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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application claims benefit of the application of PAT 11,563,732 filed 03/13/2020. Based on the filing receipt, the effective filing date of this application is March 13, 2020 which is the filing date of Patent Number 11, 563,732 from which the benefit of priority is claimed.
Information Disclosure Statement
The information disclosure statement (IDS) filed 01/14/2025 has been considered by the examiner.
Status of Claims
Claims 1-21 are cancelled.
Claims 22-32 are pending and examined herein.
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.
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 limitations 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 limitations are:
The phrase “an interference mitigation layer configured to deplete or remove endogenous substance(s) from the sample” in claim 22.
The phrase “a detection layer configured to produce an optical signal proportional to the concentration of the biomarker in the sample of the biological fluid” in claim 22.
The phrase “the optoelectronic reader is configured to perform a blank readout of the biosensor without sample applied thereto” in claim 23.
The phrase “a solid state test strip assembly configured to enzymatically remove creatine from the sample” in claim 24.
The phrase “the biosensor is configured to convert creatinine in the sample into hydrogen peroxide” in claim 25.
The phrase “a Trinder pair configured to react with hydrogen peroxide to produce the optical signal” in claim 25.
The phrase “such that the optoelectronic reader measures the optical signal at
least two wavelengths” in claim 30.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The phrase “an interference mitigation layer configured to deplete or remove endogenous substance(s) from the sample” in claim 22 is interpreted as equivalent to “an active interference mitigation layer (performing creatine removal in the case of a test for creatinine) positioned adjacent to or below the application pad and configured to enzymatically deplete an interfering species (such as creatine) in the sample”, as disclosed by p. 6, lines 10-12 of the specification.
The phrase “a detection layer configured to produce an optical signal proportional to the concentration of the biomarker in the sample of the biological fluid” in claim 22 is interpreted as equivalent to “a detection layer in which a colorimetric response is induced by the presence of the biomarker (such as creatinine)”, as disclosed by p. 6, lines 12-14 of the specification.
The phrase “the optoelectronic reader is configured to perform a blank readout of the biosensor without sample applied thereto” in claim 23 is interpreted as equivalent to a reader able to perform a blank readout of a biosensor without a sample applied thereto.
The phrase “a solid state test strip assembly configured to enzymatically remove creatine from the sample” in claim 24 is interpreted as equivalent to a test strip comprising an “enzyme formulation can comprise a creatine eliminating enzyme such as creatine kinase or catalase”, as disclosed in p. 11, lines 18-19 of the applicant’s specification.
The phrase “the biosensor is configured to convert creatinine in the sample into hydrogen peroxide” in claim 25 is interpreted as equivalent to “mediated by the following enzymes: creatinine amidohydrolase, creatine amidinohydrolase, sarcosine oxidase, and peroxidase. Chromogenic reagents, i.e. Trinder pair, are utilized to generate the optical signal”, as disclosed in p. 12, lines 13-15 of the applicant’s specification.
The phrase “a Trinder pair configured to react with hydrogen peroxide to produce the optical signal” in claim 25 is interpreted as equivalent to “Chromogenic reagents, i.e. Trinder pair, are utilized to generate the optical signal”, as disclosed in p. 12, line 15 of the applicant’s specification.
The phrase “such that the optoelectronic reader measures the optical signal at
least two wavelengths” in claim 30 is interpreted as equivalent to “the sensing device can comprise at least two separate illumination light sources at different wavelengths”, as disclosed in p. 19, lines 1-2 of the applicant’s specification.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 22-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed, and correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art. See MPEP 2163.
Claims 22-32 are directed to a method for measuring a concentration of biomarkers, such as creatinine. The method comprises providing an interference mitigation layer configured to deplete or remove endogenous substances and a detection layer configure to produce an optical signal proportional to the concentration of the biomarker. The layers are not limited except by dependent claims that recite that the interference mitigation layer includes an enzyme for elimination of the creatine, such as creatine kinase, and the detection layer is configured to convert creatinine in the sample into hydrogen peroxide. The interference mitigation layer and the detection layer are both directed at a broad genus of layers.
The scope of the claims therefore covers methods detecting a biomarker using a large genus of layers characterized by substantial variability.
