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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/23/2026 has been entered.
Response to Arguments
Applicant's arguments filed 04/23/2026, regarding the rejection of Claim 1 under 35 U.S.C. § 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. All other rejections have been updated accordingly.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a sub-pressurization device” in Claim 14.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim 3 is being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “means” for the apparatus performing the specified function
“means” is linked with the transitional phrase “for” and modified by the functional language “applying sub-pressure to the fluid path to draw fluid from the capillary bores towards the second substrate”
“means” is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant on page 10, lines 24-25 of the written description as a syringe connected to the fluid channel, and equivalents thereof.
Claim 14 is being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “sub-pressurization device” for the apparatus performing the specified function
“sub-pressurization device” is linked with the transitional phrase “thereby” and modified by the functional language “providing sub-pressure through the via and the fluid channel of the chip”
“sub-pressurization device” is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant on page 10, lines 24-25 of the written description as a syringe connected to the fluid channel, and equivalents thereof.
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 1-5 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Renlund et al (WO 2017095321 A1, cited in applicant’s IDS, hereinafter Renlund) in view of Visweswara et al (US 20190357830 A1, hereinafter Visweswara).
Regarding Claim 1, Renlund discloses a sensor assembly (See Figs. 1-2), comprising:
a first substrate (Element 102, Fig. 1-2 and 4) comprising at least one capillary bore defining a fluid path (“The chip 115 comprises a substrate 102 with a plurality of microneedles 101 arranged thereon. Each of the microneedles comprises a capillary bore 107 which extends through the microneedle and the substrate 102”, page 8) extending through said first substrate from a top side of said first substrate (See Fig. 4, which is a cross sectional view of Fig. 1; element 507, which corresponds to element 107, extends from the top side of substrate 102) to a fluid channel (Element 309, Fig. 4) on a bottom side of said first substrate (See Fig. 4; element 309 is on a bottom side of element 102; “FIG. 4 is a cross sectional view along the imaginary line C-C through a row of microneedles and the substrate 102...The capillary bore 507 is in fluid communication with the fluid channel port 318 and the fluid channel 309”, page 9);
a second substrate (Element 413, Fig. 4) arranged in connection with the first substrate (See Fig. 4), the fluid channel of the first substrate is in fluid communication with a fluid port (Element 414, Fig.4) formed in the second substrate (See Fig. 4; “a fluid port (414) in fluid communication with the fluid channel (309)”, Claim 12); and
a sensor (“In another configuration may the above described sampling chipset be used in conjunction with a sensing unit”, page 8) arranged on the second substrate in fluid communication with the fluid channel of the first substrate (“The chip may further comprise a base substrate, which comprises a fluid port in fluid communication with the fluid channel, and which opens in the backside of the base substrate. This provides an access point to the sampled fluid which can be connected to a sensor element or further fluid channels”, page 3).
Renlund discloses the claimed invention except for expressly disclosing the fluid channel of the first substrate is in fluid communication with a first metallized via and a second metallized via formed in the second substrate, thereby extending the fluid path through the first metallized via and the second metallized via, wherein the first and second metallized vias comprise conductive material integrally formed on interior walls of the vias to provide a fixed electrical path extending through the second substrate; and
the sensor comprising a first electrode and a second electrode;
wherein the first electrode is in electric contact with the first metallized via and wherein the second electrode is in electric contact with the second metallized via.
