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 .
Election/Restriction
Applicant’s election without traverse of Group III (claims 13-15 and 20-22) in the reply filed on 4/13/26 is acknowledged. Claims 1-12 and 23-24 are withdrawn.
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 first sensing element configured to bind with the target analyte (in claim 13, lines 3-4);
a second sensing element configured to bind with …. (in claim 13, lines 6-9);
a probe particles trap configured to contain the non-specifically bound probe particles….. (in claim 14, lines 2-3);
an instrument configured to exert the external force on the probe particles (in claim 20, line 6).
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.
Examiner notes that a first sensing element configured to bind with the target analyte (as recited in claim 13, lines 3-4) is interpreted to encompass first sensing elements as disclosed by Applicant such as in paragraph 0074 of the Pre-Grant Publication US 20230221319, and their equivalents.
A second sensing element configured to bind with …. (as recited in claim 13, lines 6-9) is interpreted to encompass second sensing elements as disclosed by Applicant such as in paragraph 0074, and their equivalents.
A probe particles trap configured to contain the non-specifically bound probe particles….. (as recited in claim 14, lines 2-3) is interpreted to encompass probe particles trap as disclosed by Applicant in paragraph 0152, and its equivalents.
An instrument configured to exert the external force on the probe particles (as recited in claim 20, line 6) is interpreted to encompass an instrument as disclosed by Applicant in paragraph 0179, and its equivalent.
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 Rejections - 35 USC § 102
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.
Claim(s) 13-15, 20 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190201900 (hereinafter “Shachar”).
Applicant’s claim 13 recites the following.
An article for detecting a presence of a target analyte in a sample, the article comprising:
at least one test well comprising a bottom surface coated with a first sensing element configured to bind with the target analyte in the sample,
wherein the test well is configured to receive the sample and probe particles that are contained in one or more liquid mediums,
the probe particles being coated with a second sensing element configured to bind with one selected from the group consisting of the first sensing element and the target analyte, such that the probe particles are specifically bound to the coated surface depending on the presence of the target analyte in the sample;
and a channel connected to the test well at a distance from the bottom surface to allow fluid communication between the channel and the test well, wherein the channel is configured to receive non-specifically bound probe particles in the test well upon an exertion of an external force on the probe particles which move the non-specifically bound probe particles away from the bottom surface.
The following disclosure by Shachar is relevant to Applicant’s claim 13.
Shachar discloses a diagnostic apparatus that includes a rotatable disk in which a microfluidic circuit is defined. The microfluidic circuit includes a centrifugal separation chamber receiving a sample to stratify the sample. A magnetic bead holding chamber is communicated to a mixing chamber, where mass amplifying functionalized magnetic-nanoparticles, held in a buffer solution and contained in the magnetic bead holding reservoir communicated to mixing chamber, are mixed with the separated fluid delivered to mixing chamber from the separation chamber. The functionalized magnetic nanoparticles conjugate with a target analyte in the sample. A magnet in proximity to a SAW chamber including a SAW detector draws the functionalized magnetic nanoparticles toward antibodies immobilized on the SAW sensor surface. A wash reservoir is communicated to the SAW sensor chamber, and a cleanup/waste reservoir is communicated to the SAW chamber for receiving fluid after it has passed through the SAW chamber. Abstract.
Regarding Applicant’s claim 13, Examiner notes that Shachar’s SAW chamber is equivalent to Applicant’s test well [since it has the configuration of a well] and is immobilized with antibodies [i.e., coated with antibodies]. Shachar’s functionalized magnetic nanoparticles are equivalent to Applicant’s probe particles. The element that functionalize the Shachar’s magnetic nanoparticles is equivalent to Applicant’s second sensing element [since they conjugate, i.e., bind, to the target analyte in Shachar’s invention.] The communication [i.e., channel] between the SAW sensor chamber and cleanup/waste reservoir is equivalent to Applicant’s channel that is configured to receive non-specifically bound probe particles in the test well upon exertion of an external force on the probe particles with move the non-specifically bound probe particles away from the bottom surface. [See also further below regarding a channel.]
Shachar further discloses the following.
The apparatus includes a rotatable disk having a center into which a plurality of chambers, reservoirs and channels are defined, which comprise a microfluidic circuit. A septum provides closure of the microfluidic circuit while allowing insertion of a sample with a target analyte. A sample reservoir is sealed by the septum and holds the sample. The sample reservoir is defined into the disk at a first radial position, which can be characterized as an upstream position when visualized in terms of the forces applied to fluid and other components in the fluid when the disk is spinning. Para. 0017.