Regarding the predictability or unpredictability in the art, the applicant has attested that artisans have long-sought with varying success to use test strip layers and enzymatic reactions to detect biomarkers. See p. 2-5 of applicant’s specification. For example, the applicant discloses, “the pathway taught by Deeg relies on an expensive and unstable enzyme […] the test could not reasonable be performed outside a laboratory setting” (see, p. 3 of applicant’s specification). Furthermore, the applicant states, “the cassette and relatively large number of membranes required for the Shull test strip increase both cost and complexity” (see, p. 4 of the applicant’ specification).
The specification does not disclose actual reduction to practice of layers having the necessary functional characteristics. The specification merely shares results from a method using these layers and provides prophetic examples; there is no disclosure of any specific species of layers falling within the claimed genus. The applicant gives insufficient description of an embodiment in para. 3 of p. 15 and para. 2 of p. 12 of the applicant’s specification. Details specifying reduction to practice of layers comprising particular reagents with specific concentrations are absent.
The disclosure of general methods that might be used to make the interference mitigation layer and detection layer is insufficient to describe the claimed genus of interference mitigation layer and detection layer. The Federal Circuit addressed an analogous situation in University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 927 (Fed. Cir. 2004), finding that disclosure of “assays for screening compounds, including peptides, polynucleotides, and small organic molecules to identify those that inhibit the expression or activity of the PGHS-2 gene product,” did not satisfy the written description requirement for claims requiring administration of a “compound that selectively inhibits PGHS-2.” Rochester, 119 F.3d at 918, 927; see also Ariad Pharmaceuticals, Inc., v. Eli Lilly and Company, 598 F.3d 1336, 1344 (Fed. Cir. 2010) (recognizing distinction between requirements for written description and enablement).
Furthermore, there is also no disclosure of any partial structure common to the members of the genus of interference mitigation layer and detection layer that would correlate with function (in this case, the claimed function of removing endogenous substances and producing an optical signal).
The importance of structure/function correlations was recently highlighted by the courts (Abbvie Deutschland v. Janssen Biotech and Centocor Biologics, App. No. 2013-1338, -1346 (Fed. Cir., July 1, 2014)). The Abbvie case involved antibodies and written description. The court stated: “We have held that “a sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Id. at 1350 (quoting Eli Lilly, 119 F.3d at 1568– 69).”. The courts then further stated: “With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus.” (emphasis added) and then state: " Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Ariad, 598 F.3d at 1351 (“[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.”); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1352 (Fed. Cir. 2011) (noting the technical challenges in developing fully human antibodies of a known human protein). It is true that functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date. Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002).
If it was indeed unpredictable at the time of the invention to develop the interference mitigation layer and detection layer as Applicant has argued, then one skilled in the art would not envision possession of the entire genus of interference mitigation layers and the entire genus of detection layers as claimed since the specification merely provides prophetic examples.
There is no partial structure or other identifying characteristics disclosed, common to the members of the genus of interference mitigation layers and the entire genus of detection layers, that would allow one skilled in the art to envision that Appellant has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus.
For all of these reasons, the specification does not demonstrate possession of the entire genus of interference mitigation layer and the entire genus of detection layer having the claimed functional characteristics of removing endogenous substances and producing an optical signal in proportion to the concentration of the biomarker.
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 30 and 32 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 30 recites, “in a range about 400 nm to about 700 nm”. It is unclear what is encompassed by the range from about 400 nm to about 700 nm because “about” has not been defined in the specification. Therefore, the metes and bounds of the claim cannot be ascertained.
Claim 32 recites the limitation " the mobile device is couplable to the mobile device " in the claim body. There is insufficient antecedent basis for the second recitation of the mobile device limitation in the claim. For the purpose of applying prior art, dependent claim 32 will be interpreted as “the optoelectronic reader is couplable to the mobile device” because independent claim 22 recites, “the optoelectronic reader operably connects to a mobile device”(see, lines 9-10 of claim 22).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 31 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 31 recites, “The method of claim 22, wherein the mobile device may convey the measurement of the concentration of the biomarker visually or audibly”. The phrase “may convey” is optional language. Therefore, the broadest reasonable interpretation of the claim covers mobile devices that convey the measurement of the concentration of the biomarkers visually or audibility and mobile devices that do not. Every mobile device falls under those two options; hence, the claim is not further limiting. The claim would be clearer if amended to “the mobile device s the measurement”.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
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.
