NON-FINAL 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 .
Response to Arguments
Applicant’s arguments filed on 20 November 2025 with respect to the pending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Priority
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, 365(c), or 386(c) is acknowledged.
Drawings
The drawings were received on 24 February 2023. These drawings are acceptable.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware of in the specification.
The abstract of the disclosure is acceptable.
The title of the invention is acceptable.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 1, 2, 4, 8-10, 12, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 03/00026 (Robinson et al., hereinafter Robinson) in view of the admitted prior art in paras. [0087]-[0089] and Fig. 9 and 9A of the present specification.
Regarding claim 1, Robinson discloses a fluid separation chamber (CFC disk 930, Fig. 34) for rotation about an axis (1200, Fig. 34), comprising: a central hub coinciding with the axis (as shown in Fig. 37); a generally annular low-G wall (inner wall 1117, Fig. 34) and a generally annular high-G wall (outer wall 1118, Fig. 34) extending about the central hub in a spaced apart relationship to define therebetween a separation channel (annular separation channel 990, Fig. 34) having an upstream end (input port 1220, Fig. 34) and a downstream end (removal port 1040, Fig. 34); and a plurality of radial walls (see annotated Fig. 34 below) extending from the central hub to the separation channel to define a terminal wall (see annotated Fig. 34) separating the upstream end of the separation channel from the downstream end of the separation channel, an inlet passage (entry duct 1000, Fig. 34) at the upstream end of the separation channel, and low-G and high-G outlet passages (plasma removal duct 1070, concentrated red cell removal duct 1050, Fig. 34), wherein the high-G wall has a greater radius at the downstream end of the separation channel than at the upstream end of the separation channel at each axial position (“The channel outer wall 1118 increases in radius (from the axis of rotation 1200) in one region to be at or near its maximum distance or radius 1170 from the axis of rotation 1200 and thus form a collection pocket portion 1060 for red cells”, page 25 line 31 – page 26 line 1, Fig. 34), but does not disclose that the low-G wall has a greater radius at the downstream end of the separation channel than at the upstream end at each axial position.
PNG
media_image1.png
724
800
media_image1.png
Greyscale
The admitted prior art discloses that the low-G wall (wall 58, Fig. 9A, present specification) has a greater radius at the downstream end (69, Fig. 9A, present specification) of the separation channel (66a, Fig. 9A, present specification) than at the upstream end (67, Fig. 9A, present specification). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have configured the low-G wall of Robinson to have a greater radius at the downstream end as taught by the admitted prior art for the purpose of controlling fluid flow and phase distribution within the separation channel (e.g., “causing plasma that continues to release from the red blood cells downstream of the inlet passage to flow in the direction of increasing plasma thickness”, para. [0087], present specification).
Regarding claim 2, the combination of Robinson and the admitted prior art discloses wherein the high-G wall includes a tapered section (see annotated Fig. 34, Robinson) with a radius that gradually increases from an upstream portion of the tapered section to a downstream portion of the tapered section at each axial position (“The channel outer wall 1118 increases in radius (from the axis of rotation 1200) in one region to be at or near its maximum distance or radius 1170 from the axis of rotation 1200 and thus form a collection pocket portion 1060 for red cells”, page 25 line 31 – page 26 line 1, Fig. 34, Robinson).
Regarding claim 4, the combination of Robinson and the admitted prior art discloses wherein the high-G wall (outer wall 1118, Fig. 34, Robinson) has a uniform radius upstream of the tapered section at each axial position (outer wall 1118 has uniform radius until the start of the tapering as shown in annotated Fig. 34, Robinson).
Regarding claim 8, the combination of Robinson and the admitted prior art discloses wherein the low-G wall 58 has a radius that gradually increases form the upstream end 67 of the separation channel to the downstream end 69 of the separation channel 66a at each axial position (para. [0087], Fig. 9A, present specification).
Regarding claim 9, the combination of Robinson and the admitted prior art discloses wherein the low-G wall 58 has a radius configured as a uniform spiral from the upstream end of the separation channel to the downstream end of the separation channel (para. [0087], Fig. 9A, present specification).
