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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "124" and "126" in fig. 1 have both been used to designate pump drive device [note these reference numerals on top side of wall 114; from the filed specification it is understood that the drive device 124 is on one side of the wall (top side in view of fig. 1) and the pump head 126 is on second side of the wall (bottom side in view of fig. 1)].
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 13, 14 and 21 – 23 are objected to because of the following informalities:
In each of claims 13, 14 and 23, line 3: “the magnet elements” should read --the magnet elements of the output body--.
Claim 21, line 3: “the magnet elements” should read --the magnet elements of the drive body--.
Claim 22, line 1: “at least on” should read --at least one--.
Claim 14 is objected to for being dependent on claim 13.
Claims 22 and 23 are objected to for being dependent on claim 21.
Appropriate correction is required.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 4, 5, 7 – 10, 12 – 14, 16 – 18, 20 – 24 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider et al. (DE 3338002A1 – herein after Schneider; cited by applicant on IDS dated 02/20/2025) in view of Lawyer et al. (US 2006/0210412 – herein after Lawyer).
In reference to claim 1, Schneider teaches a pump apparatus (see fig. 3) for a pharmaceutical product (see ¶3 of translation; “insulin”), the pump apparatus comprising:
a pump drive device (10); and
a pump head (12),
the pump drive device comprising a drive unit (22), a drive body (24, see fig. 3) that is rotatable about a drive axis (in ↔ direction; see fig. 3) by the drive unit, and a support body (body formed by left wall portion of the shared housing 16; see fig. 3) for supporting directly or indirectly against a separating element (partition wall 14),
the pump head comprising a base body (body formed by right wall portion of the shared housing 16; see fig. 3) for supporting on the separating element (14), a tube receptacle (housing 5 of pump 1, see fig. 2) for receiving a tube conduit (6) that guides the pharmaceutical product, a pump actuator (3+2a+2b) for acting on the tube conduit, and an output body (30; see fig. 3) that is rotatable about an output axis (in ↔ direction; see fig. 3) and that is operatively connected to the pump actuator,
the drive body and the output body each comprising a magnet assembly with magnet elements [for drive body (see fig. 4 and ¶24-¶25 of translation): magnet assembly formed of 34+36; for output body (see fig. 4 and ¶24-¶25 of translation): magnet assembly formed of 37+35] that interact in order to transmit a drive force of the drive unit to the pump actuator through the separating element (14).
Schneider remains silent on the pump apparatus, wherein the pump drive device and the pump head “being supportable on faces of the separating element facing away from each other”.
However, Lawyer teaches the pump apparatus, comprising (see fig. 1): a pump drive device (device with first casing 12); and a pump head (head with second casing 32), wherein the pump drive device and the pump head being supportable on faces of the separating element (28) facing away from each other (as evident from fig. 1). Specifically (see ¶30), the pump drive device and the pump head are supportable on the separating element in a detachable manner and are held together by magnetic attraction between the first and second magnetic assemblies (14, 34).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify the pump apparatus with shared housing of Schneider for provision of modular, magnetically-supported casings as taught by Lawyer in order to gain the benefits of flexibility and serviceability of the pharmaceutical dosing system. Lawyer teaches that (see ¶7) using separate housings held magnetically against opposite sides of a wall allows the pump module and/or drive module to be located anywhere on a surface of the partition wall and removed easily for servicing without mechanical aids. Applying Lawyer’s teaching to Schneider’s pump apparatus would allow the “wet chamber 12” (asserted pump head) to be fully detached from the partition wall for specialized cleaning or replacement without disturbing “dry chamber 10” (asserted pump drive module), thereby fulfilling hygiene and reliability goals emphasized by Schneider (see ¶3 of translation).
