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 § 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 2-5 and 16-23 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.
With respect to Claims 2 and 16,
Claims 3-5 and 17-23 are rejected because they depend from rejected claims 2 and 16, respectively.
Claim 5 recites the limitation "the flexible hollow tube" in line 1. There is insufficient antecedent basis for this limitation in the claim. It appears that applicant intended to make claim 5 dependent from claim 4. The claim has been interpreted accordingly for examination purposes.
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)(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 1-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown et al. (US 5,750,039).
With respect to Claim 1, Brown teaches a blood component separation set (Figs 1-3 and 24), comprising:
a blood component collection loop (30, 202, 210; Figures 2, 3, 24); and
a blood component collection bladder 38 including a housing defining a first end and a second end (see the annotated Figure 24 below), the blood component collection bladder 38 including a first collection flow chamber (the portion of the collection bladder 38 above wall 78) and a second collection flow chamber (the portion of the collection bladder 38 below wall 78) fluidly connected to each other by a flow chamber transition region (see the annotated Figure 24 below);
wherein the blood component collection bladder is engaged with the blood component collection loop at its first end (inlet port 48 and outlet port 50 are both disposed at the first end of the blood component collection bladder 38; Figure 24); and
wherein the first collection flow chamber and the second collection flow chamber are each fluidly engaged with the blood component collection loop at the first end of the blood component collection bladder 38 (the first flow chamber connects to inlet portion 202 of the blood component collection loop via port 48 and the second flow chamber connects to the outlet portion 210 of the blood component collection loop via port 50; Figure 24).
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Annotated Figure 24 of Brown
With respect to Claim 2, Brown teaches that the blood component collection loop (30, 202, 210; Figures 2-6 and 24) comprises a plurality of tubes including a loop inlet portion 202 and a loop exit portion 210.
With respect to Claim 3, Brown teaches that the first collection flow chamber (the portion of the collection bladder 38 above wall 78) is fluidly connected to the loop inlet portion 202 via port 48 and the second collection flow chamber (the portion of bladder 38 below wall 78) is connected to the loop exit portion 210 via port 50. See Figure 24.
With respect to Claim 4, Brown teaches a that the blood component collection loop (30, 202, 210) further comprises a flexible hollow tube 30 that receives at least a portion of the loop inlet portion 202 and loop exit portion 210. Specifically umbilicus 30 is a hollow tubular member that is configured to receive portions of the other tubing portions (Figures 1-6 and 24; Column 4, Lines 9-45).
With respect to Claim 5, Brown teaches that the flexible hollow tube 30 has a first tube end (adjacent connector 36 in Figure 2) including a first loop connector 36 and a second tube end including a second loop connector (the opposite end of the flexible hollow tube receives whole blood, and therefore a second tube end with a second loop connector is implicit), wherein the blood component collection bladder 38 is fluidically engaged at the first tube end with the blood component collection loop. See Figures 1-6 and 24.
With respect to Claim 6, Brown teaches that the blood component collection loop (30, 202, 210) is a flexible loop (the tubing members of the loop are flexible, as shown in Figures 1-7, and 24).
With respect to Claim 7, Brown teaches that the blood component collection loop (30, 202, 210) comprises a plurality of tubular passageways (the interiors of tubes 30, 202, and 210) extending therethrough. See Figures 1-6 and 24 and Column 4, Lines 9-45.
With respect to Claim 8, Brown teaches that the first collection flow chamber (the portion of the collection bladder 38 above wall 78) is connected to the blood component collection loop at a first loop connector 48. See Figure 24.
With respect to Claim 9, Brown teaches that the blood component collection bladder 38 is a rectangular-shaped bladder with the first collection flow chamber (the portion of the collection bladder 38 above wall 78) and the second collection flow chamber (the portion of bladder 38 below wall 78) extending along a length thereof. See Figure 24 and Column 12, Lines 10-14.
With respect to Claim 10, Brown teaches that the first collection flow chamber (the portion of the collection bladder 38 above wall 78) and the second collection flow chamber (the portion of bladder 38 below wall 78) are arranged in parallel extending along the length of the housing. See Figure 24.
With respect to Claim 11, Brown teaches that the first collection flow chamber (the portion of the collection bladder 38 above wall 78) and the second collection flow chamber (the portion of bladder 38 below wall 78) are separated in the housing by a wall 78 extending a portion of a length of the housing. See Figure 24.
With respect to Claim 12, Brown teaches that the first collection flow chamber (the portion of the collection bladder 38 above wall 78) and the second collection flow chamber (the portion of bladder 38 below wall 78) are fluidly connected by a flow chamber transition region (the far left portion of the interior of the bladder 38, adjacent the arrow labeled “RBC”; Figure 24) defined by the housing and the wall. See the annotated Figure 24 above.