Regarding claim 10, the combination of Robinson and the admitted prior art discloses the high-G wall (outer wall 1118, Fig. 34, Robinson) includes a tapered section (see annotated Fig. 34, Robinson) with a radius that gradually increases from an upstream portion of the tapered section to a downstream portion of the tapered section at each axial position (“The channel outer wall 1118 increases in radius (from the axis of rotation 1200) in one region to be at or near its maximum distance or radius 1170 from the axis of rotation 1200 and thus form a collection pocket portion 1060 for red cells”, page 25 line 31 – page 26 line 1, Fig. 34, Robinson), the high-G wall (outer wall 1118, Robinson) has a uniform radius upstream of the tapered section at each axial position (Fig. 34, Robinson), the low-G wall (wall 58, Fig. 9A, present specification) has a radius that gradually increases from the upstream end of the separation channel to the downstream end of the separation channel at each axial position (para. [0087], present specification), and the separation channel has a non-uniform width upstream of the tapered section at each axial position (“the width of the channel 66a (at each axial position) decreases”, para. [0089], Fig. 9A, present specification)
Regarding claim 12, the combination of Robinson and the admitted prior art discloses wherein the separation channel (annular separation channel 990, Fig. 34, Robinson) has a non-uniform width along the tapered section (see annotated Fig. 34, Robinson) at each axial position.
Regarding claim 17, the combination of Robinson and the admitted prior art discloses wherein the low-G outlet passage 74 opens into the separation channel at the upstream end 67 of the separation channel (Fig. 9A, present specification).
Regarding claim 18, the combination of Robinson and the admitted prior art discloses wherein the high-G outlet passage (concentrated red cell removal duct 1050, Fig. 34, Robinson) opens into the separation channel (annular separation channel 990, Fig. 34, Robinson) at the downstream end (removal port 1040, Fig. 34, Robinson) of the separation channel.
Regarding claim 19, the combination of Robinson and the admitted prior art discloses wherein the low-G and high-G outlet passages 74, 76 (Fig. 9, present specification) open into the separation channel at a top end 63 of the separation channel (Fig. 9, present specification).
Regarding claim 20, the combination of Robinson and the admitted prior art discloses wherein the inlet passage 68 (Fig. 9, present specification) opens into the separation channel at a bottom end 62 of the separation channel (Fig. 9, present specification).
Claims 3, 6, 13, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of admitted prior art, as applied to claim 1, 2, and 10 above, and further in view of Mulzet (U.S. Patent No. 4,447,221).
Regarding claim 3, the combination of Robinson and the admitted prior art does not explicitly disclose wherein the tapered section of the high-G wall has a radius configured as a uniform spiral.
Mulzet discloses a fluid separation chamber, wherein the high-G wall (outer wall 38, Fig. 3) spirals gradually outward (col. 5 lines 56-57, Fig. 3) from an upstream intake portion 40 to a downstream collection region 42. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have configured the tapered section of the high-G wall of the fluid separation chamber of the combination of Robinson and the admitted prior art as a spiral as taught by Mulzet, for the purpose of facilitating fluid transport through the separation channel (col. 3 lines 40-48, Mulzet). Furthermore, configuring the spiral as a uniform spiral would have been a predictable design choice since there is a finite number ways to vary the progression of a spiral, and one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success. "A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.” KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Regarding claim 6, the combination of Robinson and the admitted prior art does not explicitly disclose wherein the tapered section extends from the upstream end of the separation channel to the downstream end of the separation channel.
Mulzet discloses wherein the tapered section (high-G/outer wall 38, Fig. 3) of the high-G wall extends from the upstream end (intake portion 40, Fig. 3) of the separation channel to the downstream end (collect region 42, Fig. 3) of the separation channel. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have configured the tapered section of the high-G wall of the fluid separation chamber of the combination of Robinson and the admitted prior art as taught by Mulzet, for the purpose of facilitating fluid transport through the separation channel (col. 3 lines 40-48, Mulzet).
Regarding claim 13, the combination of Robinson and the admitted prior art discloses wherein the low-G wall has a radius configured as a uniform spiral (para. [0087], Fig. 9A of present specification), but does not explicitly disclose wherein the tapered section has a radius configured as a uniform spiral.
Mulzet discloses a fluid separation chamber, wherein the high-G wall (outer wall 38, Fig. 3) spirals gradually outward (col. 5 lines 56-57, Fig. 3) from an upstream intake portion 40 to a downstream collection region 42. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have configured the tapered section of the high-G wall of the fluid separation chamber of the combination of Robinson and the admitted prior art as a spiral as taught by Mulzet, for the purpose of facilitating fluid transport through the separation channel (col. 3 lines 40-48, Mulzet). Furthermore, configuring the spiral as a uniform spiral would have been a predictable design choice since there is a finite number ways to vary the progression of a spiral, and one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success. "A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.” KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Regarding claim 14, the combination of Robinson and the admitted prior art discloses wherein the low-G wall has a radius configured as a uniform spiral from the upstream end of the separation channel to the downstream end of the separation channel (para. [0087], Fig. 9A of present specification), but does not explicitly disclose wherein the high-G walls has a radius configured as a uniform spiral from the upstream end of the separation channel to the downstream end of the separation channel.