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 22-23 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Talalak (“A facile low-cost enzymatic paper-based assay for the determination of urine creatinine”, published 2015) as evidenced by the HP printer setup instructions (hereto referred to as HP), the “EC 3.5.2.10” entry in the Enzyme Database by ExplorEnz, and the “EC 3.5.3.3” entry in the Enzyme Database by ExplorEnz.
Talalak teaches a method of measuring concentration of a biomarker in a sample of biological fluid, the method comprising: providing a biosensor including an interference mitigation layer configured to deplete or remove endogenous substance(s) from the sample, and a detection layer configured to produce an optical signal proportional to the concentration of the biomarker in the sample of the biological fluid; applying a sample of biological fluid to the biosensor, wherein the biomarker hydrolyzes, producing the optical signal as a colorimetric response; inserting the biosensor into an optoelectronic reader, wherein the optoelectronic reader operably connects to a mobile device having a central processing unit, measuring an optical signal over time and at at least two wavelengths, wherein the optical signal is proportional to a concentration of the biomarker in the sample of biological fluid; and quantifying the optical signal and correcting variable kinetics of the sample of biological fluid with an algorithm present in the central processing unit; generating a measurement of a concentration of the biomarker; and conveying the measurement of the concentration of the biomarker via the mobile device, as in claim 22 and 31-32 (see, e.g., measuring biomarker in a sample – under title; interference mitigation layer – p. 917, under “2.4 Creatinine detection using enz-PADs”: “Although catalase, present in R1 to remove H2O2 generated from the endogenous creatine elimination reaction, moves to R2, catalase does not interfere with the peroxidase reaction in R2 because it is inhibited by the sodium azide contained in R2”, and p. 916, col. 1, para. 5: “Endogenous creatine needs to be eliminated in the first step by enzymes present in R1”; detection layer where biomarker hydrolyzes producing an optical signal – p. 917, under “Fig. 1.”; inserting the biosensor into an optoelectronic reader – p. 918, col. 1, para. 1: “Finally, the enz-PAD was imaged using a scanner (HP Deskjet F370 All-in-One scanner) at 600 dpi resolution in Jpeg format”; optoelectronic reader operably connects to mobile device having a central processing unit – p. 918, col. 1, para. 1: “An average intensity value of the rectangular area was obtained from the histogram panel of RGB channel in the Adobe Photoshop CS2 programme”; measuring the optical signal over time and at at least two wavelengths – p. 918, col. 1, para. 1: “the enz PAD devices were removed from the sample wells, and the colour was allowed to completely develop using air-drying in the detection zone for another 7 min (Fig. 2). Finally, the enz-PAD was imaged using a scanner (HP Deskjet F370 All-in-One scanner) at 600 dpi resolution in Jpeg format”, p. 918, col. 1, para. 1: “An average intensity value of the rectangular area was obtained from the histogram panel of RGB channel in the Adobe Photoshop CS2 programme”, and p. 919, under “Fig. 4.”; optical signal is proportional to the concentration of the biomarker – p. 919, under “Fig. 5.”; quantifying the optical signal and correcting variable kinetics of the sample of biological fluid with an algorithm present in the central processing unit – p. 918, col. 1, para. 1: “The detection zone, a fixed size corresponding to 70 x 90 pixels in rectangular area on the enz-PAD, was selected for measuring the colour intensity. An average intensity value of the rectangular area was obtained from the histogram panel of RGB channel in the Adobe Photoshop CS2 programme”; generating a concentration and conveying it to a mobile device – “The detection zone, a fixed size corresponding to 70 x 90 pixels in rectangular area on the enz-PAD, was selected for measuring the colour intensity. An average intensity value of the rectangular area was obtained from the histogram panel of RGB channel in the Adobe Photoshop CS2 programme”, and p. 920, under “Fig. 6.”). HP gives evidence that the optoelectronic reader of Talalak is capable of connecting with a mobile device via a wireless connection, as in claims 22 and 32 (see, e.g., p. 1, under “Add a network printer to Windows”: “Set up a Wi-Fi or wired network printer in Windows”). It is understood that the biomarker concentration is conveyed in Talalak via computing device with a central processing unit, such as a laptop, because the analysis is executed with a computer application. It is understood that calculating the average intensity of the detection zone of the test of Talalak is equivalent to quantifying the optical intensity with an algorithm. It is understood that the “histogram panel of RGB channel” indicates the optical measurements were at at least two wavelengths.