However, Visweswara, which is also directed towards a sensor assembly (Abstract), teaches
the fluid channel of the first substrate (“where one or more microneedles of the array of microneedle defines a micro-fluidic channel that fluidly couples the tissue of the patient with a conduit of the substrate, and where one or more microneedles of the array of microneedles are electrically coupled with the radio frequency circuitry”, [0010]) is in fluid communication with a first metallized via and a second metallized via (“In some embodiment, at least some of the plurality of microneedles extend through the silicon substrate by way of metallic vias”, [0008]) formed in the second substrate (Element 102b, Fig. 1), thereby extending the fluid path (“Each micro-fluidic channel 130: may allow for the collection of fluid from the tissue of a patient”, [0022], [0026]) through the first metallized via and the second metallized via (“In some embodiments, the length of the microneedles/antenna may be extended, e.g., to increase transmission and/or reception of signals from longer distances and/or provide increase signal clarity. This extension may be achieved in some embodiments by elongating a microneedle/antenna element through the silicon substrate 102 (e.g., through layer 102b) using one or more metallic through silicon vias”, [0031]), wherein the first and second metallized vias comprise conductive material integrally formed on interior walls of the vias to provide a fixed electrical path extending through the second substrate (“wherein each microneedle is arranged to act as antenna element and extends through the substrate by way of metallic vias”, Claim 10; in order to conduct electrical signals, these metallic vias must comprise conductive material to provide a fixed electrical path; it is a matter of routine optimization to integrally form these paths on the interior walls of the vias); and
the sensor comprising a first electrode and a second electrode (Elements 1421-142n, Fig. 1);
wherein the first electrode is in electric contact with the first metallized via and wherein the second electrode is in electric contact with the second metallized via (See Fig. 1; “For example, in FIG. 1, electrical contacts or electrodes 142.sub.1-n may be electrically coupled with microneedles 106 (e.g., with conductive outer and/or inner surfaces of microneedles 106) on or within second layer 102b”, [0028]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a first metallized via and a second metallized via to the second substrate of Renlund, thereby extending the fluid path through the first metallized via and the second metallized via, and modify the sensor of Renlund to comprise a first electrode and a second electrode, wherein the first electrode is in electric contact with the first metallized via and wherein the second electrode is in electric contact with the second metallized via, as suggested by Visweswara, as a way to increase transmission and/or reception of signals from longer distances and/or provide increase signal clarity from the microneedles tips of Renlund to a sensor on the second substrate (See Visweswara, [0031]).
Regarding Claim 2, modified Renlund discloses the sensor assembly according to claim 1, wherein the first substrate comprise a plurality of bores (“The chip 115 comprises a substrate 102 with a plurality of microneedles 101 arranged thereon. Each of the microneedles comprises a capillary bore 107 which extends through the microneedle and the substrate 102”, page 8).
Regarding Claim 3, modified Renlund discloses a sensor assembly according to claim 1, further comprising:
means for applying sub-pressure to the fluid path to draw fluid from the capillary bores towards the second substrate (“The fluid channel may be configured to provide an under-pressure, relative the atmospheric pressure, to the capillary bore, whereby fluid flow through the capillary bore is enhanced. An under-pressure may for example be created with a syringe connected to the fluid channel”, page 3).
Regarding Claim 4, modified Renlund discloses the sensor assembly according to claim 1, further comprising a plurality of microneedles integrally formed on the first substrate (“The chip 115 comprises a substrate 102 with a plurality of microneedles 101 arranged thereon”, page 8), wherein each microneedle comprises an elongated body extending from a distal end thereof with a bevel to a proximal end thereof on the first substrate along a longitudinal axis (“The microneedle (101) provided on a substrate (102), comprises an elongated body (503) extending from a distal end (504) with a bevel (505) to a proximal end (506) on the substrate along a longitudinal axis”, Abstract);
wherein the capillary bores extend through the elongated body in a longitudinal direction thereof and further defining define the fluid path (“the elongated body comprises a capillary bore (507) extending in a longitudinal direction thereof and defines a fluid path (508)”, Abstract); and
wherein the proximal end is integrally formed with the first substrate and the fluid path is in fluid communication with the fluid channel of the first substrate (“the proximal end is integrally connected with the substrate and the capillary bore is in fluid communication with a fluid channel (309) of the substrate”, Abstract).
Regarding Claim 5, modified Renlund discloses the sensor assembly according to claim 4, wherein the second substrate is arranged in connection with the first substrate on a side opposite the plurality of microneedles (See Figs. 1 and 4; base substrate 413 is clearly on the opposite side of substrate 102 than microneedle 101).
