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 .
Information Disclosure Statement
No IDS has been filed in this application. Applicant is reminded that each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the U.S. Patent and Trademark Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability. 37 CFR 1.56.
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.
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 13-23 are rejected under 35 U.S.C. 103 as being unpatentable over Shinoda US 2016/0121280.
Regarding claim 13, Shinoda discloses a fluidic chip (microchip 1) composed of a body comprising: a main inlet (sample fluid inlet 115) and at least one secondary inlet (sheath fluid inlet 114) not coaxial to the main inlet, each main and secondary inlet being configured to receive a substance and an outlet, the main inlet being connected to the outlet (orifice 111) by a main channel (flow path 11) comprising a substantially rectilinear portion defining a central axis Z for the fluidic chip as shown in at least Fig. 9 reproduced below, the secondary inlet also being connected to the outlet by a secondary channel, wherein the secondary channel is divided into at least two secondary ducts having identical dimensions as shown in at least Fig. 9 reproduced below (Further, the sheath fluid introduced into the sheath fluid inlet 114 first splits bidrectionally in the positive and negative directions on the Y axis from the sheath fluid inlet 114 to be fed, and then turns twice at almost 90 degrees to join at the position where the minute pipe 116 is provided. [0094]; The minute pipe 116 introduces the sample fluid that has been introduced from the sample fluid inlet 115 into a sheath fluid laminar flow flowing through the flow path 11 after the confluence. [0095]; The sample fluid and sheath fluid that have passed the detection portion F are discharged outside the flow path 11 from the orifice 111 opened at one side of the microchip 1. [0096]) which joins in an injection duct with the main channel in an evenly distributed manner around the central axis Z. See at least paragraphs 94-110. Also see whole document.
Shinoda does not explicitly disclose wherein the injection duct is a coaxial circular shape.
However, the shape of a device component has been held to be a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed injection duct was significant. See MPEP §2144.04 (IV)(B).
Therefore, one having ordinary skill in the art would have found it obvious to make such a change as a mere alternative and functionally equivalent injection duct shape and since the same expected fluid flow would have been achieved. The use of alternative and functionally equivalent shapes would have been desirable to those of ordinary skill in the art based on the desired device configuration.
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Regarding claim 14, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production (obtained by a subtractive printing technique on glass). If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See MPEP § 2113.
Regarding claim 15, Shinoda discloses wherein the body comprises an upper face comprising the main inlet and at least the secondary inlet as shown in at least Fig. 9. Shinoda discloses also implicitly discloses a lower face opposite the upper face. However, the outlet of Shinoda is not located on the lower face.
Absent unexpected results, it would have been prima facie obvious to one having ordinary skill in the art to provide the outlet on the lower face of the body, since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP §2144.04 (VI-C).
Regarding claim 16, Shinoda discloses wherein the geometry of the main and secondary channels is three-dimensional as shown in at least Figs. 9 and 12.
Regarding claim 17, the fluidic chip of Shinoda appears to be compact along the outlet axis as shown in at least Figs. 9 and 12.
Regarding claim 18, the secondary channel of Shinoda is capable of being separated in a first separation on an ordinate B of the central axis Z and separated in a second separation at an ordinate D of the central axis Z, thus defining four secondary ducts of the same length.
Further, absent unexpected results, it would have been prima facie obvious to one having ordinary skill in the art to provide a plurality of secondary ducts, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See MPEP §2144.04 (VI-B).
Regarding claim 19, Shinoda does not explicitly disclose wherein the secondary channel comprises at least one rectilinear shaped portion opening at a center of a portion in the shape of an arc of a circle extending in a plane perpendicular to the central axis Z.
However, the shape of a device component has been held to be a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed opening of the secondary channel was significant. See MPEP §2144.04 (IV)(B).
Therefore, one having ordinary skill in the art would have found it obvious to make such a change as a mere alternative and functionally equivalent opening shape and since the same expected fluid flow would have been achieved. The use of alternative and functionally equivalent shapes would have been desirable to those of ordinary skill in the art based on the desired device configuration.
Regarding claim 20, Shinoda discloses a first (inlet 124) and a second secondary inlet (inlet 134) connected respectively to a first and a second secondary channel (flow paths 12 and 13 respectively). See [0099].
Shinoda does not explicitly disclose the first secondary channel comprising a portion having a shape of an arc of a circle of a first diameter relative to a central axis extending in a plane perpendicular to the central axis, and the second secondary channel comprising a portion having a shape of an arc of a circle of a second diameter relative to the central axis extending in a plane perpendicular to the central axis, with the first diameter being smaller than the second diameter.
However, the shape of a device component has been held to be a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed first secondary channel portion and second secondary channel portion was significant. See MPEP §2144.04 (IV)(B).
Therefore, one having ordinary skill in the art would have found it obvious to make such a change as a mere alternative and functionally equivalent first secondary channel portion shape and second secondary channel portion shape and since the same expected fluid flow would have been achieved. The use of alternative and functionally equivalent shapes would have been desirable to those of ordinary skill in the art based on the desired device configuration.
Further, since providing a first diameter being smaller than the second diameter would only require a mere change in the size (or dimension) of a component which is generally recognized as being within the level of ordinary skill in the art, a mere change in size or dimension of the device, i.e. depth, would have been prima facie obvious to one of ordinary skill in the art. Furthermore, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device. See MPEP §2144.04 (IV)(A).
