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 .
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 11 February 2026.
Claims 26-29 and 31-46 are pending.
Claims 1-25 and 30 are cancelled.
Claims 33-35 and 44-46 are withdrawn.
Claims 36-46 are newly added.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The recitation to “one or more connection elements configured to aseptically…” as in Claim 26 lacks antecedent basis in the specification.
The instant specification para. [0139] provides for “The aseptic connecting element may be unitary with the aseptic disconnecting element.”, and paras. [0140-0142] discuss the aseptic sealing element and the aseptic connecting element as separate components as previously claimed prior to the instant amendments. However, it remains unclear if these sections refer to the “one or more connection elements” required by amended Claim 26 without being linked to that specific terminology. Further, Applicant references paras. [0231] and [0235-0237] as providing support for the filed amendments. However, para. [0231] merely discusses a “connector 122” (referenced as shown by Figs. 21a-d as the needle-based connector) and paras. [0235-0237] are drawn to configurations of the robotic arms and reference the tube welder and tube sealer element, wherein it is again unclear if the welder/sealer elements refer to the singularly claimed “one or more connection elements” of amended Claim 1.
Appropriate correction of the claims/specification is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
Therefore, the “one or more connection elements configured to aseptically fluidly connect” as introduced by Claim 26 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 Interpretation
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“one or more connection elements, configured to aseptically fluidly connect the first port and the second port” as in Claim 26.
“a component retaining element...configured to retain a component for handling biological material” as in Claim 28.
“an aseptic connecting element, configured to aseptically fluidly connect” as in Claim 29.
“an aseptic disconnecting element, configured to aseptically fluidly disconnect” as in Claim 29.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
***No corresponding structure found within Applicant’s disclosure – see the 35 USC 112 section below.***
“an arm extending from a distal end to a proximal end” as in para. [0035] of Applicant’s instant pre-grant publication US 2023/0123559 A1, and equivalents thereof.
“an aseptic tube welder” as in para. [0141] of Applicant’s instant pre-grant publication US 2023/0123559 A1, and equivalents thereof.
“an aseptic tube sealer” as in para. [0142] of Applicant’s instant pre-grant publication US 2023/0123559 A1, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 26-29, 31-32, and 36-43 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 26 recites “one or more connection elements, configured to aseptically fluidly connect the first port and the second port” wherein this element is interpreted under 35 USC 112f as a generic non-structural placeholder (“connection elements”) appended with particular function (“configured to aseptically fluidly connect the first port and the second port”). However, no structure appears within Applicant’s instant disclosure which corresponds to such “one or more connection elements”.
Applicant’s specification in the pre-grant publication US 2023/0123559 A1 para. [0183] discusses general definitions of connections between two members, and para. [0215] discusses screw threads as a connection “mechanism” appealingly unrelated to that of Claim 26.
Further, the instant specification para. [0139] provides for “The aseptic connecting element may be unitary with the aseptic disconnecting element.”, and paras. [0140-0142] discuss the aseptic sealing element and the aseptic connecting element as separate components. However, it remains unclear if these sections refer to the one or more connection elements without being linked to that specific terminology. Further, Applicant references paras. [0231] and [0235-0237] as providing support for the filed amendments. However, para. [0231] merely discusses a “connector 122” and paras. [0235-0237] are drawn to configurations of the robotic arms and reference the tube welder and tube sealer element, wherein it is again unclear if the welder/sealer elements refer to the singularly claimed “one or more connection elements” of amended Claim 1.
Further, Figs. 21a-d being those referenced by the “connector 122” of the specification para. [0231] merely show what appears to be Applicant’s needle-based connector of new Claim 43. As such, if such a “connector” as defined by the specification para. [0231] is positively claimed and interpreted under 35 USC 112f as in the instant drawings Figs. 21a-d as merely the needle-based connector, the details of the aseptic connecting and disconnecting elements as being tube welders/sealers as in the dependent claims would not have sufficient support through drawings merely showing the needle-based arrangement.
