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 on 07/20/2026 has been entered. Claims 1, 4, 8, and 12 have been amended. Claims 2, 3, 7, 9-11 are in the original/previously presented form. Claims 5-6 are cancelled. Claims 21-22 are newly presented. Thus, claims 1-4, and 7-22 remain pending in the application. Of these claims, claims 13-20 are withdrawn from consideration.
Drawings
The amendments to the drawings were received on 07/20/2026. Applicant addressed all previous objections. However, new objections have been raised on the amended drawings.
The drawings are objected to because the “mixing lumen” is never clearly identified in the figures. The examiner believes FIG. 4A - Fig. 5 give the closest view to where the mixing lumen may be based off a description in the specification, specifically in [0086], [0090], [0091], [0094], and [00102]. However, with no reference number, identifying marker, or figure that clearly states, “mixing lumen”, it is difficult for the examiner to understand what is being claimed by the applicant. The examiner suggests modifying the figures to clearly identify where the mixing lumen is, or providing an additional figure.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show how barrier 175 is able to open, thereby allowing constituents from the proximal and distal portions 127a, 127b to intermix as described in the specification, specifically [0088], [0089], and [00101]. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). The specification states the barrier is “associated with stopper 168” ([0088]). However, FIG. 3 depicts the first plunger stopper 164 and the second plunger stopper 168 as indistinguishable. The arrow simply identifying a distal end of the second plunger stopper 168 does not provide enough context to understand how the barrier allows for passage of constituent, considering the distal end of the second plunger stopper 168 appears visually indistinct from the distal end of the first plunger stopper 164, which has not disclosed having the ability of allowing for passage of constituent. The examiner suggests providing an additional figure displaying the novelty of the barrier 175.
The drawings are objected to because it is unclear to the examiner in amended FIG. 8B whether the new arrow referencing a seal or float 234 of vent 233 is identifying the rim of vent 233, an unseen inner component of vent 233, the entire raised portion itself, or another part. The examiner requires clarity in the drawing in order to properly determine what the applicant intends to claim. The examiner suggests providing an additional figure or view point that more clearly displays what is being identified as a seal or float 234.
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.
Specification
The amendments to the drawings were received on 07/20/2026. Applicant addressed all previous objections. However, new objections have been raised for the specification.
The disclosure is objected to because of the following informalities: Per 37 C.F.R. 1.52 (b)(6), the numbering of the paragraphs of the specification “should consist of at least four numerals enclosed in square brackets, including leading zeros…and should be highlighted in bold.” Therefore, [00100]-[00107] should be corrected to [0100]-[0107], and all paragraph numbers should be presented in bold.
Appropriate correction is required.
Claim Objections
Applicant is advised that should claim 2 be found allowable, claim 21 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is 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.
Regarding claim 12, the claim states that when a seal of the external vent enters a sealed state, flow of the first mixture is prevented through the external vent. However, claim 8, upon which claim 12 is dependent, states that “at least one of the first and second lumens comprises an external vent.” It would not be possible for the first mixture to pass through the external vent if the external vent is only located on the second lumen, as per the specification the first mixture is only located within the first lumen, until it is moved to a mixing lumen ([0006], [0017], [0018], [0020], [0025], [0031], [0032], [00105]). Due to this, the claim is rendered indefinite. The examiner suggests making the language of claim 12 more encompassing to the possibility of there only being one external vent located on the second lumen, which only contains a third constituent.
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 1-3, 7, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Colin et al. (United States Patent No. US 4,995,540 A; herein, Colin) and further in view of Wagner et al. (United States Patent Application Publication No. US 2008/0167621 A1; herein, Wagner), Rissman et al. (United States Patent No. US 8,376,989 B2; herein, Rissman), and Kuhn (United States Patent Application No. US 2011/0060274 A1).
