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
The information disclosure statements filed April 23, 2024 and March 18, 2026 fail to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement. It is noted that the applicant has included non-patent literature, Official action (dated Oct. 15, 2024) from EP 24 171 867. 5 along with IDS April 23, 2024. Similarly, applicant has included a non-patent literature reference from a foreign patent office (dated Feb. 26, 2026). This is also not cited in the IDS filed March 18, 2026. Both of these NPL must be listed in an IDS.
The information disclosure statement filed March 18, 2026 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered. Please provide an English translation for non-patent literature reference from a foreign patent office (dated Feb. 26, 2026).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “tube” in claims 6 and 7 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Claim Interpretation
In the patentability analysis of the instant apparatus claims 1-10, aspects or limitations examiner interprets as functional/process/intended use/ or not positively recite as part the claimed apparatus have been generally italicized whereas aspects interpreted as positively recited structural components are normally bolded. The bold font and italics are shown when the structure and function are initially introduced though not necessarily repeated, particularly in dependent claims. The examiner applies this formatting for both the examiner and applicant’s convenience. However, absent the referenced typestyles, the patentability analysis will still be clear regarding which limitations the examiner interprets as structural versus functional/ process/ intended use and/or not positively recited structure. Also note that it has been held that recitations in which an element is "adapted to/for", “configured to/for”, “positionable”, “moveable/immovable”, etc., only requires the ability to so perform (i.e., functional/process/intended use). The functional/process/intended use/ and/or elements not positively recited as part of the apparatus do not constitute a limitation in any patentable sense with respect to the prior art. Please note these recitations have not been ignored by the examiner.
Note: all of the claimed recitations in applicant’s claims 1-10 have been considered by the examiner and afforded the appropriate amount of patentable weight. In certain instances during prosecution, the examiner’s current interpretations regarding the patentable weight of these limitation might change based on the facts of the case.
The examiner's patentability analysis below provides one or more interpretations and claim mappings of the claimed structures and steps although other interpretations may be possible. In the patentability analysis, the Office applies the broadest reasonable interpretation (BRI) consistent with the specification and specific limitations from the specification have not been read into the claims.
See MPEP at least §2111.02, 2173.01 I 2114, and 2173.05(g).
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.
Claims 1-10 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1, line 8 recites the phrase “in close contact”, which is a relative phrase and renders the claim indefinite. The phrase “in close contact” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear from the claim or the specification what distance applicant considers close contact between the cover and the base. For the purposes of examination this will be interpreted as “in direct contact”. However, clarification is required.
Claim 1 recites “flatness of the surface of the microfluidic chip in contact with the cover and flatness of the surface of the microfluidic chip in contact with the base are both 50 µm or less; and planarity of a surface of the cover in contact with the microfluidic chip and planarity of a surface of the base in contact with the microfluidic chip are both 50 µm or less”. The terms “flatness” and “planarity” of the surfaces are not defined in the claims or specification, and it is unclear where these surfaces are located.
Claim 4 recites a depth of the recessed portion is 10% or more and 50% or less of a thickness of the microfluidic chip between the surface of the microfluidic chip in contact with the bottom surface of the recessed portion of the cover and the surface of the microfluidic chip in contact with the bottom surface of the recessed portion of the base. It is not clear if the “recessed portion” in claim 4 is referring to the recess in cover and/or base recited in claim 3. This lacks clear antecedent basis.
Claim 5 recites “a size of the microfluidic chip”. However, it is not clear along which direction of the microfluidic chip the size is measured.
Claim 7 recites “a surface of the tube”. It is not clear from the claim which surface corresponds to “a surface of the tube”. This is vague and indefinite.
Claim 10 recites a composite material of a metal and a non-metal having a Young’s modulus of 60 GPa or more. The range limitation reciting "or more" has no upper range limitation and may not be supported if embodiments in the specification recite a specific range 2163.05 (III). In this case, the specification recites a Young’s modulus of preferably 60 GPa or more and preferably 500 GPa or less (see para [0047]). Thus, the upper boundary of 500 GPa should be recited in claim 10 to overcome this rejection.
