Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I – claims 1-10 in the reply filed on 5/7/26 is acknowledged. The traversal is on the ground(s) that there would be no undue burden to search the remaining claims. This is not found persuasive because the search for claims 11-20 would require additional searching in areas and use of search terms that would not be required for the elected system.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-20 are withdrawn from consideration.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a control unit configured to determine the property of the target analyte” in claim 1
“control unit is configured to use measurement signals from at least two of the plural sensing units in determining the property of the target analyte” in claim 1
“control unit is configured to determine a property of the target analyte based on measurement signals from at least one of the plural sensing sites and the composite baseline signal” in claim 3
“the control unit being configured to determine the property of the analyte…” in claim 4
“the control unit is configured to determine the property of the target analyte based on the rate of change in a measurement signal of at least one of the plural sensing sites” in claim 10
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a system that can determine the concentration of an analyte in a sample or dissociation/affinity constant of the analyte, does not reasonably provide enablement for determination of any property of an analyte with the disclosed system. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Specifically, in In re Wands the Court set forth a non-exhaustive list of factors to
be considered in determining whether undue experimentation would be involved in
making and/or using the claimed invention. These factors include, but are not limited to:
(a) the breadth of the claims; (b) the nature of the invention; (c) the state of the prior art;
(d) the level of one of ordinary skill; (e) the level of predictability in the art; (f) the amount
of direction provided by the inventor; (g) the existence of working examples; and (h) the
quantity of experimentation needed to make or use the invention based on the content
of the disclosure.
1) Breadth of the claims - The claims are directed to a system for determining any property of a target analyte via the analyte’s interaction with different capture species on each of plural sensing sites.
2) The nature of the invention – A system for determining a property of a target analyte comprising plural sensing sites each supporting different capture species thereon and a control unit that measures signals from at least 2 of the sensing sites to determine the property of the target analyte.
3) The state of the prior art - The prior art cited by Applicants in their IDS (6/10/25 AND 1/6/25) disclose various sensors and arrays with multiple sensing sites to determine the concentration or affinity constants of target analyte bound to the sensing sites.
4) The level of one of ordinary skill - A person who is able to use a system with multiple sensing sites to determine the concentration or dissociation/affinity constants of target analyte bound to the sensing sites.
5) The level of predictability in the art – Low because the specification lacks any description on how to determine properties of analyte bound to the sensing sites other analyte concentration and dissociation/affinity constants of the analyte.
6) Amount of direction provided by the inventor -The amount of direction
provided by the specification is only directed to determining analyte concentration and dissociation/affinity constants of the analyte in the sensing site of the disclosed system ([0026] and [0030]). The breadth of the instant claims with respect to determining a property of a target analyte encompasses determining the size, weight, charge, color, etc of the target analyte but the instant specification does not teach how the disclosed system is capable of determining analyte properties other than the concentration of the analyte or the dissociation/affinity constant of the analyte.
7) The existence of working examples – There are no working example
provided in the specification. The specification only discusses hypothetical examples shown Figures 3, 4, and 6 which are directed to measurement of analyte concentrations.
8) Quantity of experimentation - Many experiments will be necessary to
determine how the disclosed system could be used to determine all properties of analytes that are encompassed by the breadth of the instant claims.
In light of the above factors, it is concluded that undue experimentation would be
involved to make and use the invention as presently claimed.
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 1-10 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.
Claims 1-10 are vague and indefinite because the claims are not clear as to what property of the target analyte is being determined. The metes and bounds of the claims cannot be determined as to what property of the analyte is being determined.
Claim limitation –
• “a control unit configured to determine the property of the target analyte” in claim 1
• “control unit is configured to use measurement signals from at least two of the plural sensing units in determining the property of the target analyte” in claim 1
• “control unit is configured to determine a property of the target analyte based on measurement signals from at least one of the plural sensing sites and the composite baseline signal” in claim 3
• “the control unit being configured to determine the property of the analyte…” in claim 4
• “the control unit is configured to determine the property of the target analyte based on the rate of change in a measurement signal of at least one of the plural sensing sites” in claim 10
in claims 1, 3, 4, and 10 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The claims do not clearly set forth the components/structures that are carrying out the claimed functions. Aside from teaching a control unit, the specification does not disclose what is performing the claimed functions. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
11. 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.
12. Claim 2 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. The limitations of claim 2 appear to be repeated from the last 2 lines of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
13. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
14. Claim(s) 1-4 and 10 is/are rejected under 35 U.S.C. 102(a)(1) or (a)(2) as being anticipated by Kavusi et al (US 8,648,016; herein referred to as Kavusi).
