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 .
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims that depend directly or indirectly from claims 1 and 21 is/are also rejected due to said dependency.
In regard to claim 1, the claim recites “the measurement chamber is configured to collect the sample and provide the sample it to the at least one cantilever pair”. It is unclear what the term “it” refers to. Clarification is requested by amendments. If it is a typo, the term should be deleted. In addition, claim 1 recites “the measurement chamber” and terms of “the analyte” which lack of sufficient antecedent bases. It is unclear whether the terms refer to “at least one measurement chamber” and “at least one analyte” or additional chamber/ analyte. Clarification is requested by amendments.
In regard to claim 10, “the sample inlet area” lacks of sufficient antecedent basis.
In regard to claim 21, the claim recites “the at least one capillary penetrates into at least one the layer and through the layer”. It is unclear how many layer(s) the claim is intended to recite. Clarification is requested by amendments.
Claim Rejections - 35 USC § 102/103
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.
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.
Claims 1-4, 6-8 and 10-23 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Wasielewski et al. (USPGPUB 2015/0051455 – applicant cited) or, in the alternative, under 35 U.S.C. 103 as obvious over Tepper et al. (USPGPUB 2011/0230736). In regard to claim 1, Wasielewski discloses a device for detection of at least one analyte in a sample (Figs. 1-36 and associated descriptions; analyte and fluid, [0017], [0015], [0119-0129]; fluid, [0115-0117]), the device comprising: at least one measurement chamber (the chamber/ space defined for containing microcantilevers/ elements 174, Figs. 22-23 and 29-34 and associated descriptions); at least one capillary configured to obtain a sample and to feed the sample to the at least one measurement chamber (microfluidic channels 176, Figs. 30-34 and associated descriptions; microfluidic channels of less than 0.1 mm, [0132]; microchannel includes those conduits having diameters or restrictive dimensions of 0.1 mm or less, [0147]); and at least one cantilever pair including a reference cantilever and a test cantilever ([0117]), wherein the measurement chamber is configured to collect the sample and provide the sample it to the at least one cantilever pair (Figs. 30-34 and associated descriptions), wherein the test cantilever is configured for selective uptake of the analyte from the sample (signal set, [0117]; Figs. 30-34 and associated descriptions) and the reference cantilever is configured for selective non-uptake of the analyte from the sample (reference set, [0117]; Figs. 30-34 and associated descriptions), wherein the selective uptake of the analyte by the test cantilever and the selective non-uptake by the reference cantilever causes at least one of a relative deformation and a relative change in a surface tension of the test cantilever relative to the reference cantilever ([0116-0141]), and wherein the at least one of the relative deformation and the relative change in the surface tension of the test cantilever and the reference cantilever results in detection of the analyte (concentration and associated equations, [0116-0141]). It is noted that the claim is rejected as best understood, see the 35 USC 112(b) rejection(s) above.
If the microfluidic channels are not inherent considered as capillary,
Tepper teaches a medical device (Figs. 1-7 and associated descriptions) configured to withdraw body fluids (samples, [0008]; blood; lymphatic fluid; urine; semen; cerebral spinal fluid; interstitial fluid; and combinations of these, [0074]; obtain body fluid, [0078]; [0098]), wherein the medical device can be configured for internal ([0071]) or external uses (microneedle and skin, [0098]) and includes sensors ([0050] and [0082]) and microfluidic channels ([0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid inlet section and the microfluidic channels of device (Wasielewski) to incorporate the microneedle(s) and associated body fluid collection configurations/ elements/ functions as taught by Tepper, since both devices are body fluid collection and analyte monitoring system and one of ordinary skill in the art would have recognized that microneedles facilitate collecting and analyzing body fluid(s) from the skin (see Tepper) and conventional microneedles suitable for collecting fluid from the skin are ranged from 5-50 microns in diameter (e.g. as evidenced by at least paragraph [0029] of Mir et al., USPGPUB 2011/0224515). The rationale would have been to collect and analyze body fluids under the skin, which is a region of interest for analyte sensing.