These sections of the disclosure do not satisfy the need for a particular corresponding structure of the “connection elements” as required under 35 USC 112f. As such, the claims are indefinitely for providing an indefinitely defined term.
Regarding Claim 43, the term "needle-based" is a term of degree or a functional descriptor that does not clearly delineate the metes and bounds of the claimed invention. Applicant is requested to clarify the specific structure of the device (e.g., "a needle," "a hollow cannula") rather than using the functional descriptor "needle-based."
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 26-29, 31-32, and 36-40 are rejected under 35 U.S.C. 103 as being unpatentable over Veratich et al. (WO 2018/087558 A1), hereinafter “Veratich”, in view of Martin et al. (US 2009/0191620 A1), hereinafter “Martin”, Luitjens et al. (WO 2011/144561 A1), hereinafter “Luitjens”, and Putnam (US 2015/0083320 A1), hereinafter “Putnam”.
Regarding Claim 26, Veraitch teaches an assembly for handling biological material, comprising:
a first biological handling element 16 defining a first volume and a first port 110; a second biological handling element 40 defining a second volume and a second port 112 (Figs. 5 and 11(a) wherein the connector of Fig. 11(a) is the chamber 10 in Fig. 5.);
wherein at least one element chosen from the first biological handling element and the second biological handling element is moveable to bring the first port and the second port into registration with one another (Taking the component shown in Fig. 11(a) as the container 10 in Fig. 5, collapsing of the corrugated container 10 brings the inlets/outlets 110/112 into registration with one another as shown by Figs. 11(b) and 11(c), thereby creating a fluid pathway between the component retaining element 16 and the container 40. – See also para. [0051] discussing valves of the containers.), as in Claim 26.
Further regarding Claim 26, Veraitch does not specifically teach the assembly discussed above further comprising one or more connection elements, configured to aseptically fluidly connect the first port and the second port to provide aseptic fluid communication between the first volume and the second volume, as in Claim 26.
However, Luitjens teaches respective methods for welding sterile tubing of bioreactors and other sterile culture apparatuses comprising the aseptic tube welder “Biowelder”, demonstrating tube welding as a common practice for providing idealized seals of sterile tubing both for sealing the ends of tubing and for sealing lengths of tubing together (See Example 1 and “A widely used procedure in the art is to open thawed cell freezing bags in a laf cabinet by e.g. cutting the inoculation line (which cannot be welded) with a sterile blade and transfer the content of the bag in a sterile container which contains a tubing that can be welded sterilely to a bioreactor.”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the assembly of Veraitch/Martin further comprising one or more connection elements, configured to aseptically fluidly connect the first port and the second port to provide aseptic fluid communication between the first volume and the second volume, such as suggested by Luitjens, so as to enable sterile welding/sealing of the two tubes of the two ports when joined as in Fig. 11(b) and seal the tubing to ensure a sterile environment is maintained in each compartment of the bioreactor.
Further regarding Claim 26, Veratich does not specifically teach the assembly discussed above further comprising one or more robotic arms; wherein the one or more robotic arms are arranged to move at least one element chosen from the first biological handling element and the second biological handling element to bring the first port and the second port into registration with one another prior to fluidly connecting the first port and the second port aseptically, as in Claim 26.
However, Putnam teaches a respective biological fluid handling assembly wherein a robotic arm arranged to move two elements of a microfluidic assay device into close proximity or direct contact for engaging end ports of microtube elements therein for establishing fluid communication between the two elements (Fig. 16, [0041], [0189]: “For such purpose, it is desirable to physically contact the tiny element for picking it up from a surface and placing it in an open channel, which is then closed to form a micro-fluidic passage. It is desirable to employ grippers, e.g. a tweezer instrument that contacts the outer surface of the device. The pick and place action is made possible by pre-aligning open channels to receive the micro-flow elements and the surface on which the free elements are supplied with the automated pick-and-place instrument. This enables the grippers to pick up and place the micro-flow elements precisely in desired flow channel positions in which they are to be fixed.”). Therein, this arrangement allows for automated assembly of the microfluidic device, thereby causing more precise connections and higher consistency between assembled devices.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the assembly of Veraitch further comprising one or more robotic arms; wherein the one or more robotic arms are arranged to move at least one element chosen from the first biological handling element and the second biological handling element to bring the first port and the second port into registration with one another prior to fluidly connecting the first port and the second port aseptically, such as suggested by Putnam, so as to allow for automated assembly of the microfluidic device, thereby causing more precise connections and higher consistency between assembled devices.