Talalak teaches the biosensors is inserted into the optoelectronic reader before the sample is applied and the optoelectronic reader is configured to perform blank readout of the biosensor, as in claim 23 (see, e.g., p. 919, under “3.4 Analytical range and limit of detection”, para. 2: “The limit of detection (LOD) was calculated based on three standard deviations of a blank sample (n= 10)”).
While Talalak does not explicitly state what computing device is used for analysis and conveying the biomarker measurements, as in claims 22 and 31-32, the use of a mobile device such as a laptop is known in the art and would have been obvious to try based on the given disclosure of Talalak. An artisan would have had a reasonable expectation of success.
Claims 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over Talalak (cited above), as applied to claims 22-23 and 31-32, and further in view of Peake (“Measurement of Serum Creatinine – Current Status and Future Goals”, published 2006) as evidenced by “An In-depth Technical Guide to the DAOS and 4-AAP Reaction Principle” by the BenchChem Technical Support Team (referred to as BenchChem hereto, published April 2026).
Talalak teaches as set forth above, and further teaches wherein the biomarker is creatinine, the biosensor is a solid state test strip assembly configured to enzymatically remove creatine from the sample and to enzymatically convert creatinine in the sample to a substance that is reactive with a chromogenic reagent, as in claim 24 (see, e.g., test strip – p. 917, under “Fig. 2.”; remove creatine from sample – p. 916, col. 1, para. 5: “Endogenous creatine needs to be eliminated in the first step by enzymes present in R1”; enzymatically convert creatinine in the sample to a substance that is reactive with a chromogenic reagent – p. 917, under “Fig. 1.”).
Talalak teaches the detection layer of the biosensor is configured to convert creatinine in the sample into hydrogen peroxide via an enzymatic reaction and the chromogenic reagent comprises a Trinder pair configured to react with hydrogen peroxide, as in claim 25 (see, e.g., p. 917, under “Fig. 1.”). BenchChem gives evidence that Talalak uses a Trinder pair configured to react with hydrogen peroxide. BenchChem discloses, “The core of the Trinder reaction is an enzyme-mediated oxidative coupling that produces a stable, colored quinoneimine dye” (see, p. 1, under “Core Principle: The Trinder Reaction”).
Talalak teaches the enzymatic reaction is mediated by a primary enzyme comprising creatinine primary enzyme comprising creatinine amidohydrolase, and coupling enzymes comprising creatine amidonohydrolase, sarcosine oxidase, and peroxidase, as in claim 26 (see, e.g., p. 917, under “Fig. 1.”). The creatininase of Talalak is equivalent to creatinine amidohydrolase as evidenced by the “EC 3.5.2.10” entry in the Enzyme Database. The creatinase of Talalak is equivalent to creatine amidinohydrolase as evidenced by the “EC 3.5.3.3” entry in the Enzyme Database.
Talalak teaches the interferences mitigation layer includes an enzyme for elimination of creatine, as in claim 28 (see, e.g., p. 916, col. 1, para. 4: “Endogenous creatine needs to be eliminated in the first step by enzymes present in R1”).
Talalak discloses, “Creatinine is the end product of creatine metabolism, which normally exists in serum and is eradicated from the blood circulation via glomerular filtration at a constant excretion rate [1 ,2). Abnormal levels of creatinine in serum or urine indicate impaired
kidney function, and creatinine has been accepted as a marker for monitoring the impact of treatment in haemodialysis patients”, as in claim 24 (see, p. 915, under “1. Introduction”, col. 1, para. 1). However, Talalak does not teach the measurement of creatinine in serum, as in claim 24.