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.
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.
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 1-10, as best understood, are rejected under 35 U.S.C. 103 as obvious over Takahashi et al., (JP 2007-162839; hereinafter “Takahashi”).
Regarding claim 1, Takahashi teaches;
a microfluidic device comprising:
a microfluidic chip (11) with a flow path 24 formed inside (the upper side 20c of the holder is manufactured so that the opening 12 of the in-device flow path 24 of the microfluidic device 11 corresponds to the female screw 20a);
a chip holder 20 includes a cover (20c upper side of the holder) and a base (20b corresponds lower side of the holder) that are in contact with a surface of the microfluidic chip (see Fig. 2) and
a fixture 23 that connects the cover and the base and allows the microfluidic chip to be held between the cover and the base (the holder 20 holding the microfluidic device 11 is sandwiched between the lower side 20b of the holder and the upper side 20c of the holder, and is fixed by the holder opening / closing screw 23);
a connector (joint 10) wherein the connector passes through one or both of the cover and the base, one end side comes in contact with the surface of the microfluidic chip at an opening portion (port 12) of the flow path of the microfluidic chip, and an other-end side is a fluid supply port or a fluid discharge port (Y-shaped glass fluid device);
flatness of the surface of the microfluidic chip in contact with the cover and
flatness of the surface of the microfluidic chip in contact with the base are both
50 μm or less the upper, the lower and the intermediate structure are planar; and
planarity of a surface of the cover in contact with the microfluidic chip and
planarity of a surface of the base in contact with the microfluidic chip are both
50 μm or less.
The examiner interprets the flatness and planarity of the surfaces as functional/ intended use since the meanings and differences between the recited flatness and/or planarity of the surfaces are indefinite for the reasons delineated above. Takahashi teaches as shown in FIG. 2, the lower end of the elastic body 15 is inserted into the opening hole 12 formed in the upper surface 25 of the microfluidic device 11 by screwing the male screw 19 of the strength member 16 into the female screw 20 of the holder 20. It is pressed tightly and communicates with the flow path 14 formed in the center of the elastic body 15. By screwing the joint 10 to the holder 20, the elastic body 15 is connected to the opening hole 12 in the upper surface 25 of the microfluidic device 11 in a state of being narrowed from above, and the in-device flow path 24 of the microfluidic device. To supply fluid. While Takahashi teaches the surfaces of microfluidic chip, the cover and base are pressed tightly, it is not clear if flatness and planarity of these surfaces disclosed in Takahashi. However if these features are considered as structural limitations not taught by Takahashi, then it would have been obvious to one of ordinary skill in the art at the time the claimed invention was filed to have determined the desired flatness/planarity being 50 microns or less, since these dimensions are considered to be merely one of several straightforward possibilities which the skilled person would select, depending on the circumstances, without exercising inventive skill, in order to provide a fluid-tight seal between components.
Applicant is advised that the Supreme Court has clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formal disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82, USPQ2d 1385, 1397 (2007), see MPEP 2143).
Regarding claim 2, Takahashi appears to teach the flatness of the surface of the microfluidic chip with which the connector is in contact is 50 µm or less, for the reasons delineated above.
Regarding claim 3, Takahashi teaches a recessed portion is formed in each of surface portions of the cover 20c and the base 20b on a side facing the microfluidic chip, and the microfluidic chip is fitted into each recessed portion such that the surface of the microfluidic chip and a bottom surface of the recessed portion 25 of the cover and the surface of the microfluidic chip and a bottom surface of the recessed portion of the base are in contact with each other (see Fig. 2).
Regarding claims 4 and 5, Takahashi does not explicitly disclose the depth of the recessed portion is 10% or more and 50% or less of a thickness of the microfluidic chip between the surface of the microfluidic chip in contact with the bottom surface of the recessed portion of the cover and the surface of the microfluidic chip in contact with the bottom surface of the recessed portion of the base or a size of the recessed portion in a direction orthogonal to the depth direction is formed to be larger than a size of the microfluidic chip by 0.01 mm or more and 0.5 mm or less.
However, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was effectively filed to have determined the desired depth of the recessed portion, since these dimensions are considered to be merely one of several straightforward possibilities which the skilled person would select, depending on the circumstances, without exercising inventive skill, in order to solve the problem posed, such as compact size and fluid-tight seal between components
Regarding claim 6, Takahashi teaches a tube 13 is connected to the connector 10 (see embodiment shown in Fig. 2).
Regarding claim 7, Takahashi teaches the connector includes a pressing member 18 and a ring-shaped ferrule 17 into which the tube is inserted, and the ferrule is configured to be brought into close contact with the surface of the microfluidic chip and a surface of the tube by pressing from the pressing member (see Fig. 2).
Regarding claim 8, Takahashi teaches the ferrule is formed of a resin material having a tensile strength of 20 MPa or more and 300 MPa or less (Takahashi teaches the ferrule is formed of a material having superiority in terms of workability and price, and a material having a Young's modulus in the vicinity of 100 GPa to 200 GPa can be used.)
Regarding claim 9, Takahashi teaches the microfluidic chip is formed silicon, glass or ceramics. Takahashi does not explicitly teach the microfluidic chip is formed of synthetic quartz glass. However, with respect to the materials of construction, it would have been obvious to one of ordinary skill in the art to determine the optimum materials of construction for microfluidic chip in Takahashi based on considerations such as cost, ease of manufacture, reactions with the processing agents and/or maintaining the required reaction conditions with respect to temperature.
Regarding claim 10, Takahashi teaches the cover (20) is made of a material such as polyether ether ketone (PEEK), high density polyethylene, polytetrafluoroethylene, or other hard polymer. Takahashi does not explicitly teach the cover and the base are each formed of a metallic material, a non-metallic material, or a composite material of a metal and a non-metal having a Young’s modulus of 60 GPa or more. However, with respect to the materials of construction, it would have been obvious to one of ordinary skill in the art to determine the optimum materials of construction for the cover and base in Takahashi based on considerations such as cost, ease of manufacture, reactions with the processing agents and/or maintaining the required reaction conditions with respect to temperature.
Claims 1-2 and 6-10, as best understood, are rejected under 35 U.S.C. 103 as obvious over Renzi et al., (US 7,553,455; hereinafter “Renzi”).
Regarding claim 1, Renzi teaches;
a microfluidic device comprising:
a microfluidic chip (substrate 20) with a flow path formed inside
(substrate 20 typically has an array of inlet and/or outlet ports on its upper surface facing the lower surface of manifold 12. The inlet and/or outlet ports are connected to an integrated network of microfluidic channels within substrate 20 through via ports,);
a chip holder includes a cover (corresponds to manifold 12 configured as a flat plate) and a base (corresponds to plate 16) that are in contact with a surface of the microfluidic chip and
a fixture 26 that connects the cover and the base and allows the microfluidic chip to be held between the cover and the base (corresponds to screws 26, other fasteners can be used including bolts that can optionally be spring loaded. Alternative means of non-permanent securing of the assembly include magnetic or vacuum-generated forces, epoxy bonds, or energy-activated devices such as, for example, a solenoid-controlled clamp, or any conventional device which facilitates parts replacement);
a connector (reads on ferrule 50) wherein the connector passes through one or both of the cover and the base, one end side comes in contact with the surface of the microfluidic chip at an opening portion (port 12) of the flow path of the microfluidic chip, and an other-end side is a fluid supply port or a fluid discharge port (substrate 20 typically has an array of inlet and/or outlet ports on its upper surface facing the lower surface of manifold 12. The inlet and/or outlet ports are connected to an integrated network of microfluidic channels within substrate 20 through via ports, as further described herein. Manifold 12 includes a corresponding array of threaded, tapered channels 36 that traverse the height of the manifold. As shown in FIG. 2, each threaded channel 36 has an upper aperture 32 on the upper surface of manifold 12 and a lower aperture 24 on the lower surface of manifold 12);
flatness of the surface of the microfluidic chip in contact with the cover and
flatness of the surface of the microfluidic chip in contact with the base are both
50 μm or less the upper, the lower and the intermediate structure are planar; and
planarity of a surface of the cover in contact with the microfluidic chip and
planarity of a surface of the base in contact with the microfluidic chip are both
50 μm or less,
The examiner interprets the flatness and planarity of the surfaces as intended use since the meanings and differences between the recited flatness and/or planarity of the surfaces are indefinite for the reasons delineated above. Thus, it is not clear if the measured flatness and planarity of the surfaces is explicitly disclosed in Renzi. However, these features are considered as structural limitations that are not taught by Renzi, then it would have been obvious to one of ordinary skill in the art at the time the claimed invention was filed to have determined the desired flatness/planarity being 50 microns or less, since these dimensions are considered to be merely one of several straightforward possibilities which the skilled person would select, depending on the circumstances, without exercising inventive skill, in order to solve the problem posed, such as compact size and fluid-tight seal between components.
