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 .
Claims 1-20 are hereby under examination.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an 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:
“an infusion module” in claim 5
“a diagnostic module” in claim 6
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.
An infusion module is interpreted to be a fluid bag with an extension tube and a pump (Fig. 1 and [0029]; infusion module contains extension tube 22 and pump 20).
A diagnostic module is interpreted to be a blood collection reservoir, a sensor, and extension tube (Fig. 1 and [0032]-[0036], diagnostic module contains extension tubing 36, blood collection reservoir 28, pump 63, and sensor 62)
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 following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1, 14, and 17 recites “the blood withdrawal fluid pathway being downstream of the infusion fluid pathway”. However, the blood withdrawal fluid pathway isn’t entirely downstream of the infusion pathway (Fig. 4C). As such, the claimed invention in which the blood withdrawal fluid pathway is fully downstream of the infusion fluid pathway is not included in the original disclosure. Claims 2-13, 15-16, and 18-20 are rejected based upon their dependencies on the rejected claims.
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.
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 1-7 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over US20120016213A1 (Burkholz, Jonathan K.), as cited by Applicant and hereto referred as Burkholz, and in view of US20120065482A1 (Robinson et. al), previously cited and hereto referred as Robinson, and in view of US6364861B1 (Feith et. al), previously cited and hereto referred as Feith.
As to claims 1 and 14, Burkholz teaches A catheter system, comprising: a catheter hub comprising a distal end and a proximal end (Burkholz, Fig. 5, IV catheter system 70; catheter assembly 76);
a catheter extending from the distal end of the catheter hub (Burkholz, Fig. 5, catheter 74)
an adapter in fluid communication with the catheter hub and the catheter, wherein the adapter comprises a first proximal port, a second proximal port, and a distal port (Burkholz, Fig. 5, Y adapter 80; access port 86; access port 82; the examiner notes, access port 86 is interpreted as the second proximal port), wherein a blood withdrawal fluid pathway extends through the second proximal port and the distal port (Burkholz, Fig. 5, blood test member 32 is inserted through port 86 where the blood flows):
However, Burkholz does not expressly teach that an infusion fluid pathway extends through the first proximal port, although Burkholz hints doing so (Burkholz, [0031], “…fluids or medicaments are administered to the patient.”). Robinson teaches a relevant art of blood pump system (Robinson, title). Robinson teaches an infusion fluid pathway extends through a proximal port and the distal port (Robinson, Fig. 90 and [0492], the examiner notes, the pathway of T-junction connected to the maintenance solution is interpreted as the infusion fluid pathway). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burkholz in view of Robinson to include a infusion fluid pathway because Burkholz teaches administering fluid or medicament and using a y adapter, and delivering the fluid or medicament using a first proximal port infusion fluid pathway allows for preventing mixing of the fluid or medicament with blood.
Burkholz-Robinson does not teach the blood withdrawal fluid pathway being downstream of the infusion fluid pathway. Feith teaches a relevant art of infusion valves (Feith, abstract). Feith teaches blood withdrawal fluid pathway being downstream of the infusion fluid pathway (Feith, col. 4, lines 64-67, “The manifold 18 is intended to be connected in the IV line 16 and oriented with the check valve 76 connected to the upstream side of the line 16.”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burkholz-Robinson in view of Feith to include blood withdrawal fluid pathway being downstream of the infusion fluid pathway because doing so would ensure that the infusion fluid would flow only down, not upstream as recognized by Feith (Feith, col. 1, lines 23-25, “This ensures that the injectate flows downstream toward the patient, not upstream toward the IV reservoir.”)
Burkholz-Robinson teaches ports containing valves (Burkholz, [0030], “Access ports can include open and closed ports, including ports that provide selective access to the IV system 20, such as access ports having one or more valves, septa, or other like barriers.”; Robinson, Fig. 90, check valves; the examiner notes, refer to Robinson Fig. 87 for check valve symbol.). However, Burkholz-Robinson does not teach a one-way septum disposed in the first proximal port and a two-way septum disposed in the second proximal port. Feith teaches a first proximal port with a one-way septum and a second proximal port with a two-way septum (Feith, Fig. 4, connector 22 has check valve 76; the examiner notes, check valve is a one-way valve; Fig. 8, port 32 has two-way valve 74; col. 2, lines 5-8, “Under some circumstances, it is desirable to have an injection port, such as the port 32, function not only to receive injectate into the flow channel 49, but also to aspirate or withdraw fluid from the flow channel 4”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burkholz-Robinson in view of Feith to include a first proximal port and a second proximal port with a one-way valve and a two-way valve, respectively, because doing so would allow administering fluid and medication through the one-way valve without concerns for fluid reflux, while being able to aspirate blood from the two-way port.
