Office Action Predictor
Application No. 17/629,280

FLOW PATH DEVICE AND BIOLOGICAL COMPONENT BAG SYSTEM

Non-Final OA §103
Filed
Jan 21, 2022
Examiner
SMITH, PETER DANIEL
Art Unit
3781
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Terumo Kabushiki Kaisha
OA Round
3 (Non-Final)
49%
Grant Probability
Moderate
3-4
OA Rounds
3y 4m
To Grant
99%
With Interview

Examiner Intelligence

49%
Career Allow Rate
30 granted / 61 resolved
Without
With
+52.2%
Interview Lift
avg trend
3y 4m
Avg Prosecution
38 pending
99
Total Applications
career history

Statute-Specific Performance

§101
0.8%
-39.2% vs TC avg
§103
58.7%
+18.7% vs TC avg
§102
18.4%
-21.6% vs TC avg
§112
19.5%
-20.5% vs TC avg
Black line = Tech Center average estimate • Based on career data

Office Action

§103
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 . Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 14th, 2025 has been entered. Claim Status Claims 1, 5-16, and 18-24 are currently pending. Claims 1, 5-7, 14, and 18 have been amended. Claims 2-4 and 17 have been cancelled. Claims 21-24 are newly added. Response to Arguments Applicant's arguments filed April 14th, 2025 have been fully considered but they are not persuasive. Regarding applicant’s argument that Goodwin does not disclose the newly amended claim limitations, examiner agrees, however, in light of the disclosure of Goodwin in view of Bertoni as presented in the 103 rejection below, the new claim limitations are considered to have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. As applicant has not presented any arguments directed at the combination of the disclosure of Goodwin in light of the teaching of Bertoni, the current argument is seen as not persuasive. Claim Interpretation Claims 1 and 14 utilize the term “aligned” in the limitations of “first flow paths is aligned with a portion of the intermediate flow path and the single second flow path”. This term as defined by Meriam Webster can have two separate meanings which presents two different scopes of invention depending on the definition that is used. The two definitions are “to bring into line” or “to be in or come into precise adjustment or correct relative position”. Utilizing the first definition one would be apprised that the claim limitation would require that the first flow path, a portion of the intermediate flow path, and the second flow path all be positioned such that a line could be drawn through all three along a direction perpendicular to the direction of extension. Utilizing the second definition the broadest reasonable interpretation of the scope of the claim language would be that simply one of the first flow paths, a portion of the intermediate flow path and the single second flow path must be arranged in a position in relation to one another that is along a direction that is perpendicular to the direction of extension of the intermediate flow path. The difference between the two is that one requires that the three parts share a portion that exists along a single axial plane that exists in a direction perpendicular to the direction of extension, wherein the other the three parts can exist in one or multiple axial planes but must simply be arranged in relation to each other such that a first flow path, a portion of the intermediate pathway, and the second flow path each exist in a direction perpendicular to the direction of extension of the intermediate pathway thus not requiring them to be in one particular line. For the purposes of examination, the claim limitation is being interpreted utilizing the first definition as this appears to be what is intended by the applicant as depicted in Fig. 2 where the element 52a positioned directly in the center of the device, along the direction parallel to the extension of intermediate pathway 54, and element 56a are positioned within a single axial line perpendicular to the direction of extension of the intermediate pathway. Claim Rejections - 35 USC § 103 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. Claim(s) 1, 5-13, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Goodwin et al. (U.S. Publication 2014/0137519) in view of Bertoni (U.S. Publication 2017/0368243). Regarding claim 1, Goodwin discloses a flow path device (Fig. 3) comprising: a flow path formation member 108 in which there are formed flow paths (122, 124, 126, 128, 130) configured to allow at least one of a biological fluid and a medicinal solution to flow therethrough (¶0040, blood, blood products, biological fluids, vaccines), the flow path formation member comprising: a first sheet 140a formed by a soft material (¶0058 flexible); and a second sheet 140b formed by a soft material (¶0058 flexible) and that is superimposed on the first sheet (¶0058 first sheet positioned on second sheet), wherein the flow paths are formed between the first sheet and the second sheet (¶0058 selectively secured together along seam lines to form fluid flow path therebetween), the flow paths comprising: a plurality of first flow paths 130 extending (extend from distal most point of flow pathway from containers at either 118 