Regarding claim 1, Colin discloses a system for producing a mixture to deliver to a treatment site (FIG.1, multi-barrel dispenser 10), comprising:
a mixing lumen (FIG. 1, nozzle assembly 16) comprising a distal end (FIG. 1, end of nozzle assembly 16 near spout 32) and a proximal end (FIG. 1, end of nozzle assembly 16 near head 30), and;
a multi-lumen chamber (FIG. 1, syringe 11) removably connected to and in fluid communication with the proximal end of the mixing lumen (col. 5 lines 58 61, syringe 11 is removably coupled to the nozzle assembly 16 using threads 36 and complementary threads 36) and comprising a first lumen (FIG. 1, compartment 12) aligned and adjacent a second lumen (FIG. 1, compartment 14);
the first lumen configured to comprise a first constituent in a proximal portion of the first lumen (FIG. 1, material B) and a second constituent in a distal portion of the first lumen (FIG. 1, material A), a first plunger internally positioned within the first lumen (FIG. 1, plunger 25), the first lumen terminating in a first port (FIG. 1, discharge opening 19); and
the second lumen configured to comprise a third constituent (FIG. 1, catalyst C), a second plunger internally positioned within the second lumen (FIG. 1, plunger 26) to distally move the third constituent and the first mixture in a second state (col. 4 lines 62-68, plungers 25,26 drive materials A,B,C from compartments 12,14 in unison), and the second lumen terminating in a second port (FIG. 1, discharge opening 20);
wherein distally moving the second plunger causes the first mixture and the second constituent to be delivered through the first and second ports (FIG. 1, col. 3 lines 40-55, col. 4 lines 62-68, plungers 25,26 drive materials A,B,C from compartments 12,14 in unison through discharge openings 19,20), and mixed together within the mixing lumen to form the mixture (col. 4 lines 1 14, material A,B,C moves through blades 37 with upstream and downstream edges 38,39 to mix).
Colin does not disclose a valve positioned between the proximal and distal ends, and the first plunger to control flow of the first constituent into the distal portion to mix with the second constituent in a first state to form a first mixture, and wherein the first lumen or the second lumen comprises an external vent configured to purge air from the respective first lumen or second lumen.
However, Wagner teaches a valve positioned between the proximal and distal ends (FIG. 12, valve-controlled manifold 604). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mixing lumen disclosed by Colin to include a valve-controlled manifold as taught by Wagner in order to eliminate a number of potential contamination sites and lengths of tubing necessary to be used ([0082]) by coupling the mixing lumen and valve.
Colin in view of Wagner still does not disclose the first plunger to control flow of the first constituent into the distal portion to mix with the second constituent in a first state to form a first mixture, and wherein the first lumen or the second lumen comprises an external vent configured to purge air from the respective first lumen or second lumen.
However, Rissman teaches the first plunger to control flow of the first constituent into the distal portion to mix with the second constituent in a first state (FIG. 12, col. 12 lines 49-56, S1 passes through the one or more proximal bypasses 318p to intermix with S2) to form a first mixture (col. 13 lines 4-9, “forming a predetermined volume of a first fluid conduit substance SX”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first lumen and first plunger disclosed by Colin to control the movement of the first substances to create a first mixture, separate from the movement of the second plunger in the second compartment as taught by Rissman in order to allow a first mixture to fully intermix before intermixing a third constituent (col. 12 line 49 col. 13 line 9). This is especially important for substances in which chemical components require more time to intermix before a new chemical component can be created in the new mixture.
Colin in view of Wagner and Rissman still does not disclose wherein the first lumen or the second lumen comprises an external vent configured to purge air from the respective first lumen or second lumen.
However, Kuhn teaches the first lumen or the second lumen comprises an external vent (Fig. 1, gas permeable membrane 8) configured to purge air from the respective first lumen or second lumen ([0122], air in chamber A can escape through gas permeable membrane 8). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second lumens as disclosed by Colin to have a gas permeable membrane for air release as taught by Kuhn in order to reduce positive pressure in a lumen ([0122]).
Regarding claim 2, in the modified system of Colin, Colin does not disclose the valve is a port extended outward from the mixing lumen and comprising a manually operable valve knob to open and close the port and to prevent backflow of fluid from the mixing lumen.
