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 .
DETAILED ACTION
Status of Claims
Claims 1-17 are pending and have been examined.
Priority
This application, Serial No. 18/176,056 (PGPub: US2023/0280339) was filed 02/28/2023. This application claims benefit of Provisional Application 63/315,361 filed 03/01/2022.
Information Disclosure Statements
The Information Disclosure Statement filed 02/28/2023 has been considered by the Examiner.
Claim Objections
Claims 3, 5 and 12-13 are objected to because of the following informalities:
Claim 3 at line 1 should correct “have” to “has”.
Claim 3 at line 2 should correct “provide” to “provides”.
Claim 5 at line 3 should remove the “a” before “bioreceptor microbubble”.
Claim 5 should delete the second period at the end of the claim.
Claim 12 at line 2 should include the word “the” before “flow control system”.
Claim 13 at line 5 should include the word “of” after “part”.
Appropriate correction is required.
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 1-17 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.
Claim 1 is indefinite because it states “the photoacoustic digital signals” at line 8 and this limitation lacks antecedent basis. For prosecution, this limitation will be interpreted as photoacoustic signals.
Claim 7 is indefinite because it states “the mixing chamber” at line 1 and this limitation lacks antecedent basis.
Claim 10 is confusing because it states that each of the second fluid channels are arranged in a pathway of the light from the light source but given the structural configurations provided in claim 1 (“light source to send a light to the detection channel”) and claim 6 (“detection channel is fluidly coupleable to the mixing chamber by…a second fluid channel coupled to the mixing chamber”), it is unclear how the light source is configured to provide to light to the detection channel as well as further upstream components including a plurality of second channels.
Claim Interpretation
Examiner would like to note that the claims are drawn to an assay device and thus patentable weight is given to the structure of the device. Claim 1 is structurally drawn to a detection channel, a light source and a hydrophone. Functional limitations such as “a detection channel fluidly coupleable to a specimen source to receive an analyte sample” only require that the prior art be capable of performing the recited functional limitation. So long as the prior art contains a detection channel that is able to be fluidly coupled to a specimen source, it will read on the limitation. Phrases such as “can” (“sample that can include a biological target bound to a bioreceptor gold nanoparticle conjugate”) are intended uses of the invention and not active structural components of the device. For example, as presently recited, bioreceptor gold nanoparticle conjugates are not actively claimed as a structure of the device but are claimed as components that can be part of a sample (with the claimed sample also not being an active component of the device) provided to a specimen source that is able to be coupled to the detection channel.
Claim Rejections - 35 USC § 102
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.
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) 1-3 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (US 2020/0271655, Pub Date: 08/27/2020, hereinafter “Smith”).
Regarding claim 1, Smith teaches throughout the publication a biochemical assay device (paragraph 0008, photoacoustic flow system), comprising:
a detection channel (paragraph 0008, flow chamber 26 with capillary) fluidly coupleable to a specimen source to receive an analyte sample (paragraph 0037, syringe pump filled with a sample to be analyzed) that can include a biological target bound to a bioreceptor gold nanoparticle conjugate (paragraph 0047, functionalized gold nanoparticles and paragraph 0049-0052, sample with nanoparticles analyzed for presence of nanoparticles);
a light source situated to send a light to the detection channel (paragraph 0039, laser positioned above flow chamber to illuminate the capillary tube), wherein the light includes one or more wavelengths absorbable by the bioreceptor gold nanoparticle conjugate bound to the biological target (paragraph 0052) to thereby generate a photoacoustic signal of the analyte sample (paragraph 0040); and
a hydrophone to detect (paragraph 0041, ultrasound transducer) and convert a summation of the photoacoustic signals into an electrical signal (paragraph 0036, signal transmitted to an oscilloscope).