and 120 side edges) from a first edge (118 or 120) of the flow path formation member toward a second edge 114 of the flow path formation member opposite the first edge (side edges are on opposite ends of flow pathway with respect to intermediate flow pathway 128, this interpretation of opposite is based on the definition of opposite seen here https://www.merriam-webster.com/dictionary/opposite meaning set over against something that is at the other end or side of an intervening line or space with the line being the flow pathway to the containers attached by first flow paths 130); and a single second flow path (122, see below illustrative diagram A of Fig. 3) extending from the second edge 114 of the flow path formation member toward the first edge (extends to intermediate flow pathway which is toward the first flow paths 130 and thus toward the first edge) and configured to communicate with the plurality of first flow paths (communicates through intermediate fluid flow path 128); and an intermediate flow path 128 extending parallel to the first edge of the flow path formation member between the plurality of first flow paths and the single second flow path to place the plurality of first flow paths and the single second flow path in communication with each other (see illustrative diagram A of Fig. 3 below), wherein the plurality of first flow paths are arranged alongside and separated from (separated by spaces 138) one another at the first edge of the flow path formation member (118 or 120) in a direction of extension of the intermediate flow path (extends in direction from distal edge 116 to proximal edge 114), wherein one of the plurality of first flow paths is aligned with a portion of the intermediate flow path along a direction (direction moving from edge 118 to 120 or vice versa) that is perpendicular to the direction of extension of the intermediate flow path (first flow paths extend in direction from edge 118 to 120 wherein intermediate flow path extend in direction of edge 116 and 114 and thus are perpendicular as can be seen in Fig. 3, portion of intermediate flow path that meets with first flow path is also positioned perpendicular to the direction of extension and is in line with first flow path), and wherein flow path sealed portions 146 configured to join the first sheet and the second sheet to each other in a liquid-tight manner are provided on both sides of each of the flow paths within the flow path formation member. PNG media_image1.png 355 746 media_image1.png Greyscale Illustrative diagram A of Fig. 3 of Goodwin (U.S. Publication 2014/0137519). Goodwin does not expressly disclose the first edge and the second edge being parallel to one another, the intermediate flow path being parallel to both the first and second edges such that it is between the plurality of first flow paths and the single second flow path, or one of the plurality of first flow paths being in a single axial line with the second flow path. However, Bertoni, in the same field of endeavor of fluid flow path devices (element 11), teaches a flow path device 11 in which a plurality of first flow paths 3b positioned parallel to a single second flow path (see below illustrative diagram of Fig. 2 of Bertoni) resulting in them being positioned on opposite edges of the flow path device 11 that are parallel to one another and the edges being parallel to the length of the connecting intermediate pathway that 3b are fluidically connected such that a direction of extension of the connecting intermediate pathway is perpendicular to the extension of the first and second flow paths for the purpose of connecting multiple first flow pathways to a single second flow path. PNG media_image2.png 548 437 media_image2.png Greyscale Illustrative diagram of Fig. 2 of Bertoni. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the plurality of first flow paths to be on an opposite side of the second flow path with respect to the intermediate flow path and thus have the first and second edges be parallel to the direction of extension of the intermediate flow path, as taught by Bertoni, since this claimed position of the plurality of first flow paths being on an opposite side does not change the flow path’s ability to direct fluid flow. Since applicant has not given any criticality to why the position of the flow path disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). While Goodwin in view of Bertoni do not expressly disclose one of the first flow pathways being in a single axial line with the second flow pathway and the portion of the intermediate pathway connecting the two, this rearrangement of parts would have been obvious to one of ordinary skill in the art before the effective filing date for the same reasoning as listed above. This modification of Goodwin in view of Bertoni would not have changed the flow path’s ability to direct fluid flow and since applicant has not given any criticality to why the position of the flow path disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Regarding claim 5, Goodwin in view of Bertoni suggest the flow path device according