However, Wagner teaches the valve is a port extended outward from the mixing lumen (FIG. 12, fourth port 638) and comprising a manually operable valve knob to open and close the port and to prevent backflow of fluid from the mixing lumen (FIG. 12, actuator 630). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified mixing lumen disclosed by Colin to include a valve comprising a port and valve knob as taught by Wagner in order to facilitate the injection, extraction, or exchange of fluids, while also having the ability to alter the general fluid flow paths between the ports ([0084]-[0086]).
Regarding claim 3, in the modified system of Colin, Colin does not disclose the port oriented between approximately 30 - 90 degrees relative to the mixing lumen.
However, Wagner teaches the port oriented between approximately 30 - 90 degrees relative to the mixing lumen (FIG. 12 and FIG. 14, [0092], fourth port 638 is at a right angle with multi-barrel syringe 602 and an acute angle with third port 636). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified mixing lumen disclosed by Colin to include a valve-controlled manifold comprising a port at a right angle to the valve knob as taught by Wagner in order to create various flow arrangements and couple to multiple types of external devices ([0086]-[0088]). Further, the applicant appears to have placed no criticality on the claimed range (see applicant’s specification [0094]).
Regarding claim 7, in the modified system of Colin, Colin discloses the proximal and distal portions of the first lumen are separated by a barrier (FIG. 1, diaphragm 46); and wherein distally moving the first plunger causes the barrier to open so the first constituent mixes with the second constituent in the first state to form the first mixture (FIG. 1, col. 4 lines 21-30, material B moves through diaphragm 46 to reach material A when a driving pressure is applied).
Regarding claim 21, in the modified system of Colin, Colin does not disclose the valve includes a single fluid port and a valve knob, and wherein the valve knob is rotatable to transition the valve between an open position and a closed position.
However, Wagner teaches the valve includes a single fluid port (FIG. 12, fourth port 638) and a valve knob lumen (FIG. 12, actuator 630), and wherein the valve knob is rotatable to transition the valve between an open position (FIGS. 15-18, [0094]-[0097], fluid exchange permitted between ports) and a closed position (FIG. 14, [0093], “no flow configuration”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified mixing lumen disclosed by Colin to include a valve comprising a port and valve knob as taught by Wagner in order to facilitate the injection, extraction, or exchange of fluids, while also having the ability to alter the general fluid flow paths between the ports ([0084]-[0086]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Colin in view of Wagner, Rissman, and Kuhn as applied to claim 1 above, and further in view of Yamada (United States Patent Application Publication No. US 2004/0064102 A1).
Regarding claim 4, in the modified system of Colin, Colin does not disclose the first plunger further comprising a proximal flange positioned at a proximal end of the first plunger, the proximal flange of the first plunger being smaller than a proximal flange of the second plunger.
However, Yamada teaches the first plunger further comprising a button positioned at a proximal end of the first plunger (FIG. 1c, first plunger 22 has thumb press 22T), the button being smaller than a proximal flange of the second plunger (FIG. 1d, thumb press 22T of first plunger 22 has diameter d1 which is smaller than diameter d2 of thumb press 24T of second plunger 24). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified plungers disclosed by Colin to incorporate a button on the end of the first plunger, with the flange of the second plunger being larger in diameter than the button of the first plunger as taught by Yamada in order to more easily distinguish between the two plungers ([0022]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Colin in view of Wagner, Rissman, and Kuhn as applied to claim 1 above, and further in view of Kriesel (United States Patent No. US 5,354,278).
Regarding claim 22, in the modified system of Colin, Colin does not disclose a cap configured to seal the external vent, the cap being detachable from the external vent.
However, Kriesel teaches a cap configured to seal the external vent (FIG. 12, vent cap 139), the cap being detachable from the external vent (FIG. 24, col. 10 lines 60-61, vent cap 139 is removable). Therefore, , it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified external vent disclosed by Colin to include a detachable cap as taught by Kriesel in order to allow air within a lumen to escape (col. 10 lines 60-61).
Claims 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Colin, and further in view of Rissman and Kuhn.
