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 .
This Office action is in response to communications filed June 23, 2026.
Status of Claims
1. Claims 1, 3-7, 10-16 and 18-21 are pending and currently under consideration for patentability.
Claims 2, 8-9 and 17 are cancelled and claim 21 is newly presented, as of the June 23, 2026 claim amendment.
Response to Amendments
2. Claims 2-9, 11-15 and 17-20 have been amended to overcome the previously applied claim objections; accordingly, the objections are withdrawn herein.
Response to Arguments
3. Applicant’s arguments with respect to claim(s) 1, 3-7, 10-16 and 18-21 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Fahey (US PGPUB 2003/0201270 A1) is newly presented as a primary reference of rejection, in view of the newly amended claims.
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.
4. Claims 1 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Fahey (US PGPUB 2003/0201270 A1).
5. With regard to claims 1, Fahey discloses a container (16; abstract; Figs. 1-12) comprising: a body portion (wall, 26) having a proximal end (end with cap, 22) and a distal end (end with annular bottom section, 30) and defining an interior volume ([0052-0053]; Fig. 2), the body portion (26) including; a bottom (30) at the distal end and an indentation (inside wall section, 32) extending from the bottom (30) into the interior volume (compartment, 40) to define an open internal core (recess, 34), the open internal core (34) being open (access aperture, 35) at the distal end and increasing an external surface area of the container (16; [0027]; [0030]; [0060]; [0081]; Fig. 2); and an opening (24) within the body portion (26) configured to receive liquids (abstract; [0052]; [0070]; [0079-0081]).
Fahey fails to explicitly disclose, within the embodiment of Figs. 1-12, that the container (16) is a blood component cooling container, where the opening is configured to receive collected plasma.
However, within the alternate embodiment of Figs. 15-22, Fahey discloses the container as a blood component cooling container (container, 92 is used to contain blood or blood plasma; [0079]), where the opening (104) is configured to receive collected plasma ([0077]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the container disclosed by Fahey in the Figure 1, 2 embodiment to be a blood component cooling container, similar to that disclosed by Fahey in the Figure 15-22 embodiment, in order to maximizes surface-area exposure of the containers, thus facilitating the external cooling of the blood or blood plasma, as suggested by Fahey in paragraph [0081].
8. With regard to claim 10, Fahey discloses a method of storing liquids (abstract) comprising: introducing liquids into a container (16; [0052]; [0070]), the container including: a body portion (26) having a proximal end (end with cap, 22) and a distal end (end with annular bottom section, 30) and defining an interior volume ([0052-0053]; Fig. 2), the body portion (26) including; a bottom (30) at the distal end and an indentation (inside wall section, 32) extending from the bottom (30) into the interior volume (compartment, 40) to define an open internal core (recess, 34), the open internal core (34) being open (access aperture, 35) at the distal end and increasing an external surface area of the container (16; [0027]; [0030]; [0060]; [0081]; Fig. 2) and an opening (24) within the body portion (26) configured to receive liquids (abstract; [0052]; [0070]; [0079-0081]); and transferring the container (16) to a freezer ([0026-0027]; [0030]), the open internal core (34) reducing the freezing time of the liquid within the blood container (16; [0026-0027]; [0030]).
Fahey fails to explicitly disclose, within the embodiment of Figs. 1-12, that the method is a method of storing plasma, comprising: introducing plasma into a container; and transferring the blood component cooling container to a freezer; wherein the container is a blood component cooling container, where the opening is configured to receive collected plasma.
However, within the alternate embodiment of Figs. 15-22, Fahey discloses a method of storing plasma ([0079-0081]; [0083]), comprising: introducing plasma into a container (container, 92 is used to contain blood or blood plasma; [0079]); and transferring the blood component cooling container to a freezer ([0026-0027];[0030]; [0081]); wherein the container as a blood component cooling container (92; [0079]), where the opening (104) is configured to receive collected plasma ([0077]) and the open internal core (98) reducing the freezing time of the plasma within the blood component cooling container (92; [0079-0082]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method and container disclosed by Fahey in the Figure 1, 2 embodiment to be a method of storing plasma with a blood component cooling container, similar to that disclosed by Fahey in the Figure 15-22 embodiment, in order to maximizes surface-area exposure of the containers, thus facilitating the external cooling of the blood or blood plasma, as suggested by Fahey in paragraph [0081].
9. Claims 3, 4, 7, 11, 12, 16 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Fahey, as applied to claims 1 and 10 above, and further in view of Fischel et al. (US 4,755,300).
10. With regard to claims 3, 4 and 12, Fahey is silent in regard to the blood component cooling container being tapered from the distal end to the proximal end; 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 Fahey, 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.