Burkholz-Robinson-Feith teaches the two-way septum is a passive septum configured to automatically open in response to a flow of blood (Feith, Figs. 15-16 and col. 6, lines 16-36) in a proximal direction through the blood withdrawal fluid pathway (Feith, col. 1, line 52, “withdraw a blood sample”; the examiner notes, Feith teaches two-way septum passively automatically opening during aspiration and also teaches the purpose of aspiration including blood withdrawal).
As to claim 2, Burkholz-Robinson-Feith teaches further comprising an extension tube, wherein the extension tube comprises a distal end coupled to the catheter hub and a proximal end coupled to the distal port of the adapter (Burkholz, Fig. 5, extension tubing 78).
As to claims 3 and 15, Burkholz does not teach that the first proximal port is aligned with the distal port and the infusion fluid pathway is straight. However, Feith teaches the first proximal port is aligned with the distal port and the infusion fluid pathway is straight (Feith, Fig. 3, flow channel 49 is straight). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Burkholz in view of Feith to include straight infusion fluid pathway because doing so is one of many methods of designing a y-adapter with predictable outcomes of allowing for fluid to flow through.
As to claims 4 and 16, Burkholz-Robinson-Feith teaches the second proximal port comprises a side port disposed between the first proximal port and the distal port (Burkholz, Fig. 5, side port 86 is between access port 82 and the distal port that is connected to tubing 78).
As to claim 5, Burkholz does not teach an infusion module and a diagnostic module with extension tubes. However, Robinson teaches an infusion module, wherein the infusion module comprises a first extension tube configured to direct a first fluid in a distal direction through the infusion fluid pathway for infusion into a patient's vasculature; and a diagnostic module, wherein the diagnostic module comprises a second extension tube configured to direct blood in a proximal direction from the patient's vasculature through the blood withdrawal fluid pathway (Robinson, Fig. 90 and [0492], “In addition to providing the glucose sensor with non-blood based calibration solutions this system can also enable the calibration of the device using blood. In operation the blood sample can be withdrawn from the patient and exposed to the analyte sensor.”; the examiner notes, blood is drawn to the blood reservoir in a proximal direction, and maintenance solution is provided in a distal direction). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Burkholz in view of Robinson to include an infusion module and a diagnostic module with extension tubes because doing so would allow for detecting the amount of glucose needed in the blood and delivering the necessary medication.
As to claim 6, Burkholz-Robinson-Feith teaches distal end of the first extension tube is coupled to the first proximal port and a distal end of the second extension tube is coupled to the second proximal port (Robinson, Fig. 90, the extension tubes from the maintenance solution and saline is coupled to the T-juction).
As to claim 7, Burkholz-Robinson-Feith teaches the infusion module comprises at least one of a first pump and a gravity-based device to direct the fluid in the distal direction through the infusion fluid pathway (Robinson, Fig. 90, maintenance solution is hanging above and uses gravity to direct the first fluid in distal direction; [0582], “This fluid infusion can be accomplished by gravity flow, a pressurized bag or other means”).
As to claim 8, Burkholz-Robinson-Feith teaches the diagnostic module is configured to apply a pressure differential across the two-way septum to open the two-way septum (Feith, Fig. 8, port 32 has two-way valve 74; col. 6, lines 29-32, “Under the fluid pressure of an injectate, as illustrated by an arrow 112 in FIG. 15, the valve element 74 is bent downwardly opening the first seal at the first valve seat 110.”) and direct blood in the proximal direction through the blood withdrawal fluid pathway (Robinson, Fig. 90, the pump applies pressure draw blood to the blood reservoir)
As to claim 9, Burkholz-Robinson-Feith teaches the diagnostic module further comprises a second pump to push a second fluid in the distal direction through the blood withdrawal fluid pathway to reinfuse the blood into the patient's vasculature (Robinson, [0492], “Following this baseline measurement a predetermined amount of glucose can be added to the blood as it is pushed back towards the patient…”; Fig. 90, a second pump; [0318], “The pump (3) operates to draw saline from the container (4) and push the blood back into the patient through junction (13) and catheter (12). After a sufficient quantity of blood has been reinfused (e.g., by volume, or by acceptable blood/saline mixing threshold)…”)
As to claim 10, Burkholz-Robinson-Feith teaches the diagnostic module further comprises at least one sensor to perform a diagnostic test on the blood (Robinson, Fig. 90, analyte sensor; the examiner notes, the diagnostic module is interpreted to include extension tubing, blood collection reservoir, pump, and sensor).