Regarding claim 8, Colin discloses a system for producing a mixture to deliver to a treatment site (FIG.1, multi-barrel dispenser 10), comprising:
a mixing lumen (FIG. 1, nozzle assembly 16) comprising a distal end (FIG. 1, end of nozzle assembly 16 near spout 32) and a proximal end (FIG. 1, end of nozzle assembly 16 near head 30);
a multi-lumen chamber (FIG. 1, syringe 11) removably connected to and in fluid communication with the proximal end of the mixing lumen (col. 5 lines 58 61, ”syringe 11 is removably coupled to the nozzle assembly 16” using threads 36 and complementary threads 36) and comprising a first lumen (FIG. 1, compartment 12) aligned and adjacent a second lumen (FIG. 1, compartment 14);
the first lumen configured to comprise a first constituent in a proximal portion of the first lumen (FIG. 1, material B) and a second constituent in a distal portion of the first lumen (FIG. 1, material A), a first plunger internally positioned within the first lumen (FIG. 1, plunger 25); and
the second lumen configured to comprise a third constituent (FIG. 1, catalyst C), a second plunger internally positioned within the second lumen (FIG. 1, plunger 26) to distally move the third constituent and the first mixture in a second state (col. 4 lines 62-68, plungers 25,26 drive materials A,B,C from compartments 12,14 in unison);
wherein distally moving the second plunger causes the first mixture and the second constituent to be delivered through respective lumen ports (FIG. 1, col. 3 lines 40-55, col. 4 lines 62-68, plungers 25,26 drive materials A,B,C from compartments 12,14 in unison through discharge openings 19,20) and mixed together within the mixing lumen to form the mixture (col. 4 lines 1-14, material A,B,C moves through blades 37 with upstream and downstream edges 38,39 to mix).
Colin does not disclose the first plunger to control flow of the first constituent into the distal portion to mix with the second constituent in a first state to form a first mixture, and wherein at least one of the first and second lumens comprises an external vent in fluid communication with the respective first and second lumen so that air is purged from the respective first or second lumen through the external vent.
However, Rissman teaches the first plunger to control flow of the first constituent into the distal portion to mix with the second constituent in a first state (FIG. 12, col. 12 lines 49-56, S1 passes through the one or more proximal bypasses 318p to intermix with S2) to form a first mixture (col. 13 lines 4-9, “forming a predetermined volume of a first fluid conduit substance SX”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first lumen and first plunger disclosed by Colin to control the movement of the first constituent and second constituent to create a first mixture, separate from the movement of the second plunger in the second lumen as taught by Rissman in order to allow a first mixture to fully intermix before intermixing a third constituent (col. 12 line 49 col. 13 line 9). This is especially important for substances in which chemical components require more time to intermix before a new chemical component can be created in the new mixture.
Colin in view of Rissman still does not disclose at least one of the first and second lumens comprises an external vent in fluid communication with the respective first and second lumen so that air is purged from the respective first or second lumen through the external vent.
However, Kuhn teaches at least one of the first and second lumens comprises an external vent in fluid communication with the respective first and second lumen (Fig. 1, gas permeable membrane 8) so that air is purged from the respective first or second lumen through the external vent ([0122], air in chamber A can escape through gas permeable membrane 8). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the compartments as disclosed by Colin to have a gas permeable membrane for air release as taught by Kuhn in order to reduce positive pressure a lumen ([0122]).
Regarding claim 9, in the modified system of Colin, Colin does not disclose air is purged from the respective first or second lumen through the external vent during mixing of the first mixture and the third constituents to form the mixture.
However, Kuhn teaches air is purged from the respective first or second lumen through the external vent during mixing of the first mixture and the third constituents to form the mixture ([0122], during mixing of contents trapped air can escape by way of the membrane 8). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified first lumen or second lumen disclosed by Colin to have a gas permeable membrane for air release during mixing as taught by Kuhn in order to reduce positive pressure in a lumen during mixing ([0122]).
Regarding claim 10, in the modified system of Colin, Colin does not disclose the external vent comprising a one-way valve with an air-permeable fluid-impermeable membrane.
However, Kuhn teaches the external vent comprising a one-way valve with an air-permeable fluid-impermeable membrane ([0122], “membrane 8 is only permeable with respect to gas, but not with respect to the liquid”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified external vent disclosed by Colin to have a gas only permeable membrane for air release as taught by Kuhn in order to reduce positive pressure in a lumen and prevent leaks of liquid substances being homogeneously mixed ([0122]).