In reference to claim 2, Schneider, as modified, teaches the pump apparatus, wherein the pump head is holdable in position via the magnet elements through the separating element at the pump drive device [this claimed feature is an inherent characteristic (in view of Lawyer’s disclosure in ¶30) in the modified pump apparatus of Schneider; in the modified pump apparatus, Lawyer’s magnet elements 14 are equivalent to Schneider’s magnet elements 34, 36 and Lawyer’s magnet elements 34 are equivalent to Schneider’s magnet elements 35, 37].
In reference to claim 4, Schneider teaches the pump apparatus, wherein the magnet assemblies (34+36 and 37+35; in Schneider) are each formed as multipole assemblies, and the drive body and the output body, with the drive axis and the output axis in line, are couplable to each other in a plurality of angular relative positions [see Schneider’s disclosure in ¶28 of translation: the discussed arrangement of the magnets constitutes “a multipole assembly” and periodic, repeating pattern of magnets (N-S-N-S) along the circumference of the discs implies the drive body 24 and the output body 30 to be inherently couplable in a plurality of angular positions].
In reference to claim 5, Schneider, as modified, teaches the pump apparatus, wherein the pump head, with the drive axis and the output axis in line, with the magnet assemblies in any angular relative position, is holdable on the pump drive device [this claimed feature is an inherent characteristic in the modified pump apparatus of Schneider (in view of Lawyer’s disclosure in ¶30: “the magnetic drive member 16 and the magnetic driven member 36 generate sufficient magnetic attraction therebetween to clamp the first casing 12 and the second casing 32 against the spacer 42 with sufficient force to support both casings against gravity without the use of mechanical aids”); in the modified pump apparatus, Lawyer’s magnet elements 14 are equivalent to Schneider’s magnet elements 34, 36 and Lawyer’s magnet elements 34 are equivalent to Schneider’s magnet elements 35, 37].
In reference to claim 7, Schneider teaches the pump apparatus, wherein at least one of the following applies: the pump head has a pharmaceutical-compliant configuration (condition A); the pump head is non-destructively washable with a cleaning fluid (condition B); the pump head is sterilizable non-destructively (condition C) [at least condition A is considered to be met: (see Schneider’s disclosure in ¶2, ¶3, ¶21 of translation) Schneider explicitly teaches a dosing device for the “medical sector,” specifically for administering medications like “insulin”; such a device inherently requires a pharmaceutical-compliant configuration to meet the “high demands…placed on the reliability and operational safety”].
In reference to claim 8, Schneider teaches the pump apparatus, wherein the pump head (modified pump head in view of modification discussed above in claim 1) comprises a shaft (40, in Lawyer’s fig. 1 or 4, in Schneider’s fig. 3) that is connected to the output body (30; in Schneider’s fig. 3) and to the pump actuator (3+2a+2b; in Schneider’s fig. 3) in a rotationally fixed manner and wherein the output body (34, in Lawyer or 30, in Schneider) and/or the shaft (40, in Lawyer or 4, in Schneider) is rotatably mounted on the base body (32; in Lawyer’s fig. 1) about the output axis via at least one bearing element (41; in Lawyer’s fig. 1).
In reference to claim 9, Schneider, as modified, teaches the pump apparatus, [in view of the modification discussed above in claim 1] wherein the base body (32; Lawyer’s fig. 1) comprises or forms a frame (border) and/or a bottom wall (viewed as wall portion extending vertically in view of orientation of the pump apparatus seen in Lawyer’s fig. 1) that faces the pump drive device (12; Lawyer’s fig. 1) and forms an edge (top edge) that is adapted to abut the separating element (42; Lawyer’s fig. 1), wherein the frame encloses a receiving chamber (space) that receives the output body (34, in Lawyer or 30, in Schneider).
In reference to claim 10, Schneider, as modified, teaches the pump apparatus, [in view of the modification discussed above in claim 1] wherein the base body (32; Lawyer’s fig. 1) comprises a cover element (formed by wall in casing 32 that defines groove for bearing 41; Lawyer’s fig. 1) covering the receiving chamber (covering the receiving chamber on its bottom side) to a side of the pump actuator (3+2a+2b within housing of Schneider’s pump 1; Schneider’s fig. 3) and wherein the output body (34, in Lawyer or 30, in Schneider) or a shaft (40, in Lawyer or 4, in Schneider) connected to the output body engages through a through-opening (opening in which bearing 41 is placed; Lawyer’s fig. 1) of the cover element and is connected to the pump actuator at a side (in ↓ direction in view of Lawyer’s fig. 1) of the frame facing away from the receiving chamber.
