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 .
Response to Amendment
The Amendment filed 7/23/2026 has been entered. Claims 1-28 and 32-34 remain pending in the application. Applicant’s amendments to the Specification and Claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 3/24/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/23/2026 and 3/24/2026 were filed after the mailing date of the Non-Final Office Action on 3/24/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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, 6-15, 18, 19, 22-24 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Kriesel (US 5,569,236) in view of Kent (EP 1807178 B1).
Regarding claim 1, Kriesel teaches a neurosurgical apparatus (figures 8, 11, 18-19) comprising: a cannula 229 (figure 19);
a variable volume fluid dispenser (figures 8, 11, 18-19) for medical therapy and diagnostic use, wherein the variable volume fluid dispenser comprises:
a tubular body (body of elements 104, 180) having a proximal end 104b, 180a and a distal end 104c, 180b wherein the tubular body (body of elements 104, 180) defines an interior volume (hollow portion inside elements 104, 180) between the proximal end and the distal end;
a fluidic connector 112, 132, 130, 194, 196, 198, 166, 216, 200a, 220 (or 201 engaged with element 227) on each of the proximal end and the distal end; and
a piston 106, 182, “P” located within the interior volume,
further wherein;
the piston is configured to move axially between the proximal end and the distal end (column 12, lines 32-36) under the action of fluid displacement via the fluidic connectors, wherein the piston position relative to the distal end defines the volume (volume occupied by fluid/drug) of fluid to be dispensed,
the cannula 229 is configured for connection to the distal end fluidic connector 104c.
Kriesel is silent regarding a cannula comprising a bubble vent configured to prevent gas and/or micro-organisms from entering the cannula, the cannula is configured to connection to the distal end fluidic connector via the bubble vent; the bubble vent comprises a first membrane and a second membrane separated by an air gap; the first membrane is hydrophobic and the second membrane is hydrophilic and the first membrane and the second membrane are arranged such that fluid entering the bubble vent passes through the first membrane before reaching the second membrane.
However Kent teaches a design of a liquid gas separator device (figure 2A) wherein the cannula 112 (figure 1) comprising a bubble vent 110 configured to prevent gas and/or micro-organisms from entering the cannula (paragraph 0014, lines 2-5); the cannula 112 is configured to connection to the distal end fluidic connector (connection that enables connecting to element 108) via the bubble vent 110, the bubble vent comprises a first membrane 204 and a second membrane 206 separated by an air gap 208a, the first membrane 204 is hydrophobic (paragraph 0020, lines 2-3) and the second membrane 206 is hydrophilic (paragraph 0023, lines 3-5) and the first membrane 204 and the second membrane 206 are arranged such that fluid entering the bubble vent passes through the first membrane 204 before reaching the second membrane 206 for the purpose of removing air bubbles from the fluid prior to delivering the fluid to the patient (paragraph 0014, line 2-last line).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the cannula of Kriesel to incorporate a cannula comprising a bubble vent configured to prevent gas and/or micro-organisms from entering the cannula, the cannula is configured to connection to the distal end fluidic connector via the bubble vent; the bubble vent comprises a first membrane and a second membrane separated by an air gap; the first membrane is hydrophobic and the second membrane is hydrophilic and the first membrane and the second membrane are arranged such that fluid entering the bubble vent passes through the first membrane before reaching the second membrane as taught by Montalvo for the purpose of removing air bubbles from the fluid prior to delivering the fluid to the patient (paragraph 0014, line 2-last line).
Regarding claim 2, Kriesel teaches wherein the piston 106, 182, “P” is operable to divide the interior volume into a proximal volume (volume between element 106, 182, “P” and end at element 104c, 180b) and a distal volume (volume between element 106, 182, “P” and end at element 104b, 180a), wherein the volume of the fluid to be dispensed (volume of fluid/medication inside the chamber will be less than entire volume in the hollow portion inside elements 180 and 104 because the portion of the volume inside elements 180 and 104 will be occupied by piston 106, 182, “P”), which is less than the capacity of the interior volume is contained in the distal volume.
Regarding claim 3, Kriesel teaches wherein the tubular body is formed from a rigid pharmacologically inert material (column 9, lines 11-13, “glass”).
Regarding claim 4, Kriesel teaches wherein the tubular body is made of glass (column 9, lines 11-13, “glass”).
