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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/14/26 has been entered.
Response to Amendment
Applicant amended claims 1 and 10, canceled claim 18, and added claim 21. Claims 1-17 and 19-21 are currently pending.
Response to Arguments
Applicant’s arguments, see pages 8-11 of Applicant’s Remarks, filed 01/14/26, with respect to the rejections of claims 1-4 and 10-20 under 35 U.S.C. 103 as being unpatentable over Holmes in view of Rosenberg and in further view of Hoover, of claim 5 in further view of Segal, and of claims 6-9 in further view of Lappas have been fully considered and are not persuasive.
With respect to the Rosenberg, see pages 8-9, Applicant argues that Rosenberg generally discloses a plasmapheresis system which employs an intervening member comprising a matching plug and receptacle for hanging a media bag from a hook, and therefore does not disclose or render obvious that the first and second hanger apertures of the respective first and second bags have different transverse dimensions, as required by amended claim 1, or that the first and second hooks have different transverse dimensions and are configured to directly support the respective first and second bags, as required by amended claim 10.
However, as discussed below, Rosenberg teaches that by providing corresponding plugs and receptacles with distinct shapes and/or sizes, mismatches can be avoided and the safety of the system can be improved. Furthermore, as discussed below, the receptacles and plugs taught by Rosenberg are comparable structures to the media bag hanger apertures and hooks disclosed by Holmes (and claimed by the present application) because the plugs of Rosenberg and hooks of Holmes are inserted or fitted into the receptacles of Rosenberg and apertures of Holmes, respectively. Therefore, in view of the motivation of improving the safety of the system by preventing mismatches as taught by Rosenberg, it would be obvious to apply the teachings of Rosenberg to the hanger apertures and hooks of Holmes by changing the sizes and/or shapes of the corresponding hanger apertures and hooks to be distinct such that the first hanger aperture of the first bag can only be supported on the first hook, and the second hanger aperture of the second bag can only be supported on the second hook. Furthermore, because the teachings of Rosenberg are being applied to change the sizes and/or shapes of the hanger apertures and hooks of the system disclosed by Holmes, the hooks would be still be configured to directly support the media bags as disclosed by Holmes.
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.
Claims 1-4, 10-17, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Holmes et al. (US 2018/0304004 A1) in view of Rosenberg et al. (US 3,625,212 A) and in further view of Hoover (US 5,439,460 A).
Regarding claims 1-4 and 18-19, Holmes discloses a separation assembly for an apheresis system (Fig. 2A, feat. 200; ¶0118-0121), the separation assembly comprising: a first media bag containing a first fluid medium (114; ¶0118), the first media bag defining a first hanger aperture having a first transverse dimension (Fig. 2A: Bag 114 is mounted on a hook of post 232A via an aperture); a second media bag containing a second fluid medium (118; ¶0120), the second media bag defining a second hanger aperture defining a second transverse dimension (Fig. 2A: Bag 118 is mounted on a hook of post 232B via an aperture); a vessel configured to contain a third fluid medium (122; ¶0120); and a separation set (Fig. 5A, feat. 500; ¶0170) including, a first tube (Figs. 2A and 5A, feat. 110) having a first fitting (Fig. 5A, feat. 508) configured to be coupled to the first media bag (Fig. 2A, feat. 114: bag 114 is connected to tube 110, and therefore fitting 508 is configured to be coupled to bag 114), the first tube defining a first length (Figs. 2A and 5A, feat. 110), and a second tube (Figs. 2A and 5A, feat. 116) having a second fitting (Fig. 5A, feat. 512) configured to be coupled to the second media bag (Fig. 2A, feat. 118: bag 118 is connected to tube 116, and therefore fitting 512 is configured to be coupled to bag 118), the second tube defining a second length (Fig. 5A, feat. 116), with respect to claim 1. Holmes further discloses that the separation set further includes a third tube (Fig. 5A, feat. 120; ¶0170) configured to be coupled to the vessel (Fig. 2A, feat. 122), with respect to claim 2; that the separation set further includes a Y-connector (Fig. 5A, feat. 280; ¶0170), and the second tube and the third tube are fluidly connected via the Y-connector (Fig. 5A, feats. 116 and 120), with respect to claim 3; and that the first fluid medium includes anticoagulant (Fig. 2A, feat. 114; ¶0118), the second fluid medium includes saline (Fig. 2A, feat. 118; ¶0120), and the third fluid medium includes plasma (Fig. 2A, feat. 122; ¶0120), with respect to claim 4.