While Smith does not explicitly teach that the generated signals are indicative of an individual acoustic detection event from the bioreceptor gold nanoparticle conjugates to the biological target in the sample, such limitation is drawn to a functional limitation of the light source that must be capable of generating a photoacoustic signal indicative of an individual acoustic event. Smith teaches a laser light incident on a sample and a transducer used to measure the photoacoustic effect (see paragraphs 0039-0041). Additionally, Smith teaches the same structural limitations with the same functions as recited in the claims (detection channel, light source and hydrophone) and is thus interpreted as being capable of performing the claimed functional limitations.
Regarding claim 2, Smith teaches the device wherein the bioreceptor portion of the bioreceptor gold nanoparticle conjugate includes an antibody or an aptamer capable of binding to the biological target (paragraphs 0045-0050, gold nanoparticle functionalized with antibody or aptamer).
Regarding claim 3, Smith teaches the device wherein the bioreceptor gold nanoparticle conjugate have an average size that is up to 20 nm or a hydrodynamic diameter of about 25 nm to about 150 nm (paragraph 0047). While Smith does not explicitly recite that the nanoparticles provide the photoacoustic signal with a light absorption maximum value that is in a range of visible light from 400 to 800 nm, such limitation is drawn to intended use of the nanoparticles, which have not been actively claimed as a component of the device. Smith teaches the same structural limitations of nanoparticles that can have a diameter of 20nm and therefore they would be seen as capable as performing the recited intended use.
Regarding claim 15, Smith teaches the device wherein the biological target is a biomolecule (paragraph 0025, circulating tumor cells).
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) 4, 6, 10-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2020/0271655, Pub Date: 08/27/2020), as applied to claim 1 above, and further in view of O’Brien et al. (US 2012/0064566, Pub Date: 03/15/2012, hereinafter “O’Brien”).
Regarding claim 4, Smith teaches the device as described above and as seen in Figure 1 comprising tubing 62 that extends to a pump system including a first syringe pump and a second syringe pump, wherein one of the syringes is filled with sample to be analyzed (paragraph 0037). However, Smith does not explicitly teach the device further including a fluid channel, the fluid channel including: a first inlet port fluidly couplable to the specimen source for holding the biological target therein, and a second inlet port fluidly couplable to a container for holding the bioreceptor gold nanoparticle conjugate therein, wherein a bioreceptor portion of the bioreceptor gold nanoparticle conjugate is capable of binding to the biological target.
O’Brien teaches throughout the publication a multiple flow system and method for detecting substances in a fluid (abstract). More specifically, O’Brien teaches at Figure 1, a connector channel 28 (interpreted as claimed fluid channel) comprising a first inlet port (inlet leading to channel 24) and a second inlet port (inlet leading to channel 26), wherein one of the ports can include a fluid to be detected or gold nanoparticles added to cells (paragraph 0025). Additionally, O’Brien teaches that any number of multiple different fluids or number of tubes may be utilized as well as any shape connector to allow the multiple fluids to enter into downstream portions of the flow system (paragraphs 0022-0023).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the syringe flow system of Smith to incorporate a multiple flow system having at least three tubes for substances to enter the device as taught by O’Brien because it would have been desirable to have more control over fluids entering the system and decrease potential error involved (Smith, paragraph 0018). While Smith in view of O’Brien teach that one tube allows air, one tube allows the sample, and numerous other tubes/substances are envisioned with the device, the references do not explicitly teach that a first port holds the biological target and a second port holds the bioreceptor gold nanoparticle conjugate therein, wherein a bioreceptor portion of the bioreceptor gold nanoparticle conjugate is capable of binding to the biological target. However, these limitations are drawn to intended use of the systems and therefore the prior art only needs to be capable of performing the recited intended use. So long as the first and second inlet ports are capable of holding samples and gold nanoparticle conjugates, it reads on the limitation.
