DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 8/3/2026 wherein claims 1, 12, 14 and 33 have been amended.
Claims 1, 2, 4, 5, 7, 8 and 12 are presented for examination on the merits.
The following rejections are made.
Response to Applicants’ Arguments
Applicant’s amendments filed 8/3/2026 overcomes the rejection of claim 12 made by the Examiner under 35 USC 103 over Cullis et al. (EP 2496700) in view of Markland et al. (US 2010/0003300). This rejection has been withdrawn as the combination of Cullis and Markland fails to teach a delivery system, e.g. hypodermic needle, cannula, catheter, microneedle array, as being in direct communication with the mixing channel. This rejection has been withdrawn.
Applicant’s arguments filed 8/3/2026 regarding the rejection of claims 1, 2, 4 and 5 made by the Examiner under 35 USC 102(a)(1) over Walsh et al. (US 2016/0235688) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 4/1/2026.
Applicant’s arguments filed 8/3/2026 regarding the rejection of claims 1, 2, 4, 5 and 8 made by the Examiner under 35 USC 102(a)(1) over Cullis et al. (EP 2496700) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 4/1/2026.
Applicant’s arguments filed 8/3/2026 regarding the rejection of claim 7 made by the Examiner under 35 USC 103 over Walsh et al. (US 2016/0235688) in view of Hjertman et al. (NO 308987) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 4/1/2026.
In regards to the 102(a)(1) and 103 rejections, Applicant asserts the following:
A) Walsh discloses the use of a syringe upstream at the inlet manifold solely to supply air pressure to drive mixing, not downstream as an administration device. Thus Walsh fails to disclose a delivery system downstream from and a directly in communication with the mixing channel, configured to receive components from the mixing channel for direct administration to a patient. Cullis similarly fails to teach a delivery system in direct communication with the mixing channel.
In response to A, the Examiner is not persuaded that the “delivery system” of claim 1 is all that limiting except for in the context of instant claim 12 which specifically defines the delivery system. Claim 1 simply requires “a delivery system” which is in direct communication with the mixing channel such that the “delivery system receives components from the mixing channel for direct administration to the patient”.
Walsh discloses a device which after moving through the mixing channel connects to a downstream output for diluting the mixture with an aqueous buffer. Claim 1 does not preclude this dilution well/output as being viewed as a ‘delivery system’ ‘for direct administration to a patient’ as the claim does not limit the system by which the components are to be administered. The dilution well/output could be administered to a patient, as is the intention of the apparatus, thereby making it a ‘delivery system’ capable of direct administration to a patient.
Cullis similarly provides an output in direct communication with a mixing chamber for collecting the mixture. The output for collecting the mixture subjects the mixture to dialysis. However, this collection output can be understood to be a ‘delivery system’ as claim 1 fails to define a ‘delivery system’. Thus, a collecting vessel for dialyzing the output would comprise the purified output and could, theoretically, be directly administered to a patient.
The issue with the ’delivery system’ of claim 1 is that it is not defined. Anything containing the direct output of the mixing channel can theoretically be considered a ‘delivery system’ capable of ‘direct administration to a patient’. The claimed delivery system is a critical structural limitation but is presently without structure. Absent some defining structure of what the ‘delivery system’ is, it is being interpreted broadly, such as the output/collection vessels of Walsh and Cullis.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walsh et al. (US 20160235688).
Walsh discloses a device for producing therapeutic microparticles according to the following generic structure:
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(see Figure 1).
Regarding claims 1 and 5, Walsh’s possess a plurality of inputs for combining separate liquid components, such that device comprises a first input (i.e. input 1, first chamber) providing a first input liquid into a channel adapted for flowing and a second input (i.e. input 2, second chamber) providing a second input liquid into a channel adapted for flowing wherein the first and second chambers are connected to a downstream mixing chamber (see claim 1). The first and second chambers are in fluid communication with their mixing channel, which then connects to a downstream output (i.e. delivery system) (see claim 37). The first and second inputs are to be syringes (see [0072]). Walsh states that syringes are used as they possess a plunger (i.e. piston; ‘actuator’) that forces fluids through the mixing device (see [0037]). The ‘plunger’ of Walsh is considered synonymous with the actuator ‘piston’ claimed.
Regarding claim 2 and 4, Walsh discloses a first channel connecting the first chamber to the mixing channel, and a second channel connecting the second chamber to the mixing channel (see [0087]). It is taught that the first and second channels converge into a single feed and then to the mixing channel (see [0087] and figure 1). The contents from the two chambers are then mixed with a micromixer (see claim 28) and ejected into a dilution output/buffer well. Because instant claim 1 does define a structure for the claimed ‘delivery system’, Walsh’s dilution well/output is being broadly understood as a ‘delivery system’ ‘for direct administration to a patient’ as the collected mixture of Walsh is intended to be administered. The dilution well/output could be administered to a patient, as is the intention of the apparatus, thereby making the output collection a ‘delivery system’ capable of direct administration to a patient.