Holmes does not disclose that the second transverse dimension is greater than the first transverse dimension. Holmes depicts that the second tube (Fig. 5A, feat. 116) is a different length than the first tube (Fig. 5A, feat. 110), but does not disclose that the drawings are to scale. Therefore, Holmes does not disclose that the second length is different from the first length.
Rosenberg teaches methods systems and methods for eliminating mistakes in plasmapheresis by providing fluid bags (Figs. 3-4, feats. 19 and 25; Col. 1, lines 66-73) and their respective hanger hooks (15, 16; Col. 1, lines 56-73) with keyed plugs (Figs. 1 and 5-7, feat. 21) and receptacles (Figs. 1 and 5-7, feat. 24; Col. 2, lines 24-43) such that each plug can only be fitted to its corresponding receptacle (Col. 1, lines 18-34). This may be accomplished by providing the corresponding plugs and receptacles with distinct shapes and/or sizes, so long as the abutment between the plug and receptacle is broad enough to support the fluid bag (Figs. 1 and 5-9; Col. 2, lines 24-43). Rosenberg teaches that such a system advantageously makes incorrect fluid bags physically unsupportable in the case of a mismatch, thereby improving safety (Col. 1, lines 4-34). The receptacles and plugs taught by Rosenberg are comparable structures to the media bag hanger apertures and hooks disclosed by Holmes because the plugs of Rosenberg and hooks of Holmes are inserted or fitted into the receptacles of Rosenberg and apertures of Holmes, respectively. By modifying the hanger apertures of the first and second media bags of Holmes to have distinct shapes and/or sizes (also known as dimensions), which may be accomplished by making the second hanger aperture have a larger transverse dimension than the first hanger aperture, like the receptacles of Rosenberg and the corresponding first and second hooks to have distinct shapes and/or sizes (also known as dimensions) which are keyed to the respective hanger apertures of the first and second media bags like the plugs of Rosenberg, the first media bag would be unsupportable on the second hook and the second media bag would be unsupportable on the first hook, and the safety of the system would be improved as taught by Rosenberg. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the assembly disclosed by Holmes so that the second transverse dimension is greater than the first transverse dimension, with respect to claim 1 and so that the first hanger aperture defines a first shape and the second hanger aperture defines a second shaped different from the first shape, with respect to claim 19, in order to make the second media bag unsupportable on the first media bag’s hanger, and the first media bag unsupportable on the second media bag’s hanger, and improve the safety of the system as taught by Rosenberg.
Holmes in view of Rosenberg does not suggest that the second length is different from the first length.
Hoover teaches a plasmapheresis apparatus (Figs. 18-19; Col. 8, lines 20-26) comprising an anticoagulant bag (34; Col. 6, line 56 – Col. 7, line 34) and anticoagulant line (46), which are analogous to the first media bag and first tube, and a saline bag (38) and saline line (48), which are analogous to the second media bag and second tube. Hoover teaches that the anticoagulant bag and saline bag should be positioned so that the anticoagulant line can only reach the anticoagulant bag and the saline line can only reach the saline line in order to ensure fluid separation (Col. 7, lines 8-34). Hoover further teaches that the length of fluid lines, alongside positioning of the fluid containers and other separation means, should be taken advantage of to ensure the separation of infusion and collection fluids (Col. 2, line 58 – Col. 3, line 2). Hoover therefore suggests that the length of the fluid lines, and fluid lines with different lengths, may be utilized to ensure that the proper tubes are connected to the proper fluid containers. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the assembly suggested by Holmes in view of Rosenberg so that the second length is different from the first length in order to ensure separation between the fluid media in the first and second bags and that the proper tubes are connected to the proper containers as suggested by Hoover.