In reference to claim 12, Schneider, as modified, teaches the pump apparatus, [in view of the modification discussed above in claim 1] wherein the output body (34, in Lawyer or 30, in Schneider) is spaced apart from a bottom wall (wall that defines opening for component 41; Lawyer’s fig. 1) of the base body (32; Lawyer’s fig. 1), or from the separating element (14; Schneider’s fig. 3 or 42; Lawyer’s fig. 1) via a gap (39; Lawyer’s fig. 1 and ¶29) when the pump head (modified pump head) is in contact with the separating element.
In reference to claim 13, Schneider teaches the pump apparatus, wherein (see figs. 3-4 and ¶26 of translation: “As an alternative to the raised sections 40, 41, the discs 34, 35 can also be lowered and provided with grooves at the points where the magnets 36, 37 are to be placed”) the output body (30) comprises a receiving element (35) facing the separating element (14), the receiving element (35) comprising a plurality of receptacles (grooves) for the magnet elements (37) of the output body, as well as a connecting element (43) connected to the receiving element (35), which is directly or indirectly connected to the pump actuator (3+2a+2b).
In reference to claim 14, Schneider teaches the pump apparatus, wherein at least one of the receiving element (35) and the connecting element is configured to be disk-shaped or ring-shaped (as evident from Schneider’s disclosure in ¶24 of translation), wherein the magnet elements (37) of the output body are arranged in a circumferential direction of the output axis (as evident from Schneider’s disclosure in ¶28 of translation).
In reference to claim 16, Schneider, as modified, teaches the pump apparatus, [in view of the modification discussed above in claim 1] wherein the support body (12; Lawyer’s fig. 1) is secured or is securable on the separating element (42; Lawyer’s fig. 1 or 14; Schneider’s fig. 3) directly or indirectly via at least one holding part (friction member 44; Lawyer’s fig. 1) on the separating element.
In reference to claim 17, Schneider teaches the pump apparatus, [in view of the modification discussed above in claim 1] wherein the support body (12; Lawyer’s fig. 1) is detachably secured or is detachably securable on the at least one holding part (friction member 44; Lawyer’s fig. 1) or on the separating element (42; Lawyer’s fig. 1 or 14; Schneider’s fig. 3) [the claimed feature is an inherent characteristic in the modified pump apparatus since as discussed above in claim 1, the pump drive device and the pump head are detachable].
In reference to claim 18, Schneider teaches the pump apparatus, [in view of the modification discussed above in claim 1] wherein the at least one holding part (friction member 44; Lawyer’s fig. 1) is or comprises a base, which the support body (12; Lawyer’s fig. 1) abuts and which is connected to the separating element (42; Lawyer’s fig. 1), wherein the drive body (24, Schneider’s fig. 3 or 14, Lawyer’s fig. 1) is positioned laterally next to the at least one holding part and extends beyond one end (top end; Lawyer’s fig. 1) of the support body (12; Lawyer’s fig. 1) facing away (↓) from the drive unit (18; Lawyer’s fig. 1).
In reference to claim 20, Schneider teaches the pump apparatus, [in view of the modification discussed above in claim 1] wherein the drive body (24, Schneider’s fig. 3 or 14, Lawyer’s fig. 1) is spaced apart from the separating element (42, Lawyer’s fig. 1) via a gap (24, Lawyer’s fig. 1 and ¶27) when the pump drive device (modified pump drive device) is in a connected state with the separating element.