Claim(s) 1, 2, 4, 5 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cullis et al. (EP 2496700).
Cullis discloses a device for making lipid particles containing a nucleic acid according to the following generic structure:
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(see Figure 1).
Regarding claims 1, 2, and 5, Cullis describes an apparatus with a plurality of chambers (e.g. region A, Region B) that combine at a mixing channel (region C, region D), where the mixing occurs downstream from the inlet chambers (see Figure 1, [0097] and Example 2). The inlet channels are in fluid communication with their respective chambers, which then converge at the mixing channel (see [0089]). A delivery system is downstream and in fluid communication with the mixing channel (see Figure 15A). Cullis also discloses a syringe pump is used to control the flow of inlet streams in the device, which has the same function as the actuator in the instant invention (plunger function of a syringe synonymous with piston) (see [0160]).
Regarding claim 4, Cullis discloses that once the contents reach the second region of the apparatus, the contents are mixed with a microfluidic mixer (see [0021] and Example 2)
Regarding claim 8, Cullis discloses that their device may possess a third inlet chamber in the mixing apparatus according to the following:
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wherein the third chamber, like the first and second chambers, is configured to allow fluids to flow from the chamber to the mixing chamber.
The outlet dispenses the mixture into a collection container for dialysis. However, this collection output can be understood to be a ‘delivery system’ as claim 1 fails to define a ‘delivery system’. Thus, a collecting vessel for dialyzing the output would comprise the purified output and could, theoretically, be directly administered to a patient.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Walsh et al. (US 20160235688) in view of Hjertman et al. (NO 308987; translation provided).
Walsh is relied upon for disclosure described in the rejection of claims 1, 2, 4 and 5 under 35 U.S.C. 102(a)(1).
Walsh fails to teach the device as comprising a biased spring coupled to the piston; and an anchor coupled to the biased spring, wherein the anchor comprises a retaining pin, wherein removing the retaining pin from the anchor is configured to release the biased spring to actuate the piston in each chamber.
Hjertman teaches a dual chamber cartridge device for mixing liquid components prior to injection wherein the chambers of the device contain a spring that pushes a piston down to expel the contents of the cartridge (see page 2). Hjertman’s device has locking (i.e. retaining) pins which serve to control the springs displacement function and provide controlled metering of liquids from the cartridge thereby reducing waste and improving metering accuracy (see page 3). The spring of the device is attached to the piston which is being interpreted as an ‘anchor’. When pressure is released from the locking lugs, it releases the spring freeing the movement of the piston rod to dispense the liquid (see claim 3). It is noted that the spring of Hjertman is biased as it pushes the plunger in a single direction.
It would have been obvious to one of ordinary skill in the art to use the spring mechanism of Hjertman in the apparatus taught by Walsh as doing so would provide for more accurate metered volumes to the mixing chamber and better control over rates of mixing. The use of a known technique to improve similar devices in the same way is supportive of obviousness. See MPEP 2143(I)(c).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Cullis et al. (EP 2496700) in view of Oda et al. (US 2020/0345935).
Cullis is relied upon for disclosure described in the rejection of claims 1, 2, 4, 5, and 8 under 35 U.S.C. 102(a)(1).
Cullis fails to teach a delivery system directly in communication with the mixing channel, wherein the delivery system receives components from the mixing channel for direct administration to a patient.
Oda is directed to a multi-chamber syringe for delivering therapeutic compositions wherein the syringe comprises a syringe body, a first and second plunger and an inner tube wherein the syringe body possesses a cavity and a syringe port, wherein the syringe port is in fluid communication with the syringe cavity. The first plunger is disposed within the syringe cavity and defining a first chamber in the syringe cavity, wherein the first chamber is in fluid communication with the syringe port. The second plunger is disposed within the syringe cavity, the first plunger and the second plunger cooperatively defining a second chamber in the syringe cavity. The inner tube comprises an inner tube lumen, wherein the inner tube and the first plunger shaft lumen define an annulus therebetween, the annulus in fluid communication with the first plunger channel and the annulus permits fluid communication between the syringe port and the first plunger channel, wherein the composition dispensed by the syringe is suitable for direct administration to a patient via IV catheter (see abstract and claim 1). It is taught that such a configuration whereby direct in situ preparation results in a system that eliminates or substantially reduces delivering excess medical fluid to a patient and reduces the overall profile of the syringe body (see [0023]). Thus, it would have been obvious to modify Cullis’s mixing system such that it was configured to provide direct administration of the resulting preparation to a patient via a catheter so as to reduce waste and enhance the overall profile of the delivery system. See MPEP 2143(I)(A).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