Regarding claims 10-17 and 20, Holmes discloses an apheresis system (Fig. 2A, feat. 200; ¶0118-0121) comprising: a housing (204; ¶0124), a first post (232A) including a first hook having a first transverse dimension, the first hook configured to directly support a first media bag (Fig. 2A: Bag 114 is mounted on a hook of post 232A via an aperture); a second post (232B) including a second hook having a second transverse dimension, the second hook configured to directly support a second media bag (Fig. 2A: Bag 118 is mounted on a hook of post 232B via an aperture); a centrifuge in the housing (¶0124-0126: housing 204 has an access panel 224 to access a centrifuge in the housing); and a separation set (Fig. 5A, feat. 500; ¶0170) including, a first tube (Figs. 2A and 5A, feat. 110), and a second tube (Figs. 2A and 5A, feat. 116), wherein, when the separation set is installed on the housing, the first tube (Fig. 2A, feat. 110) reaches the first media bag (Fig. 2A, feat. 114), and the second tube (Fig. 2A, feat. 116) reaches the second media bag (Fig. 2A, feat. 118), with respect to claim 10. Holmes further discloses that the separation set further includes a third tube (Fig. 5A, feat. 120; ¶0170), with respect to claim 11; that the separation set further includes a Y-connector (Fig. 5A, feat. 280; ¶0170), and the second tube and the third tube are fluidly connected via the Y-connector (Fig. 5A, feats. 116 and 120), with respect to claim 12; that the housing defines a receptacle (Fig. 2D, feat. 276; ¶0135-0136), and the receptacle is configured to receive at least a portion of the Y-connector in a predetermined orientation (Fig. 2D, feat. 280; ¶0135-0136), with respect to claim 13; that the first media bag (Fig. 2A, feat. 114) contains a first fluid medium (¶0118) and is fluidly connected to the first tube (Fig. 2A, feat. 110; ¶0118), and that the second media bag (Fig. 2A, feat. 118) contains a second fluid medium (¶0120) and is fluidly connected to the second tube (Fig. 2A, feat. 116; ¶0120), with respect to claim 14; a vessel defining a longitudinal axis and configured to contain a third fluid medium (Fig. 2A, feat. 122; ¶0120), wherein the separation set (Fig. 5A, feat. 500; ¶0170) further includes a third tube configured to be fluidly connected to the vessel (Figs. 2A and 5A, feat. 120; ¶0120), with respect to claim 15; that the first fluid medium includes anticoagulant (Fig. 2A, feat. 114; ¶0118), the second fluid medium includes saline (Fig. 2A, feat. 118; ¶0120), and the third fluid medium includes plasma (Fig. 2A, feat. 122; ¶0120), with respect to claim 16; and a cradle (Fig. 2A, feat. 232C; ¶0120 and 0124) attached to the housing (Fig. 2A, feat. 204), the cradle configured to retain the vessel at a desired orientation (Fig. 2A, feat. 122; ¶0120), with respect to claim 17.
Holmes does not disclose that the second transverse dimension is different than the first transverse dimension, that the first tube reaches the first media bag and not the second media bag, or that the second tube reaches the second media bag and not the first media bag.
