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 .
Specification
The abstract of the disclosure is objected to because the abstract recites 'for example' rendering it indefinite. A suggestion would be to delete the phrase 'for example'. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The use of the term 'tween [0071 and 0085]' and 'triton [0071 and 0085]', which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because of the following informalities:
There is a period missing at the end of paragraph [0090].
There is a quotation symbol at the end of paragraph [00209].
Appropriate correction is required.
Claim Interpretation (1)
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.
Claim 11 includes the limitation “means for sample collection and optionally, quantification and/or storage”. The specification defines the ‘means for sample collection and optionally, quantification and/or storage’ to include sponge, swab material, such as cotton or synthetic fiber (Specification, para 00192) and furthermore the means for sample collection and storage may be the same such as tube, cylinder and sponge (Specification, para 00193). Under the 3-prong analysis, the limitation should be interpreted under 112(f) for the following reasons:
The claim limitation uses the term ‘means’.
The term ‘means’ is modified by functional language. The functional language is ‘for sample collection and optionally, quantification and/or storage’.
The generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. See MPEP §2181(I). The term "means" is not modified by sufficient structure.
Claim Interpretation (2)
Claims 3, 4, 11, and 13 recite the limitation ‘optionally…’. Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure (See MPEP 2111.04). The examiner, using broadest reasonable interpretation, interprets the ‘optional’ limitations as steps not being required to be performed.
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.
Claim 6, 8, and 10-15 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 6 recites the limitation "the bioreceptor". That limitation is not mentioned in the previous claims of which claim 1 is dependent upon. There is insufficient antecedent basis for this limitation in the claim. The examiner interprets this limitation as ‘the nanoparticle conjugate bioreceptor’ for examination purposes.
Claim 8 recites the limitation "the carrier". That limitation is not mentioned in the previous claims of which claim 7 is dependent upon. There is insufficient antecedent basis for this limitation in the claim. The examiner interprets this limitation as ‘the cannabinoid/metabolite carrier conjugate’ for examination purposes.
Claim 10 recites the limitation "the optical fiber” That limitation is not mentioned in the previous claims of which claim 1 is dependent upon. There is insufficient antecedent basis for this limitation in the claim. The examiner interprets this limitation as ‘the fiber optic sensor’ for examination purposes. Claims 11-15 are dependent upon claim 10, thus also rejected.
Claim 14 recites the limitation “use of the device as defined in claim 10…”. Claim 14 recites a use without any active, positive steps delimiting how this use is practiced, thus the claim is indefinite. See MPEP 2173.05(q).
Claim 15 recites the limitation “use of the test kit of claim 11…”. Claim 15 recites a use without any active, positive steps delimiting how this use is practiced, thus the claim is indefinite. See MPEP 2173.05(q).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Claim 1 recites the steps for detecting presence or absence of a cannabinoid or metabolite thereof in a biological sample. Thus, the claim is a method, which is one of the statutory categories of invention. Claim 2-15 also are dependent on Claim 1.