A magnetic bead holding reservoir is defined into the disk beginning at a third radial position further from the center of the disk than the first radial position of the sample reservoir or upstream from a mixing chamber. A separation siphon is communicated to the separation chamber. The mixing chamber is communicated to the separation chamber through the separation siphon, where mass amplifying functionalized magnetic-nanoparticles, held in a buffer solution and contained in the magnetic bead holding reservoir communicated to mixing chamber, are mixed with the separated fluid delivered to mixing chamber from the separation chamber. The functionalized magnetic nanoparticles conjugate in the mixing chamber with a target analyte in the sample. The mixing chamber is defined into the disk beginning at a fourth radial position further from the center of the disk than the first, second and third radial positions or downstream from the separation chamber and from the magnetic bead reservoir. Para. 0019.
A surface acoustic wave detector (SAW) having a SAW sensor surface is provided in a SAW chamber. A first valve-controlled channel is defined in the disk. The surface acoustic wave (SAW) chamber is communicated to mixing chamber through the first valve-controlled channel. The SAW sensing chamber contains the surface acoustic wave detector (SAW). The SAW chamber is defined into the disk beginning at a sixth radial further from to the center of the disk than the fourth radial position or downstream from the mixing chamber. A movable magnet is selectively positionable in proximity to the SAW chamber to draw the functionalized magnetic nanoparticles toward antibodies immobilized on the SAW sensor surface. Para. 0020.
The illustrated embodiments of the invention include within their scope a method for operating a field portable diagnostic apparatus having a microfluidic circuit defined in a rotatable disk with a center including the steps of: disposing a sample having at least one analyte therein into a sample reservoir defined in the disk; disposing the disk into a reader; spinning the disk in the reader in a separation step at a separation rate for a separation time to separate the sample into separated components; moving a separated component into a mixing chamber by spinning the disk; mixing functionalized magnetic nanoparticles with the separated component in a mixing chamber by spinning the disk using selectively reversed or oscillating cycles of rotation; immobilizing conjugated functionalized magnetic nanoparticles in the mixing chamber by applying a magnetic field to the mixing chamber and thereafter removing unconjugated functionalized magnetic nanoparticles in the mixing chamber by spinning the disk with the magnetic field in place in a fluid exchange step; resuspending the conjugated functionalized magnetic nanoparticles in a PBS buffer and simultaneously transferring the conjugated functionalized magnetic nanoparticles to a SAW chamber by spinning the disk in a conjugation step; washing the conjugated functionalized magnetic nanopartides in the SAW chamber with a PBS solution by spinning the disk in a wash step; spin drying a SAW detector in the SAW chamber to remove all fluid from the SAW detector by spinning the disk in a spin-dry step; positioning the disk to couple an RF isolator arm to the disk to power the SAW detector; and measuring the at least one analyte in the SAW detector in a measurement step. Para. 0031.
The apparatus includes: a rotatable disk with a center; a microfluidic circuit defined in the rotatable disk; a separation chamber receiving a sample, the separation chamber defined into the disk so that centrifugal forces stratify the sample into components in the separation chamber when the disk is spun; a magnetic bead holding reservoir defined into the disk; a mixing chamber defined into the disk communicated to the separation chamber and to the magnetic bead holding reservoir, where mass amplifying functionalized magnetic-nanoparticles, held in a buffer solution and contained in the magnetic bead holding reservoir communicated to mixing chamber, are mixed with the separated fluid delivered to mixing chamber from the separation chamber, the functionalized magnetic nanoparticles conjugating in the mixing chamber with a target analyte in the sample; a SAW chamber defined into the disk including a surface acoustic wave detector (SAW); a magnet in proximity to the SAW chamber to draw the functionalized magnetic nanoparticles toward antibodies immobilized on the SAW sensor surface; a flushing or wash reservoir defined into the disk communicated SAW sensor chamber; and a cleanup/waste reservoir defined into the disk communicated to the SAW chamber for receiving fluid after it has passed through the SAW chamber.
Para. 0041-0042.
A self-healing septum provides positive closure of sample inlet and reservoir 12 of the closed microfluidic circuit of system 10 while allowing insertion of a patient's sample or analyte, typically by means of a syringe. A blood-plasma separation chamber 14 is communicated to sample reservoir 12 where centrifugal forces are applied to stratify a sample. A mixing chamber 16 is communicated to blood-plasma separation chamber 14 through siphon 28. The magnetic bead holding reservoir 18 contains functionalized magnetic nanoparticles 180. A reservoir 24 contains a pure PBS solution that is released into the SAW chamber 26 containing the conjugated magnetic nanoparticles 180. A second PBS or deionized (DI) water, flushing reservoir 201 shown in another embodiment in FIG. 12 is communicated to SAW sensor chamber 26 through laser valve 204, which reservoir 201 contains either a PBS solution or DI water that is released into the SAW sensor chamber 26 containing conjugated magnetic nanoparticles 180. A SAW sensor chamber 26 is communicated to mixing chamber 16 through laser valve 202 in FIG. 12, in which chamber 16 is the sensor surface of the surface acoustic wave detector (SAW) 38. A cleanup/waste reservoir 36 is provided for holding all fluid after it has passed from the SAW sensor chamber 26 and through siphon 32 and for receiving through siphon 30 any of the contents of mixing chamber 16 not delivered to SAW chamber 26. Para. 0123-0132.