Applicant is advised that the Supreme Court has clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formal disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82, USPQ2d 1385, 1397 (2007), see MPEP 2143).
Regarding claim 2, Renzi appears to teach flatness of the surface of the microfluidic chip with which the connector is in contact is 50 µm or less, for the reasons delineated above.
Regarding claim 6, Renzi teaches a tube 121 is connected to the connector (ferrule; see embodiment shown in Figs. 5-7).
Regarding claim 7, Renzi teaches the connector includes a pressing member (reads on hexagonal nut 114) and a ring-shaped ferrule 112 into which the tube is inserted, and the ferrule is configured to be brought into close contact with the surface of the microfluidic chip and a surface of the tube by pressing from the pressing member.
Regarding claim 8, Renzi teaches the ferrule is formed of a resin material having a tensile strength of 20 MPa or more and 300 MPa or less (Renzi teaches the ferrule is formed of polyether ether ketone (PEEK), which is a high-performance thermoplastic resin with a known tensile strength of 90–100 MPa.
Regarding claim 9, Renzi teaches the microfluidic chip is formed of synthetic quartz glass (i.e., Renzi teaches suitable substrates 20 for the present invention can be any substantially planar microfluidic member that has an integrated network of microfluidic channels disposed therein. The substrate is preferably fabricated from glass, quartz, silicon or plastic by conventional techniques).
Regarding claim 10, Renzi teaches the cover (12 manifold) is made of a material such as polyether ether ketone (PEEK), high density polyethylene, polytetrafluoroethylene, or other hard polymer. Renzi does not explicitly teach the cover and the base are each formed of a metallic material, a non-metallic material, or a composite material of a metal and a non-metal having a Young’s modulus of 60 GPa or more. However, with respect to the materials of construction, it would have been obvious to one of ordinary skill in the art to determine the optimum materials of construction for the cover and base in Renzi based on considerations such as cost, ease of manufacture, reactions with the processing agents and/or maintaining the required reaction conditions with respect to temperature.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Pertinent Prior Art
While the following prior art listed below is not specifically discussed in this Official action, the examiner considers the listed prior art relevant to the overall prosecution and may be relied upon during subsequent examination(s) based on applicant’s future response(s).
Gu et al., (CN 105396633) teach a soft micro-fluidic chip inverse clamp, comprising a bottom plate, one side of bottom plate is concave formed with groove, side wall to periphery of the concave groove form with a step part, the bottom of the groove so as to place the hard micro-fluidic chip, the upper step part so as to support the soft micro-fluidic chip, the soft micro-fluidic chip thickness greater than the depth of the step part, top end open to cover the groove is fixed with cover plate, the upper cover plate corresponding to the soft micro-fluidic chip and liquid inlet and outlet seat is provided with hole way, the way hole installed with inlet joint, bottom of the groove is provided with the following communicated over the observation window. The clamp by pressure seat equal soft PDMS micro-fluidic chip, can at any time change PDMS chip, and by one of universal joint finish PEEK fluid and transport, the device is simple and easy to use, operation is convenient, cost is low.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached between 9:30am-7pm EST.
Examiner interviews are available via telephone and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P. Kathryn Wright/Primary Examiner, Art Unit 1798
Prosecution Insights