In reference to claim 21, Schneider teaches the pump apparatus, wherein the drive body (24, Schneider’s fig. 3) comprises a receiving element (34, Schneider’s fig. 4) facing the separating element (14, Schneider’s fig. 3), the receiving element comprising a plurality of receptacles (grooves) for the magnet elements (36, Schneider’s fig. 3) of the drive body [see figs. 3-4 and ¶26 of translation: “As an alternative to the raised sections 40, 41, the discs 34, 35 can also be lowered and provided with grooves at the points where the magnets 36, 37 are to be placed”], as well as a connecting element (42, Schneider’s fig. 3) connected to the receiving element, which is coupled to a shaft (32, Schneider’s fig. 3) of the pump drive device.
In reference to claim 22, Schneider teaches the pump apparatus, wherein at least one of the receiving element (34, Schneider’s fig. 4) and the connecting element are configured to be disk-shaped or ring-shaped (as evident from Schneider’s disclosure in ¶24 of translation), wherein the magnet elements are arranged in a circumferential direction of the drive axis (as evident from Schneider’s disclosure in ¶28 of translation).
In reference to claim 23, Schneider teaches the pump apparatus, wherein the output body (30) comprises a receiving element (35) facing the separating element (14), the receiving element (35) of the output body (30) comprising a plurality of receptacles (grooves) for the magnet elements (37) of the output body [see figs. 3-4 and ¶26 of translation: “As an alternative to the raised sections 40, 41, the discs 34, 35 can also be lowered and provided with grooves at the points where the magnets 36, 37 are to be placed”], and wherein the receiving element (34) of the drive body (24) and the receiving element (35) of the output body (30) are formed as identical parts (as evident from disclosure in ¶32 of translation).
In reference to claim 24, Schneider teaches the pump apparatus, wherein the pump apparatus is a peristaltic pump (see ¶15 of translation), wherein the tube receptacle (housing 5 of pump 1, see fig. 2) comprises (see ¶18 of translation and fig. 2) a grooved recess (referred as “circular cutout”) for the tube conduit (6), and wherein the pump actuator (3+2a+2b) is arranged inside the tube receptacle (5) and comprises at least one pressure element (2a, 2b), which is in a rotation about the output axis in squeezing engagement with the tube conduit (6).
In reference to claim 27, Schneider teaches a pump assembly comprising:
a chamber (wet chamber 12; this chamber is formed by “]” walls of the housing 16) that comprises a wall (14) forming a separating element and an inner space (space within 12) enclosed by the wall; and
at least one pump apparatus (see fig. 3) for a pharmaceutical product (see ¶3 of translation; “insulin”), the at least one pump apparatus comprising a pump drive device (device formed of components 18+20+22+23+32+24) and a pump head (head formed of components 30+4+1+6+28),
the pump drive device comprising a drive unit (22), a drive body (24, see fig. 3) that is rotatable about a drive axis (in ↔ direction; see fig. 3) by the drive unit,
the pump head comprising a tube receptacle (housing 5 of pump 1, see fig. 2) for receiving a tube conduit (6) that guides the pharmaceutical product, a pump actuator (3+2a+2b) for acting on the tube conduit, and an output body (30; see fig. 3) that is rotatable about an output axis (in ↔ direction; see fig. 3) and that is operatively connected to the pump actuator,
the drive body and the output body each comprising a magnet assembly with magnet elements [for drive body (see fig. 4 and ¶24-¶25 of translation): magnet assembly formed of 34+36; for output body (see fig. 4 and ¶24-¶25 of translation): magnet assembly formed of 37+35] that interact in order to transmit a drive force of the drive unit to the pump actuator through the separating element (14),
the pump drive device (device formed of components 18+20+22+23+32+24) being arranged outside the chamber (12), and
the pump head (head formed of components 30+4+1+6+28) being arranged in the inner space (space within 12) and operatively connected to the pump drive device via the magnet elements (magnets 37, 36) of the pump head and of the pump drive device.
