Board of Patent Appeals and Interferences
Patent and Trademark Office (P.T.O.)
*1 EX PARTE HERBERT M. CULLIS
Appeal No. 86-0561
January 27, 1989
Application for Patent filed August 12, 1977, Serial No. 824,182. Blood Component Centrifuge Having Collapsible Inner Liner.
Robert A. Benziger et al. for appellant
Primary Examiner--George H. Krizmanich
Before Calvert, Vice Chairman, and Parsons and Pate, Examiners-in-Chief
The appellant's invention pertains to a blood component centrifuge assembly and a process for separating blood components via continually processing the blood. The centrifuge assembly comprises a rotor having a multi-portion blood receiving channel. The channel is divided into an arcuate first part having a constant radius, and a second spiral-like portion with parts thereof located at progressively different distances from the center. The assembly is provided with a plurality of fluid connection means for introducing the blood and extracting the blood components, the red cells, the white cells and the platelets.
Independent claims 39 and 40, drawn to the centrifuge assembly and the process respectively, are representative of the appealed claims. A copy of appealed claims 39 and 40 is appended.
The references of record relied upon by the examiner are:
Pruessner 3,703,984 Nov. 28, 1972
Jones et al. (Jones) 4,007,871 Feb. 15, 1977
Kellogg et al. (Kellogg '461) 4,094,461 June 13, 1978
Rastgeldi [FN2] 873,494 July 26, 1961
Claims 32, 33, 36 and 37 stand rejected as unpatentable over claim 12 of Kellogg '848 in view of Pruessner under 35 U.S.C. 102(g)/103. It is the examiner's position that since claim 12 corresponds exactly to proposed Count 3 of Interference No. 100,210 in which applicant failed to present a claim corresponding to claim 12 to form the proposed Count 3, that accordingly, claim 12 of Kellogg '848 is prior art under 35 U.S.C. 102(g) [FN3].
The examiner considers Pruessner's disclosure of a centrifuge for separating organic and inorganic materials from a solution having a rotor 70 including a channel, of which one portion 80 is circular-like or arcuate and another portion 78 is spiral-like, would have suggested its use in the separation of blood and its components since blood is considered to include both organic and inorganic materials. The examiner also reasons the second and third fluid connections of Pruessner would have been for the red blood cells and the white blood cells.
*2 Thus, the examiner concludes that to remove the container of claim 12 (Kellogg '848) and to provide the centrifuge of claim 12 with the fluid connection means such as 76, 86 and 88 of Pruessner and then use the modified claim 12 centrifuge of Kellogg '848 as a blood centrifuge in view of Pruessner would have been obvious to one having ordinary skill in the art. The examiner also holds the removal of the container and its function is of no patentable moment.
Claim 35 stands rejected under 35 U.S.C. 103 as unpatentable over claim 12 of Kellogg '848 in view of Pruessner as applied to claims 32, 33 and 36 above, and further in view of Kellogg '461. The examiner considers Kellogg '461 to teach the expedient of making a bowl containing separable outer and inner walls as defined by bowl 24 and filler 25, and that to employ this expedient in claim 12 of Kellogg '848 would have been obvious.
Claims 34 and 38 through 42 stand rejected under 35 U.S.C. 103 as being unpatentable over claim 12 of Kellogg '848 in view of Pruessner as applied to claims 32, 33, 36 and 37 above, and further in view of Jones. According to the examiner, Jones shows a chamber 11 which is no greater than 360 degrees including first, second, third and fourth fluid connection means 19, 37, 35 and 33 for entry and extraction of various blood components. The examiner holds that in view of this teaching, to provide claim 12 of Kellogg '848 with a chamber of no more than 360 degrees arc and the various blood outlet means as suggested by Jones would have been obvious. The examiner is of the further opinion that the various process steps recited in claims 40 through 42 find response in the structure of claim 12 (Kellogg '848) as modified by the secondary references.
Claims 32 and 33 stand further rejected under 35 U.S.C. 102(b) as being anticipated by Pruessner. The examiner states the rejection as follows:
The reference rotor is a centrifuge assembly for separating organic and inorganic materials which are considered to be included in blood and, accordingly, the reference anticipates the limitations of claim 32, lines 1 and 2. The one portion and another portion are the one portion 80 and another portion 78 (fig. 7) with inlet 76 and outlets 86, 88 being the fluid connection means, all as broadly recited in claim 32.
The first, second and third fluid connections of claim 33 are the connection, 76, 86 and 88 of the reference.
Claims 34 and 36 through 42 are also further rejected under 35 U.S.C. 103 as being unpatentable over Pruessner in view of Jones.
Pruessner is applied as in the rejection of claims 32 and 33 above. According to the examiner, Jones shows a container having a channel 11 including inlet 19 for whole blood and outlets 37, 35 and 33 for various separated blood components such as red cells, white cells and plasma, the outlets 37, 35 and 33 located at different radial distances from within the channel and the channel 11 having an arc of no greater than 360 degrees.