Step 2A Prong One: Claim 1 recite a judicial exception and identify the abstract idea/law of nature/natural phenomenon. Claim 1 recites “detecting a change in optical property of the fiber optic sensor in response to direct binding of the cannabinoid or metabolite thereof to the nanoparticle conjugated bioreceptor(s)”. Claim 9 also recites “detecting a change in optical property of the fiber optic sensor in response to binding of free nanoparticle conjugated bioreceptor(s) in solution phase”. The "mental processes" abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions (See MPEP 2106(a)(2)(III)). Detecting a change is making a comparison which can be done in the mind, thus is a mental evaluation. Thus, the detecting step would fall under the abstract idea groups of mental processes. (Step 2A -Prong 1: Yes)
Step 2A Prong Two: The judicial exception is not integrated into a practical application because the claims do not impose any meaningful limits on practicing the abstract idea. Claim 1 and Claim 9 describes “contacting” the sample to the nanoparticle conjugate receptor which is data gathering step which does not impose any meaningful limits on practicing the abstract idea. Claim 10 adds the additional element of a device used to measure the change in optical property of the fiberoptic sensor, however, does not add a practical limitation on how the “detecting a change in the optical property” is limited. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea of detecting the change in the optical property. The claim is directed at an abstract idea. (Step 2A -Prong 2: No)
Step 2B: Claims 1 does not have any steps or features which are significantly more, and the steps are well known in the art as taught in the prior art below. Claim 1 is ineligible. Claims 2-15 do not appear to have ‘significantly’ more or have any limitations which make the method be of practical application. Claims 2-8 merely add parameters for the method of detecting presence or absence of a cannabinoid or metabolite which are well understood routine and conventional as referenced in the prior art below. Claim 9 adds a step to the method of detecting cannabinoid and metabolite in solution phase which is well understood routine and conventional as referenced in the prior art below. Claim 10 adds a device to the step of detecting the change in optical property which is well known and understood in the prior art taught by Kim in view of Sai. Claim 11-13 adds the addition element of a kit to perform the method of claim 1 which in well know and conventional in the art. Claims 14-15 are intended uses of the device and kit which are well understood routine and conventional in the art. Since it is claimed to be at a high level of generality, there are no meaningful limitations claimed, such as a particular or unconventional machine or transformation of a particular article. (Step 2B: No)
Thus, claim 1 is ineligible. Claims 2-15 are dependent on Claim 1 and are also rejected.
Claim Rejections - 35 USC § 103
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 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, 2, 3, 6, 10, 11, 12, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (US 20220099667 A1), and further in view of Sai et al. (WO 2021229610 A2).
Regarding claim 1, Kim teaches a method of detecting presence or absence of a cannabinoid or metabolite thereof in a biological sample, comprising:
contacting the biological sample (para 0062) with nanoparticle conjugated bioreceptor(s) capable of binding the cannabinoid or metabolite thereof, wherein the nanoparticle conjugated bioreceptor(s) are either immobilized on a conjugate pad (‘On the conjugate pad, a gold nanoparticle conjugate immobilized with an antibody capable of specifically binding to a sample substance’, para 0003), and detecting a change in optical property in response to direct binding of the cannabinoid or metabolite thereof to the nanoparticle conjugated bioreceptor(s) immobilized on the conjugate pad (para 0105).
Kim does not teach the nanoparticle conjugate bioreceptor being immobilized on a fiber optic sensor.
However, Sai teaches a biosensor device which includes an optical fiber probe for detection in biological samples (Abstract). Sai further teaches a fiber optic sensor device comprises an optical fiber which has a probe region which included immobilized bioreceptor molecules configured to bind to target biomolecules (pg 1, para 0008). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Kim with the nanoparticle conjugate bioreceptor being immobilized on a fiber optic sensor as taught by Sai for the benefit of sensing a change in the optical properties of the sample (pg 1, para 0008).
Regarding claim 2, Kim in view of Sai teaches the invention of claim 1. Kim teaches the biological sample is blood, plasma, serum, saliva, urine, and tears from a subject (para 0062).
Regarding claim 3, Kim in view of Sai teaches the invention of claim 1. Kim teaches the biological sample is saliva (para 0062). The claim limitation “optionally diluted” is being interpreted as not being required to be performed.
Regarding claim 6, Kim in view of Sai teaches the invention of claim 1. Kim teaches the bioreceptor is selected from a group comprising antibodies and aptamers (para 0035).
Regarding claim 10, Kim in view of Sai teaches the invention of claim 1.
Kim does not teach the change in optical property of the fiber optic sensor is measured using a device comprising: a light source located proximal to one end of the optical fiber; and a detector located proximal to another end of the optical fiber, wherein the detector is configured to sense the change in the optical property of light that traverses through the optical fiber when the probe region is exposed to the biological sample comprising the cannabinoid or metabolite thereof.
However, Sai teaches biosensor device which includes a light source located proximal to one end of an optical fiber and detector located proximal to another end of the optical fiber wherein the detector is configured to sense the change in the optical property of light that traverses through the optical fiber when the probe region is exposed to the biological sample (pg 1, para 0008) to the benefit of improved sensitivity (pg 6, para 0064-0067). Thus, it would be obvious to one of ordinary skill in the art to modify the teachings of Kim with the change in optical property of the fiber optic sensor is measured using a device comprising: a light source located proximal to one end of the optical fiber; and a detector located proximal to another end of the optical fiber, wherein the detector is configured to sense the change in the optical property of light that traverses through the optical fiber when the probe region is exposed to the biological sample comprising the cannabinoid or metabolite thereof as taught by Sai for the benefit of improved sensitivity (pg 6, para 0064-0067).