Further, the above referenced recitation of Claim 26 is drawn to a process recitation of bringing ports into registration with one another prior to fluidic connection of the ports. As the claims are drawn to a device, such process recitation is not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II). Herein, the commensurately arranged one or more robotic arms of Putnam are fully capable of completing the claimed arranging process. Applicant may wish to instead provide a controller “configured/programmed to” perform the desired process steps for those limitations to bear patentable weight.
Regarding Claim 27, the prior art meets the limitations of Claim 26 as discussed above. Further, Veraitch teaches the assembly discussed above wherein the first biological handling element 16 comprises a substantially planar interface including the first port 110 (Fig. 5 - The flat base of the corrugated tube container.), the first port 110 adapted to fluidly couple to the first volume (See Figs. 5 and 11(a) wherein the connector of Fig. 11(a) is the chamber 10 in Fig. 5.), as in Claim 27.
Regarding Claim 28, the prior art meets the limitations of Claim 26 as discussed above. Further, Veraitch teaches the assembly discussed above wherein the second biological handling element 40 comprises a component retaining element retaining a component including the second volume and the second port 112 (Fig. 5 – the base of the connecting container 10 retaining the second port 112 (Fig. 11(a)) and forming a portion of the upper ceiling of the container 40, thereby retaining its second volume. See also Fig. 2(a) showing the component retaining element comprising a means for compression and decompression with an arm: “This device may contain a centrifuge or other spinning device (not shown), as well as means (20,22) by which the primary container (10) and the auxiliary containers (16) may be compressed or uncompressed to effect transfer of their contents. An arm or other means (not shown) may move the means (20) which may be in the form of a lever or plunger so that it is able to compress the auxiliary container (16(a)).”), as in Claim 28.
Regarding Claim 29, the prior art meets the limitations of Claim 26 as discussed above. Further, Veratich does not specifically teach the assembly discussed above wherein the one or more connection elements comprises a unitary structure including an aseptic connecting element and an aseptic disconnecting element, the aseptic disconnecting element configured to aseptically fluidly disconnect the first port and the second port to prevent aseptic fluid communication between the first volume and the second volume, as in Claim 29.
However, Luitjens teaches respective methods for welding sterile tubing of bioreactors and other sterile culture apparatuses comprising the aseptic tube welder “Biowelder”, demonstrating tube welding as a common practice for providing idealized seals of sterile tubing both for sealing the ends of tubing and for sealing lengths of tubing together (See Example 1 and “A widely used procedure in the art is to open thawed cell freezing bags in a laf cabinet by e.g. cutting the inoculation line (which cannot be welded) with a sterile blade and transfer the content of the bag in a sterile container which contains a tubing that can be welded sterilely to a bioreactor.”). Therein, as the functions of sealing and welding are provided through a same structure, such structure is a unitary structure.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the assembly of Veratich wherein the one or more connection elements comprises a unitary structure including an aseptic connecting element and an aseptic disconnecting element, the aseptic disconnecting element configured to aseptically fluidly disconnect the first port and the second port to prevent aseptic fluid communication between the first volume and the second volume, such as suggested by Luitjens, so as to enable sterile welding/sealing of the two tubes of the two ports when joined as in Fig. 11(b) and seal the tubing to ensure a sterile environment is maintained in each compartment of the bioreactor.