Schneider remains silent on the pump assembly: wherein the pump drive device comprises “a support body for supporting directly or indirectly” against the separating element; wherein the pump head comprises “a base body for supporting” on the separating element; wherein the pump drive device and the pump head “being supportable on faces of the separating element facing away from each other”; the pump drive device “secured on” the wall.
However, Lawyer teaches the pump apparatus, comprising (see fig. 1): a pump drive device (device on top side of wall 42); a separating element (42); and a pump head (device on bottom side of wall 42), the pump drive device comprising a support body (12) for supporting directly or indirectly against the separating element (42); the pump head comprising a base body (32) for supporting (as evident from fig. 1) on the separating element (42); the pump drive device and the pump head being supportable on faces of the separating element facing away from each other (as evident from fig. 1); and the pump drive device secured (as seen in fig. 1) on the wall (wall of 42). Specifically (see ¶30), the pump drive device and the pump head are supportable on the separating element in a detachable manner and are held together by magnetic attraction between the first and second magnetic assemblies (14, 34).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify the pump apparatus of Schneider for provision of a support body to the pump drive device and a base body to the pump head as taught by Lawyer in order to gain the benefits of flexibility and serviceability of the pharmaceutical dosing system. Lawyer teaches that (see ¶7) using separate housings held magnetically against opposite sides of a wall allows the pump module and/or drive module to be located anywhere on a surface of the partition wall and removed easily for servicing without mechanical aids. Applying Lawyer’s teaching to Schneider’s pump apparatus would allow the pump head to be fully detached from the partition wall for specialized cleaning or replacement without disturbing the pump drive module, thereby fulfilling hygiene and reliability goals emphasized by Schneider (see ¶3 of translation).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Schneider in view of Lawyer and further in view of Lin, Hsin-Yung (US 2019/0039921 – herein after Lin).
Schneider, as modified, teaches the pump apparatus, wherein the pump head is holdable in position via the magnet elements on the separating element [this claimed feature is an inherent characteristic in the modified pump apparatus of Schneider; see McDougall’s disclosure in col. 1, lines 55-58: the pump head (referred as impeller assembly) and the pump drive device (referred as motor assembly) are “held together magnetically with a wall….between them”) and McDougall’s disclosure in col. 7, lines 14-19: the “rotational magnets” themselves attract each other, “adding to the hold of the assemblies to each other”].
Schneider, as modified, remains silent on the pump apparatus, wherein the pump head is free of a connection with the separating element and is holdable in position solely via the magnet elements on the separating element.
However, Lin teaches a pump apparatus (see figs. 10-12), wherein a pump head (142) is free of a connection with the separating element (12) and is holdable in position solely via the magnet elements on the separating element [see ¶7, ¶13, ¶17, ¶48: the drive module 144 is “non-mechanically” connected to the pump head 142 such that it drives the pumping element in the pump head by magnetic coupling].
Since applicant in the instant application has not disclosed any criticality associated with having the pump head “free of connection” with the separating element and holdable in position “solely” via the magnet elements on the separating element (for instance, see ¶26 in pg. pub of the instant application, where applicant use phrase such as “preferably”), it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to have the pump head “free of connection” with the separating element and holdable in position “solely” via the magnet elements on the separating element in the modified pump apparatus of Schneider as a matter of design choice since such an arrangement is known in the art (as recognized by Lin above) which yields the predictable result of a cleaner, simpler interface. One of ordinary skill in the art, furthermore, would have expected the modified pump apparatus of Schneider to perform equally well with this claimed arrangement of the pump head with respect to the separating element. Selecting between a stabilized friction mounting (Lawyer) and a completely, connection-free, suspended mounting (Lin) is a standard design decision based on the specific torque and stability requirements of the pharmaceutical pump.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Schneider in view of Lawyer and further in view of Jang et al. (“Capability improvement design method considering eddy current loss reduction of axial-flux permanent magnet coupling with Halbach array structure using 3-D FEM” – herein after Jang).
Schneider, as modified, remains silent on the pump apparatus, wherein the magnet assemblies are in each case formed as Halbach arrays of the magnet elements.