Regarding claim 11, Kim in view of Sai teaches the invention of claim 10. Kim further teaches using the blocking agent (‘blocker’, para 0119). The claim limitation states “A test kit…” in the preamble language which does not limit the structure of the claimed invention thus has no patentable weight. The claim limitation “optionally, quantification and/or storage” is being interpreted as not being required to be performed.
Kim does not teach means for sample collection such as a swab.
Sai teaches a clinical sample analysis where the sample is collected with a swab (para 0117). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Kim with means for sample collection such as a swab taught by Sai for the benefit of convenience as swabs can be bought anywhere.
Regarding claim 12, Kim in view of Sai teaches the invention of claim 11. Kim further teaches the blocking agent (‘blocker’) being bovine serum albumin or polyethylene glycol (PEG) (para 0119).
Regarding claim 14, Kim in view of Sai teaches the invention of claim 10. The invention of claim 10 is capable of qualitative and/or quantitative detection of cannabinoid or metabolite thereof in a biological sample as taught by Kim (para 0063).
Regarding claim 15, Kim in view of Sai teaches the invention of claim 11. The invention of claim 11 is capable of qualitative and/or quantitative detection of cannabinoid or metabolite thereof in a biological sample as taught by Kim (para 0063).
Claims 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (US 20220099667 A1) and Sai et al. (WO 2021229610 A2) as applied to claim 3 and 11, respectively, further in view of non-patent literature “Saliva-Based Molecular Testing for SARS-CoV-2 that Bypasses RNA Extraction” by Ranoa et al.
Regarding claim 4, Kim in view of Sai teaches the invention of claim 3. The claim limitation “optionally about 10 to 300 mM NaCl and/or about 0.1 to 0.5 wt% lipid polymer stabilizer in water” is being interpreted as not being required to be performed.
Kim in view of Sail does not teach the dilution solution comprises about 10 to 100 mM Tris, about 10 to 200 mM boric acid, and about 1 to 20 mM EDTA in water and optionally about 10 to 300 mM NaCl and/or about 0.1 to 0.5 wt% lipid polymer stabilizer in water.
However, Ranoa teaches a method of processing fresh saliva from healthy donors which can be used for assay testing (pg 19, Section: Collection and processing of fresh saliva from healthy donors). Ranoa further discloses a method of detecting an analyte in a biological sample, in particular saliva, comprising diluting a the biological sample with a dilution solution, the dilution solution is with 100mM Tris HCl pH8.0, 90mM boric acid, and 1mM EDTA (pg 19, Section: Collection and processing of fresh saliva from healthy donors) for the benefit of minimizing interference from the biological sample. Thus it would be obvious to one of ordinary skill in the art before the effective filing date to modify Kim in view of Sai with the dilution solution comprises about 10 to 100 mM Tris, about 10 to 200 mM boric acid, and about 1 to 20 mM EDTA in water as taught by Ranoa for the benefit of minimizing interference from the biological sample saliva.
Regarding claim 13, Kim in view of Sai teaches the invention of claim 11. The claim limitation “optionally about 10 to 300 mM NaCl and/or about 0.1 to 0.5 wt% lipid polymer stabilizer in water” is being interpreted as not being required to be performed.
Kim in view of Sai does not teach the dilution solution comprises about 10 to 100 mM Tris, about 10 to 200 mM boric acid, and about 1 to 20 mM EDTA in water and optionally about 10 to 300 mM NaCl and/or about 0.1 to 0.5 wt% lipid polymer stabilizer in water.