With respect to Claim 13, Brown teaches a blood component separation set (Figs 1-3 and 24), comprising:
a blood component collection bladder 38 defining a first open end and a second closed end (the inlet and outlet ports are both disposed on the first end; see the annotated Figure 24 below) and including a housing defining a first collection flow chamber (the portion of the collection bladder 38 above wall 78) and a second collection flow chamber (the portion of the collection bladder 38 below wall 78) fluidly engaged with the first open end;
wherein the first collection flow chamber and the second collection flow chamber are separated in the housing by a wall 78 extending along a portion of a lenth of the housing (Figure 24); and
the first collection flow chamber and the second collection flow chamber are fluidly connected by a flow chamber transition region defined by the housing and the wall 78 (see annotated Figure 24 below).
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Annotated Figure 24 of Brown
With respect to Claim 14, Brown teaches that the wall 78 in the housing extends from the first open end toward the second sealed end. See Figure 24.
With respect to Claim 15, Brown teaches that the flow chamber transition region is disposed adjacent the second sealed end of the housing and defines a separation between the wall 78 and the second sealed end of the housing (see annotated Figure 24 above).
With respect to Claim 16, Brown teaches that the separation set further comprises a blood component collection loop (30, 202, 210; Figures 1-6 and 24), wherein the blood component collection loop is engaged with the blood component collection loop at its first open end (inlet port 48 and outlet port 50 are both disposed at the first end of the blood component collection bladder 38; Figure 24), and wherein the first collection flow chamber and the second collection flow chamber are each fluidly engaged with the blood component collection loop at the first open end of the blood component collection bladder 38 (the first flow chamber connects to inlet portion 202 of the blood component collection loop via port 48 and the second flow chamber connects to the outlet portion 210 of the blood component collection loop via port 50; Figure 24).
With respect to Claim 17, Brown teaches that the blood component collection loop (30, 202, 210; Figures 2-6 and 24) comprises a plurality of tubes including a loop inlet portion 202 and a loop exit portion 210.
With respect to Claim 18, Brown teaches that the first collection flow chamber (the portion of the collection bladder 38 above wall 78) is fluidly connected to the loop inlet portion 202 via port 48 and the second collection flow chamber (the portion of bladder 38 below wall 78) is connected to the loop exit portion 210 via port 50. See Figure 24.
With respect to Claim 19, Brown teaches a that the blood component collection loop (30, 202, 210) further comprises a flexible hollow tube 30 that receives at least a portion of the loop inlet portion 202 and loop exit portion 210. Specifically umbilicus 30 is a tubular member that is configured to receive portions of the other tubing portions (Figures 1-6 and 24; Column 4, Lines 9-45).
With respect to Claim 20, Brown teaches that the flexible hollow tube 30 has a first tube end (adjacent connector 36 in Figure 2) including a first loop connector 36 and a second tube end including a second loop connector (the opposite end of the flexible hollow tube receives whole blood, and therefore a second tube end with a second loop connector is implicit), wherein the blood component collection bladder 38 is fluidically engaged at the first tube end with the blood component collection loop. See Figures 1-6 and 24.
With respect to Claim 21, Brown teaches that the blood component collection loop (30, 202, 210) is a flexible loop (the tubing members of the loop are flexible, as shown in Figures 1-7, and 24).
With respect to Claim 22, Brown teaches that the blood component collection loop (30, 202, 210) comprises a plurality of tubular passageways (the interiors of tubes 30, 202, and 210) extending therethrough. See Figures 1-6 and 24 and Column 4, Lines 9-45.
With respect to Claim 23, Brown teaches that the first collection flow chamber (the portion of the collection bladder 38 above wall 78) is connected to the blood component collection loop at a first loop connector 48. See Figure 24.
With respect to Claim 24, Brown teaches that the blood component collection bladder 38 is a rectangular-shaped bladder with the first collection flow chamber (the portion of the collection bladder 38 above wall 78) and the second collection flow chamber (the portion of bladder 38 below wall 78) extending along a length thereof. See Figure 24 and Column 12, Lines 10-14.
With respect to Claim 25, Brown teaches that the first collection flow chamber (the portion of the collection bladder 38 above wall 78) and the second collection flow chamber (the portion of bladder 38 below wall 78) are arranged in parallel extending along the length of the housing. See Figure 24.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Brown (US 2003/0102272) teaches a blood separation system comprising an umbilicus and a multi-chamber separation bladder.
Westberg et al. (US 6,524,231) teaches a blood separation system comprising an umbilicus and a multi-chamber separator (Figures 25 and 33).
Urdahl (US 5,658,240) teaches a blood separation device comprising a blood component collection bladder and collection loop (Figures 4A-4B).
Dolecek (US 2004/0058794) teaches a blood separation system comprising an umbilicus that connects directly to a blood component collection container (Figures 26-43).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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