Regarding Claim 31, the prior art meets the limitations of Claim 26 as discussed above. Further, Veraitch teaches the assembly discussed above wherein the first port comprises a first tube, the second port comprises a second tube (Fig. 11(a) shows the first port and the second port as tubes.), as in Claim 31.
Further regarding Claim 31, Veraitch/Martin does not specifically teach the assembly discussed above wherein the one or more connection elements comprises an aseptic tube welder, as in Claim 31.
However, Luitjens teaches respective methods for welding sterile tubing of bioreactors and other sterile culture apparatuses comprising the aseptic tube welder “Biowelder”, demonstrating tube welding as a common practice for providing idealized seals of sterile tubing both for sealing the ends of tubing and for sealing lengths of tubing together (See Example 1 and “A widely used procedure in the art is to open thawed cell freezing bags in a laf cabinet by e.g. cutting the inoculation line (which cannot be welded) with a sterile blade and transfer the content of the bag in a sterile container which contains a tubing that can be welded sterilely to a bioreactor.”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the assembly of Veraitch/Martin wherein the aseptic connecting element comprises an aseptic tube welder, such as suggested by Luitjens, so as to enable sterile sealing of the two tubes of the two ports when joined as in Fig. 11(b) and seal the tubing to ensure a sterile environment is maintained in each compartment of the bioreactor.
Regarding Claim 32, the prior art meets the limitations of Claim 26 as discussed above. Further, Veraitch teaches the assembly discussed above wherein the first port comprises a first tube, the second port comprises a second tube (Fig. 11(a) shows the first port and the second port as tubes.), as in Claim 32.
Further regarding Claim 32, Veraitch/Martin does not specifically teach the assembly discussed above wherein the one or more connection elements comprises an aseptic tube sealer configured to aseptically fluidly disconnect the first port and the second port to prevent aseptic fluid communication between the first volume and the second volume, as in Claim 32.
However, Luitjens teaches respective methods for welding sterile tubing of bioreactors and other sterile culture apparatuses comprising the aseptic tube welder/sealer “Biowelder”, demonstrating tube welding as a common practice for providing idealized seals of sterile tubing both for sealing the ends of tubing and for sealing lengths of tubing together (See Example 1 and “A widely used procedure in the art is to open thawed cell freezing bags in a laf cabinet by e.g. cutting the inoculation line (which cannot be welded) with a sterile blade and transfer the content of the bag in a sterile container which contains a tubing that can be welded sterilely to a bioreactor.”). Further, as the tube sealer is configured to seal ends or lengths of tubing, the tube sealer of Luitjens sealing the first port and the second port prevents aseptic fluid communication between the first volume and the second volume.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the assembly of Veraitch/Martin wherein the aseptic connecting element comprises an aseptic tube sealer, such as suggested by Luitjens, so as to enable sterile sealing of the two tubes of the two ports when joined as in Fig. 11(b) and seal the tubing to ensure a sterile environment is maintained in each compartment of the bioreactor.
Regarding Claim 36, the prior art meets the limitations of Claim 26 as discussed above. Further, Veritach is modified in view of Putnam to provide one or more robotic arms for automatically joining ends of the microfluidic elements wherein said one or more robotic arms are controlled by a controller (Fig. 50B, [0088]) so as to enable such automated handling of the fluidic elements.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when providing to the assembly of Veritach the one or more robotic arms of Putnam, to provide the one or more robotic arms as being controlled by a controller, such as set forth by Putnam, so as to enable the automated element handling responsible for the benefits of increased consistency between runs.
Further, this recitation is drawn to a mere process recitation not providing additional patentable distinction over the prior art capable of performing such process. Applicant must positively introduce the “a controller” and detail the robotic arms as being controlled by the controller.