Kavusi discloses a system and method of quantitating the concentration of a molecule of interest in one embodiment includes establishing a plurality of test environments at a plurality of test sites (i.e. binding sites), each of the plurality of test environments associated with one of a plurality of response curves, each of the plurality of response curves different from the other of the plurality of response curves, storing a combined response curve resulting from a summation of the plurality of response curves, exposing the plurality of test sites to a sample having a concentration of a molecule of interest, obtaining a plurality of quantitation signals, each of the plurality of quantitation signals associated with one of the plurality of test sites, associating a summation of the plurality of quantitation signals with the stored combined response curve, and generating a signal related to the concentration of the molecule of interest based upon the association (Col. 3, line 59, to Col. 4, lines 7).
FIG. 5, there is depicted a representation of a multisite biosensor system generally designated 100. The biosensor system 100 includes an I/O device 102, a processing circuit 104 and a memory 106. The I/O device 102 may include a user interface, graphical user interface, keyboards, pointing devices, remote and/or local communication links, displays, and other devices that allow externally generated information to be provided to the biosensor system 100, and that allow internal information of the biosensor system 100 to be communicated externally.
The processing circuit 104 may suitably be a general purpose computer processing circuit such as a microprocessor and its associated circuitry. The processing circuit 104 is operable to carry out the operations attributed to it herein.
Within the memory 106 are various program instructions 108. The program instructions 108, some of which are described more fully below, are executable by the processing circuit 104 and/or any other components as appropriate. Affinity databases 110 and response curve (RC) databases 112 are also located within the memory 106.
The biosensor system 100 further includes environment control equipment 114, environment detector suite 116, and a label reader 118. The label reader 118 may be included in a single device along with the other components of the system 100.
Figure 6 shows a microarray with the binding sites 124. The binding sites 124 and the calibration arrays 126 and 128 are prepared with a capturing agent effective for capturing a biomolecule of interest (Col. 5).
Figure 7 shows a diagram of the assay procedure (also see Col. 6-7).
FIG. 8 depicts a combined response curve 180 that extends substantially linearly throughout a concentration range of interest that is bounded by a minimum concentration 182 and a maximum concentration 184. The concentration range of interest is larger than the dynamic range of any single test site 124 for a given test environment.
By way of example, the response curve 186 is associated with a first test site 124. The response curve 186 has a minimum LoQ 188 and a maximum LoQ 190. The minimum LoQ 188 is greater than the minimum concentration 182 while the maximum LoQ 190 is much less than the maximum concentration 184. Accordingly, the test site 124 associated with the response curve 186 can be used to provide reliable quantitation of samples with a concentration slightly above the minimum concentration 182 of the concentration range of interest and much less than the maximum concentration 184. Accordingly, the test site 124 associated with the responses curve 186 cannot be used to provide reliable quantitation of concentrations throughout the concentration range of interest.
With continued reference to FIG. 8, the response curve 192 has a minimum LoQ 194 and a maximum LoQ 196. The minimum LoQ 194 is less than the maximum LoQ 190 for the response curve 186, while the maximum LoQ 196 is greater than the maximum concentration 184. Accordingly, the test site 124 associated with the response curve 192 can be used to provide reliable quantitation of samples with a concentration at the maximum LoQ 190 for the response curve 186 and up to concentrations that are at the maximum concentration 184 of the concentration range of interest.
Thus, quantitation of samples within the concentration range of interest, which extends from the minimum concentration 182 to the maximum concentration 184, is possible by summing the signals obtained from the test sites 124 associated with the response curves 186 and 192. The concentration associated with the combined signal is obtained using the response curve 180, which is a summation of the response curves 186 and 192. Because the response curve 180 is a summation of the response curves 186 and 192, the minimum LoQ 198 for the response curve 180 will be a concentration slightly less than the minimum LoQ for the most sensitive response curve (response curve 186), while the maximum LoQ 200 for the response curve 180 will be a concentration slightly greater than the maximum LoQ for the least sensitive response curve (response curve 192).
Therefore, by carefully controlling the environment at each of a plurality of test sites 124, a combined output signal may be obtained which has a relatively linear relationship to the concentration of a molecule of interest. Moreover, while only two response curves were needed to fully cover the concentration range of interest in FIG. 8, the test environment at additional sites may be further controlled to provide response curves that are higher than the response curve 192 (to the right as depicted in FIG. 8), or lower than the response curve 186 (to the left as depicted in FIG. 8) if increased dynamic range is desired.
An important consideration in selecting the environmental factor(s) controlled at block 150 of FIG. 7 is to select two or more test environments that result in response curves that overlap in the desired manner. An "overlap" is a range of concentrations which are within the dynamic range of at least two response curves. Linearity of a combined response curve can be optimized by controlling the test environment at different test sites 124 to provide an overlap as depicted in FIG. 8.
As the overlap is increased, the combined response curve increases in slope. By way of example, FIG. 9 depicts a response curve 210 and a response curve 212. The affinity at the test site associated with the response curve 212 is only slightly less than the affinity at the test site associated with the response curve 210. This low modulation of affinity results in a combined response curve 214 that exhibits an increased slope as compared to the response curve 180. The dynamic range of the combined response curve 214, however, is much less than the dynamic range of the combined response curve 180. Accordingly, decreasing the overlap allows for a greater dynamic range for a fixed number of test site environments.