As to claim 11, Burkholz-Robinson-Feith teaches a saline flush device, wherein the second pump is configured to reintroduce blood into the blood withdrawal pathway and distally through the catheter via the saline flush device (Robinson, Fig. 90, the bag holding the saline is interpreted as a saline flush device; [0492], “Following this baseline measurement a predetermined amount of glucose can be added to the blood as it is pushed back towards the patient…”).
As to claims 12-13, Burkholz-Robinson-Feith teaches the saline flush device is embedded in the second pump of the diagnostic module (Robinson, Fig. 90, the saline bag is connected to the second pump) and the saline flush device is separate from the the diagnostic module (Robinson, Fig. 90, the saline solution bag is not attached to the sensor, which is interpreted as part of the diagnostic module).
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of US6033561A (Schoendorfer, Donald W.), previously cited and hereto referred as Schoendorfer, and in view of Feith.
As to claim 17, Robinson teaches a method to facilitate fluid infusion and blood withdrawal, comprising: priming an adapter (Robinson, [0310], “The description assumes a primed state of the system”; Fig. 3, junction 13)
directing a first fluid in a distal direction through the infusion pathway to infuse the first fluid into a patient's vasculature;
withdrawing blood from the patient's vasculature in a proximal direction through the blood withdrawal fluid pathway to direct the blood into a blood collection reservoir (Robinson, [0318], “In operation, the pump (3) operates to draw blood from the patient through the catheter (12) and junction (13) into the left side (2) of the system.”);
performing an analysis of the blood in the blood collection reservoir (Robinson, [0318], “The sensor (1) determines a desired property of the blood, e.g., the glucose concentration in the blood.”); and
after performing the analysis, pushing a second fluid in the distal direction through at least one of the blood collection reservoir and the blood withdrawal fluid pathway to reinfuse the blood into the patient's vasculature (Robinson, [0318], “The pump (3) operates to draw saline from the container (4) and push the blood back into the patient through junction (13) and catheter (12).”).
Robinson does not expressly teach directing a first fluid in a distal direction through the infusion pathway to infuse the first fluid into a patient's vasculature, although Robinson hints at it (Robinson, Fig. 90, maintenance solution provides a first fluid). Schoendorfer teaches a relevant art of withdrawing blood (Schoendorfer, abstract). Schoendorfer teaches directing a first fluid in a distal direction through the infusion pathway to infuse the first fluid into a patient's vasculature (Schoendorfer, col. 8, lines 65-66, “anticoagulant solution may be pumped from anti coagulant reservoir 212A”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Robinson in view of Schoendorfer to include directing a first fluid in a distal direction through the infusion pathway to infuse the first fluid into a patient's vasculature so that preparation for withdrawing blood can be done, such as infusing anticoagulant.
Robinson-Schoendorfer does not teach that the adapter comprises: a first proximal port; a second proximal port; and a distal port, wherein an infusion fluid pathway extends between the first proximal port and the distal port, wherein a blood withdrawal fluid pathway extends between the second proximal port and the distal port; a one-way septum disposed in the first proximal port and configured to open to allow fluid flow in a distal direction at a pressure differential across the one-way septum, wherein the one-way septum is disposed within the infusion fluid pathway; and a two-way septum disposed in the second proximal port, wherein the two-way septum is disposed within the blood withdrawal fluid pathway.
Feith teaches an injection adapter that comprises: a first proximal port (Feith, Fig. 3, connector 22); a second proximal port (Feith, Fig. 3, port 32); and a distal port (Feith, Fig. 3, connector 24), wherein an infusion fluid pathway extends between the first proximal port and the distal port (Feith, Fig. 3, flow channel 49), wherein a blood withdrawal fluid pathway extends between the second proximal port and the distal port (Feith, Fig. 5, flow path from cylinder 54 to connector 24); a one-way septum disposed in the first proximal port and configured to open to allow fluid flow in a distal direction at a pressure differential across the one-way septum (Feith, Fig. 4, check valve 76; the examiner notes, a check valve opens by using a pressure differential), wherein the one-way septum is disposed within the infusion fluid pathway (Feith, Fig. 4, check valve 76 is between connector 22 and connector 24); and a two-way septum disposed in the second proximal port, wherein the two-way septum is disposed within the blood withdrawal fluid pathway (Feith, col. 2, lines 9-11, “An infusion/aspiration port is preferably disposed upstream of the other injection ports and downstream of the check valve.”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Robinson-Schoendorfer in view of Feith to include the above adapter because doing so would allow administering fluid and medication without concerns for fluid reflux through the first proximal port, while being able to aspirate blood from the two-way port.