Regarding Claim 37, the prior art meets the limitations of Claim 26 as discussed above. Further, Veritach is modified in view of Putnam to provide one or more robotic arms for automatically joining ends of the microfluidic elements wherein said one or more robotic arms are controlled by a controller (Fig. 50B, [0088]) so as to enable such automated handling of the fluidic elements, and wherein the controller comprises a user interface, and wherein the controller is arranged to control the one or more robotic arms in response to user input to the user interface (See para. [0551] discussing optimization of parameters of the device, thereby necessarily requiring a user interface for modifying such parameters. – Further, the controller must necessarily receive a start signal from a user interaction so as to know when to start the scan. As such, a start button or sensor indicating the cartridge is received must necessarily be present and configured with the controller so as to be interfaced by the user.).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when providing to the assembly of Veritach the one or more robotic arms of Putnam, to provide the one or more robotic arms as being controlled by a controller and wherein the controller comprises a user interface, and wherein the controller is arranged to control the one or more robotic arms in response to user input to the user interface, such as set forth by Putnam, so as to enable the automated element handling responsible for the benefits of increased consistency between runs.
Further, as the controller of Claim 36, on which Claim 37 depends, is not a positively claimed element, the recitations of Claim 37 detailing the elements of the controller does not hold patentable weight.
Regarding Claim 38, the prior art meets the limitations of Claim 26 as discussed above. Further, Veritach is modified in view of Putnam to provide one or more robotic arms for automatically joining ends of the microfluidic elements wherein said one or more robotic arms are controlled by a controller (Fig. 50B, [0088]) so as to enable such automated handling of the fluidic elements. As such, one skilled in the art would recognize that such a modification results in the device of Veritach being an automated assembly.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when providing to the assembly of Veritach the one or more robotic arms of Putnam, to provide such an assembly as being automated, such as set forth by Putnam, so as to enable the automated element handling responsible for the benefits of increased consistency between runs.
Further, the term “automated assembly” is merely nominal in nature and does not provide additional patentable distinction over a commensurately structured assembly.
Regarding Claim 39, the prior art meets the limitations of Claim 26 as discussed above. Further, Veritach is modified in view of Putnam to provide one or more robotic arms for automatically joining ends of the microfluidic elements wherein said ends comprise ports/tube openings brought into registration with one another to be fluidically connected ([0264]: “The pick and place action is made possible by pre-aligning open channels to receive the hollow flow elements and the surface on which the free elements are supplied with the automated pick-and-place instrument. This enables the grippers to pick up and place the hollow flow elements precisely from supply pockets to desired flow channel positions in which they are to be fixed.”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when providing to the assembly of Veritach the one or more robotic arms of Putnam, to provide such an assembly as being arranged for aligning the first port and the second port; and positioning the first port and the second port close enough to fluidly connect the first port and the second port aseptically, such as disclosed by Putnam, so as to ensure proper welding of the sub-volumes of Veritach which comprise aligned ports for feeding biological fluid therebetween.
Examiner further notes that this recitation is drawn to a process recitation of movement of the first and second ports. As the claims are drawn to a device, such process recitation is not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II).
Regarding Claim 40, the prior art meets the limitations of Claim 26 as discussed above. Further, Veritach is modified in view of Luitjens to provide an aseptic tube welding element to connect or disconnect the ports of Veritach, such as complemented by Veritach regarding the device comprising a plurality of detachable volumes connected by ports. Therein, the tube welder of Luitjens is configured to aseptically fluidly disconnect the first port and the second port to prevent aseptic fluid communication between the first volume and the second volume, by way of welding the open ends of tubes or a length of tubing into two lengths sealed at the welded separated ends (See Example 1 and “A widely used procedure in the art is to open thawed cell freezing bags in a laf cabinet by e.g. cutting the inoculation line (which cannot be welded) with a sterile blade and transfer the content of the bag in a sterile container which contains a tubing that can be welded sterilely to a bioreactor.”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when providing to Veritach the tube welder of Luitjens, to provide said tube welder as configured to aseptically fluidly disconnect the first port and the second port to prevent aseptic fluid communication between the first volume and the second volume, such as disclosed by Luitjens, so as to achieve the function tube welding intended by Luitjens, as would be appreciated by the modular device of Veritach.
