DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
1. Claims 1-20 are pending and currently under consideration for patentability.
Priority
2. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on April 24, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Interpretation
4. With regard to the limitations of claims 7 and 18, examiner interprets any generally cylindrical-shaped container as capable of being opened using an automatic bottle opener. For the automatic bottle opener to hold more patentable weight, examiner suggests more positively claiming such features, similar to that in claim 13.
Claim Objections
5. Claims 2-9, 11-15 and 17-20 are objected to because of the following informalities:
The preambles of claims 2-9, 11-15 and 17-20 recite “A blood component cooling container according to claim…” and “A method according to claim…”. However, antecedent basis for “A blood component cooling container” and “A method of storing plasma” are provided antecedent basis in independent claims 1, 16 and 10, respectively. Accordingly, examiner suggests using the following language: ---[[ The blood component cooling container according to claim…--- and ---[[ The method according to claim…---
Appropriate correction is required.
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 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.
6. Claims 1, 2, 6, 10 and 14-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rinfret et al. (US 3,158,283).
7. With regard to claims 1, 16 and 17, Rinfret discloses a blood component cooling container (container for rapid cooling, storage and rapid warming of, e.g. blood; col. 1, lines 11-15; Figs. 3-5) comprising: a body portion (corrugated walls, 10, joined by walls, 12) having a proximal end (top-side) and a distal end (bottom-side) and defining an interior volume (enclosed storage space, 14; col. 3, lines 69-72), the body portion (10, 12) including, a plurality of cooling vanes (peak, 22 and trough, 24 corrugations of 10; col. 3, lines 66-69) extending radially outward from and spaced about the body portion (corrugations shown uniformly radiating outward from 12, on all sides), the plurality of cooling vanes increasing the external surface area of the blood component cooling container (col. 2, lines 57-58); and an opening (opening means, 16) within the body portion configured to receive collected plasma (cl. 3, line 75- col. 4, line 2); wherein each of the plurality of cooling vanes (22, 24 of 10) defines a vane internal volume (see Fig. 5), the interior volume (14)of the blood component cooling container including the vane internal volume (the area within the corrugation from 22 to 24 as seen in Fig. 3 is part of the interior volume of the container)..
8. With regard to claim 10, Rinfret discloses a method of storing plasma (low temperature preservation of, e.g. blood; col. 1, lines 11-15; Figs. 3-5) comprising: introducing plasma into a blood component cooling container (col. 3, line 75 – col. 4, line 2), the blood component cooling container including: a body portion (10, 12) having a proximal end (top) and a distal end (bottom) and defining an interior volume (14; col. 3, lines 69-72), the body portion (10, 12) including, a plurality of cooling vanes (22, 24 of 10; col. 3, lines 66-72) extending radially outward from the body portion (corrugations shown uniformly radiating outward from 12, on all sides), the plurality of cooling vanes increasing the external surface area of the blood component cooling container (col. 2, lines 57-58), and an opening (16) within the body portion configured to receive the plasma (cl. 3, line 75- col. 4, line 2); and transferring the blood component cooling container to a freezer (col. 1, lines 26-28; long term storage at low temperatures – i.e. a “freezer”), the plurality of cooling vanes reducing the freezing time of the plasma within the blood component cooling container (increasing surface area by, e.g. adding cooling vanes inherently increases heat transfer and reduces freezing time).
9. With regard to claim 2, Rinfret discloses that the plurality of cooling vanes (22, 24 of 10) includes two cooling vanes (over 20 cooling vanes, which includes two; Figs. 3-5).
10. With regard to claims 5 and 14, Rinfret discloses a flexible metallic frame located on the external surface of the blood component cooling container (col. 4, lines 26-40 describe metals that may be used for the container, and metals are inherently flexible), the flexible metallic frame improving the heat exchange properties of the blood component cooling container (col. 4, lines 14-40 explains the necessity of choosing metals with relatively high conductivity).
11. With regard to claims 6 and 15, Rinfret discloses that the flexible metallic frame contacts a bottom and at least a portion of a side of the blood component cooling container (the entire container may be formed of metal; col. 4, lines 26-28).
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 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.
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
12. Claims 3, 4, 8, 9, 11, 12 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rinfret in view of Fischel et al. (US 4,755,300).
13. With regard to claims 3, 4 and 12, Rinfret is silent in regard to the blood component cooling container being tapered from the distal end to the proximal end; and wherein a diameter of the proximal end is greater than a diameter of the distal end.
However, within the same field of endeavor of blood component generation, collection and storage, Fischel discloses a coquette membrane filtration apparatus for separating suspended components in a fluid medium using high shear (abstract) comprising a stationary elongated containment vessel (12) and spinner element (14) tapering from a distal end (top end) to a proximal end (bottom end) of each (col. 9, lines 44-52); and wherein a diameter of their proximal ends are greater than a diameter of their distal ends (Figs. 1, 2, 4, 10).
Therefore, 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 blood component cooling container disclosed by Rinfret, to be tapered from top to bottom, similar to that disclosed by Fischel, in order to provide a blood component cooling container that is shaped to fit within known stationary elongated containment vessels similar to Fischel which allow for rotatable mounting on a pin to more easily and uniformly create the frozen shell encouraged by Rinfret in column 2, lines 14-32, when immersed in a refrigerant bath to ensure favorable heat transfer characteristics during freezing and subsequent thawing.