to claim 1. Goodwin further discloses the single second flow path communicates with a central portion of the intermediate flow path in the direction of extension thereof (placed in center of all two side edges). Regarding claim 6, Goodwin in view of Bertoni suggest the flow path device according to claim 1. Goodwin further discloses the plurality of first flow paths is greater than three (Fig. 3 shows 8). Regarding claim 7, Goodwin in view of Bertoni suggest the flow path device according to claim 1. Goodwin further discloses the flow path sealed portions comprise: first flow path sealed portions provided on both sides of each of the plurality of first flow paths; intermediate flow path sealed portions provided on both sides of the intermediate flow path; and second flow path sealed portions provided on both sides of the single second flow path (see illustrative diagram B of Fig. 3 below). PNG media_image3.png 321 785 media_image3.png Greyscale Illustrative diagram B of Fig. 3 of Goodwin (U.S. Publication 2014/0137519). Regarding claim 8, Goodwin in view of Bertoni suggest the flow path device according to claim 7. Goodwin further discloses non-sealed portions where the first sheet and the second sheet are not joined to each other are provided at positions other than the flow paths, within the flow path formation member; and the non-sealed portions are provided along the first flow path sealed portions, the intermediate flow path sealed portions, and the second flow path sealed portions (see illustrative diagram of Fig. 3B above). Regarding claim 9, Goodwin in view of Bertoni suggest the flow path device according to claim 1. Goodwin further discloses an outer edge sealed portion 147, which is configured to extend in a manner so as to surround the non-sealed portions and join the first sheet and the second sheet to each other, is provided in the flow path formation member. Regarding claim 10, Goodwin in view of Bertoni suggest the flow path device according to claim 1. Goodwin further discloses the flow paths include a plurality of communication paths (124; communicates with 153) configured to communicate with the plurality of first flow paths respectively (124 communicates connector 153 to flow path 130); the flow path sealed portions include communication path sealed portions (portion of 147 surrounding communication path sealed around 153 ¶0075 welded) provided on both sides of each of the plurality of communication paths; and spaces configured to extend along the communication path sealed portions are formed between the communication path sealed portions that lie adjacent to each other (space between flow paths). Regarding claim 11, Goodwin in view of Bertoni suggest the flow path device according to claim 1. Goodwin further discloses the flow paths include a connecting flow path (see illustrative diagram A of Fig. 3 above) in communication with the single second flow path; the flow path sealed portions include connecting flow path sealed portions (portions of 147 directly adjacent to connecting flow path) provided on both sides of the connecting flow path; and the connecting flow path sealed portions extend along an outer shape (outer shape of flow paths determined by sealed portions) of the flow path formation member. Regarding claim 12, Goodwin in view of Bertoni suggest the flow path device according to claim 1. Goodwin further discloses the first flow path sealed portions, the intermediate flow path sealed portions, and the second flow path sealed portions extend along an outer shape (sealed portion of flow paths determine outer shape of flow path) of the flow path formation member. Regarding claim 13, Goodwin in view of Bertoni suggest the flow path device according to claim 1. Goodwin further discloses the flow path sealed portions comprise: a plurality of first port members (152, 153) configured to form ports in communication respectively with the plurality of first flow paths; and a single second port member 150 configured to form a port in communication with the single second flow path. Regarding claim 18, Goodwin in view of Bertoni suggest the flow path device according to claim 1. Goodwin further discloses: a plurality of first port members (152 and 153) in communication with the plurality of first flow paths at the first edge of the flow path formation member; and a single second port member 150 in communication with the single second flow path at the second edge of the flow path formation member. Regarding claim 19, Goodwin in view of Bertoni suggest the flow path device according to claim 18. Goodwin further discloses the first sheet and the second sheet being fixed (¶0072 secured between sheets by welding, glue, press-fit; ¶0074 secured between sheets by welding, glue, press-fit) to the plurality of first port members and the single second port member. Regarding claim 20, Goodwin in view of Bertoni suggest the flow path device according to claim 19. Goodwin further discloses a part of each first port member 174 and a part of the single second port member 158 remaining exposed upon fixation of the first sheet