Claims 41 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Veratich in view of Martin, Luitjens, and Putnam, as applied to Claims 26-29, 31-32, and 36-40 above, and in further view of Hauwaerts et al. (WO 2018/015561 A1), hereinafter “Hauwaerts”.
Regarding Claim 41, the prior art meets the limitations of Claim 26 as discussed above. Further, Veritach is modified in view of Putnam to provide one or more robotic arms for automatically joining ends of the microfluidic elements wherein a first arm comprises gripping elements ([0189]) so as to enable the alignment of the microfluidic elements.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when providing to Veritach the one or more robotic arms of Putnam, to include one with a gripping element so as to enable the pick and place functions provided through Putnam so as to enable the sought alignment of microfluidic elements in Putnam.
Further regarding Claim 41, Veritach/Putnam/Martin/Luitjens do not specifically teach a second robotic arm having an aseptic connecting/disconnecting element, as in Claim 41.
However, Hauwaerts teaches placement and removal of a tube welder on a length of tubing (as opposed to placing the tubing in the fixed tube welder as in Luitjens) (“Step 1 : Sit a tube welder on the cell processing module and load apheresis into an allocated container (Figure 6a); Step 2: Load an input tube from the cell processing module and an output tube form the apheresis bag into the tube welder and weld them (Figure 6b); Step 3: Release welded tube from the tube welder and dispose of tube ends (Figure 6c); Step 4: Remove the tube welder from the top of the cell processing module and place the welded tube connection on top of the apheresis bag (Figure 6d); Step 5: The CPM and patient cell product may now be loaded into the CPS for processing (Figure 6e).”). In Hauwaerts, this tube welding process is performed manually by an operator. However, when in combination with the automated system of Veritach/Putnam, such a tube welder would be actuated instead by a robotic arm of Putnam so as to enable the automated assembly/disassembly taught by Putnam. See further MPEP § 2144.04 -- automating a process is generally not considered novel or non-obvious: "broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient" to distinguish over the prior art.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the assembly of Veritach/Putnam/Martin/Luitjens with an applyable/removable tube welder, such as suggested by Hauwaerts, and wherein such a tube welder is automated with a robotic arm such as sought by the fully automated assembly of Putnam and which would further generally be obvious to one skilled in the art as merely automating what exists in the prior art as a manual process.
Regarding Claim 42, the prior art meets the limitations of Claim 26 as discussed above. Further, Veritach is modified in view of Putnam to provide one or more robotic arms for automatically joining ends of the microfluidic elements wherein a first arm comprises gripping elements ([0189]) so as to enable the alignment of the microfluidic elements.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when providing to Veritach the one or more robotic arms of Putnam, to include one with a gripping element so as to enable the pick and place functions provided through Putnam so as to enable the sought alignment of microfluidic elements in Putnam.
Further regarding Claim 42, as discussed above regarding Claim 41, one of ordinary skill in the art would find it obvious to provide the assembly of Veritach/Putnam/Martin/Luitjens with a tube welding element suggested by Hauwaerts, said tube welding element necessarily comprising at least a connecting and disconnecting function as otherwise provided through Luitjens. Therein, the prior art does not suggest separate welding and sealing elements attached to separate robotic arms as required by Claim 42.
However, merely making as separate pieces what exists in the prior art as one integral piece absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04 (V)(B). Herein, one skilled in the art would find it obvious to provide the welding and sealing elements separately so as to simultaneously perform those respective functions as opposed to an integral element actuatable upon a single piece of tubing for a single welding/sealing action. As such, the separate welding and sealing elements attached to separate robotic arms as required by Claim 42 is seen as a mere matter of routine design and engineering choice.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Veratich in view of Martin, Luitjens, and Putnam, as applied to Claims 26-29, 31-32, and 36-40 above, and in further view of Brancazio (US 2012/0123297 A1), hereinafter “Brancazio”.
Regarding Claim 43, the prior art meets the limitations of Claim 26 as discussed above. Further, Veritach/Putnam/Martin/Luitjens does not specifically teach the assembly discussed above wherein the one or more connection elements the one or more connection elements includes a needle-based connector, as in Claim 43.