As discussed above, Rosenberg teaches systems and methods for eliminating mistakes in plasmapheresis by providing fluid bags (Figs. 3-4, feats. 19 and 25; Col. 1, lines 66-73) and their respective hanger hooks (15, 16; Col. 1, lines 56-73) with keyed plugs (Figs. 1 and 5-7, feat. 21) and receptacles (Figs. 1 and 5-7, feat. 24; Col. 2, lines 24-43) such that each plug can only be fitted to its corresponding receptacle (Col. 1, lines 18-34). This may be accomplished by providing the corresponding plugs and receptacles with distinct shapes and/or sizes, so long as the abutment between the plug and receptacle is broad enough to support the fluid bag (Figs. 1 and 5-9; Col. 2, lines 24-43). Rosenberg teaches that such a system advantageously makes incorrect fluid bags physically unsupportable in the case of a mismatch, thereby improving safety (Col. 1, lines 4-34). The receptacles and plugs taught by Rosenberg are comparable structures to the media bag hanger apertures and hooks disclosed by Holmes because the plugs of Rosenberg and hooks of Holmes are inserted or fitted into the receptacles of Rosenberg and apertures of Holmes, respectively. By modifying the hanger apertures of the first and second media bags of Holmes to have distinct shapes and/or sizes (also known as dimensions) like the receptacles of Rosenberg and the corresponding first and second hooks to have distinct shapes and/or sizes (also known as dimensions) which are keyed to the respective hanger apertures of the first and second media bags like the plugs of Rosenberg, the first media bag would be unsupportable on the second hook and the second media bag would be unsupportable on the first hook, and the safety of the system would be improved as taught by Rosenberg. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Holmes so that the second transverse dimension is different than the first transverse dimension, with respect to claim 10, and so that the first media bag defines a first hanger aperture, and the second media bag defines a second hanger aperture, the second hanger aperture differing in size, shape, or both size and shape compared to the first hanger aperture, with respect to claim 20, in order to make the second media bag unsupportable on the first media bag’s hanger, and the first media bag unsupportable on the second media bag’s hanger, and improve the safety of the system as taught by Rosenberg.
Holmes in view of Rosenberg does not suggest that the first tube reaches the first media bag and not the second media bag, or that the second tube reaches the second media bag and not the first media bag.
Hoover teaches a plasmapheresis apparatus (Figs. 18-19; Col. 8, lines 20-26) comprising an anticoagulant bag (34; Col. 6, line 56 – Col. 7, line 34) and anticoagulant line (46), which are analogous to the first media bag and first tube, and a saline bag (38) and saline line (48), which are analogous to the second media bag and second tube. Hoover teaches that the anticoagulant bag and saline bag should be positioned so that the anticoagulant line can only reach the anticoagulant bag and the saline line can only reach the saline line in order to ensure fluid separation (Col. 7, lines 8-34). Hoover further teaches that the length of fluid lines, alongside positioning of the fluid containers and other separation means, should be taken advantage of to ensure the separation of infusion and collection fluids (Col. 2, line 58 – Col. 3, line 2). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Holmes in view of Rosenberg so that the first tube reaches the first media bag and not the second media bag and so that the second tube reaches the second media bag and not the first media bag in order to ensure the separation of the fluids from the first and second media bags as taught by Hoover.
Regarding claim 21, Holmes in view of Rosenberg and in further view of Hoover suggests the apheresis system of claim 1, but does not disclose that the first hanger aperture defines a first stadium shape and the second hanger aperture defines a second stadium shape. However, as long as the first hanger aperture and the second hanger aperture have distinct sizes such that the first hanger aperture can only be supported by the first hook and the second hanger aperture can only be supported by the second hook, as suggested by Rosenburg, making the first hanger aperture define a first stadium shape and the second hanger aperture define a second stadium shape would be a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that providing the first and second hanger apertures with respective first and second stadium shapes is significant. Please see MPEP §2144.04(IV)(B).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Holmes et al. (US 2018/0304004 A1) in view of Rosenberg et al. (US 3,625,212 A), in further view of Hoover (US 5,439,460 A), and in further view of Segal et al. (US 6,402,207 B1).
Regarding claim 5, Holmes in view of Rosenberg and in further view of Hoover suggests the assembly of claim 1. Holmes further discloses that the first fitting has a first shape (Fig. 5A, feat. 508) and that the second fitting has a second shape (Fig. 5A, feat. 512), but does not disclose that the first media bag includes a first receptacle configured to receive the first fitting, the second media bag includes a second receptacle configured to receive the second fitting, the first fitting is configured to engage only the first receptacle of the first and second receptacles, and the second fitting is configured to engage only the second receptacle of the first and second receptacles.