Regarding claim 6, Kriesel teaches wherein the tubular body is made of plastic (column 9, lines 11-13, “plastic”).
Regarding claim 7, Kriesel teaches wherein the tubular body is made of laboratory grade polypropylene and/or polyethylene resins (column 9, lines 49-52).
Regarding claim 8, Kriesel teaches wherein one or both fluidic connectors comprise a hollow needle 229 (figure 19).
Regarding claim 9, Kriesel teaches wherein one or both fluidic connectors comprise a seal 216 pierceable by a hollow needle 214.
Regarding claim 10, Kriesel teaches wherein one or both fluidic connectors comprise a split seal 216 that can be opened to facilitate fluid flow.
Regarding claim 11, Kriesel teaches wherein one or both of the fluid connectors comprise a valve (figure 10A), which can be opened/activated by connection to an activating reciprocal connecting member 140 (column 12, line 65-column 13, line 8).
Regarding claim 12, Kriesel teaches wherein the valve is a mechanical valve, which requires physical activation of the valve to permit fluid flow (column 11, lines 27-31, column 12, line 65-column 13, line 18).
Regarding claim 13, Kriesel teaches wherein the valve is a pressure sensitive valve, which is operable to open upon fluid flow and to close when the fluid flow stops (column 11, lines 27-31, column 12, line 65-column 13, line 18).
Regarding claim 14, Kriesel teaches wherein one or both of the fluidic connectors comprise a needleless connector, 194, 196, 198, 216, 220.
Regarding claim 15, Kriesel teaches wherein one or both of the fluidic connectors comprise a removable cap 220.
Regarding claim 18, Kriesel discloses wherein the proximal end connecting member 200a is a fitting 202, which is configured to connect with a reciprocal fitting (fitting on element 104 that allows connection with element 220).
Kriesel is silent regarding the fitting and a reciprocal fitting being a Luer fitting in one embodiment. However, Kriesel teaches in a different embodiment (figure 8) wherein the fitting is a Luer fitting (column 10, lines 15-20) for the purpose of using a well-known form of an alternative fitting (column 10, lines 15-20).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the fitting type of one embodiment of Kriesel to incorporate a Luer fitting as taught by different embodiment of Kriesel for the purpose of using a well-known form of an alternative fitting (column 10, lines 15-20).
Regarding claim 19, Kriesel teaches wherein the distal end connecting member is a Luer fitting (column 10, lines 15-23), which is configured to connect with a reciprocal Luer fitting.
Regarding claim 22, Kriesel teaches wherein the piston 106 includes a perimeter seal member 106a operable to create a fluid and gas seal within the interior volume of the tubular body.
Regarding claim 23, Kriesel teaches wherein the perimeter seal member 106a includes one or more contact surfaces (surface of element 106a).
Regarding claim 24, Kriesel teaches wherein the perimeter seal 106a is configured with low friction properties, such that movement of the piston 106 relative to the inner surface of the dispenser is free with very little resistance under the action of the fluid displacement via the fluidic connectors (column 10, lines 6-15).
Regarding claim 29, Kriesel teaches further comprising a cannula 229 (figure 19) for connection to the distal fluidic connector (element 201 engaged with element 227).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kriesel (US 5,569,236) in view of Kent (EP 1807178 B1) and further in view of Ericson et al. (US 2,017,276).
Regarding claim 17, Kriesel/Kent (hereinafter referred as “modified Kriesel”) discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Kriesel is silent regarding wherein the distal end fluidic connector includes a connecting member incorporating a hollow needle configured to pierce a pierceable reciprocal connecting member provided on apparatus to which the dispenser is to be connected.
However, Ericson teaches wherein the distal end fluid connector 15 includes a connecting member 13a incorporating a hollow needle 13 (element 13 is configured to perform the function as claimed in claim 17) configured to pierce a pierceable reciprocal connecting member provided on apparatus to which the dispenser is to be connected for the purpose of using a well-known alternative connection means to establish fluidic connection with the tubular body (figure 1, page 1, second column, lines 18-34).
Therefore, it would have been prima facie obvious to modify the distal end fluidic connector of modified Kriesel to incorporate wherein the distal end fluidic connector includes a connecting member incorporating a hollow needle configured to pierce a pierceable reciprocal connecting member provided on apparatus to which the dispenser is to be connected as taught by Ericson for the purpose of using a well-known alternative connection means to establish fluidic connection with the tubular body (figure 1, page 1, second column, lines 18-34).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kriesel (US 5,569,236) in view of Kent (EP 1807178 B1) and further in view of Tischlinger (US 3,885,297).