Peake teaches measurement of creatinine in serum, as in claim 24 (see, e.g., under title: “Measurement of Serum Creatinine – Current Status and Future Goals”).
Talalak and Peake are analogous to the field of the claimed invention because they are both in the field of creatinine measurement. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to use the method of Talalak on the sample type of Peake because Peake discloses, “Even to measure the clearance of endogenous substances, such as urea and creatinine, requires both serum and an accurately timed urine collection, so efforts have been directed at more convenient “urine-free” estimates of GFR.3
The abbreviated Modification of Diet in Renal Disease (MDRD) equations were developed in 1999 to allow the estimation of eGFR based on routine measurement of serum creatinine, along with the readily available demographic variables age, gender and race” (see, p. 173, under “Introduction”, para. 1 to para. 2). An artisan would have been motivated to use the method of Talalak on serum because measuring the clearance of creatinine using urinary samples requires accurately timed urine collection, therefore, the measurement of serum creatinine is more convenient. An artisan would have had a reasonable expectation of success based on the given disclosures.
Talalak teaches the chromogenic reagent comprises a Trinder pair, as in claim 27 (see, e.g., p. 917, under “Fig. 1.”). However, Talalak and Peake fail to explicitly disclose the Trinder pair comprises MAOS (N-Ethyl-N-(2-hydroxy-3-sulfopropy 1 )-3, 5-dimethy laniline) and 4-AA ( aminoanti pyrine), as in claim 27.
However, an artisan would have found it obvious to simply substitute the Trinder pair of Talalak with the Trinder pair, MAOS (N-Ethyl-N-(2-hydroxy-3-sulfopropy 1 )-3, 5-dimethy laniline) and 4-AA ( aminoanti pyrine). The simple substitution of functional equivalents would have been obvious to one skilled in the art because BenchChem discloses, “The core of the Trinder reaction is an enzyme-mediated oxidative coupling that produces a stable, colored quinoneimine dye” (see, p. 1, under “Core Principle: The Trinder Reaction”). Both the Trinder pair of Talalak and the Trinder pair, MAOS (N-Ethyl-N-(2-hydroxy-3-sulfopropy 1 )-3, 5-dimethy laniline) and 4-AA ( aminoanti pyrine), are based on the same principle with equivalent results. An artisan would have had a reasonable expectation of success based on the given disclosures.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Talalak and Peake, as applied to claims 24-28 above, and further in view of Jena (US 20140072189 A1, published 2014-03-13).
Talalak and Peake teach as set forth above, but fail to teach the optoelectronic reader has at least two LED with independent respective emission peaks in a range from about 400 nm to about 700 nm, as in claim 30. However, Jena teaches at least two LED with independent respective emission peaks in a range from about 400 nm to about 700 nm, as in claim 30 (see, e.g., para. [0086]-[0088]).
Talalak and Jena are analogous to the field of the claimed invention because they are both in the field of colorimetric assays. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to use the multiple LEDs of Jena in the method of Talalak as modified by Peake. An artisan would have been motivated to do so because Jena discloses that the multiple LEDs allows the device to detect out-of-range conditions (see, e.g., para. [0086]-[0088]). An artisan would have had a reasonable expectation of success based on the given disclosures.
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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Claims 22-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22-30 of U.S. Patent No. 11,536,732 (referred to as ‘732 hereto) in view of Jena cited above. Although the claims at issue are not identical, they are not patentably distinct from each other.
With respect to claim 22 and 31-32, ‘732 teaches a method of measuring concentration of a biomarker in a sample of biological fluid, the method comprising: providing a biosensor including an interference mitigation layer configured to deplete or remove endogenous substance(s) from the sample, and a detection layer configured to produce an optical signal proportional to the concentration of the biomarker in the sample of the biological fluid; applying a sample of biological fluid to the biosensor, wherein the biomarker hydrolyzes, producing the optical signal as a colorimetric response; inserting the biosensor into an optoelectronic reader, wherein the optoelectronic reader operably connects to a mobile device having a central processing unit, measuring an optical signal over time and at least two wavelengths, wherein the optical signal is proportional to a concentration of the biomarker in the sample of biological fluid; and quantifying the optical signal and correcting variable kinetics of the sample of biological fluid with an algorithm present in the central processing unit; generating a measurement of a concentration of the biomarker; and conveying the measurement of the concentration of the biomarker via the mobile device (see, claim 22 of ‘732).
