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 Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hatamian (US 20120153207 A1; cited by applicant).
With respect to claim 1, Hatamian discloses a specimen collection container assembly (see Fig. 4A-4B, 6A-6B, entire structure) comprising:
a collection tube (see paragraph 0095, and Fig. 4A, test tube #410);
an interior reservoir formed within the collection tube (see paragraph 0095 and Fig. 4A-4B: an interior reservoir is formed within test tube #410 as better seen in Fig. 4B), wherein the interior reservoir comprises:
an upper chamber (see Fig. 4B: upper chamber is interpreted to be the area above #210),
a lower chamber (see Fig. 4B: lower chamber is interpreted to be the area below #210) , and
an elongated channel fluidly coupling the upper chamber and the lower chamber (see Fig. 5A-5B and paragraph 0099-0100: a middle portion between regions #240 and #250 which is interpreted to be an elongated channel within housing #210 as it allows passage of a plug #310), wherein a diameter of the elongated channel is smaller than both a diameter of the upper chamber and a diameter of the lower chamber (see paragraph 0090 and Fig. 2D,5A, smaller middle diameter #252 which is the middle portion between regions #240 and #250 is smaller than the upper diameter #242 and lower diameter #252); and
a bead-type separator (see Fig. 4A-4B, 5A-5B and paragraph 0095: plug #310),
wherein the bead-type separator is configured to plug an upper neck portion between the upper chamber and the elongated channel (see paragraph 0095-101 and Fig. 5A-5B, plug #310 is configured to plug an upper neck portion interpreted to be region #240 between the upper chamber interpreted to be the area above #210 and the elongated channel interpreted to be the area in between the regions #240 and #250), and further wherein the bead-type separator is insertable into the interior reservoir after a specimen sample is collected (see paragraph 0096, the plug #310 is inserted after the housing #210 has been inserted; and see paragraph 0116 and 0156, sample may be in test tube #410 at any time before, during or after the insertion of ball #1212) and the collection tube is subjected to centrifugation (see paragraph 0099-0101, test tube #410 will under centrifugation; and see paragraph 0114 and Fig. 6A-6B:, centrifuge #610) .
With respect to claim 2, all limitations of claim 1 apply in which Hatamian further discloses wherein the bead-type separator is ellipsoidal in shape (see Fig. 4A and paragraph 0093, plug #310 is spherical which is ellipsoidal).
With respect to claim 3, all limitations of claim 1 apply in which Hatamian further discloses wherein the bead-type separator is formed of a hard material (see Fig. 4A and paragraph 0086 and 0093, plug #310 is formed of various materials including glass and high density materials that are hard materials further that the plug #310 can be formed of the same material as housing #210 which is silicone rubber; interpreted in light of applicant’s specification [0031] which discloses that separator can be formed of rubber or gel).
With respect to claim 4, all limitations of claim 1 apply in which Hatamian further discloses wherein the bead-type separator is sized and configured to plug the upper neck portion by way of fluid pressure from a specimen sample collected within the interior reservoir (see paragraph 0095-101 and Fig. 5A-5B, plug #310 is configured to plug an upper neck portion interpreted to be region #240 between the upper chamber interpreted to be the area above #210 and the elongated channel interpreted to be the area in between the regions #240 and #250; and see Fig. 4A and paragraph 0094: plug #310 is sized to experience a force due to fluid such as blood within a test tube during centrifugation).
With respect to claim 5, all limitations of claim 1 apply in which Hatamian further discloses wherein the bead-type separator is sized and configured to plug the upper neck portion by way of a friction fit with an interior surface of the elongated channel proximate the upper neck portion (see paragraph 0095-101 and Fig. 5A-5B, plug #310 is configured to plug an upper neck portion interpreted to be region #240 between the upper chamber interpreted to be the area above #210 and the elongated channel interpreted to be the area in between the regions #240 and #250; and see paragraph 0106 and Fig. 5B: plug #310 is firmly secured between sidewalls of housing #210 in the middle region).