Regarding claim 6, Smith in view of O’Brien teach the device further including a mixing chamber (O’Brien, Figure 1, chamber 20) fluidly coupleable to the fluid channel (O’Brien, connector 28), and the detection channel is fluidly coupleable to the mixing chamber by a sample inlet (O’Brien, inlet connecting chamber 20 to channel 24) fluidly coupled to a second fluid channel (channel 24) coupled to the mixing chamber (20). Although the references do not explicitly teach that a flow of the biological target and the bioreceptor gold nanoparticle conjugate from the fluid channel are held in the mixing chamber to provide the analyte sample that includes the biological target bound to the bioreceptor gold nanoparticle conjugate, these limitations are drawn to intended use of the systems and therefore the prior art only needs to be capable of performing the recited intended use. So long as the mixing chamber and channels are capable of holding samples and gold nanoparticle conjugates, it reads on the limitation.
Regarding claim 10, Smith in view of O’Brien teach the device wherein the mixing chamber is coupled to a plurality of the second fluid channels (O’Brien, paragraphs 0022-0023, multiple tubes and fluids) wherein each of the second fluid channels are arranged in a pathway of the light from the light source (see Figure 1, for example, downstream end of channel 24 connected to detection channel would receive light).
Regarding claim 11, Smith teaches the device wherein the device is part of an assay system wherein: the mixing chamber is part of a flow control system of the assay system (see flow pump system 30 in Figure 1 of Smith); and the detection channel, the light source and the hydrophone are part of a data acquisition system of the assay system (see Figure 1 of Smith, enlarged boxed portion illustrating channel 26, light 102 and transducer 14).
Regarding claim 12, Smith in view of O’Brien teaches that the assay system further includes: a reservoir as part of flow control system and the reservoir fluidly coupled to the mixing chamber (O’Brien, paragraphs 0022-0023, multiple tubes and flows can be included with would inherently include a reservoir, all tubes and substances are fluidly coupled via the connector 28). Although the references do not explicitly teach that the reservoir holding a buffered fluid therein and that the reservoir flows the buffered fluid to mixing chamber as the analyte sample is delivered to the detection channel, these limitations are drawn to intended use of the systems and therefore the prior art only needs to be capable of performing the recited intended use. So long as the reservoirs and tubing are capable of flowing buffers, it reads on the limitation.
Regarding claim 14, Smith teaches the device wherein the assay system further includes: a user interface, the user interface: to collect source information about the biological target and send the source information to a computer of the user interface, to collect analysis information about the analyte sample obtained by the data collection system (paragraph 0041, data acquisition system with computer). Although Smith does not specifically teach that the user interface sends an electrical control signal from the computer to the flow control system to thereby control the flow of cleaning fluid through the mixing chamber, and to send another electrical control signal from the computer to the data acquisition system to thereby control the light from the light source, such limitations are drawn to intended use of the device and therefore the prior art only needs to be capable of performing the recited intended use. So long as the data acquisition system and computer are capable of providing input to the device, it reads on the limitation. Smith teaches the same structural limitations as recited in the claims and is therefore considered capable of performing the same intended use.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2020/0271655, Pub Date: 08/27/2020) in view of O’Brien et al. (US 2012/0064566, Pub Date: 03/15/2012), as applied to claim 1 and 4 above (hereinafter “Modified Smith”), and further in view of Lajoinie et al. (BioMicrofluidics 10, 011501, 2016, hereinafter “Lajoinie”).
Regarding claim 5, Modified Smith teaches the device as described above wherein the first inlet port is fluidly couplable to a second container (see O’Brien, Figure 1) and wherein an optional markers can be incorporated within the system (Smith, paragraph 0045). However, Modified Smith does not specifically teach that the container can hold a bioreceptor microbubble conjugate therein, wherein a first bioreceptor portion of the a bioreceptor microbubble conjugate includes an antibody or an aptamer capable of binding to the biological target, and a second bioreceptor portion of the bioreceptor microbubble conjugate includes a second antibody or a second aptamer capable of binding to the biological target.