11. With regard to claim 7, Fahey 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 shaped plasma collection bottle (78) tapering from a distal end (top end) to a proximal end (bottom end) of each (col. 9, lines 44-52); wherein the bottle (78) is 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 Fahey, 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, with a reasonable expectation of success.
12. With regard to claim 11, Fahey 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 Fahey, 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.
13. With regard to claims 16 and 18, Fahey discloses a container (16; abstract; Figs. 1-12) comprising: a body portion (wall, 26) having a proximal end (end with cap, 22) and a distal end (end with annular bottom section, 30) and defining an interior volume ([0052-0053]; Fig. 2), the body portion (26) including; a bottom (30) at the distal end; at least one convection member comprising an indentation (inside wall section, 32) extending from the bottom (30) into the interior volume (compartment, 40) to define an open internal core (recess, 34), the open internal core (34) being open (access aperture, 35) at the distal end, the at least one convection member (32) increasing an external surface area of the container (16; [0027]; [0030]; [0060]; [0081]; Fig. 2); and an opening (24) within the body portion (26) configured to receive liquids (abstract; [0052]; [0070]; [0079-0081]).
Fahey fails to explicitly disclose, within the embodiment of Figs. 1-12, that the container (16) is a blood component cooling container, where the opening is configured to receive collected plasma.
However, within the alternate embodiment of Figs. 15-22, Fahey discloses the container as a blood component cooling container (container, 92 is used to contain blood or blood plasma; [0079]), where the opening (104) is configured to receive collected plasma ([0077]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the container disclosed by Fahey in the Figure 1, 2 embodiment to be a blood component cooling container, similar to that disclosed by Fahey in the Figure 15-22 embodiment, in order to maximizes surface-area exposure of the containers, thus facilitating the external cooling of the blood or blood plasma, as suggested by Fahey in paragraph [0081].
Additionally, Fahey is silent in regard to the blood component cooling container having a generally frustum/cylindrical shape, being tapered from the distal end to the proximal end; wherein a diameter of the proximal end is greater than a diameter of the distal end, such that the blood component cooling container may be opened using an automatic bottle opener.
However, Fischel discloses a generally frustum/cylindrical shaped plasma collection bottle (78) 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), wherein the bottle (78) is 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 Fahey, to be generally frustum/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, with a reasonable expectation of success.
14. With regard to claims 19-21, While Fahey discloses that the open internal core (34) is circular (Figs. 1, 2, 4), Fahey fails to explicitly disclose that the open internal core is cross-shaped or star-shaped.
However, Fahey explicitly discloses different shaped open internal cores (triangle recess 66, hexagonal recess, 70, square recess 74; Figs. 9-11; [0073]), and clearly suggests alternate shaped open internal cores, as desired ([0074]).
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 shape of the circular open internal core disclosed by Fahey, to be cross- or star-shaped, similar to the alternate shaped internal open cores shown in Figs. 9-11, in order to further maximize the surface area of the plasma for more rapid cooling within the container, as suggested by Fahey in paragraphs [0074] and [0030].
15. Claims 5, 6, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Fahey, as applied to claims 1 and 10 above, and further in view of Rinfret et al. (US 3,158,283).
16. With regard to claims 5-6 and 14-15, Fahey is silent in regard to a flexible metallic frame located on the external surface of the blood component cooling container, the flexible metallic frame improving the heat exchange properties of the blood component cooling container; wherein the flexible metallic frame contacts a bottom and at least a portion of a side of the blood component cooling container.
However, within the same field of blood plasma containers, 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) including: 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); wherein the flexible metallic frame contacts a bottom and at least a portion of a side of the blood component cooling container..
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 container disclosed by Fahey, to include a metallic frame, similar to that disclosed by Rinfret, in order to improve heat exchange properties of the blood component cooling container, as suggested by Rinfret in column 4, liens 14-40, leading to even further enhancement to rapid cooling/heating.
18. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Fahey in view of Fischel, as applied to claim 12 above, in further view of Mikhailov (US PGPUB 2012/0304597).
19. With regard to claim 13, Fahey discloses removing the blood component cooling container (92; as modified above) from the freezer ([0027]; [0030]; [0079-0084]); defrosting, at least partially, the blood component cooling container ([0079]); assist in maintaining desired temperatures in or out of the cooler), the open internal core (34) reducing the defrosting time of the plasma within the blood component cooling container ([0079]; [0030]); and removing the plasma from the blood component cooling container (via 24; [0052]), the taper (as modified by Fischel, above) fully capable of preventing frozen plasma from getting stuck inside the blood component cooling container (92).
However, Fahey 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 Fahey 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, with a reasonable expectation of success. Automatic bottle openers are also well-known in the art; and such a modification would require routine skill in the art.
Conclusion
20. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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