010/0099074 A1), and Skiffington et al. (US 5,965,453).
Regarding claim 49, Irmscher et al. discloses an assay assembly (analysis device, 300), the assembly (see figures 1-7 and 12 and paragraphs 0144-0185) comprising:
a. a sample collection tube comprising a first chamber (container, 100);
b. a test cartridge (200) comprising:
a sample inlet,
one or more reaction chambers, since a swab (400) is placed more or less in a central portion forming a receiving chamber (see figure 4 and paragraph 0173).
Nolan et al. discloses an assembly comprising:
a sample collection tube holder (rack, 58), (see figures 5-7 and paragraphs 0068-0070).
The prior art references fail to disclose or suggest an assembly comprising:
b. a test cartridge (200) comprising:
a sample collection tube holder, wherein the sample collection tube holder is configured to operatively couple the sample collection tube and the test cartridge in a first stable state and in a second stable state;
c. a bi-stable locking mechanism having at least one first state and at least one second state, wherein the first state of the bi-stable locking mechanism comprises the sample collection tube holder operatively coupling the sample collection tube and the test cartridge in the first stable state, and the second state of the bistable locking mechanism comprises the sample collection tube holder operatively coupling the sample collection tube and the test cartridge in the second stable state; and
d. a fluidic coupling mechanism, wherein responsive to the sample collection tube holder operatively coupling the sample collection tube and the test cartridge in the second stable state, the fluidic coupling mechanism is configured to place the first chamber of the sample collection tube in fluidic communication with the sample inlet of the test cartridge.
Claim 72 discloses on claim 49.
Regarding claim 135, Irmscher et al. discloses an assay assembly (analysis device, 300), the assembly (see figures 1-7 and 12 and paragraphs 0144-0185) comprising:
a sample collection tube comprising:
a first chamber (container, 100);
a breakable seal or valve (a seal, e.g. a pierceable membrane, see paragraph 0172); and
a test cartridge (200) comprising
a sample inlet
one or more reaction chambers, since a swab (400) is placed more or less in a central portion forming a receiving chamber, see figure 4 and paragraph 0173).
a puncture element (71).
Skiffington et al. discloses an assembly (see figures 1- and column 9, line 66 through column 10, line 34) comprising:
c. a sample collector comprising:
a handle (15) comprising a cap (cover, 12); and
a sample collection portion, since the applicant’s specification discloses a swab can be a sample collection and handle (see applicant’s specification, 0011).
The prior art references fail to disclose or suggest an assembly comprising:
a test cartridge comprising:
a puncturing element, wherein the sample collection tube is operatively coupleable with the test cartridge; and
a sample collector comprising:
a handle comprising a cap that is operatively coupleable with the sample collection tube; and
a sample collection portion, wherein responsive to the cap not being operatively coupled to the sample collection tube, the sample collection tube and the test cartridge are operatively coupled in a first stable state such that the puncturing element of the test cartridge does not break the breakable seal of the sample collection tube or such that the valve is not actuated, and wherein responsive to the cap being operatively coupled to the sample collection tube, the sample collection portion of the sample collector is located within the first chamber of the sample collection tube and the sample collection tube and the test cartridge are operatively coupled in a second stable state such that the puncturing element of the test cartridge breaks the breakable seal of the sample collection tube or the valve is actuated, thereby placing the first chamber of the sample collection tube in fluidic communication with the sample inlet of the test cartridge.
Claims 139 and 146 depend on claim 135.
Regarding claim 187, Irmscher et al. discloses an assembly comprising: a sample collection (analysis devices, 300) (see figures 1-7 and 12 and paragraphs 0144-0185).
Irmscher et al. fails to disclose or suggest an assembly comprising:
a sample collection tube comprising:
a main chamber;
an outlet port; and
a breakable seal, the breakable seal sealing the main chamber from the outlet port; and
a fluid transfer mechanism that is operatively couplable with the sample collection tube, the fluid transfer mechanism comprising:
an interface, wherein the outlet port of the sample collection tube is configured to receive the interface of the fluid transfer mechanism;
a channel formed in the interface, the channel comprising a first end and a second end, and having a length and at least one diameter, the first end comprising an inlet; and
a puncturing element comprising a hollow cylinder having an inner diameter, an outer diameter, and a length, and wherein a first segment of the puncturing element includes a first portion of the length of the hollow cylinder, a second segment of the puncturing element includes a second portion of the length of the hollow cylinder, and the outer diameter of the hollow cylinder is equivalent to the at least one diameter of the channel in the interface,
wherein the first segment of the puncturing element is embedded within at least a portion of the length of the channel, thereby forming a single effective diameter of the channel along the length of the channel, the single effective diameter equivalent to the inner diameter of the hollow cylinder of the puncturing element, wherein the second segment of the puncturing element extends beyond the inlet of the channel, and
wherein operatively coupling the sample collection tube and the fluid transfer mechanism comprises the outlet port receiving the interface of the fluid transfer mechanism such that at least one portion of the interface has a diameter that is equivalent to a diameter of at least one portion of the outlet port and such that the at least one portion of the interface is located within the at least one portion of the outlet port, thereby fluidically sealing the outlet port with the interface and puncturing the breakable seal of the sample collection tube with the second segment of the puncturing element of the fluid transfer mechanism, thereby placing the main chamber of the sample collection tube in fluidic communication with the channel of the fluid transfer mechanism.
Claims 189-190, 202, and 206 depends on claim 187.
Regarding claim 215, Irmscher et al. discloses a method comprising: a. obtaining an assay assembly (analysis device, 300), the assembly (see figures 1-7 and 12 and paragraphs 0144-0185) comprising:
a sample collection tube comprising a first chamber (container, 100);
a test cartridge (200), comprising:
1. a sample inlet, where the swab enters the analysis device,
2. one or more reaction chambers, since a swab (400) is placed more or less in a central portion forming a receiving chamber (see figure 4 and paragraph 0173) and
Irmscher et al. fails to disclose or suggest a method comprising: a. obtaining an assay assembly, the assembly comprising: a test cartridge comprising:
3. a sample collection tube holder configured to operatively couple the sample collection tube and the test cartridge in a first stable state and a second stable state; " a fluidic coupling mechanism; and " a bi-stable locking mechanism, wherein the bi-stable locking mechanism is in at least one first state, thereby causing the sample collection tube holder to operatively couple the sample collection tube and the test cartridge in the first stable state; and
b. transitioning the bi-stable locking mechanism from the at least one first state to at least one second state, thereby causing the sample collection tube holder to operatively couple the sample collection tube and the test cartridge in the second stable state, and thereby causing the fluidic coupling mechanism to place the first chamber of the sample collection tube in fluidic communication with the sample inlet of the test cartridge.
Claim 265 is drawn to a method comprising obtaining the assay assembly of claim 135.
Claim 298 is drawn to a method comprising obtaining the assay assembly of claim 187.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATASHA E YOUNG whose telephone number is (571)270-3163. The examiner can normally be reached M-F 7:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wang Claire can be reached at 571-270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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NATASHA E. YOUNG
Examiner
Art Unit 1774
/NATASHA E YOUNG/Primary Examiner, Art Unit 1774