Lajoinie teaches throughout the publication uses for microbubbles in a wide range of therapeutic applications (abstract). More specifically, Lajoinie teaches functionalized microbubbles including microbubbles with attached antibodies targeted to receptors or for targeting circulating tumor cells (see pages 8-9, section 2. Functionalized and drug-loaded microbubbles). The microbubbles can be exposed to laser light to general acoustic effects (page 9, section 4).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate as an optional marker in one of the containers in the device of Modified Smith, functionalized microbubbles as taught by Lajoinie because Modified Smith is generic regarding the type of optional marker that can be employed for interaction with the circulating tumor cells and Lajoinie teaches that functionalized microbubbles provide simplicity when using for therapeutics (Lajoinie, page 9, section 2). Although Lajoinie does not specifically teach that a first bioreceptor portion of the a bioreceptor microbubble conjugate includes an antibody or an aptamer capable of binding to the biological target, and a second bioreceptor portion of the bioreceptor microbubble conjugate includes a second antibody or a second aptamer capable of binding to the biological target, such limitation is drawn to intended use of the second container for holding a bioreceptor microbubble these limitations are drawn to intended use of the systems and therefore the prior art only needs to be capable of performing the recited intended use. So long as the second container is capable of holding a microbubble receptor, it reads on the limitation. Modified Smith in view of Lajoinie teach the same structural limitations as recited in the claims and is therefore considered capable of performing the same intended use.
Claim(s) 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2020/0271655, Pub Date: 08/27/2020), as applied to claim 1 above, and further in view of Huang et al. (Science, Vol 304, pages 987-990).
Regarding claims 7-9, Smith teaches the device as described above but fails to teach a mixing chamber that includes a deterministic lateral displacement microfluidic device.
Huang teaches throughout the publication a microfluidic particle-separation device that makes use of bifurcation of laminar flow around obstacles (abstract). More specifically, Huang teaches a microfluidic path defined by microstructures attached to interior walls of the microfluidic channel (see Figures 1 and 3), wherein the microstructures are sized and distributed to cause different velocities when flowing though the microfluidic path in proportion to different- sized ones of the fluid substances (page 988, left column, first three full paragraphs). Huang further teaches wherein the microstructures are arranged as an array of pillars disposed in a regular pattern (see Figures 1-3 and page 988, left column, third full paragraph), as in claim 8; and further teaches wherein the array of pillars includes different regions in the mixing chamber, each of the regions having the pillars differently sized, or, differently spaced apart, or, disposed in different forms of the regular pattern (see Figures 1-3), as in claim 9.
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the device of Smith, a mixing chamber comprising a deterministic lateral displacement region as taught Huang because it would have lead to higher resolution of desired targets within the mixing chamber (Huang, abstract) and for flow to downstream elements and since Smith teaches that the sample and particles may need to be mixed before testing to maintain a consistent distribution of cells to interact with the particles (Smith, paragraph 0037). Although Smith in view of Huang do not specifically teach that the microstructures are sized to cause different velocities of the biological target bound to the bioreceptor gold nanoparticle conjugate as they move through the chamber, such limitation is drawn to intended use of the device and therefore the prior art only needs to be capable of performing the recited intended use. So long as the microstructures in the device of Smith in view of Huang are capable of manipulating particles at different velocities, it reads on the limitation. Smith in view of Huang teaches the same structural limitations as recited in the claims and is therefore considered capable of performing the same intended use.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2020/0271655, Pub Date: 08/27/2020) in view of O’Brien et al. (US 2012/0064566, Pub Date: 03/15/2012, hereinafter “O’Brien”), as applied to claims 4, 6 and 11 above (hereinafter “Modified Smith”), and further in view of Appleyard et al. (US 2017/0052105 Pub Date: 02/23/2017).
