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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1, 2, 4, 5, 7, 8, and 12) in the reply filed on 02/19/2026 is acknowledged. The traversal is on the ground(s) that the groups of claims do not lack a single general inventive concept in view of WO2010/139078, stating it fails to disclose a delivery system downstream from the mixing channel that is in fluid communication with the mixing channel, as presently claimed. This is not found persuasive because WO2010/139078 discloses a plurality of chambers connected to a downstream mixing chamber via a mixing channel. Additionally, WO2010/139078 further teaches a discharge device, which functions as a delivery system of the mixed contents (paragraph 19). Applicant also argues that there would be no search burden per MPEP 806.05(d), however this is not considered persuasive because it pertains to applications filed under 35 USC 111(a) whereas the present application was submitted under 35 USC 371. See MPEP 823.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 2, 4, 5, 7, 8, 12, 14, 15, 19, 21, 25, 29, 33-35, 38, 42, 45 and 46 are pending, claims 14, 15, 19, 21, 25, 29, 33-35, 38, 42, 45, and 46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and
Claims 1, 2, 4, 5, 7, 8, and 12 are under current examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/02/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claim 12 is objected to because of the following informalities: it is believed that "...between from the mixing channel...", should read "...between the mixing channel...". Removal of the word “from” is requested.
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).
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
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 Markland et al. (US 2010/0003300).
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 teaches that post synthesis of the microparticles in the mixing chamber, the produced microparticles are subject to dialysis (i.e. ‘a separation unit’) so as to reduce the amount of unwanted solvent in the final formulation (see [0085] and Example 1-2). Post dialysis, the microparticles are to be administered to a subject in need thereof via injection (‘a delivery system’) (see [0121]). In all, Cullis describes an apparatus that 1) mixes inlet streams to produce microparticles, 2) separates the microparticles via dialysis and 3) provides the separated microparticles via a delivery system such as injection
However, Cullis fails to suggest the delivery system as being a hypodermic needle, a catheter, cannula or a microneedle array.
Markland is directed to microparticles suspensions suitable for administration via injection (see claim 1) wherein injection is carried forward using a hypodermic needle or catheter (see claim 16). It would have been obvious to modify Cullis’s delivery system such that the administration via injection was performed using a hypodermic needle or a catheter. The selection of a known material (e.g. hypodermic needle) based on its suitability for its intended use (e.g. injection) is indicative of obviousness. See MPEP 2144.07.
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
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
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