With respect to claim 23, ‘732 teaches wherein the biosensor is inserted into the optoelectronic reader before the sample of biological fluid is applied to the biosensor, and the optoelectronic reader is configured to perform a blank readout of the biosensor without sample applied thereto (see, claim 23 of ‘732).
With respect to claim 24, ‘732 teaches wherein the biological fluid is blood, serum, or plasma, wherein the biomarker is creatinine, and wherein the biosensor is a solid state test strip assembly configured to enzymatically remove creatine from the sample, and to enzymatically convert creatinine in the sample to a substance that is reactive with a chromogenic reagent to produce the optical signal for reading by the optoelectronic reader (see, claim 24 of ‘732).
With respect to claim 25, ‘732 teaches wherein the detection layer of the biosensor is configured to convert creatinine in the sample into hydrogen peroxide via an enzymatic reaction, and the chromogenic reagent comprises a Trinder pair configured to react with hydrogen peroxide to produce the optical signal (see, claim 25 of ‘732).
With respect to claim 26, ‘732 teaches wherein the enzymatic reaction is mediated by a primary enzyme comprising creatinine amidohydrolase, and coupling enzymes comprising creatine amidinohydrolase, sarcosine oxidase, and peroxidase (see, claim 26 of ‘732).
With respect to claim 27, ‘732 teaches, wherein the Trinder pair comprises MAOS (N-Ethyl- N-(2-hydroxy-3-sulfopropyl)-3,5-dimethylaniline) and 4-AA (aminoantipyrine) (see, claim 27 of ‘732).
With respect to claim 28, ‘732 teaches wherein interference mitigation layer includes an enzyme for elimination of the creatine (see, claim 28 of ‘732).
With respect to claim 29, ‘732 teaches wherein the enzyme is creatine kinase (see, claim 29 of ‘732).
With respect to claim 30, ‘732 teaches wherein the optoelectronic reader uses an LED with an emission peak in a range from about 400 nm to about 700 nm, such that the optoelectronic reader measures the optical signal at least two wavelengths (see, claim 30 of ‘732).
‘732 teaches as set forth above, but fails to teach the optoelectronic reader has at least two LED with independent respective emission peaks in a range from about 400 nm to about 700 nm, as in claims 22 and 30. However, Jena teaches at least two LED with independent respective emission peaks in a range from about 400 nm to about 700 nm, as in claims 22 and 30 (see, e.g., para. [0086]-[0088]).
‘732 and Jena are analogous to the field of the claimed invention because they are both in the field of colorimetric assays. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to use the multiple LEDs of Jena in the method of Talalak as modified by Peake. An artisan would have been motivated to do so because Jena discloses that the multiple LEDs allows the device to detect out-of-range conditions (see, e.g., para. [0086]-[0088]). An artisan would have had a reasonable expectation of success based on the given disclosures.
Claims 22-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-8, 13, and 16 of U.S. Patent No. 11,982,680 (referred to as ‘680 hereto) in view of Jena (cited above) and Talalak (cited above). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘680 recites a biosensor, not a method as in the instant application, however, the ‘680 discloses in claim 1 that the biosensor is for measuring a concentration of a biomarker.
With respect to claim 22 and 31-32, ‘680 teaches a method of measuring concentration of a biomarker in a sample of biological fluid, the method comprising: providing a biosensor including an interference mitigation layer configured to deplete or remove endogenous substance(s) from the sample, and a detection layer configured to produce an optical signal proportional to the concentration of the biomarker in the sample of the biological fluid; applying a sample of biological fluid to the biosensor, wherein the biomarker hydrolyzes, producing the optical signal as a colorimetric response; inserting the biosensor into an optoelectronic reader, wherein the optoelectronic reader operably connects to a mobile device having a central processing unit, measuring an optical signal over time and at at least two wavelengths, wherein the optical signal is proportional to a concentration of the biomarker in the sample of biological fluid; and quantifying the optical signal and correcting variable kinetics of the sample of biological fluid with an algorithm present in the central processing unit; generating a measurement of a concentration of the biomarker; and conveying the measurement of the concentration of the biomarker via the mobile device (see, claim 1 of ‘680).