Regarding claim 13, Modified Smith teaches the device as described above and further teaches the laser light source includes an optical fiber to illuminate the detection channel (Smith, paragraph 0039) and also that the device includes a signal amplifier and a data conversion function as part the data acquisition system, the signal amplifier to receive the electrical signal from the hydrophone and generate an amplified electrical signal and the data conversion function (Smith, see paragraphs 0036 and 0069, signal amplified, oscilloscope and multipurpose programmable function). Although Modified Smith does not specifically teach that the function is to digitize the analog signal information and to generate a signal versus time profile corresponding to the amplified electrical signal corresponding to the photoacoustic signal, such limitation is drawn to intended use of the device and therefore the prior art only needs to be capable of performing the recited intended use. So long as the data acquisition system and computer are capable of processing the signal information for analysis, it reads on the limitation. Smith teaches the same structural limitations as recited in the claims and is therefore considered capable of performing the same intended use.
While Modified Smith fails to teach a beam splitter as part of the data acquisition system, the beam splitter optically coupled to the light source, Appleyard teaches throughout the publication a microfluidic chip with a plurality of channels to analyze a sample fluid with a mixture of objects (abstract). More specifically, Appleyard teaches that the device comprises a beam splitter to split the light beams between multiple systems (paragraph 0377).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the device of Modified Smith, a beam splitter as taught by Appleyard because it would have been desirable to split the laser light source between a variety of locations for additional analysis (Appleyard, paragraph 0377).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2020/0271655, Pub Date: 08/27/2020), as applied to claim 1 above, and further in view of Masters et al. (US 2006/0257945, Pub Date: 11/16/2006).
Regarding claim 16, Smith teaches the device as described above but fails to teach that the biological target is Adenovirus, Herpes simplex, type 1, Herpes simplex, type 2, Varicella-zoster virus, Epstein-Barr virus, Human cytomegalovirus, Human herpesvirus, Human papillomavirus, BK virus, JC virus, Smallpox, Parvovirus, Rotavirus, Orbivirus, Coltivirus, Banna virus, Human astrovirus, Norwalk virus Human coronavirus 229E, Human coronavirus NL63, Human coronavirus OC43, Human coronavirus HKU1, Middle East respiratory syndrome-related coronavirus, Severe acute respiratory syndrome coronavirus, Severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2), Hepatitis C virus, yellow fever virus, dengue virus, West Nile virus, TBE virus, Zika virus, Hepatitis E virus Rubella virus hepatitis A virus, poliovirus, rhinovirus, Lassa virus, Ebola virus, Marburg virus, Influenza virus Measles virus, Mumps virus, Parainfluenza virus, Respiratory syncytial virus, Rabies virus, Hepatitis D, HIV, or Hepatitis B virus.
Masters teaches throughout the publication methods for detecting a part of a cell such as a cell surface protein (paragraph 0070) or alternatively, for detecting virus in a sample comprising introducing a plurality of particles with a capture agent into a fluid chamber and monitoring signal output by an acoustic device to detect the viral load of the sample (paragraph 0015). More specifically, Masters teaches that the device can detect pathogen or microbe, such as bacteria or bacterial spores, viruses, parasites, prions or other pathogens or their cell wall or surface components such as Rhinovirus, Yellow Fever, Adenovirus, Influenza B virus, Influenza A, Avian flu, rhinovirus, coronavirus (e.g., SARS), Human Immunodeficiency virus (HIV), Hepatitis viruses, Herpes virus, West Nile Virus, and Ebola virus (paragraph 0079).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the device of Smith, detection of viruses as taught by Masters because it would have been desirable to extend the device detection abilities to viruses as well, thereby increasing the device usability.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2020/0271655, Pub Date: 08/27/2020), as applied to claim 1 above, and further in view of Appleyard et al. (US 2017/0052105 Pub Date: 02/23/2017).
Regarding claim 17, Smith teaches the device as described above but fails to teach that the electrical signals are digitized.
Appleyard teaches throughout the publication a microfluidic chip with a plurality of channels to analyze a sample fluid with a mixture of objects (abstract). More specifically, Appleyard teaches that electronic signals can be digitized and sent to a digital signal processor (paragraph 0193).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the device of Smith, digitized signals as taught by Appleyard because it would have been desirable to provide the data and results in a format that allows for efficient processing and analysis (Appleyard, paragraphs 0281-0282).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677