Regarding claim 5, modified Kriesel discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Kriesel is silent regarding wherein the tubular body is made of borosilicate glass.
However, Tischlinger teaches a design of a syringe in background wherein the body is made of borosilicate glass (column 1, lines 35-38) for the purpose of manufacturing a tubular body having high order of chemical inertness (column 1, lines 35-38).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the glass material of modified Krisel to incorporate borosilicate glass as taught by Tischlinger for the purpose of a tubular body having high order of chemical inertness (column 1, lines 35-38).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kriesel (US 5,569,236) in view of Kent (EP 1807178 B1) and further in view of Gibson (US 2015/0374919 A1).
Regarding claim 16, modified Kriesel discloses the claimed invention substantially as claimed, as set forth above in claim 1. Kriesel further discloses the end fluidic connector 220 including vents for gas passage (column 14, lines 66-67) but is silent regarding wherein the proximal end fluidic connector comprises a septum stopper pierceable by a hollow needle.
However, Gibson teaches a design of a dispenser (figure 9) comprising a fluidic connector 656 comprises a septum stopper 656 pierceable by a hollow needle 702 for the purpose of storing the hollow needle into the sterile environment (paragraph 0071) and reduce the time and material needed for preparing the dispenser to dispense the fluid (paragraph 0004).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the proximal end fluidic connector of modified Kriesel to incorporate a septum stopper pierceable by a hollow needle as taught by Gibson for the purpose of storing the hollow needle into the sterile environment (paragraph 0071) and reduce the time and material needed for preparing the dispenser to dispense the fluid (paragraph 0004).
While Kriesel discloses the distal end fluidic connector including vents, it would be obvious to one of ordinary skill in the art to modify the proximal end fluidic connector of Kriesel to incorporate vents as taught by different part of Kriesel for the purpose of releasing any gas/air from the solution (column 14, lines 66-67).
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Kriesel (US 5,569,236) in view of Kent (EP 1807178 B1) and further in view of McNaughton (US 5,024,660).
Regarding claim 20, modified Kriesel discloses the claimed invention substantially as claimed, as set forth above in claim 1. Kriesel is silent regarding wherein at least an axial portion of the tubular body is transparent and includes markings internally or externally to indicate the position of a distal end of the piston, thereby indicating volume of the fluid to be dispensed.
However, McNaughton teaches a design of a dispenser (figure 1) wherein at least an axial portion of the tubular body is transparent (column 2, lines 43-47) and includes markings 14 internally or externally to indicate the position of a distal end of the piston, thereby indicating volume of fluid to be dispensed for the purpose of determining the fluid inside the tubular body (column 2, lines 43-47).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the tubular body of modified Kriesel to incorporate wherein at least an axial portion of the tubular body is transparent and includes markings internally or externally to indicate the position of a distal end of the piston, thereby indicating volume of fluid to be dispensed as taught by McNaughton for the purpose of determining the fluid inside the tubular body (column 2, lines 43-47).
Regarding claim 21, modified Kriesel discloses the claimed invention substantially as claimed, as set forth above in claim 1. Kriesel is silent regarding wherein the markings include a calibrated scale including graduated marks.
However, McNaughton teaches wherein the markings include a calibrated scale including graduated marks 14 (markings has to be calibrated scale in order to accurately calculate the volume inside the tubular body) for the purpose of determining the fluid inside the tubular body (column 2, lines 43-47).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the tubular body of modified Kriesel to incorporate wherein the markings include a calibrated scale including graduated marks as taught by McNaughton for the purpose of determining the fluid inside the tubular body (column 2, lines 43-47).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Kriesel (US 5,569,236) in view of Kent (EP 1807178 B1) and further in view of Gray (US 2003/0139706 A1).
Regarding claim 25, modified Kriesel discloses the claimed invention substantially as claimed, as set forth above in claims 1, 22 and 24. Modified Kriesel is silent regarding wherein at least an outer surface of the perimeter seal includes glass.