Regarding claim 11, in the modified system of Colin, Colin does not disclose unwanted air of first or second lumen is purged through the external vent by a pressure of fluid flow in the first or second lumen.
However, Kuhn teaches unwanted air of first or second lumen is purged through the external vent by a pressure of fluid flow in the first or second lumen ([0122], air in chamber A can escape through gas permeable membrane 8 as plunger forces mediums to mix). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified first lumen or second lumen disclosed by Colin to have a gas permeable membrane for air release as taught by Kuhn in order to reduce positive pressure in a lumen, specifically when fluid substances are being driven through the lumen ([0122]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Colin in view of Rissman and Kuhn as applied to claim 8 above, and further in view of Weaver et al. (United States Patent Application Publication No. US 2009/0320684 A1; herein, Weaver).
Regarding claim 12, in the modified system of Colin, Colin does not disclose after air is purged through the external vent, a seal of the external vent is automatically urged to a sealed state thereby preventing flow of the first mixture through the external vent.
However, Weaver teaches after air is purged through the external vent venting, a seal of the external vent (FIG. 3B, self-sealing vent structure 146 of self-sealing vent assembly 141) is automatically urged to a sealed state thereby preventing flow of the first mixture through the external vent ([0093], [0100], [0102], [0103]; when contacted by liquid, the self-sealing vent structure will self-seal and inhibit fluid from passing). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified external vent disclosed by Colin to have a seal capable of automatically entering a sealed state to prevent the flow of fluid as taught by Weaver in order to prevent the first mixture from leaking out of the lumen and becoming contaminated ([0093]).
Response to Arguments
Applicant's arguments filed 07/20/2026 have been fully considered but they are not persuasive.
Regarding claims 1 and 8, applicant argues on pg. 15-17 of the Remarks that “A person of ordinary skill in the art would not have contemplated or found motivation to attempt to modify Colin as proposed in the Office Action…Air distal to impression materials (A) and (B) or catalyst (C) in the compartments would be purged through spout (32) or orifice (33) when "a predetermined minimum driving force [is] applied to each compartment from a pair of plungers (25) and (26)." Colin at col. 3, II. 50-52. Colin is silent to spout (32) or orifice (33) being closed or sealed, and thus a need for "air release...in order to reduce positive pressure in compartment" is not present in Colin.”. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the particular problem of concern is there is no need to reduce positive pressure in the compartments disclosed by Colin because air will eventually be purged when the compartments open to the spout and/or orifice. This argument is not persuasive because one having ordinary skill in the art would understand that as the driving force is being applied (col. 3 lines 50-53), pressure is building in the compartments (col. 4 lines 56-58), becoming positive pressure as more force is applied. That air and pressure cannot be released to the external environment until passed through the diaphragm membranes. Colin does not specify the exact value of the “predetermined minimum driving force” needed to pass the materials and catalyst through the diaphragm membranes. This is because one having a basic understanding of pressurization would understand factors such as the volume and length of the compartments, composition of the base impression materials and catalyst, and material used to comprise the diaphragm membranes all affect how much force would be needed. Colin does not provide specific details for any of these factors, other than the compartments “being preferably of a cylindrical configuration and of equal size and volume” (col. 3 lines 38-40), a list of “Example Compositions” (col. 5), and that the diaphragm member seen in FIG. 4A “may be used” for the two diaphragm membranes (col. 3 lines 52-55), leaving all these factors open to interpretation regarding the assembly of the apparatus. Thus, the combination of the external vent taught by Kuhn and the lumens disclosed by Colin is valid, given that positive pressure may need to be released from the lumens prior to the materials passing through the diaphragm membranes dependent on the assembly of the device and the materials to be mixed. Therefore, the use of Kuhn and Colin stands in the final rejection and the rejection recited above stands.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Steffen et al. (United States Patent Application Publication No. US 2015/0094689 A1) is considered relevant prior art with regards to a dual syringe delivery device having an air source vent.
THIS ACTION IS MADE FINAL. 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 Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
Prosecution Insights