Regarding Claim 11, modified Renlund discloses the sensor assembly according to claim 1. Modified Renlund discloses the claimed invention except for expressly disclosing wherein the first and second metallized vias are hollow, thereby providing fluid communication between two opposite sides of the second substrate. However, Visweswara teaches wherein the first and second metallized vias (“In some embodiment, at least some of the plurality of microneedles extend through the silicon substrate by way of metallic vias”, [0008]) are hollow (under broadest reasonable interpretation vias are hollow holes or cylinders). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the sensing apparatus of Renlund by making the vias hollow, as taught by Visweswara, thereby providing fluid communication between two opposite sides of the second substrate, because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art.
Claims 7-9 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Renlund in view of Visweswara, and further in view of Polsky et al (US 20180338713 A1, cited in applicant’s IDS, hereinafter Polsky).
Regarding Claim 7, modified Renlund discloses the sensor assembly according to claim 1. Modified Renlund discloses the claimed invention except for expressly disclosing wherein the sensor is located on a side of the second substrate directed towards the first substrate. However, Polsky teaches wherein the sensor (Element 331, Fig. 2D; “an ion selective electrode 331”, [0087]) is located on a side of the second substrate (Elements 330, 340, and 350, Fig. 2D) directed towards the first substrate (Element 320, Fig. 2D; Fig. 2D shows that element 330 is on a side of the combined layers 330-350 directed towards first substrate 320). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the sensor assembly of Renlund with the sensor placement of Polsky for the advantage of placing a sensor in the fluidic path provided by the fluidic channel, as taught by Polsky ([0087]).
Regarding Claim 8, modified Renlund teaches the sensor assembly according to claim 1. Modified Renlund discloses the claimed invention except for expressly disclosing wherein the sensor is at least partly located on the side of the second substrate that is directed towards the first substrate. However, Polsky teaches wherein the sensor (Element 331, Fig. 2D; “an ion selective electrode 331”, [0087]) is at least partly located on the side of the second substrate (Elements 330, 340, and 350, Fig. 2D) that is directed towards the first substrate (Element 320, Fig. 2D; Fig. 2D shows that element 330 is on a side of the combined layers 330-350 directed towards first substrate 320). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the sensor assembly of Renlund with the sensor placement of Polsky for the advantage of placing a sensor in the fluidic path provided by the fluidic channel, as taught by Polsky ([0087]).
Regarding Claim 9, modified Renlund discloses the sensor assembly according to claim 1. Modified Renlund discloses the claimed invention except for expressly disclosing wherein the sensor is at least partly located in the first and second vias. However, Polsky teaches wherein the sensor (Elements 353-354, Fig. 2D) is at least partly located in the first and second vias (Elements 333-334, 341 and 351, Fig. 2D; “The outlets and accesses in this base layer facilitates insertion of one or more wiring 351, electrodes 353, 354, and/or fluidic connectors 356”, [0088]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the sensory assembly of Renlund with the sensor placement of Polsky, to facilitate the connection of the sensor to the fluidic channel.
Regarding Claim 12, modified Renlund discloses the sensor assembly according to claim 1. Modified Renlund discloses the claimed invention except for expressly disclosing wherein the sensor is an electro-chemical sensor. However, Polsky teaches wherein the sensor is an electro-chemical sensor (“an array of one or more electrochemical working electrodes fixed within the platform”, [0020]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the sensing assembly of Renlund with the electro-chemical sensor of Polsky, for the advantage of monitoring the physiological state of a human using electro-chemical sensing means ([0003]-[0004] of Polsky).
Regarding Claim 13, modified Renlund discloses the sensor assembly according to claim 1. Modified Renlund discloses the claimed invention except for expressly disclosing wherein the wall surfaces of the first and second metallized vias are hydrophilic. However, Renlund teaches the advantage of transporting sensed fluid through hydrophilic surfaces (“The walls of the capillary bore may comprise hydrophilic surfaces, which enhances the fluid flow in the capillary bore”, page 3), and Polsky at least teaches vias (Elements 333-334, 341 and 351, Fig. 2D). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the wall surfaces of the vias of modified Renlund hydrophilic, for the advantage of enhancing fluid flow.