*3 It is the examiner's position that to provide the centrifuge assembly of Pruessner with the various inlet and outlets for entry and extraction of blood components including the channel of an arc of no more than 360 degrees as suggested by Jones would have been obvious to one of ordinary skill in the art. The method steps of claims 40 through 42 are considered by the examiner to have been obvious in view of the references as combined.
Claim 35 stands further rejected under 35 U.S.C. 103 as unpatentable over Pruessner in view of Jones as applied to claims 34 and 36 through 42 above, and further in view of Kellogg '461 or Rastgeldi. Again, according to the examiner, Kellogg '461 teaches the expedient of a bowl having separable outer and inner walls defined by the bowl 24 and filler 25. The examiner also notes the separable outer and inner walls of members 12 and 13 in Figure 9 of Rastgeldi and concludes that to provide Pruessner with the separable walls suggested by either Kellogg or Rastgeldi would have been obvious.
It is the appellant's argument that the subject matter of claim 12 of Kellogg '848 does not represent prior art as to the invention in this application. The appellant maintains the disclosure of the subject application does not provide support for the "semi-rigid material" limitation of Kellogg ' 848 claim 12 and, therefore, appellant did not disclaim the subject matter of claim 12 when he refused to copy the proposed claim (substitute Count 3) for the purpose of interference as suggested by the examiner, citing In re Ogiue, 517 F.2d 1182, 186 U.S.P.Q. 227, 234 (C.C.P.A.1975).
The appellant argues, with respect to the alternative rejection employing Pruessner as the primary reference, that Pruessner is not directed to a blood component centrifuge, but to separating salt in a salt water solution at many times the G-force involved in a blood centrifuge and, thus, teaches away from use as a blood centrifuge. The appellant also argues the channel of Pruessner does not correspond to that claimed by appellant and that modification thereof proposed by the examiner is not suggested by the secondary references, but is the result of hindsight.
After carefully considering the complete record, including the arguments and positions presented by the examiner and the appellant, we have concluded (1) that claim 12 of Kellogg '848 does not represent prior art as to the claims of the subject application, (2) that the disclosure of Pruessner does anticipate claims 32 and 33, and further combined with Jones, renders prima facie obvious the subject matter of claims 34, 40 and 42, and (3) that claims 35 through 39 and 42 would not have been prima facie obvious from the collective teachings of the prior art relied upon by the examiner.
Normally, when a claim is suggested to an applicant for purpose of interference and the applicant refuses to make it, such refusal constitutes a concession that the subject matter of the claim was the prior invention of another in this country, and thus is prior art against the applicant under 35 U.S.C. 102(g)/103. In re Ogiue, supra. However, if the applicant's disclosure does not support the suggested claim, there is no such disclaimer, and the suggested claim is not prior art. In re Phillips, 673 F.2d 1273, 213 U.S.P.Q. 353 (C.C.P.A.1982); Ex parte Inoue, 217 U.S.P.Q. 461 (Bd.App.1981). Accordingly, in the present case, the viability of the rejection over claim 12 of Kellogg '848, which corresponds exactly to the claim suggested to appellant in the interference, turns upon whether appellant's disclosure supports that claim.
*4 The container disclosed by appellant is not "of a semi-rigid material" as recited in claim 12 of Kellogg '848.
The bag or container employed by appellant and Kellogg are totally different, one (Kellogg '848) being a semi-rigid preform shaped to fit the channel in the centrifuge, and the other (appellant's) being a flexible elongated flat container or bag of a thin walled tubular plastic material, apparently without a self-sustaining pre-formed shape, which is required to be supported in the channel by hanger pin 34. While the subcombination, the centrifuge structure per se, might be the same, the combinations of the centrifuge and the bag or container of semi-rigid material are not. Accordingly, appellant's specification lacking support for a container of semi-rigid material, appellant had no right to make the suggested claim, and his refusal to do so served only to disclaim that to which he had no right in the first place, the combination of the centrifuge and the semi-rigid bag.
Accordingly, the rejections based upon claim 12 of Kellogg '848 cannot be sustained.
Turning to the alternative rejection, we are in agreement with the examiner that the subject matter set forth in claims 32 and 33 is anticipated by the centrifuge of Pruessner. As the examiner points out, the multi-portion channel as claimed finds total response in the channel segments 80 and 78 of Pruessner. Pruessner also discloses an inlet 76 and outlet means 86, 88 which are fully responsive to the fluid connection means as recited in appealed claims 32 and 33. The appellant's basis for distinction is not a structural difference but rather the intended use of the apparatus as a centrifuge for blood. The manner or method in which a machine is to be utilized is not germane to the issue of patentability of the machine itself. In re Casey, 370 F.2d 576, 152 U.S.P.Q. 235 (C.C.P.A.1967). A statement of intended use does not qualify or distinguish the structural apparatus claimed over the reference. In re Sinex, 309 F.2d 488, 135 U.S.P.Q. 302 (C.C.P.A.1962). Moreover, while appellant has inferred the centrifuge of Pruessner is incapable of functioning as a blood centrifuge for separating blood components, the appellant has presented no objective evidence in support of this argument. Accordingly, we will sustain the Section 102 rejection of claims 32 and 33.