As the overlap is decreased, however, the slope of the resulting combined response curve is reduced. By way of example, FIG. 10 depicts a response curve 220 and a response curve 222. The affinity at the test site associated with the response curve 222 is significantly less than the affinity at the test site associated with the response curve 220. This high modulation of affinity results in a combined response curve 224 that exhibits a decreased slope as compared to the response curve 180. The dynamic range of the combined response curve 224, moreover, is greater than the dynamic range of the combined response curve 180. The combined response curve 224, however, also has a flattened region 226. In the flattened region 226, the potential error in the quantitation of analyte concentration is increased. Providing another test site with an affinity greater than the affinity of the test site associated with the response curve 222 and less than the affinity of the test site associated with the response curve 220, however, can eliminate the flattened region 226 (Cols. 7-8).
In some embodiments, the electric field within each of the test sites may be controlled to be different from the electric field within each of the other of the test sites. The electric field can be used to modify, e.g., local concentrations, pH, etc. The underlying mechanisms include electrolysis and ion attraction. The use of an AC signal may further provide local mixing by creating movement of ions within the sample, e.g., through electrohydrodaynamic effects. Many voltage ranges which provide the foregoing effects are CMOS compatible. Accordingly, a CMOS chip with surface electrodes may be used. Depending upon the desired effect, one, two or more electrodes may be provided at a particular test site and either exposed or isolated from the test sample. Another fabrication method incorporates glass slides with electrodes (e.g., ITO, gold) or plastic or paper membrane with printed electrodes (e.g., carbon, gold, silver).
The type of sensor or sensors incorporated into the label reader 118 will vary depending upon the particular label used. Various embodiments may thus use luminescence, fluorescence, colorimetric, electrochemical, impedance, and magnetic sensors. The sensors should be configured to allow isolation of the signal produced by a selected one or more test sites. Likewise, the sensors incorporated into the environment detector suite 116 may include IR sensors, and Hall sensors. AMR sensors or GMR sensors may be provided to monitor the density of magnetic beads on a test site surface. ISFETs or CMOS based charge detection circuits may be used in electrochemical embodiments.
The concentration of a molecule of interest can thus be obtained over a wide range of concentrations even if the range of concentrations exceeds the dynamic range that can be realized with a single test site. Moreover, the procedure 130 can be used in a variety of test site platforms including 96-well plates, plates with fewer or additional wells, microarray platforms, printed circuit board platforms, CMOS chip platforms, multiplexed assays, protein arrays, lateral flow devices, sandwich assays, competitive assays, bead based arrays or other appropriate platforms. The procedure 130 may further be used for the detection of a variety of molecules of interest as well as different types of molecules in addition to antibodies. By way of example, the procedure 130 may also be used for the detection of Nucleic Acid, protein, or small molecules (Col. 9-10).
With respect to claim 1, the system of Kavusi has a “control circuit” comprising a processor and memory with software that does a summation of the signals from each binding site and compares it to a stored combined response curve to generate a signal related to the concentration of analyte.
With respect to claim 3, Figure 7 shows a diagram of the method steps and includes a step of determining a control or baseline signal in box 158.
With respect to claim 4, Kavusi measures at least 2 binding site to determine analyte concentration.
With respect to claim 10, there are no specific components recited in the claim to define the control unit. The computer/processor of Kavusi is capable of carrying out the functional limitations being claimed and thus reads on the claimed control unit.
Claim Rejections - 35 USC § 103
15. 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.
16. Claim(s) 5-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kavusi et al (US 8,648,016; herein referred to as Kavusi).
With respect to claims 5-7, Kavusi teaches controlling the environment of the binding sites to provide for a response curve with a minimum and maximum limit of concentration to be detected (LOQ) and a dynamic range for each binding site so the response curves can overlap for at least two binding sites (Col. 7, lines 13-25, and Col. 8, lines 14-22). LOQ and LOD are related to each other by the affinity probe molecule density and concentration (Col. 2, lines 13-21). Thus, it has been long settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation. Application of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation. Id. At 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art”. Kavusi teaches that the binding site environments can be controlled to regulate the parameters of the response curve – dynamic range and LOD via LOQ. Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of LOD and dynamic range of each binding site by normal optimization procedures known in the assay art.
With respect to claims 8 and 9, Kavusi teaches modulating affinities in the binding sites using different pressures at different binding sites (Col. 9, lines 54-61). Thus, it has been long settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation. Application of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation. Id. At 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art”. Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of binding affinity of each binding site by normal optimization procedures known in the assay art.
Conclusion
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L CHIN whose telephone number is (571)272-0815. The examiner can normally be reached Monday - Friday, 10:00am - 6:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
8/12/2026
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