Regarding Claim 14, modified Renlund discloses the measurement device comprising a sensor assembly according to claim 1, further comprising a sub-pressurization device (“a syringe connected to the fluid channel”, page 3) arranged in connection with the sensor assembly on a side opposite the at least one microneedle and in fluid communication with the first and second metallized vias of the second substrate, thereby providing sub-pressure through the first and second metallized vias and the fluid channel on the bottom side of said first substrate (“The chip may further comprise a base substrate, which comprises a fluid port in fluid communication with the fluid channel, and which opens in the backside of the base substrate. This provides an access point to the sampled fluid which can be connected to a sensor element or further fluid channels. The fluid port may comprise an increasing area in the longitudinal direction of the port towards the back of the base substrate. This allows a fluid tight connection to other fluid channels such as tubes or syringes”, pages 3-4; by connecting a syringe to the backside of base substrate 413 of modified Renlund, sub-pressure would be provided through the first and second vias and fluid channel of the chip, wherein the chip is element 115, Fig. 1).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Renlund in view of Visweswara, and further in view of Tyvoll et al (US 20050158704 A1, hereinafter Tyvoll).
Regarding Claim 6, modified Renlund discloses the sensor assembly according to claim 1. Modified Renlund discloses the claimed invention except for expressly disclosing wherein the first electrode is shaped as a spiral and the second electrode is shaped as a spiral, and wherein the spiral shapes of the first and second electrodes are nested. However, Tyvoll, which also discloses a sensor assembly (Fig. 1), teaches disclosing wherein the first electrode is shaped as a spiral (Any of Elements 232A-D, Fig. 6A) and the second electrode is shaped as a spiral (Any of Elements 232A-D not considered the first electrode, Fig. 6A), and wherein the spiral shapes of the first and second electrodes are nested (See Fig. 6A). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the sensor assembly of Renlund such that the first and second electrode are nested spiral shapes, as taught by Tyvoll, because this configuration also gives the electrodes the ability to move particles, as taught by Tyvoll (“As shown in FIG. 6A, spiral electrode array 230 also comprises four distinct electrode elements arranged concentrically together which can correspond to four distinct signal channels (e.g., A, B, C, D). These distinct channels enable independent driving of the four electrode elements to create a traveling wave that moves particles (e.g., red blood cells) laterally across surface of spiral electrode 230”, [0066]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Renlund in view of Visweswara, and further in view of Maiz-Aguinaga et al (US 20160058342 A1, cited in applicant’s IDS, hereinafter Maiz-Aguinaga).
Regarding Claim 10, modified Renlund discloses the sensor assembly according to claim 1. Modified Renlund discloses the claimed invention except for expressly disclosing wherein the first and second metallized vias further comprise a signal path extending through the second substrate and the sensor is arranged in electrical connection with the signal path. However, Maiz-Aguinaga, which is also directed towards a sensor assembly (See Abstract), teaches wherein the via further comprises a signal path (Element 216, Fig. 3a; identical to element 116, Fig. 2a; “Perforations 116 in the casing 112 are used to incorporate electrical conductors and provide electrical access to the sensors 108to provide power, read the results…”, [0027]) extending through the second substrate (See Fig. 3a, wherein the second substrate is element 222) and the sensor is arranged in electrical connection with the signal path (Electrodes 108/208 are in contact with elements 116/216, [0027] and [0029]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the first and second metallized vias of modified Renlund with the signal path of Maiz-Aguinaga, for the advantages of powering the sensors and transmitting data, as taught by Maiz-Aguinaga ([0027]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Huang et al (US 20180279929 A1)
See Pushpala et al (US 20170128009 A1)
See Galano (US 20210244322 A1).
See Mir et al (US 20060264715 A1).
See Parunak et al (US 20190038191 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN EPHRAIM COOPER whose telephone number is (571)272-2860. The examiner can normally be reached Monday-Friday 7:30AM-5:30PM EST.
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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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