We are also in agreement with the examiner's position that the collective teachings of Pruessner and Jones suggest the prima facie obviousness of the subject matter of claims 34, 40 and 41. It is our view that one of ordinary skill in the art, from the collective disclosures of centrifuges and their uses by Pruessner and Jones, would have been led thereby to use of the Pruessner centrifuge for blood components separation, as well as the provision of a fourth outlet for the extraction of a third component of an intermediate specific weight. Again, it is appellant's argument that one of ordinary skill would not use Pruessner for the separation of blood components. We think otherwise. Pruessner disclosed apparatus and method for separating organic and inorganic compounds, and one of ordinary skill in the art, aware not only of Pruessner's centrifuge but also the concept of using a centrifuge for the separation of blood components (Jones), would have been led thereby to so use the Pruessner apparatus and to provide it with a fourth outlet for extracting a third component. Thus, we believe the examiner has made out a prima facie case with respect to the subject matter of claims 34, 40 and 41 and that the appellant has failed to rebut the prima facie case with objective evidence of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 U.S.P.Q. 143 (C.C.P.A.1976).
*5 However, we do not find the cited art to suggest the obviousness of providing the Pruessner apparatus (Figures 6 and 7) with separable outer and inner walls defining the blood receiving channel, the limit of 360 degrees for the extent of the multi-portion blood receiving channel or extracting anything from the spiral-like portion of the Pruessner channel. We find in this art no suggestion or motivation which would have led the artisan to make the modification proposed by the examiner.
"There must, however, be a reason apparent at the time the invention was made to the person of ordinary skill in the art for applying the teaching at hand, or the use of the teaching as evidence of obviousness will entail prohibited hindsight. Graham v. John Deere Co., 383 U.S. 1, 36, 148 USPQ 459, 474 (1966)."
In re Nomiya, 509 F.2d 569, 184 U.S.P.Q. 607, 613 (C.C.P.A.1975).
Accordingly, we will not sustain the rejection of claims 35 through 39 and 42.
The decision of the examiner rejecting claims 32 through 42 under 35 U.S.C. 102(g)/103 using claim 12 of Kellogg '848 is reversed.
The decision of the examiner rejecting claims 32 and 33 under 35 U.S.C. 102(b) and claims 34, 40 and 41 under 35 U.S.C. 103 over Pruessner and Jones is affirmed.
37 C.F.R. 1.136(a) does not apply to the times for taking any subsequent action in connection with this appeal.
BOARD OF PATENT APPEALS AND INTERFERENCES
Ian A. Calvert
Marion Parsons, Jr
William F. Pate, III
FN1. In Kellogg '848, only claim 12 is relied upon as prior art.
FN2. This reference, while relied upon in the final rejection and cited in the statement of the rejection in the answer, was not listed in the examiner's answer.
Should the party Cullis desire to contest priority as to the proposed Count 3, he should so indicate by making the suggested claim in his application on or before 24 APR 1982. Failure to do so within the time allowed will be taken as a disclaimer of the subject matter thereof.
Cullis responded by filing a paper in which he declined to make the claim, asserting that he did not support the "semi-rigid material" limitation, and that the claim was unpatentable over prior art. The interference therefore was terminated, having been dissolved as to the original count.
*6 39. A blood component centrifuge assembly which comprises:
means providing a multi-portion blood receiving channel in said rotor;
one portion of said channel being arcuate and having a constant radius extending from the true center of said rotor;
said multi-portion blood receiving channel having a total arc that is no greater than 360<<degrees>>;
fluid connection means at separated locations of said channel for introducing blood and extracting blood components from said channel;
said fluid connection means comprising a first fluid connection for introducing whole blood, a second fluid connection for extracting a first blood component and a third fluid connection for extracting a second blood component;
one of said fluid connection means (a) communicating with the spiral-like portion of the channel, (b) being adapted for extracting a blood component from said spiral-like portion, and (c) being located at a greater radial distance from the true center of the rotor than the radial distance where the blood component enters said spiral-like portion.
40. A process for separating blood components comprising the steps of:
providing a centrifuge rotor for receiving whole blood;
providing in the rotor a blood receiving channel having (a) an arcuate portion having a constant radius from the true center of the rotor and (b) a spiral-like portion having parts disposed at progressively different distances from the true center of the rotor;
rotating the rotor to centrifuge the whole blood;
extracting a first blood component from a second location downstream of the first location; and
extracting a second blood component from a third location downstream of the second location.