[See figure 2, disclosing SAW sensor chamber 26 and cleanup/waste reservoir 36, and a channel between [which is equivalent to the channel recited in Applicant’s claim 13.]
A sample is introduced to the sample reservoir 12 in FIG. 2, and the disk 13 is placed in the reader 20. The disk 13 is spun, and the centrifugal force drives the fluid from the sample reservoir 12 to the blood plasma separation chamber 14…. Mixed fluid flows into the SAW chamber 26, where the magnetic nanoparticles 180 conjugate onto the surface of the SAW sensor 38. Laser valves 203, 202 and 204 on the outlets of PBS wash reservoir 24, mixing chamber 16, and DI wash
reservoir 205 respectively are communicated by through-holes defined through disk 13 to channels or siphons on the underside of disk 13 communicating with SAW chamber 26. F Para. 0133.
FIG. 22 is a diagram conceptually illustrating the various uses of magnetic forces in the illustrated embodiments on magnetic nanopartides 180 by magnet 22. Inset diagram 224 illustrates the use of magnetic forces to control the transfer of magnetic nanoparticles 180, such as by controlling movement direction among a plurality of diverging channels or selectively immobilizing magnetic nanopartides 180 during a fluid exchange or wash. …Para. 0178.
As to claim 14, the channel is connected to the test well adjacent an opening of the test well, the opening being formed at a top portion of the test well [see figure 2 of Shachar, disclosing SAW sensor chamber 26 and cleanup/waste reservoir 36, and a channel between [which is equivalent to the channel recited in Applicant’s claim 13.] Examiner notes that a “top portion” as recited in Applicant’s claim 14 does not preclude this interpretation, since the above-mentioned channel of Shachar is considered to be adjacent an opening of the SAW sensor chamber (i.e., well), the opening being considered to be formed at a top portion of the test well.
As to claim 15, see Shachar in paragraph 0135 which discloses that in one embodiment the plurality of channels 40 in the SAW detector 38 in FIG. 10 include one reference lane 200 and three functionalized sensing lanes 201, with each lane being functionalized to a different target allowing for the multiplexing of testing targets on a single chip 42.
The reference lane is understood to be a blank control lane [i.e., well] or negative control well as recited by Applicant.
As to claim 20, see discussion above regarding claim 13. The element that functionalize the Shachar’s magnetic nanoparticles is equivalent to Applicant’s second sensing element [since they conjugate, i.e., bind, to the target analyte in Shachar’s invention.] The syringe (para. 0125) or the means producing the centrifugal force (para. 0126), or the magnet (para. 0020) is equivalent to the claimed instrument configured to exert the external force on the probe particles.
As to claim 22, Shachar discloses use of a syringe in combination with the disclosed device (see para. 0125). Examiner notes that the limitations in Applicant’s claim 22 regarding use of the syringe relates to intended use. Since the prior art syringe is capable of performing the recited intended use, it meets the recited intended use.
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) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190201900 (hereinafter “Shachar”).
Shachar, disclosed above, does not disclose that the magnet is a magnetic needle.
Specifically, Shachar discloses that a movable magnet is selectively positionable in proximity to the SAW chamber to draw the functionalized magnetic nanoparticles toward antibodies immobilized on the SAW sensor surface. Para. 0020.
However, providing the magnet in the shape of a needle would have required ordinary skills in the art since it would have been predictable that this configuration would have resulted in providing the functions disclosed by Shachar.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Liu et al., “Glucose oxidase-catalyzed growth of gold nanoparticles enables quantitative detection of attomolar cancer biomarkers. Anal. Chem., 4 June 2014, Vo. 86, No. 12, pages 5800-5806. [Cited in Applicant’s IDS of 4/21/25.]
[This reference discloses an immunoassay format with captured target on a substrate of a 96-well plate, wherein the captured target pulls down glucose oxidase conjugated with detection antibody on the surfaces of magnetic beads (page 5801, left column), and wherein supernatant was removed by a magnetic stand (page 5802, left column). However, this reference does not disclose a microfluidic device.]
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Montgomery whose telephone number is (571)272-0894. The examiner can normally be reached Mon-Fri, 9-5:30 PM PST.
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/Ann Montgomery/Primary Examiner, Art Unit 1678
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