and the second sheet thereto (remain exposed to be coupled to receive conduits ¶0072 and ¶0074). Claims 14-15 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Matkovich et al. (U.S. Patent No. 5,670,060) in view of Goodwin et al. (U.S. Publication 2014/0137519) and further in view of Bertoni (U.S. Publication 2017/0368243). Regarding claim 14, Matkovich teaches a biological component bag system (Fig. 1) configured to collect a desired biological component from a biological fluid (Col. 6 lines 16-26 processing transition zone material to form a supernatant and sediment and passing supernatant through porous medium to separate supernatant layer from sediment layer), the biological component bag system comprising: a plurality of first bags 20 in which the biological fluid is accommodated (Col. 7 lines 9-21); a flow path device 21 to which the plurality of first bags are connected; and a second bag 22 configured to accommodate the biological component guided from the plurality of first bags via the flow path device; wherein the flow path device comprises a flow path formation member 40 in which there are formed flow paths configured to allow at least one of the biological fluid and a medicinal solution to flow therethrough; the flow path formation member comprising: the flow paths comprising: a plurality of first flow paths lines coming from container 20 before first junction); and a single second flow path 60 configured to communicate with the plurality of first flow paths. Goodwin teaches that the formation member comprises a first sheet 140a formed by a soft material (¶0058 flexible); and a second sheet 140b formed by a soft material (¶0058 flexible) and that is superimposed on the first sheet (¶0058 first sheet positioned on second sheet); wherein the flow paths are formed between the first sheet and the second sheet (¶0058 selectively secured together along seam lines to form fluid flow path therebetween); wherein flow path sealed portions 146 configured to join the first sheet and the second sheet to each other in a liquid-tight manner are provided on both sides of each of the flow paths within the flow path formation member. a flow path formation member 108 in which there are formed flow paths (122, 124, 126, 128, 130) configured to allow at least one of a biological fluid and a medicinal solution to flow therethrough (¶0040, blood, blood products, biological fluids, vaccines), the flow path formation member comprising: a first sheet 140a formed by a soft material (¶0058 flexible); and a second sheet 140b formed by a soft material (¶0058 flexible) and that is superimposed on the first sheet (¶0058 first sheet positioned on second sheet), wherein the flow paths are formed between the first sheet and the second sheet (¶0058 selectively secured together along seam lines to form fluid flow path therebetween), the flow paths comprising: a plurality of first flow paths 130 extending (extend from distal most point of flow pathway from containers at either 118 and 120 side edges) from a first edge (118 or 120) of the flow path formation member toward a second edge 114 of the flow path formation member opposite the first edge (side edges are on opposite ends of flow pathway with respect to intermediate flow pathway 128, this interpretation of opposite is based on the definition of opposite seen here https://www.merriam-webster.com/dictionary/opposite meaning set over against something that is at the other end or side of an intervening line or space with the line being the flow pathway to the containers attached by first flow paths 130); and a single second flow path (122, see below illustrative diagram A of Fig. 3) extending from the second edge 114 of the flow path formation member toward the first edge (extends to intermediate flow pathway which is toward the first flow paths 130 and thus toward the first edge) and configured to communicate with the plurality of first flow paths (communicates through intermediate fluid flow path 128); and an intermediate flow path 128 extending parallel to the first edge of the flow path formation member between the plurality of first flow paths and the single second flow path to place the plurality of first flow paths and the single second flow path in communication with each other (see illustrative diagram A of Fig. 3 below), wherein the plurality of first flow paths are arranged alongside and separated from (separated by spaces 138) one another at the first edge of the flow path formation member (118 or 120) in a direction of extension of the intermediate flow path (extends in direction from distal edge 116 to proximal edge 114), wherein one of the plurality of first flow paths is aligned with a portion of the intermediate flow path along a direction (direction moving from edge 118 to 120 or vice versa) that is perpendicular to the direction of extension of the intermediate flow path (first flow paths extend in direction from edge 118 to 120 wherein intermediate flow path extend in direction of edge 116 and 114 and thus are perpendicular as can be seen in Fig. 3, portion of intermediate flow path that meets with first flow path is also positioned perpendicular to the direction of extension and is in line with first flow path), and wherein flow path sealed portions 146 configured to join the first sheet and the second sheet to each other in a liquid-tight manner are provided on both sides of each of the flow paths within the flow path formation member. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the flow path formation member of Matkovich that performs the function of providing a fluid flow pathway that joins multiple biological fluid bag containers for the flow path formation member of Goodwin since these elements perform the same function of providing a fluid flow pathway that joins multiple biological fluid bag containers. Simply substituting one flow pathway joining means for another would yield the predictable result of allowing a(n) plurality of bags to connected fluidically. See MPEP 2143. Matkovich in view of Goodwin do not expressly teach or suggest the first edge and the second edge being parallel to one another, the intermediate flow path being parallel to both the first and second edges such that it is between the plurality of first flow paths and the single second flow path, or one of the plurality of first flow paths being in a single axial line with the second flow path. However, Bertoni, in the same field of endeavor of fluid flow path devices (element 11), teaches a flow path device 11 in which a plurality of first flow paths 3b positioned parallel to a single second flow path (see above illustrative diagram of Fig. 2 of Bertoni) resulting in them being positioned on opposite edges of the flow path device 11 that are parallel to one another and the edges being parallel to the length of the connecting intermediate pathway that 3b are fluidically connected such that a direction of extension of the connecting intermediate pathway is perpendicular to the extension of the first and second flow paths for the purpose of connecting multiple first flow pathways to a single second flow path. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the plurality of first flow paths to be on an opposite side of the second flow path with respect to the intermediate flow path and thus have the first and second edges be parallel to the direction of extension of the intermediate flow path, as taught by Bertoni, since this claimed position of the plurality of first flow paths being on an opposite side does not change the flow path’s ability to direct fluid flow. Since applicant has not given any criticality to why the position of the flow path disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). While Matkovich in view of Goodwin and Bertoni do not expressly disclose one of the first flow pathways being in a single axial line with the second flow pathway and the portion of the intermediate pathway connecting the two, this rearrangement of parts would have been obvious to one of ordinary skill in the art before the effective filing date for the same reasoning as listed above. This modification of Matkovich in view of Goodwin and Bertoni would not have changed the flow path’s ability to direct fluid flow and since applicant has not given any criticality to why the position of the flow path disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Regarding claim 15, Matkovich in view of Goodwin and Bertoni suggest the biological component bag system according to claim 14. Matkovich further discloses a medicinal solution (Col. 19 lines 46-53, storage solution, an additive or the like added to transition zone material); a filter 70 configured to remove a predetermined biological component (Col. 7 lines 31-37 red cell barrier, removes red blood cells) from a liquid containing medicinal solution and the biological component (liquid contained in container 22) accommodated inside the second bag 22 via the flow path device; and a third bag 80 configured to accommodate the biological component that has passed through the filter (Col. 19 lines 65-67 and Col. 20 lines 1-14, platelet-containing layer passed from 22 through filter and recovered in additional container 80). Matkovich does not expressly disclose the medicinal solution being in a bag connected to the flow path device, however, as Matkovich discloses containers connected to the device capable of storing liquid solutions, it would have been obvious to one of ordinary skill in the art to have added the medicinal solution using a bag connected to the flow path device since it has been held that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of applying this known technique to a known device (method, or product) that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. This known technique of connecting a bag containing solution to be added to biological fluids to a flow path device would have yielded predictable results of adding the medicinal solution to the biological fluid. This would result in utilizing already provided fluid pathways to add the fluid instead of incorporating a different means to add the fluid thus simplifying the use of the device. See MPEP 