However, Brancazio teaches a respective microfluidic device wherein a first module is fluidically joined with a second module via a needle piercing a septum ([0091-0093), wherein this arrangement provides to aseptically join the elements without exposure to atmosphere (discussed by Brancazio as preventing loss of vacuum within the collection chamber 907).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the assembly of Veritach/Putnam/Martin/Luitjens wherein the one or more connection elements the one or more connection elements includes a needle-based connector, such as suggested by Brancazio, so as to further provide for sterile transfer of materials between separate modules of the device.
Response to Arguments
Drawings
Examiner acknowledges Applicant’s request for acceptance of the drawings. Examiner will indicate acceptance of the drawings if the case is moved to allowance. Note that a new objection to the drawings is provided above in the body of the action as necessitated by Applicant’s amendments reciting “one or more connection elements”, wherein such a term is not referenced by the specification to a corresponding structure shown through the drawings.
35 USC 112f
Applicant contends the instant claim limitations interpreted under 35 USC 112f would be readily understood by one having ordinary skill in the art. Examiner does not agree. The terms “one or more connection elements”, “a component retaining element”, “an aseptic connecting element”, and “an aseptic disconnecting element” interpreted under 35 USC 112f as discussed in the Claim Interpretation section above recite generic placeholders having no structural meaning. Each of these components is claimed as a mere “element(s)” (the generic placeholder) appended with particular function. As such, Examiner’s interpretation of these terms under 35 USC 112f herein is maintained as proper.
35 USC 112b
Applicant’s cancellation and amendment of those claims rejected by the previous office action as indefinite under 35 USC 112b sufficiently overcome those rejections. As such, those rejections under 35 USC 112b set forth by the previous office action are withdrawn. Note that a new grounds of rejection under 35 USC 112b is provided in the body of the action above as necessitated by Applicant’s amendments providing “one or more connection elements” failing to satisfy the requirements of 35 USC 112f..
35 USC 102
As all those claims previously rejected under 35 USC 102 are now cancelled, those rejections under 35 USC 102 are now withdrawn.
35 USC 103
Applicant’s cancellation of Claims 13-16 and 18 obviate the rejections under 35 USC 103 set forth thereover by the prior office action. As such, those rejections of Claims 13-16 and 18 under 35 USC 103 are withdrawn.
Veraitch in view of Martin and Luitjens
Applicant’s arguments are on the alleged grounds that none of the applied prior art references teach the amended Claim 26 recitations requiring one or more robotic arms for aligning and bringing into registration the ports of the separate biological handling elements.
Applicant’s arguments are not persuasive because this deficiency in the previously applied prior art is cured by obvious combination with the prior art of Putnam, newly added herein as necessitated by Applicant’s amendments requiring the one or more robotic arms, wherein Putnam teaches a robotic pick and pull gripper assembly for aligning elements of microfluidic devices so as to be connected for fluidic communication therethrough (see the rejection of Claim 26 above in the body of the action) so as to enable better consistency between runs and higher throughput.
Thus, Examiner sets forth the rejection of Claims 26-29, 31-32, and 36-40 as unpatentable under 35 USC 103 over Veritach in view of Putnam, Martin, and Luitjens, as discussed above in the body of the action and as necessitated by Applicant’s amendments.
Further in view of the above, Applicant’s arguments that Claims 27-39 and 31-32 are allowable for their dependence on the allegedly allowable Claim 26 are moot as Claim 26 is set forth as rejected under the new grounds of rejection under 35 USC 103 as discussed above.
New Claims
Similarly, as in the dependent claims discussed above, Applicant’s arguments that new Claims 36-43 are allowable for their dependence on the allegedly allowable Claim 26 are moot as Claim 26 is set forth as rejected under the new grounds of rejection under 35 USC 103 as discussed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN JOSEPH KASS whose telephone number is (703)756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jill Warden, can be reached at telephone number (703)756-5501. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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