In regard to claim 2, Wasielewski or as modified by Tepper discloses the detection of the analyte in the sample is conducted continuously in a time-resolved manner (Fig. 7 and associated descriptions; select one channel at a time from numerous (such as 30) channels sequentially, [0093] of Wasielewski).
In regard to claim 3, Wasielewski or as modified by Tepper discloses wherein the analyte is a biomarker and the sample is a body fluid (referring to claim 1 above).
In regard to claim 4, Wasielewski or as modified by Tepper discloses the at least one capillary is configured to feed the sample to the at least one measurement chamber via at least one of diffusion forces and capillary forces (referring to claim 1 above).
In regard to claim 6, Wasielewski or as modified by Tepper discloses the at least one capillary is a microneedle (referring to claim 1 above).
In regard to claim 7, Wasielewski or as modified by Tepper discloses the at least one measurement chamber encloses a measurement volume that is defined by a sample feeding area having the at least one capillary (referring to claim 1 above), adjoined by at least one measurement chamber wall (inherent properties of element 176 and associated side walls and/or bottom wall for constructing the measurement chamber, Figs. 31-32 and associated descriptions of Wasielewski ), and a measurement chamber lid (element 172, Fig. 31 and associated descriptions of Wasielewski).
In regard to claim 8, Wasielewski or as modified by Tepper discloses the at least one cantilever pair is arranged on or in the measurement chamber wall (inherent properties for mounting the cantilever pairs, Figs. 31 and associated descriptions of Wasielewski).
In regard to claim 10, Wasielewski or as modified by Tepper discloses the sample inlet area comprises a multitude of capillaries (rejected as best understood, see the 35 USC 112(b) rejection(s) above; elements 176, Figs. 29-32 and associated descriptions of Wasielewski).
In regard to claim 11, Wasielewski or as modified by Tepper discloses a microelectronic circuit configured to receive an electrical signal from the at least one cantilever pair (Figs. 7 and 34 and associated descriptions; [0021-0022]; ASIC or SOC, [0091] of Wasielewski).
In regard to claim 12, Wasielewski or as modified by Tepper discloses the microelectronic circuit is arranged outside the measurement chamber and around the measurement chamber (EMD, Figs. 32 and 34 and associated descriptions of Wasielewski).
In regard to claim 13, Wasielewski or as modified by Tepper discloses the microelectronic circuit is connected to an antenna (elements 26/32/58, Figs. 1-6 and associated descriptions) that runs around the measurement chamber (element 58 runs outside and around sensors 52, Fig. 6 and associated descriptions; sensors 174, Figs. 31-32 and associated descriptions of Wasielewski).
In regard to claim 14, Wasielewski or as modified by Tepper discloses the microelectronic circuit has at least one of a battery and an accumulator that is configured to be charged inductively via the antenna (battery, [0091]; battery pr induction, [0015]; [0021]; [0038]; [0042]; [0110]; [0141] of Wasielewski).
In regard to claim 15, Wasielewski or as modified by Tepper discloses the microelectronic circuit is configured to be read out via the antenna (elements 26/32/58, Figs. 1-6 and associated descriptions of Wasielewski).
In regard to claim 16, Wasielewski or as modified by Tepper discloses the at least one cantilever pair is formed from or on a chip (Figs. 7, 20, 22-25, 29-30, and 34 and associated descriptions; chip, [0091] and [0118] of Wasielewski).
In regard to claim 17, Wasielewski or as modified by Tepper discloses the EMDs comprises system on chip and connected to the sensors (Figs. 7, 32 and 34 and associated descriptions of Wasielewski) but does not specifically disclose the measurement chamber comprises a cavity in the chip. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device to integrate the measurement chamber in a cavity in the chip in order to reduce the size of the device.
In regard to claim 18, Wasielewski or as modified by Tepper discloses the chip has application-specific integrated circuits ([0021-0022]; [0091]; [0038-0039]; [0042] of Wasielewski).
In regard to claim 19, Wasielewski or as modified by Tepper discloses the chip has a multitude of cantilever pairs that are arranged around the cavity (referring to claim 17 above; Figs. 7, 32 and 34 and associated descriptions of Wasielewski), where each cantilever pair is configured for the detection of an analyte (same or different analyte(s) for elements 174, Figs. 7, 32 and 34 and associated descriptions; referring to claim 1 above; [0017]; [0021]; [0025]; [0051] of Wasielewski).