Mulzet discloses wherein the high-G wall (outer wall 38, Fig. 3) spirals gradually outward (col. 5 lines 56-57, Fig. 3) from an upstream intake portion 40 to a downstream collection region 42. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have configured the tapered section of the high-G wall of the fluid separation chamber of the combination of Robinson and the admitted prior art as taught by Mulzet, for the purpose of facilitating fluid transport through the separation channel (col. 3 lines 40-48, Mulzet). Furthermore, configuring the spiral as a uniform spiral would have been a predictable design choice since there is a finite number ways to vary the progression of a spiral, and one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success. "A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.” KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Regarding claim 16, the combination of Robinson, the admitted prior art, and Mulzet discloses the fluid separation chamber of claim 14. The admitted prior art discloses wherein the separation channel has a non-uniform width from the upstream end of the separation channel to the downstream end of the separation channel at each axial position (“the width of the channel 66a (at each axial position) decreases”, para. [0089], Fig. 9A, present specification). Mulzet also discloses wherein the separation channel (circular groove 23, Fig. 3, Mulzet) has a non-uniform width from the upstream end 40 of the separation channel to the downstream end 42 of the separation channel at each axial position (Fig. 3, Mulzet). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the separation channel of modified Robinson with a non-uniform width as taught by the admitted prior art and Mulzet, because varying the channel width represents a known and predictable design choice for controlling flow behavior and cell separation (col. 7 lines 17-27, Mulzet).
Claims 5 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of the admitted prior art, as applied to claims 4 and 10 above, respectively, and further in view of Mulzet (U.S. Patent No. 4,386,730, hereinafter Mulzet ‘730).
Regarding claim 5, the combination of Robinson and the admitted prior art does not disclose wherein the tapered section extends along an approximately semicircular portion of the separation channel.
Mulzet ‘730 discloses analogous art related to a channeled rotor assembly, wherein the tapered section (outermost or second portion ARC3, ARC4, ARC5, and ARC6, Fig. 2) extends along an approximately semicircular portion of the separation channel (Fig. 2). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the fluid separation chamber of the combination of Robinson and the admitted prior art with the tapered section as taught by Mulzet ‘730 for the purpose of achieving higher flow velocity to prevent platelet aggregation (col. 5 lines 24-41, Mulzet ‘730).
Regarding claim 11, the combination of Robinson and the admitted prior art does not disclose wherein the separation channel has a substantially uniform width along the tapered section at each axial position.
Mulzet 730’ discloses wherein the separation channel (channel 5, Fig. 1) has a substantially uniform width along the tapered section (outermost or second portion ARC3, ARC4, ARC5, and ARC6, Fig. 2) at each axial position (width of the channel is uniform along the tapered section, e.g., “one sixteenth inch”, col. 5 lines 24-41). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to apply the uniform width configuration taught by Mulzet ’730 to the separation channel of the combination of Robinson and the admitted prior art, since maintaining constant spacing between the walls of the separation channel is a known and predictable design choice for achieving a certain consistent flow velocity within the channel (col. 5 lines 36-41, Mulzet ‘730).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of the admitted prior art, and further in view of Mulzet, as applied to claim 14 above, and further in view of Mulzet ‘730.
Regarding claim 15, the combination of Robinson, the admitted prior art, and Mulzet does not disclose wherein the separation channel has a substantially uniform width from the upstream end of the separation channel to the downstream end of the separation channel at each axial position.
Mulzet ‘730 discloses a separation channel (channel 5, Fig. 1) having a substantially uniform width along the spiral portion of the channel (outermost portions ARC3-ARC6, Fig. 2), wherein the width is maintained constant (e.g., “one sixteenth inch”, col. 5 lines 24-41). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to apply the uniform width configuration taught by Mulzet ’730 to the separation channel of the combination of Robinson, the admitted prior art, and Mulzet, since maintaining constant spacing between the walls of the separation channel is a known and predictable design choice for achieving a certain consistent flow velocity within the channel (col. 5 lines 36-41, Mulzet ‘730).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHUYI S LIU whose telephone number is (571)272-0496. The examiner can normally be reached MON - FRI 9:30AM - 2:30PM 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, Claire Wang can be reached at 571-270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Shuyi S. Liu/ Examiner, Art Unit 1774