Segal teaches medical connector systems (Figs. 1-3 and 5A-D) comprising a first portion (Fig. 1, feat. 1; Col. 4, lines 11-50) with a protuberance (15) and a second portion (Fig. 1, feat. 3) with a receptacle (25) such that the protuberance and receptacle are complementary in shape. The protuberance (15) and receptacle (25) may take a variety of shapes (Figs. 5A-D; Col. 6, lines 38-64). The first (1) and second (2) connector portions are path specific such that they can only be put in fluid communication with other connector portions with complementary shaped protuberances or receptacles (Col. 5, lines 32-46) in order to ensure that only fluids of the proper type be connected to specific types of tubing (Col. 1, line 63 – Col. 2, line 3). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the assembly suggested by Holmes in view of Rosenberg and in further view of Hoover so that the first fitting has a first shape and that the second fitting has a second shape, the first media bag includes a first receptacle configured to receive the first fitting, the second media bag includes a second receptacle configured to receive the second fitting, the first fitting is configured to engage only the first receptacle of the first and second receptacles, and the second fitting is configured to engage only the second receptacle of the first and second receptacles in order to ensure that only the proper fluid media bag can be connected to the proper tube as taught by Segal.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Holmes et al. (US 2018/0304004 A1) in view of Rosenberg et al. (US 3,625,212 A), in further view of Hoover (US 5,439,460 A), and in further view of Lappas (US 5,224,932 A).
Regarding claims 6-8, Holmes in view of Rosenberg and in further view of Hoover suggests the assembly of claim 1, but does not suggest that the first fitting includes a first visual indicium, and the second fitting includes a second visual indicium different from the first visual indicium.
Lappas teaches an intravenous administration system (Fig. 1, feat. 10; Col. 5, lines 9-38) with a plurality of administration sets (32a-32d), each comprising a container (12a-12d), a fitting (40a-40d; Col. 7, lines 5-16), and a tube (36a-36d). Each administration set is associated with a particular color such that the container, fitting, and tube in a given administration set have the same color, and different administration sets have different colors (Col. 5, lines 46-68, Col. 6, lines 52-65, and Col. 7, lines 29-53). Lappas teaches that this advantageously allows the fluid in a container, fitting, or tube to be quickly and reliably identified (Col. 3, lines 10-20), which helps to ensure that proper and compatible connections are made between elements in the administration set (Col. 1, line 58 – Col. 2, line 20; Col. 3, lines 21-28). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the assembly suggested by Holmes in view of Rosenberg and in further view of Hoover so that the first fitting includes a first visual indicium, and the second fitting includes a second visual indicium different from the first visual indicium, with respect to claim 6, so that the first visual indicium is a first color and the second visual indicium is a second color different from the first color, with respect to claim 7, and so that the first media bag includes the first color and the second media bag includes the second color, with respect to claim 8, in order to ensure that proper and compatible connections are made in the assembly as taught by Lappas.
Regarding claim 9, Holmes in view of Rosenberg, in further view of Hoover, and in further view of Lappas suggests the assembly of claim 8. Lappas further teaches that the containers, fittings, and tubes may be colored red, yellow, blue, or green (Col. 6, lines 52-65), but is silent with respect to any element being white. However, coloring a container, fitting, and tube white is an ornamental change which does not impact the function taught by Lappas, because as long as the different colors allow a user to distinguish between two sets of containers, fittings, and tubes, the function of the colored elements taught by Lappas is fulfilled. Therefore, the second color being white as claimed does not patentably distinguish over the teachings of Lappas. Please see the discussion regarding In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947) in MPEP §2144.04(I). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the assembly suggested by Holmes in view of Rosenberg, in further view of Hoover, and in further view of Lappas so that the first color is red and the second color is white.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Coelho et al. (US 2003/0191005 A1) discloses a blood component separation apparatus with bags comprising apertures with distinct shapes which correspond to matching hooks.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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 5712727159. 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.
/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781