In regard to claim 20, Wasielewski or as modified by Tepper discloses the chip is arranged on the microelectronic circuit (Figs. 1-7, 25 and 34 and associated descriptions; [0021-0022]; [0091]; [0038-0039]; [0042] of Wasielewski).
In regard to claim 21, Wasielewski or as modified by Tepper discloses a sensor device for detection of an analyte in a sample (referring to claim 1 above), the sensor device comprising: the device according to claim 1 (referring to claim 1 above), wherein the device is arranged in an emplastrum that is configured to be bonded to a layer (adhesives and skin, [0097] of Tepper; referring to claim 1 above) such that the at least one capillary penetrates into at least one the layer and through the layer (microneedle(s), referring to claim 1 above), and wherein the at least one capillary is configured to obtain the sample and feeds the sample to the measurement chamber (referring to claim 1 above).
In regard to claim 22, Wasielewski or as modified by Tepper discloses the layer is one of skin of a living creature or a food package (skin, [0097] of Tepper; referring to claim 1 above).
In regard to claim 23, Wasielewski or as modified by Tepper discloses all the claimed limitations except a diagonal of the sensor device is between 10 mm and 15 mm and a height is between 2 mm and 3 mm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try different dimensions/ sizes of the device, including a diagonal of the sensor device is between 10 mm and 15 mm and a height is between 2 mm and 3 mm, through investigations/ experiments in order to find the optimal dimensions/ sizes of the device for different applications/ different measurement sites. The rationale would have been “obvious to try”, see KSR International Co. v. Teleflex Inc., 550 USPQ2d 398, 421(2007)
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Wasielewski and Tepper as applied to claims 1-4, 6-8 and 10-23 above, and further in view of Mir et al. (USPGPUB 2011/0224515 – cited above). In regard to claim 5, Wasielewski as modified by Tepper discloses at least one microneedle (referring to claim 1 above) but does not specifically disclose the at least one microneedle has a diameter of less than 200 μm and a length between 500 μm and 5000 μm.
Mir teaches a fluid collection and analysis device (Fig. 1A and associated descriptions) comprises microneedle(s) has a diameter of less than 200 μm and a length between 500 μm and 5000 μm (microneedle(s) with 5-50 microns in diameter and 20-2000 microns in height, [0029]) is/are suitable for penetrating the subject's stratum corneum and reach the underlying interstitial fluid or capillary network to collect body fluid for analysis ([0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the diameter and length of the microneedles (Wasielewski as modified by Tepper) with the diameter and length as taught by Mir to yield predictable results, since both devices are skin-mounted body fluid collection/ analysis systems and one of ordinary skill in the art would have recognized that the diameter and length as taught by Mir are alternative equivalent dimensions of microneedle(s) for collecting body fluids form the skin (see Mir). The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
Allowable Subject Matter
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: In regard to claim 9, Liu et al. (USPGPUB 20050112557) teaches a system (Figs. 1-2) comprises a mesoporous-chip based biosensor (elements 60, Figs. 1-2) including mesoporous channels (element 122, Fig. 2); a pump (element 50, Fig. 1; [0021]); sample deliver capillary tubes (elements 15 and 55, Fig. 1) which deliver the sample into the mesoporous chip (Fig. 1 and [0021]). However, the prior of record does not teach or suggest “the at least one measurement chamber has a nanoporous reservoir as a sample inlet area that is configured to take up the sample and function as a pump for the sample” in combination with the other claimed elements/ steps.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kam et al. (USPN 10,105,080) teaches an optical analyte detection patch device (Figs. 1-7) comprises a plurality of microneedles that penetrate skin and that receive interstitial fluid from the skin tissue using passive forces (e.g., diffusion, capillary action (Figs. 1-5; Col 5 lines 1-22); sampling chamber/ reservoir/ pump/ microfluidic device (Col 5 lines 1-22); and electronics including processor(s) and antenna (Fig. 6).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHU CHUAN LIU whose telephone number is (571)270-5507. The examiner can normally be reached M-Th (6am-6pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791
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