With respect to claim 6, all limitations of claim 1 apply in which Hatamian further discloses wherein an overall volume of the lower chamber is configured according to a total volume of a hematocrit portion of a specimen sample collectable within the interior reservoir (see paragraph 0097, the location of housing #210 within test tube #410 and therefore the lower volume of the portion of test tube #410 below housing #210 which is interpreted to be the lower chamber is configured according to a known fraction of red blood cells and therefore hemocrit portion of a blood sample).
With respect to claim 7, all limitations of claim 1 apply in which Hatamian further discloses wherein the collection tube further comprises an open lip portion (see paragraph 0097 and Fig. 4A, when cap #420 is removed the test tube #410 forms an open lip; and see paragraph 0109, the cap #420 can be withdrawn).
With respect to claim 8, all limitations of claim 7 apply in which Hatamian further discloses wherein the open lip portion is at least partially formed as a scoop to accommodate the collection of a capillary blood sample into the interior reservoir (see paragraph 0097 and Fig. 4A, when cap #420 is removed the test tube #410 forms an open lip; and see paragraph 0109, the cap #420 can be withdrawn or pierced to inject a patients’ blood into the test tube #410 interior reservoir).
With respect to claim 9, Hatamian discloses a specimen collection container (see Fig. 4A-4B, 6A-6B, entire structure) comprising:
a collection tube (see paragraph 0095, and Fig. 4A, test tube #410);
an interior reservoir formed within the collection tube (see paragraph 0095 and Fig. 4A-4B: an interior reservoir is formed within test tube #410 as better seen in Fig. 4B), wherein the interior reservoir comprises:
an upper chamber (see Fig. 4B: upper chamber is interpreted to be the area above #210),
a lower chamber (see Fig. 4B: lower chamber is interpreted to be the area below #210) , and
an elongated channel fluidly coupling the upper chamber and the lower chamber (see Fig. 5A-5B and paragraph 0099-0100: a middle portion between regions #240 and #250 which is interpreted to be an elongated channel within housing #210 as it allows passage of a plug #310), wherein a diameter of the elongated channel is smaller than both a diameter of the upper chamber and a diameter of the lower chamber (see paragraph 0090 and Fig. 2D,5A, smaller middle diameter #252 which is the middle portion between regions #240 and #250 is smaller than the upper diameter #242 and lower diameter #252);
wherein an overall volume of the lower chamber is configured according to a total volume of a hematocrit portion of a maximum specimen sample volume collectable within the interior reservoir (see paragraph 0097, the location of housing #210 within test tube #410 and therefore the lower volume of the portion of test tube #410 below housing #210 which is interpreted to be the lower chamber is configured according to a known fraction of red blood cells and therefore hemocrit portion of a blood sample).
With respect to claim 10, all limitations of claim 9 apply in which Hatamian further discloses wherein the elongated channel comprises an upper neck portion providing the transition between the upper chamber and the elongated channel (see paragraph 0095-101 and Fig. 5A-5B, a transition is provided between an upper neck portion interpreted to be region #240 between the upper chamber interpreted to be the area above #210 and the elongated channel interpreted to be the area in between the regions #240 and #250).
With respect to claim 11, all limitations of claim 10 apply in which Hatamian further discloses wherein the elongated channel further comprises a lower neck portion providing a transition between the lower chamber and the elongated channel (see paragraph 0095-101 and Fig. 5A-5B, a transition is provided between an lower neck portion interpreted to be region #250 between the lower chamber interpreted to be the area below #210 and the elongated channel interpreted to be the area in between the regions #240 and #250).
With respect to claim 12, all limitations of claim 9 apply in which Hatamian further discloses wherein the collection tube further comprises an open lip portion (see paragraph 0097 and Fig. 4A, when cap #420 is removed the test tube #410 forms an open lip; and see paragraph 0109, the cap #420 can be withdrawn).
With respect to claim 13, all limitations of claim 12 apply in which Hatamian further discloses wherein the open lip portion is at least partially formed as a scoop to accommodate the collection of a capillary blood sample into the interior reservoir (see paragraph 0097 and Fig. 4A, when cap #420 is removed the test tube #410 forms an open lip; and see paragraph 0109, the cap #420 can be withdrawn or pierced to inject a patients’ blood into the test tube #410 interior reservoir).