However, Jang teaches an axial-flux permanent magnet coupling with Halbach array structure.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify the magnet assemblies in the modified pump apparatus of Schneider for being formed as Halbach arrays as taught by Jang for the purpose of utilizing the coupling that offers the advantage of a “compact and flat construction” (see disclosure under point II of Jang) and to provide “overload protection” and allow for the product to be “minimized” by accurately anticipating maximum torque capabilities (see disclosure under point III of Jang).
Claims 11, 15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider in view of Lawyer and further in view of Kletschka, Harold (US 4895493 – herein after Kletschka).
Regarding claim 11,
Schneider, as modified, remains silent on the pump apparatus, wherein at least one sealing element is provided for a seal between the cover element and the frame and/or at least one sealing element is provided for a seal between the output body or the shaft (40, in Lawyer or 4, in Schneider) and the edge of the through-opening (edge of opening in which bearing 41 is placed; Lawyer’s fig. 1).
However, Kletschka teaches a pump apparatus, wherein at least one sealing element (for instance, seals 19; see fig. 1) is provided for a seal between the output body (13) or the shaft (12) and the edge of the through-opening (left edge of the opening in body 14 that receives bearings 30 with seals 19 within them).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to provide at least one sealing element as taught by Kletschka between the output body or the shaft and the edge of the through-opening in the modified pump apparatus of Schneider for the purpose of ensuring the hermetic separation and operational longevity of the pharmaceutical dosing system.
Regarding claim 15,
Schneider, as modified, teaches the pump apparatus, wherein the pump drive device (modified pump drive device) comprises a shaft (20, in Lawyer or 32, in Schneider) that is connected to the drive body (24, Schneider’s fig. 3 or 14, Lawyer’s fig. 1) in a rotationally fixed manner and is coupled via a coupling element to a drive shaft of the drive unit or is comprised by the drive unit (Lawyer’s shaft 20 is a drive shaft of the drive unit 18 or Schneider’s shaft 32 is a drive shaft of the drive unit 22).
Schneider, as modified, remains silent on the pump apparatus, wherein the shaft is rotatably mounted on the support body via at least one bearing element.
However, Kletschka teaches a pump apparatus, the shaft (17, see fig. 1; this claimed shaft is a shaft corresponding to pump drive device) is rotatably mounted on the support body (15) via at least one bearing element (30).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify the support body in the modified pump apparatus of Schneider for rotatably mounting the shaft via at least one bearing element on the support body as taught by Kletschka for the well-known purpose of assisting rotation of the shaft, as recognized by Kletschka (see col. 3, lines 44-47). It is known in the art that bearings support the shaft and minimize the friction of rotation.
Regarding claim 19,
Schneider, as modified, teaches the pump apparatus, wherein the support body (12; Lawyer’s fig. 1), on a face (top face) facing away (↑) from the drive body (14, Lawyer’s fig. 1), comprises or forms a flange (flange formed by wall extending in radial direction toward axis 17; Lawyer’s fig. 1) and via this flange abuts a housing (casing) of the drive unit (18; Lawyer’s fig. 1) and wherein the pump drive device comprises a shaft (20, Lawyer’s fig. 1 or 32, Schneider’s fig. 3).
Schneider, as modified, remains silent on the pump apparatus, wherein the shaft extends in a through-opening of the support body.
However, Kletschka teaches a pump apparatus, wherein the shaft (17, see fig. 1; this claimed shaft is a shaft corresponding to pump drive device) extends in a through-opening (opening for bearing 30) of the support body (15).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify the support body in the modified pump apparatus of Schneider for extending the shaft in a through-opening of the support body as taught by Kletschka for the purpose of providing bearing in order to assist rotation of the shaft, as recognized by Kletschka (see col. 3, lines 44-47). It is known in the art that bearings support the shaft and minimize the friction of rotation.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Schneider in view of Lawyer and further in view of Nagahama et al. (US 2019/0145398 – herein after Nagahama).