However, Ranoa further teaches a method of processing fresh saliva from healthy donors which can be used for testing (pg 19, Section: Collection and processing of fresh saliva from healthy donors).Ranoa further discloses a method of detecting an analyte in a biological sample, in particular saliva, comprising diluting a the biological sample with a dilution solution, the dilution solution is with 100mM Tris HCl pH8.0, 90mM boric acid, and 1mM EDTA (pg 19, Section: Collection and processing of fresh saliva from healthy donors) for the benefit of minimizing interference from the biological sample. Thus it would be obvious to one of ordinary skill in the art before the effective filing date to modify Kim in view of Sai with the dilution solution comprises about 10 to 100 mM Tris, about 10 to 200 mM boric acid, and about 1 to 20 mM EDTA in water as taught by Ranoa for the benefit of minimizing interference from the biological sample saliva.
Claims 5, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (US 20220099667 A1) and Sai et al. (WO 2021229610 A2) as applied to claim 1, further in view of Kuchar et al. (CZ 28908 U1). The examiner has obtained a machine translation of the CZ document above from Espacenet. The rejection below is based off the machine translation.
Regarding claim 5, Kim in view of Sai teaches the invention of claim 1.
Kim in view of Sai does not teach the cannabinoid or metabolite thereof is selected from a group comprising tetrahydrocannabinol (THC), cannabidiol (CBD) and cannabinol (CBN) or any combination thereof.
Kuchar teaches immunochromatography and the use of cannabinoid receptors for the analysis of presence of cannabinoids in body fluids (pg 6, para 0019). Kuchar further teaches compounds such as tetrahydrocannabinol and cannabidiol for the benefit of being able to bind to cannabinoid receptors (pg 3, para 007). Thus it would be obvious to one of ordinary skill in the art before the effective filing date to modify Kim in view of Sai with cannabinoid or metabolite thereof is selected from a group comprising tetrahydrocannabinol (THC) and cannabidiol (CBD) as taught by Kuchar for the benefit of being able to bind to cannabinoid receptors for detection (pg 3, para 007).
Regarding claim 7, Kim in view of Sai teaches the invention of claim 1.
Kim in view of Sai does not teach the cannabinoid or metabolite thereof immobilized on the fiber optic sensor surface is immobilized in the form of a cannabinoid/metabolite-carrier conjugate.
Kuchar teaches a method of analysis of presence of cannabinoids in body fluids (pf 5, para 0012) with the use of carrier proteins such as BSA (pg 5, para 0013) for the benefit of selective detection. Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Kim in view of Sai with carrier conjugates as taught by Kuchar for the benefit of selective detection.
Regarding claim 8, Kim in view of Sai and further in view of Kuchar teaches the invention of claim 7.
Kim in view of Sai does not teach the carrier is selected from a group comprising Bovine Serum Albumin (BSA), serum globulins, albumins and ovalbumin or any combination thereof.’
Kuchar teaches that carrier protein can be bovine serum albumin (BSA) to form an immunogen (pg 5, para 0013). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Kim and Sai with the carrier protein being BSA as taught by Kuchar for the benefit of forming an immunogen for detection (pg 5, para 0013).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (US 20220099667 A1) and Sai et al. (WO 2021229610 A2) as applied to claim 1, further in view of Prins et al. (US 20170315115 A1).
Regarding claim 9, Kim in view of Sai teaches the invention of claim 1.
Kim in view of Sai does not teach the wherein the nanoparticle conjugated bioreceptor(s) are in solution phase; and detecting a change in optical property of the fiber optic sensor in response to binding of free nanoparticle conjugated bioreceptor(s) in solution phase to cannabinoid or metabolite thereof immobilized on a fiber optic sensor surface.
However, Prins teaches a sensing device used to sense and detect analytes (Abstract) in biological fluids such as saliva (para 0002). Prins further teaches a probe biosensing element could be a nanoparticle (para 0026) and the probe can be functionalized with specific receptors (para 0029) which are capable of binding to specific metabolites (para 0030). Prins further teaches one probe being mobile in solution (para 0028) for benefit of better access to analyte of interest. Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teaching of Kim in view of Sai with the nanoparticle conjugated bioreceptor(s) are in solution phase as taught by Prins for the benefit of better access to analyte of interest.
Conclusion
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/H.R.B./ Examiner, Art Unit 1798
/CHARLES CAPOZZI/ Supervisory Patent Examiner, Art Unit 1798
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