However, Gray teaches a design of a dispenser (figure 1) wherein at least on outer surface of the perimeter seal includes glass (paragraph 0084, entire piston and all other components of Gray’s dispenser can be made from glass, “glass materials”) for the purpose of using a well-known alternative material for designing perimeter seal (paragraph 0084).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the material of the outer surface of the perimeter seal of modified Kriesel to include glass as taught by Gray for the purpose of using a well-known alternative material for designing the perimeter seal (paragraph 0084).
Claims 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Kriesel (US 5,569,236) in view of Kent (EP 1807178 B1) and further in view of Cowan et al. (US 2013/0126559 A1).
Regarding claim 26, modified Kriesel discloses the claimed invention substantially as claimed, as set forth above in claims 1, 22 and 24. Kriesel is silent regarding wherein at an outer surface of the perimeter seal includes polytetrafluoroethylene (PTFE).
However, Cowan teaches a design of a dispenser (figure 1) wherein at an outer surface of the perimeter seal 22 includes polytetrafluoroethylene (PTFE) (paragraph 0034, lines 3-9) for the purpose of using a well0known alternative material to design the perimeter seal that provides appropriate sealing properties (paragraph 0034, lines 1-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the material of an outer surface of the perimeter seal of modified Kriesel to incorporate polytetrafluoroethylene (PTFE) as taught by Cowan for the purpose of using a well0known alternative material to design the perimeter seal that provides appropriate sealing properties (paragraph 0034, lines 1-9).
Regarding claim 27, Kriesel discloses the claimed invention substantially as claimed, as set forth above in claims 1, 22 and 24. Kriesel is silent regarding wherein at an outer surface of the perimeter seal includes polytetrafluoroethylene (PTFE).
However, Cowan teaches a design of a dispenser (figure 1) wherein at an outer surface of the perimeter seal 22 includes polytetrafluoroethylene (PTFE) (paragraph 0034, lines 3-9) for the purpose of using a well-known alternative material to design the perimeter seal that provides appropriate sealing properties (paragraph 0034, lines 1-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the material of an outer surface of the perimeter seal of Kriesel to incorporate polytetrafluoroethylene (PTFE) as taught by Cowan for the purpose of using a well-known alternative material to design the perimeter seal that provides appropriate sealing properties (paragraph 0034, lines 1-9).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Kriesel (US 5,569,236) in view of Kent (EP 1807178 B1) and further in view of Hamacher et al. (US 2005/0167267 A1).
Regarding claim 28, modified Kriesel discloses the claimed invention substantially as claimed, as set forth above in claims 1, 22 and 24. Modified Kriesel is silent regarding wherein at least an outer surface of the perimeter seal includes polyether ether ketone (PEEK).
However, Hamacher teaches a design of a dispenser (figure 1) comprising wherein at least an outer surface of the perimeter seal includes polyether ether ketone (PEEK) (paragraph 0018, lines 2-4) for the purpose of designing a perimeter seal using a chemically inert material (paragraph 0018, lines 2-4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the material of an outer surface of the perimeter seal of modified Kriesel to incorporate polyether ether ketone as taught by Hamacher for the purpose of designing a perimeter seal using a chemically inert material (paragraph 0018, lines 2-4).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Kriesel (US 5,569,236) in view of Kent (EP 1807178 B1) and further in view of Montalvo (US 2016/0144102 A1).
Regarding claim 34, modified Kriesel discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Kriesel is silent regarding wherein the bubble vent is permanently joined to and/or integrally formed with the cannula.
However Montalvo teaches a design of a fluid conduit assembly wherein the bubble vent (entire structure of element 900 shown in figure 6 except for elements 908 and 914) is permanently joined to and/or integrally formed with the cannula 908 (see figure 6, paragraph 0030) for the purpose of permanently connecting to the infusion device thereby removing air bubbles from the fluid prior to delivering the fluid to the patient (paragraph 0004, lines 1-5).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the cannula of Kriesel to incorporate wherein the cannula comprises a septum-sealed connector configured to prevent gas and/or micro- organisms from entering the cannula, wherein the septum-sealed connector comprises a first membrane and a second membrane separated by an air gap, wherein the first membrane is hydrophobic and the second membrane is hydrophilic as taught by Montalvo for the purpose of permanently connecting to the infusion device thereby removing air bubbles from the fluid prior to delivering the fluid to the patient (paragraph 0004, lines 1-5).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the arguments do not apply in view of the present rejection.
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 NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