2143. Regarding claim 21, Matkovich in view of Goodwin and Bertoni suggest the biological component bag system according to claim 14. Goodwin further discloses the single second flow path communicates with a central portion of the intermediate flow path in the direction of extension thereof (placed in center of all two side edges). As such the substitution of the flow path formation member of Matkovich for the flow path formation member of Goodwin would have rendered these claim limitations obvious to one of ordinary skill in the art as detailed in the rejection of claim 14 above. Regarding claim 22, Matkovich in view of Goodwin and Bertoni suggest the biological component bag system according to claim 14. Goodwin further discloses the plurality of first flow paths is greater than three (Fig. 3 shows 8). As such the substitution of the flow path formation member of Matkovich for the flow path formation member of Goodwin would have rendered these claim limitations obvious to one of ordinary skill in the art as detailed in the rejection of claim 14 above. Regarding claim 23, Matkovich in view of Goodwin and Bertoni suggest the biological component bag system according to claim 14. Goodwin further discloses the flow path sealed portions comprise: first flow path sealed portions provided on both sides of each of the plurality of first flow paths; intermediate flow path sealed portions provided on both sides of the intermediate flow path; and second flow path sealed portions provided on both sides of the single second flow path (see illustrative diagram B of Fig. 3 above). As such the substitution of the flow path formation member of Matkovich for the flow path formation member of Goodwin would have rendered these claim limitations obvious to one of ordinary skill in the art as detailed in the rejection of claim 14 above. Regarding claim 24, Matkovich in view of Goodwin and Bertoni suggest the biological component bag system according to claim 14. Goodwin further suggests non-sealed portions where the first sheet and the second sheet are not joined to each other are provided at positions other than the flow paths, within the flow path formation member; and the non-sealed portions are provided along the first flow path sealed portions, the intermediate flow path sealed portions, and the second flow path sealed portions (see illustrative diagram of Fig. 3B above). As such the substitution of the flow path formation member of Matkovich for the flow path formation member of Goodwin would have rendered these claim limitations obvious to one of ordinary skill in the art as detailed in the rejection of claim 14 above. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Matkovich et al. (U.S. Patent No. 5,670,060) in view of Goodwin et al. (U.S. Publication 2014/0137519) and Bertoni (U.S. Publication 2017/0368243), and further in view of Min et al. (U.S. Publication 2020/0196593). Regarding claim 16, Matkovich in view of Goodwin suggest the biological component bag system according to claim 15. Matkovich further discloses a buffy coat (Col. 19 lines 59-64, buffy coat) as the biological fluid is accommodated in each of the plurality of first bags; an additive solution as the medicinal solution is accommodated in the medicinal solution bag the filter 70 removes leukocytes (Col. 20 lines 1-14 red cell barrier/leukocyte depletion medium) from the buffy coat; and blood platelets that have passed through the filter and the additive solution are accommodated in the third bag (Col. 20 lines 1-14 platelet rich fluid recovered in container 80). Matkovich does not expressly disclose the additive solution being specifically a platelet additive solution. However, Min, in the same field of endeavor of platelet storage containers, teaches combining platelet containing fluid with a platelet additive solution (¶0006 cryopreservative solution) for the purpose for the purpose of cryopreserving the platelets in order to store long term (¶0006). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the additive solution to be a platelet additive solution as disclosed by Min for the purpose of storing the collected platelets long term (¶0006 of Min). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm. 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, Nicholas Weiss can be reached at 571-270-1775. 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. /PETER DANIEL SMITH/Examiner, Art Unit 3781 /GUY K TOWNSEND/Primary Examiner, Art Unit 3781
Read full office action

Prosecution Timeline

Jan 21, 2022
Application Filed
Oct 22, 2024
Non-Final Rejection — §103
Dec 05, 2024
Response Filed
Mar 12, 2025
Final Rejection — §103
Apr 14, 2025
Response after Non-Final Action
Jun 18, 2025
Request for Continued Examination
Jun 23, 2025
Response after Non-Final Action
Sep 25, 2025
Non-Final Rejection — §103
Apr 02, 2026
Response after Non-Final Action

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Prosecution Projections

3-4
Expected OA Rounds
49%
Grant Probability
99%
With Interview (+52.2%)
3y 4m
Median Time to Grant
High
PTA Risk
Based on 61 resolved cases by this examiner