Schneider remains silent on the pump apparatus, wherein at least one of the following applies: the pump actuator and/or the tube receptacle is held detachably on the pump head (condition A); the pump head comprises a cover body that is transferable from a closed position to an open position and vice versa, the cover body covering the pump actuator and/or the tube receptacle in the closed position and releasing the pump actuator and/or the tube receptacle in the open position (condition B).
However, Nagahama teaches the pump apparatus, wherein the pump actuator and/or the tube receptacle (tube space S within component 20, see fig. 2) is held detachably on the pump head (30) [condition A]; and the pump head (30) comprises (see fig. 1 and ¶36) a cover body (20) that is transferable from a closed position (position seen in fig. 3b) to an open position (position seen in fig. 1) and vice versa, the cover body (20) covering the pump actuator (32) and/or the tube receptacle (tube space S, see fig. 2) in the closed position and releasing the pump actuator and/or the tube receptacle in the open position [condition B].
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify the pump in the modified pump apparatus of Schneider for providing a cover body as taught by Nagahama for the purpose of improving ease of assembly and maintenance by non-skilled users. Nagahama teaches that (see ¶59) providing a detachable holder (cover body) with a defined tube space allows even a “general user not skilled in mounting tubes” to properly mount the tube in the apparatus.
Claims 26 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider in view of Lawyer and further in view of Savard et al. (US 2003/0062382 – herein after Savard).
Regarding claim 26,
Schneider, as modified, remains silent on the pump apparatus, wherein the pump apparatus comprises a plurality of pump heads that are selectively couplable to the pump drive device.
However, Savard teaches (see ¶10) a high-precision dispensing system where the pump head is a module that “may be easily disconnected”. Savard states that a “second, clean pump head may thus be installed allowing the system to be returned to operation very quickly” while the first is being serviced. Savard emphasizes that this separation of the pump head from the drive mechanism allows for a modular exchange to avoid production downtime.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to provide a plurality of pump heads for selectively coupling to the pump drive device as taught by Savard in the modified pump apparatus of Schneider in order to maximize equipment uptime and operational efficiency, as recognized by Savard (see ¶10).
Regarding claim 28,
Schneider, as modified, teaches the pump assembly, comprising: the chamber (12; Schneider’s fig. 3) with the inner space (space within 12; Schneider’s fig. 3) and a surrounding space (such as space within room 10; Schneider’s fig. 3) outside the chamber.
Schneider, as modified, remains silent on the pump assembly, wherein the chamber is a clean room chamber and the inner space has a higher degree of sterility than the surrounding space outside the chamber.
However, Savard teaches (see ¶10) a precision fluid dispensing system within a clean room environment. Savard teaches that contamination from air bubbles or external particles must be carefully controlled within the fluid path to avoid process failure.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify the chamber in the modified pump assembly of Schneider for a clean room as taught by Savard so that the pump head is situated within the clean room since it is a standard industrial requirement for high-purity fluid handling. Savard teaches that (see ¶2) “contamination in semiconductor device fabrication processes…lower yields”. Likewise, Schneider recognizes that (see ¶3 of translation) medical dosing requires “high demands…on the reliability and operational safety” of the drug-handling components. A person of ordinary skill in the art would recognize that in a modular “outside/inside” wall arrangement (per Lawyer), the “inner space” containing the pharmaceutical product (per Schneider) or high-purity chemicals (per Savard) must necessarily be maintained at a higher degree of sterility to meet safety and product standards. Providing a clean room chamber is a predictable and routine application of environmental control technology to ensure the device performs its known function of sterile fluid delivery.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHIRAG JARIWALA whose telephone number is (571)272-0467. The examiner can normally be reached M-F 8 AM-5 PM.
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, ESSAMA OMGBA can be reached at 469-295-9278. 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.
/CHIRAG JARIWALA/Examiner, Art Unit 3746
/ESSAMA OMGBA/Supervisory Patent Examiner, Art Unit 3746
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