Regarding claim 21, Shinoda does not explicitly disclose wherein the first and the second secondary channels each comprise two circular arc-shaped portions at two different ordinates from the central axis Z, thus each defining four secondary ducts having a same length.
However, the shape of a device component has been held to be a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed first secondary channel portion and second secondary channel portion was significant. See MPEP §2144.04 (IV)(B).
Therefore, one having ordinary skill in the art would have found it obvious to make such a change as a mere alternative and functionally equivalent first secondary channel portion shape and second secondary channel portion shape and since the same expected fluid flow would have been achieved. The use of alternative and functionally equivalent shapes would have been desirable to those of ordinary skill in the art based on the desired device configuration.
Further, absent unexpected results, it would have been prima facie obvious to one having ordinary skill in the art to provide two circular arc-shaped portions at two different ordinates from the central axis Z, thus each defining four secondary ducts having a same length, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See MPEP §2144.04 (VI-B).
Regarding claim 22, Shinoda does not explicitly disclose wherein the main channel comprises four main ducts having a same length.
However, absent unexpected results, it would have been prima facie obvious to one having ordinary skill in the art to provide four main ducts having a same length, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See MPEP §2144.04 (VI-B).
Regarding claim 23, Shinoda does not explicitly disclose wherein each main and secondary channel comprises a circle-shaped portion opening onto the outlet, each circle- shaped portion being concentric.
However, the shape of a device component has been held to be a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the main and secondary channel portion was significant. See MPEP §2144.04 (IV)(B).
Therefore, one having ordinary skill in the art would have found it obvious to make such a change as a mere alternative and functionally equivalent main and secondary channel portion shape and since the same expected fluid flow would have been achieved. The use of alternative and functionally equivalent shapes would have been desirable to those of ordinary skill in the art based on the desired device configuration.
Claims 13 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Korny et al. (hereinafter Korny) US 2017/0199173.
Regarding claims 13 and 24, Korny discloses a fluidic chip (microfluidic device; [0071, 0085 and 0089]) composed of a body comprising: a main inlet (first inlet 10) and at least one secondary inlet (second inlet 20 and third inlet 30) not coaxial to the main inlet, each main and secondary inlet being configured to receive a substance and an outlet (nozzle 15), the main inlet being connected to the outlet by a main channel (The first inlet is connected via a short microchannel to optional filter 12, which outputs to optional mixing zone 14, which in turn connects to nozzle 15.) comprising a substantially rectilinear portion defining a central axis Z for the fluidic chip as shown in at least Fig. 1A reproduced below, the secondary inlet also being connected to the outlet by a secondary channel, wherein the secondary channel is divided into at least two secondary ducts having identical dimensions as shown in at least Fig. 1A (Both second and third inlets are connected via microchannels to optional mixing zones 24 and 34, which then are connected via microchannels to additional inputs that, together with the output of the oil microchannel, form the T-junction of the nozzle (rectangle on FIG. 1A). The intersection of three substantially perpendicular inlet microchannels forms the nozzle. [0089];) which joins in an injection duct (The output of the nozzle feeds into a collecting space 41 at the top of incubation chamber 40. [0089]) with the main channel in an evenly distributed manner around the central axis Z. Also see whole document.
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Korny does not explicitly disclose wherein the injection duct is a coaxial circular shape.
However, the shape of a device component has been held to be a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed injection duct was significant. See MPEP §2144.04 (IV)(B).
Therefore, one having ordinary skill in the art would have found it obvious to make such a change as a mere alternative and functionally equivalent injection duct shape and since the same expected fluid flow would have been achieved. The use of alternative and functionally equivalent shapes would have been desirable to those of ordinary skill in the art based on the desired device configuration.
Korny also discloses a cell encapsulation system comprising two containers (reservoirs/syringe pumps), one of the containers capable of comprising a cell solution and the other of the containers capable of comprising a solution capable of gelling [0079-0085 and 0095]], the main and secondary inlets (first inlet 10 is intended for the introduction of the oil phase. The first inlet is connected via a short microchannel to optional filter 12, which outputs to optional mixing zone 14, which in turn connects to nozzle 15. Second inlet 20 can be used for either a cell suspension or a calcium solution, as can third inlet 30) are each implicitly connected to one of the containers via a dispenser (The device may also include one or more valves, pumps, vacuum channels, ports, heaters, vents, reservoirs, reagents, or waste chambers, or any combination thereof. [0085]; The solutions were introduced simultaneously into the device using syringe pumps. [0095]). The encapsulation device is capable of being arranged so that the jet splits, at the outlet of the encapsulation device, into drops whose outer layer is the solution capable of gelling and whose core is the cell solution; and able to form a concentric jet from the solutions provided by the dispensers in view of [0089 and 0095].
Lastly, Korny discloses a gelling bath (incubation chamber/docking station) arranged downstream of the encapsulation device to collect the drops formed by the encapsulation device and arranged to cause a gelling of the outer layer of each drop during its immersion in the bath as shown in at least Figs. 1A. 1B and 1C. Also see [0089].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Wednesday 08:00-18:00 EST.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796