With respect to claim 24, ‘680 teaches wherein the biological fluid is blood, serum, or plasma, wherein the biomarker is creatinine, and wherein the biosensor is a solid state test strip assembly configured to enzymatically remove creatine from the sample, and to enzymatically convert creatinine in the sample to a substance that is reactive with a chromogenic reagent to produce the optical signal for reading by the optoelectronic reader (see, claims 5-6 of ‘680).
With respect to claim 25, ‘680 teaches wherein the detection layer of the biosensor is configured to convert creatinine in the sample into hydrogen peroxide via an enzymatic reaction, and the chromogenic reagent comprises a Trinder pair configured to react with hydrogen peroxide to produce the optical signal (see, claims 5-6 of ‘680).
With respect to claim 26, ‘680 teaches wherein the enzymatic reaction is mediated by a primary enzyme comprising creatinine amidohydrolase, and coupling enzymes comprising creatine amidinohydrolase, sarcosine oxidase, and peroxidase (see, claim 7 of ‘680).
With respect to claim 27, ‘680 teaches, wherein the Trinder pair comprises MAOS (N-Ethyl- N-(2-hydroxy-3-sulfopropyl)-3,5-dimethylaniline) and 4-AA (aminoantipyrine) (see, claim 8 of ‘680).
With respect to claim 28, ‘680 teaches wherein interference mitigation layer includes an enzyme for elimination of the creatine (see, claim 13 of ‘680).
With respect to claim 29, ‘680 teaches wherein the enzyme is creatine kinase (see, claim 13 of ‘680).
With respect to claim 30, ‘680 teaches wherein the optoelectronic reader uses an LED (see, claim 16 of ‘680).
‘680 teaches as set forth above, but fails to teach the optoelectronic reader has at least two LED with independent respective emission peaks in a range from about 400 nm to about 700 nm, as in claims 22 and 30. However, Jena teaches at least two LED with independent respective emission peaks in a range from about 400 nm to about 700 nm, as in claims 22 and 30 (see, e.g., para. [0086]-[0088]).
‘680 and Jena are analogous to the field of the claimed invention because they are both in the field of colorimetric assays. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to use the multiple LEDs of Jena in the method of Talalak as modified by Peake. An artisan would have been motivated to do so because Jena discloses that the multiple LEDs allows the device to detect out-of-range conditions (see, e.g., para. [0086]-[0088]). An artisan would have had a reasonable expectation of success based on the given disclosures.
‘680 and Jena teach as set forth above, but fail to teach wherein the biosensor is inserted into the optoelectronic reader before the sample of biological fluid is applied to the biosensor, and the optoelectronic reader is configured to perform a blank readout of the biosensor without sample applied thereto, as in claim 23.
However, Talalak teaches wherein the biosensor is inserted into the optoelectronic reader before the sample of biological fluid is applied to the biosensor, and the optoelectronic reader is configured to perform a blank readout of the biosensor without sample applied thereto, as in claim 23 (see, e.g., p. 919, col. 1, under “3.4. Analytical range and limit of detection”, para. 2).
‘680, Jena, and Talalak are analogous to the field of the claimed invention because they are all in the field of colorimetric assays. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to incorporate the method step of Talalak into the disclosure of ‘680 and Jena. An artisan would have been motivated to do so because Talalak discloses the blank samples are needed to calculate the limit of detection (see, e.g., p. 919, col. 1, under “3.4. Analytical range and limit of detection”, para. 2). An artisan would have had a reasonable expectation of success based on the given disclosures.
Conclusion
No claims are allowed. Claim 29 is free of the art because while Talalak (cited above) teaches an interference mitigation layer using enzymes, the enzymes do not include creatine kinase (see, e.g., Talalak, p. 916, col. 1, para. 5: “Endogenous creatine needs to be eliminated in the first step by enzymes present in R1”). However, claim 29 is still rejected under 35 U.S.C 112(a), 35 U.S.C 112(b), and double patenting rejections.
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/MICHAEL CAMERON SVEIVEN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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