Robinson-Schoendorfer does not teach the blood withdrawal fluid pathway being downstream of the infusion fluid pathway. Feith teaches a relevant art of infusion valves (Feith, abstract). Feith teaches blood withdrawal fluid pathway being downstream of the infusion fluid pathway (Feith, col. 4, lines 64-67, “The manifold 18 is intended to be connected in the IV line 16 and oriented with the check valve 76 connected to the upstream side of the line 16.”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Robinson-Schoendorfer in view of Feith to include blood withdrawal fluid pathway being downstream of the infusion fluid pathway because doing so would ensure that the infusion fluid would flow only down, not upstream as recognized by Feith (Feith, col. 1, lines 23-25, “This ensures that the injectate flows downstream toward the patient, not upstream toward the IV reservoir.”)
Robinson-Schoendorfer-Feith teaches the two-way septum is a passive septum configured to automatically open in response to a flow of blood (Feith, Figs. 15-16 and col. 6, lines 16-36) in a proximal direction through the blood withdrawal fluid pathway (Feith, col. 1, line 52, “withdraw a blood sample”; the examiner notes, Feith teaches two-way septum passively automatically opening during aspiration and also teaches the purpose of aspiration including blood withdrawal).
As to claim 18, Robinson-Schoendorfer-Feith teaches directing the first fluid in the distal direction comprises utilizing a flow of the first fluid to open a one-way septum disposed within the first proximal port (Feith, col. 4, lines 64-67, “The manifold 18 is intended to be connected in the IV line 16 and oriented with the check valve 76 connected to the upstream side of the line 16.”).
As to claim 19, Robinson-Schoendorfer-Feith teaches in response to utilizing a flow of the first fluid to open the one-way septum, the two-way septum remains closed (Feith, col. 6, lines 26-29, “In its normal state, the port 32 is positioned with the valve element 74, biased to form a first seal with the first valve seat 110 and a second seal with third valve seat 103 as illustrated in FIG. 14.”)
As to claim 20, Robinson-Schoendorfer-Feith teaches in response to pushing the second fluid in the distal direction through at least one of the blood collection reservoir and the blood withdrawal fluid pathway to reinfuse the blood into the patient's vasculature, the one-way septum remains closed (Feith, col. 5, lines 61-65, “When an injectate is introduced through one of the adjacent ports, such as port 30 or 32, a relatively high pressure occurs in the flow channel 49. By operation of the check valve 76, this pressure is exerted against the underside of the valve element 70 of the port 27.”).
Response to Arguments
Applicant's arguments filed 3/3/2026 have been fully considered but they are not persuasive.
As to the 103 rejections, applicant alleges on pg. 8, Applicant alleges, “As agreed to during the Interview, Feith does not disclose the claimed features of "the blood withdrawal fluid pathway being downstream of the infusion fluid pathway" and "wherein the two-way septum is a passive septum configured to automatically open in response to a flow of blood in a proximal direction through the blood withdrawal fluid pathway"”. However, upon further search and consideration where the infusion pathway is interpreted as access port 82 and blood withdrawal fluid pathway as access port 86 in Fig. 5, as taught by Burkholz, Burkholz in view of Feith does teach that blood withdrawal fluid pathway being downstream of the infusion fluid pathway. In Fig. 1 of Feith, the check valve is located in upstream at the top of manifold 18, and the injectate/aspiration port is located downstream of manifold 18. In Fig. 4 of Feith, check value 76 is located in the infusion fluid pathway, upstream of two-way injectate/aspiration port 32.
Additionally, Feith teaches that the two-way septum is a passive septum because the operation of the valve elements are passive (Feith, col. 6, lines 29-33, “Under the fluid pressure of an injectate, as illustrated by an arrow 112 in FIG. 15, the valve element 74 is bent downwardly opening the first seal at the first valve seat 110."; col. 6, lines 37-38, "Aspiration is accommodated by applying a suction to the lumen 61 as illustrated by an arrow 114 in FIG. 16.”; also refer to Figs. 12-18)
As such, the combination of the cited references does teach the amended claim, and the rejection is maintained.
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 ELINA S JANG whose telephone number is (571)272-7019. The examiner can normally be reached M-F 9:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELINA SOHYUN JANG/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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