14. With regard to claims 8 and 18, Rinfret is silent in regard to the blood component cooling container having a generally cylindrical shape, such that the blood component cooling container may be opened using an automatic bottle opener.
However, Fischel discloses a generally cylindrical plasma collection bottle (78) fully capable of being opened using an automatic bottle opener (best seen in Fig. 11; col. 14, lines 3-22).
Therefore, 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 blood component cooling container disclosed by Rinfret, to be generally cylindrical in shape, similar to that disclosed by Fischel, in order to utilize bottles well known in the art of specimen collection, rather than a bag – so that a hanger or means of keeping the container upright in storage are not required.
15. With regard to claim 9, While Rinfret discloses a plurality of curved cooling vanes (22, 24; Figs. 1-5), Rinfret is silent in regard to each of the plurality of cooling vanes being curved such that the blood component cooling container has a generally cylindrical shape.
However, Fischel discloses the spinner (14) having a plurality of vanes (ribs, 16 and longitudinal channels, 17) being curved such that the spinner (14) has a generally cylindrical shape conforming to the generally cylindrical shape of the stationary elongated containment vessel (12; col. 9, lines 44-52; Figs. 1, 2, 4, 10).
Therefore, 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 blood component cooling container disclosed by Rinfret, to be generally cylindrical in shape, similar to that disclosed by Fischel, in order to provide a blood component cooling container that is shaped to fit within known stationary elongated containment vessels similar to Fischel which allow for rotatable mounting on a pin to more easily and uniformly create the frozen shell encouraged by Rinfret in column 2, lines 14-32, when immersed in a refrigerant bath to ensure favorable heat transfer characteristics during freezing and subsequent thawing.
16. With regard to claim 11, Rinfret fails to explicitly disclose that the plasma is collected during a plasmapheresis procedure; or the method step of introducing the plasma into the blood component cooling container includes transferring plasma from a blood component separation device of a plasmapheresis system to the blood component cooling container.
However, Fischel discloses plasma collection (via 78; see Fig. 11) during a plasmapheresis procedure (abstract); and the method step of introducing the plasma into the blood component cooling container (78) includes transferring plasma from a blood component separation device (membrane filtration apparatus, 10) of a plasmapheresis system to the blood component cooling container (78; col. 13, line 49 – col. 14, line 22).
Therefore, 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 blood collection disclosed by Rinfret, to be during a plasmapheresis procedure, where the plasma is transferred from a blood component separation device, similar to that disclosed by Fischel, in order to utilize plasma collection devices within a known procedure yielding plasma, as suggested by Fischel in the abstract.
17. With regard to claims 19 and 20, Rinfret fails to explicitly disclose that the at least one convection member including at least one slit or indent within the body portion.
However, Fischel discloses a spinner (14; Figs. 1, 2, 4) having a body portion for insertion into a stationary elongated containment vessel (12); and wherein the spinner (14) includes at least one slit or indent (longitudinal channels, 17) within the body portion (col. 9, lines 44-53; col. 10, lines 51-63).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the corrugations disclosed by Rinfret, with the formed slit or indent, similar to that disclosed by Fischel, in order to ease manufacture of the container while maintaining the peak and trough corrugation functionality desired by Rinfret.
18. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Rinfret in view of Fischel, as applied to claim 24 above, in further view of Mikhailov (US PGPUB 2012/0304597).
19. With regard to claim 13, Rinfret discloses removing the blood component cooling container from the freezer; defrosting, at least partially, the blood component cooling container (col. 1, lines 20-25; col. 2, lines 14-17), the plurality of cooling vanes reducing the defrosting time of the plasma within the blood component cooling container (col. 2, line 53 – col. 3, line 18); and removing the plasma from the blood component cooling container (via 16), the taper (as modified by Fischel, above) fully capable of preventing frozen plasma from getting stuck inside the blood component cooling container (col. 3, lines 64-75).
However, Rinfret and Fischel are silent in regard to opening the blood component cooling container using an automatic bottle opener.
Mikhailov, which is reasonably pertinent to the particular problem with which the applicant was concerned, namely opening containers using an automatic bottle opener, discloses a universal container capper/decapper (abstract; Fig. 1) for capping/decapping containers transporting specimen ([0003-0004]; [0046-0050]).
Therefore, 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 method disclosed by Rinfret in view of Fischel, to include a step of opening the container with a bottle opener, similar to that disclosed by Mikhailov, in order to ensure the seal of the container and utilize well-known openers so that spillage and environmental contaminants do not taint the specimen. Additionally, it would have been obvious for the bottle opener to be automatic rather than manually actuated, in order to reduce stress on the user. Automatic bottle openers are also well-known in the art; and, such a modification would require routine skill in the art.
Conclusion
20. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Harms et al. (US 5,364,385) discloses a storage bag for blood and blood components including a plurality of vanes formed in its body.
Wisniewski et al. (US 6,196,296) discloses a freezing and thawing vessel with thermal bridge formed between container and heat exchange member.
Miroslav (US PGPUB 2007/0186554) discloses a thermal hydro-machine on hot gas with recirculation
21. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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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/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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