With respect to claim 14, Hatamian discloses a method of collecting and analyzing a capillary blood sample (see Fig. 4A-4B, 6A-6B, entire structure; and see paragraph 0120, methods of collecting and analyzing blood sample via centrifugation), the method comprising:
providing a specimen collection container (see paragraph 0093-0095 and Fig. 4A: providing a container that collects fluid in form of blood) comprising:
a collection tube (see paragraph 0095, and Fig. 4A, test tube #410);
an interior reservoir formed within the collection tube (see paragraph 0095 and Fig. 4A-4B: an interior reservoir is formed within test tube #410 as better seen in Fig. 4B), wherein the interior reservoir comprises:
an upper chamber (see Fig. 4B: upper chamber is interpreted to be the area above #210),
a lower chamber (see Fig. 4B: lower chamber is interpreted to be the area below #210) , and
an elongated channel fluidly coupling the upper chamber and the lower chamber (see Fig. 5A-5B and paragraph 0099-0100: a middle portion between regions #240 and #250 which is interpreted to be an elongated channel within housing #210 as it allows passage of a plug #310), wherein a diameter of the elongated channel is smaller than both a diameter of the upper chamber and a diameter of the lower chamber (see paragraph 0090 and Fig. 2D,5A, smaller middle diameter #252 which is the middle portion between regions #240 and #250 is smaller than the upper diameter #242 and lower diameter #252);
collecting the capillary blood sample within the specimen collection container such that the lower chamber, the elongated channel, and at least a portion of the upper chamber are filled with the capillary blood sample (see paragraph 0099 and Fig. 5A: a patient’s blood if injected into a test tube #410 where it flows through the lower channel, the elongated channel and the upper chamber);
subjecting the specimen collection container to centrifugation (see paragraph 0100 and Fig. 5B, centrifugation begins of test tube #410); and
inserting a bead-type separator into the specimen collection container after centrifugation in order to plug an upper neck portion of the elongated channel between the upper chamber and the elongated channel (see paragraph 0095-101 and Fig. 5A-5B, plug #310 is configured to plug an upper neck portion interpreted to be region #240 between the upper chamber interpreted to be the area above #210 and the elongated channel interpreted to be the area in between the regions #240 and #250; and see paragraph 0096, the plug #310 is inserted after the housing #210 has been inserted; and see paragraph 0116 and 0156, sample may be in test tube #410 at any time before, during or after the insertion of ball #1212).
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.
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.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hatamian in view of Sparks (US 20170304823 A1; cited by applicant).
With respect to claim 15, all limitations of claim 14 apply in which Hatamian does not specifically disclose inserting a probe into the specimen collection container to collect a sample from a plasma/serum portion of the capillary blood sample.
Sparks teaches inserting a probe into a specimen collection container (see Fig. 5 and paragraph 0140, aspirating syringe #514 is inserted into sample through a port to a position inside upper chamber interpreted to be the region above ball of the collecting tube and a second syringe #516 is inserted to remove composition #515) to collect a sample from a plasma/serum portion of a capillary blood sample (see paragraph 0140, a predetermined amount of fraction #511 which is platelet poor plasma is removed via #514 and the composition #515 of platelet rich plasma is removed via #516).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hatamian with the teachings of Sparks to have inserted a probe to collect a sample of plasma from a blood sample because it would have resulted in the predictable result of removing a component of liquid sample after it has been separated as it is known that proximal end of container would contain plasma and the distal end of container would contain red blood cells (Sparks: see [0035]) and utilizing a syringe/probe is known to remove components from a contain after centrifuging (Sparks: see [0080]).
With respect to claim 16, all limitations of claim 15 apply in which Sparks further teaches wherein the probe is restricted from being inserted beyond the upper chamber of the specimen collection container by the bead-type separator (see paragraph 0140 and Fig. 5, both the aspirating syringe #514 and a second syringe #516 are prevented from being inserted beyond the upper chamber interpreted to be the region above the ball of the container as the ball restricts the syringes from moving into the lower chamber which is interpreted to be the area below the ball).
Conclusion
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/N.N.P./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791