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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11, 980, 498 in view of Luchini et al (Pub. No.: US 2012/0164749)
The patented claim discloses all of the claimed limitations [see column 28 lines 20-58]; but the patented claim doesn’t disclose smart hydrogel.
Nonetheless, Luchini et al disclose smart hydrogel [see 0012].
Therefore, it would have been motivated to combine claim with Luchini et al by using smart hydrogel; because Smart hydrogels can release therapeutic agents in a controlled manner in response to specific physiological conditions, improving drug efficacy and minimizing side effects.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 11, 980, 498 in view of Luchini et al (Pub. No.: US 2012/0164749)
The patented claim discloses all of the claimed limitations [see column 29 lines 59-68, column 30 lines 1-53]; but the patented claim doesn’t disclose smart hydrogel.
Nonetheless, Luchini et al disclose smart hydrogel [see 0012].
Therefore, it would have been motivated to combine claim with Luchini et al by using smart hydrogel; because Smart hydrogels can release therapeutic agents in a controlled manner in response to specific physiological conditions, improving drug efficacy and minimizing side effects.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Ziaie et al (Pub. No.: US 2015/0087945) in view of Fabiilli et al (Pub. No.: US 2013/0330389)
Regarding claims 1, 4, 17, Ziaie et al disclose a system for identifying one or more changes in a microresonator structure (hydrogel) positioned within an environment [see 0081, 0087-0088, 0094] and having an acoustic resonance frequency in an ultrasound range [see 0026];
the system comprising:
a microresonator structure having an acoustic resonance frequency [see 0026],
the microresonator structure being positioned within the environment and configured to exhibit a change in resonance frequency in response to interaction with one or more predefined analytes in the environment [see 0043-0044, 0087-0090, 0094];
wherein the microresonator structure (ferrogel) is sufficiently unconstrained so as to be configured to resonate [see 0076];
piezoresistive transduction for querying the microresonator structure (hydrogel) within the environment at or near the acoustic resonance frequency of the microresonator structure [see 0097, 0150, 0175, 0177, 0222] by disclosing piezoresistive transduction schemes have been used to interrogate the hydrogel volumetric response [see 0150];
a computer system (data-processing system) in communication with the ultrasound transducer, the computer system having one or more processors [see 0133-0135]and being configured to:
receive, from the piezoresistive transduction, ultrasound data as provided by query of the microresonator structure by the piezoresistive transduction [see 0150, 0133-0135, 0175] at or near the resonance frequency [see 0095];
determine, at the one or more processors, at least one of:
a change in resonance frequency as induced by interaction of the one or more predefined analytes with the microresonator structure in the environment [see 0004, 0027, 0095-0096] by disclosing changes in glucose or other chemical environment can result in changes in the hydrogel 130 height which can result in changes in the inductance (i.e., lumped inductance resulting from the device coils 120 and the hydrogel 130 with embedded ferromagnetic particles), resulting in changes in natural (resonant) frequency of the implantable device [see 0095];
a change in mean grayscale value (MGV) associated with the ultrasound data of the microresonator structure due to the change in the resonance frequency of the microresonator
structure as induced by interaction of the one or more predefined analytes with the
microresonator structure in the environment;
or
a change in amplitude or intensity of an ultrasound query wave or pulse as induced by interaction of the one or more predefined analytes with the microresonator structure in the environment.
Ziaie et al may not explicitly mention an ultrasound transducer for acquiring data.
Nonetheless, Fabiilli et al disclose an ultrasound transducer for acquiring data [see 0036, 0061-0062, fig 5]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Ziaie et al and Fabiilli et al by using an ultrasound transducer for querying the microresonator structure within the environment; because Environmentally sensitive hydrogels can exhibit reversible volume and shape responses to a variety of chemical and physical stimuli such as piezoresistive transduction schemes for hydrogel volumetric response [see 0150, Ziaie et al].
Regarding claim 2, Ziaie et al disclose wherein the ultrasound data is ultrasound image data,
wherein the computer system is configured to determine the change in mean grayscale value (MGV) associated with the ultrasound image data of the microresonator structure due to the change in the resonance frequency of the microresonator structure as induced by interaction of the one or more predefined analytes with the microresonator structure in the environment.
Regarding claim 3, Ziaie et al disclose determine the change in resonance frequency of the microresonator structure as induced by interaction of the one or more predefined analytes with the microresonator structure in the environment [see 0062, 0095]
Regarding claims 5, 18, Ziaie et al don’t disclose receiving ultrasound data of the microresonator structure at a first time and at a second time, and wherein the computer system determines, at the one or more processors, a change in MGV, change in resonance frequency, or change in amplitude or intensity of the ultrasound wave or pulse associated with the microresonator structure based on differences in the ultrasound data of the microresonator structure at the first time and at the second time.
Nonetheless, Fabiilli et al disclose receiving ultrasound data of the microresonator structure at a first time and at a second time and wherein the computer system determines, at the one or more processors, a change in MGV, change in resonance frequency, or change in amplitude or intensity of the ultrasound wave or pulse associated with the microresonator structure based on differences in the ultrasound data of the microresonator structure at the first time and at the second time [see 0063, 0123-0124]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Ziaie et al and Fabiilli et al by receiving ultrasound data of the microresonator structure at a first time and at a second time, and wherein the computer system determines, at the one or more processors, a change in MGV, change in resonance frequency, or change in amplitude or intensity of the ultrasound wave or pulse associated with the microresonator structure based on differences in the ultrasound data of the microresonator structure at the first time and at the second time; to monitor changes accurately.
Regarding claim 6, Ziaie et al disclose wherein the microresonator structure does not include any markers, contrast agents, or external connections [see 0194] by disclosing thin uniform film [see 0194].
Regarding claims 7, 19, Ziaie et al disclose wherein the microresonator structure consists of a gel material and optionally a polymer backplane [see 0177].
Regarding claim 8, Ziaie et al disclose wherein the microresonator structure is in the form of a sheet [see 0092, 0101].
Regarding claims 9, 20, Ziaie et al disclose wherein the microresonator structure is in the form of one or more pillars, a backplane with one or more pillars extending therefrom, a dome, a pyramid, triangular prism, or a cube or other rectangular prism [see 0164, 0238].
Regarding claim 10, Ziaie et al disclose wherein the microresonator structure has a thickness (increasing) from 100 µm to 1000 µm and is 0.1 mm to 20 mm in length [see 0105].
Regarding claims 11, 21, Ziaie et al don’t disclose wherein the microresonator structure is biodegradable in vivo, the method further comprising allowing the microresonator to biodegrade in vivo.
Nonetheless, Fabiilli et al disclose wherein the microresonator structure is biodegradable in vivo, the method further comprising allowing the microresonator to biodegrade in vivo [see 0036, 0121].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Ziaie et al and Fabiilli et al by using microresonator structure is biodegradable in vivo, the method further comprising allowing the microresonator to biodegrade in vivo; this provides a more realistic and systemic view of degradation, absorption, distribution, metabolism, and excretion (ADME) than isolated cell cultures; Because in vivo studies mimic the full physiological environment, results are generally considered more reliable and relevant to human applications. This reduces the risk of unexpected failures in clinical trials and helps optimize dosage, release rates, and safety profiles and allow direct assessment of biocompatibility and how well the material integrates with surrounding tissue.
Regarding claims 12, Ziaie et al don’t disclose wherein the microresonator structure is configured as a plurality of microresonator pillars or other particles confined within a scaffold.
Nonetheless, Fabiilli et al disclose wherein the microresonator structure is configured as a plurality of microresonator pillars or other particles confined within a scaffold [see 0025, 0037, 0122-0124].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Ziaie et al and Fabiilli et al by using particles confined within a scaffold; The scaffold in the device is able to provide a substrate for cell adhesion and/or new tissue formation [see 0037, Fabiilli et al].
Regarding claim 13, Ziaie et al disclose a control positioned within the environment, the control configured to not (by using a lock, see 0090) change resonance frequency in response to interaction with the one or more predefined analytes [see 0090].
Regarding claim 14, Ziaie et al disclose wherein any change in dimension or volume of the microresonator as a result of interaction with the one or more predefined analytes in the environment is not readily discernable in any ultrasound image that may be generated from the ultrasound data [see 0079, 0081].
Regarding claim 15, Ziaie et al disclose wherein the microresonator structure (hydrogel) is unconstrained to allow swelling or shrinking of the microresonator structure in multiple dimensions [see 0101, 0202-0203].
Regarding claim 16, Ziaie et al disclose wherein the microresonator structure (hydrogel) is attached to a substrate [see 0204] by disclosing a substrate and a membrane arranged to form a cavity in which the hydrogel is located and can swell or shrink, wherein the membrane is configured to allow passage of a fluid across the membrane and block passage of particles of a predetermined size that are suspended in the fluid. In some examples, the hydrogel, the substrate, and the membrane are configured so that the hydrogel does not completely fill the cavity [see 0204].
Regarding claim 20, Ziaie et al disclose wherein the microresonator structure (hydrogel) is in the form of one or more of:
(i) a sheet [see 0092, 0101, 0203];
(ii) a backplane with one or more pillars extending therefrom;
(iii) a plurality of microresonator pillars or other particles confined within a scaffold, or
(iv) pillars free of a backplane, a dome, a pyramid, triangular prism, or a cube or other
rectangular prism [see 0164].
Allowable Subject Matter
Claim 22 is allowed.
The following is an examiner’s statement of reasons for allowance: No prior arts of record alone or in combination discloses the following:
Claim 22,
“a substrate having a tip;
a microresonator structure having a resonance frequency, positioned on the substrate tip,
the microresonator structure being positioned within a detection environment during use, and configured to exhibit a change in resonance frequency in response to interaction with a drug or other analyte in the detection environment,
wherein the microresonator structure is sufficiently unconstrained so as to be configured to resonate;
an ultrasound transducer for querying the microresonator structure within the detection environment at or near the resonance frequency of the microresonator structure”
The closest prior arts:
Ziaie et al (Pub. No.: US 2015/0087945) disclose the following”
a computer system in electrical communication with the ultrasound transducer, the computer system having one or more processors and being configured to:
receive, from the ultrasound transducer, ultrasound data as provided by query of the microresonator
structure by the ultrasound transducer at or near the resonance frequency;
determine, at the one or more processors, at least one of:
a change in resonance frequency as induced by interaction of the drug or other analyte with the microresonator structure in the detection environment;
a change in mean grayscale value (MGV) associated with the ultrasound data of the microresonator structure due to the change in the resonance frequency of the microresonator
structure as induced by interaction of the drug or other analyte with the microresonator structure in the detection environment;
or
a change in amplitude or intensity of an ultrasound query wave or pulse as induced by interaction of the drug or other analyte with the microresonator structure in the detection environment (as explained above).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3797
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