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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. The Applicant’s submission filed on 11/28/2025 has been entered.
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.
No claim limitations are interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 11 and 15 are objected to because of the following informalities:
in claim 11, line 3: “are configured” should be “is configured”; and
in claim 15, line 36: “a respective indicator element” should be “the respective indicator element”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-5, 7, 10-22, 24-25, and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “the indication of the second indicating element section at a radially outer surface of the second indicating element section” in lines 44-46, but it is not clear if this indication is referring to the indication of “the second indicating element section configured to: indicate that the first indicating element section is adequately exposed to” of claim 1, lines 9-12 or the indication of “the second indicating element section configured to…indicate that the first indicating element section is unusable responsive to the second indicating element section being exposed to water” of claim 1, lines 9-14. Clarification is required.
Claims 3-5, 7, and 10-14 are rejected by virtue of their dependence from claim 1.
Claim 15 recites “the respective indicator element” in line 32 and “the source of the body fluid” in line 49 in which there are insufficient antecedent bases for these limitations in the claim.
Claim 15 recites “the indication of the second indicating element section at a radially outer surface of the second indicating element section” in lines 52-54, but it is not clear if this indication is referring to the indication of “the second indicating element section visibly indicating: that the first indicating element section is adequately exposed to and/or saturated by the body fluid for the measurement to be relied upon” of claim 15, lines 22-25 or the indication of “the second indicating element section visibly indicating…that the first indicating element section is unusable responsive to the second indicating element section being exposed to water” of claim 15, lines 22-28. Clarification is required.
Claims 16-22, 24-25, and 27 are rejected by virtue of their dependence from claim 15.
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.
Claims 1, 3-5, 7, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2015/0168244 (Gilbert)(previously cited), in view of U.S. Patent Application Publication No. 2012/0165626 (Irina), and further in view of U.S. Patent Application Publication No. 2013/0280696 (Millenson)(previously cited), and further in view of WO 00/74763 (Prausnitz)(previously cited), and further in view of U.S. Patent Application Publication No. 2014/0051173 (Barstis)(previously cited), and further in view of U.S. Patent No. 2011/0313267 (Choi)(previously cited).
Gilbert teaches a diffuser (the diffuser 120 of Gilbert); a connection tube section (the connection tube 132 of Gilbert); a first indicating element section (one of the indicating elements 108; paragraphs 0105, 0110, 0152, and 0192-0193 of Gilbert); and a second indicating element section (another of the indicating elements 108; paragraphs 0105, 0110, 0152, and 0192-0193 of Gilbert).
Gilbert teaches that a sufficient amount of fluid should be collected (paragraphs 0168 of Gilbert). Irina teaches that a test trip may be used with a dye indicator that indicates that a sufficient amount of sample has been collected. The optical change may be detected by an optical system, or by visual inspection (paragraphs 0091 and 0108 of Irina). Once the test strip has collected a sufficient volume of the sample, the test strip can be used to determine the analyte in the sample (paragraph 0109 of Irina). This helps ensure accurate testing (paragraph 0089 of Irina). Further, Irina teaches that such an arrangement is suitable to evaluate the concentration of any analyte or analytes in any body fluid sample (e.g., sweat, blood, serum, urine, saliva, amniotic fluid, etc.(paragraph 0009 of Irina). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a second indicating element section to indicate that a sufficient volume of the sample has been collected, as suggested by Irina, since it ensures accurate testing.
As to the placement of the indicators 108 of Gilbert, Gilbert teaches that the rearrangement of the indicating elements may overlap or be adjacent or any other arrangement (paragraph 0157 of Gilbert). According to one example, the indicating elements are at the same distance from the collection area (FIG. 13E of Gilbert). Millenson teaches that indicating elements may have one in front of the other such that one indicating element is closer to the collection area than the other indicating element (the test zones 144 in FIG. 2 of Millenson; test zones 144a and 144b in FIG. 12 of Millenson; the test zones 144a in FIG. 28 of Millenson; paragraphs 0063, 0071, 0077, and 0122 of Millenson). It would have been obvious to position the indicating elements 108 one after the other such that one indicating element is closer to the collection area than the other indicating element since (1) Gilbert teaches other arrangements may be used and Millenson teaches such arrangements and/or (2) it is a simple substitution of one known element for another to obtain predictable results.
Also, it would have been obvious to position the another of the indicating elements 108 used to indicate that a sufficient volume of the sample has been collected further from the source of the body fluid than the one indicating element since the another indicating element is used to indicate that a sufficient volume of the sample has been collected for analysis using the one indicating element and placing the another indicating element closer to the source than the one indicating element would make such an indication less reliable.
Alternatively, it would have been obvious to position the another of the indicating elements 108 used to indicate that a sufficient volume of the sample has been collected further from the source of the body fluid than the one indicating element since a sequence of the two indicating elements is required; there is a finite number of solutions to this problem (the another indicating element is closer to the source of the body fluid than the one indicating element or the one indicating element is closer to the source of the body fluid than the another indicating element); and one of ordinary skill in the art would have pursued the known potential solutions with a reasonable expectation of success to arrive at the arrangement that provides the best results for the another indicating element to indicate that a sufficient volume of the sample has been collected for analysis using the one indicating element.
Gilbert teaches a housing (the housing 110 of Gilbert) having a tubular body, the diffuser being at least partially disposed in the tubular body (FIG. 1A of Gilbert). Gilbert further teaches that blood can be collected using needles (paragraph 0092 of Gilbert). Prausnitz teaches that microneedle array (page 16 and FIGS. 25-26 of Prausnitz). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the microneedle array of Prausnitz as the fluid collector of the combination since (1) it is a simple substitution of one known element for another to obtain predictable results, (2) it causes less trauma to the patient; and/or (3) it permit blood collection at the skin surface.
Gilbert teaches that one of the indicating element may be used to measure a chemical property such as pH and other substances (paragraphs 0108 and 0152-0156 of Gilbert). Prausnitz teaches that blood glucose is a suitable substance to monitor (pages 19-20, 22, and 56 of Prausnitz). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an indicating element section for determining glucose level since Gilbert teaches that chemical substances may be determined in blood and Prausnitz teaches one such substance. Barstis teaches a detector kit that uses an indicating element section (called a control) used to verify that the testing kit has not become contaminated during storage or use (paragraph 0053 of Barstis). Choi teaches that outside moisture is one such contaminant (abstract, paragraph 0008, 0013-0014, and 0184 of Choi). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an indicating element section to verify that the testing kit has not become contaminated during storage or use due to moisture since it would provide a greater confidence in the test results of the glucose.
Also, Gilbert teaches that the indicating elements may overlap (paragraph 0157 of Gilbert). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the indicating element section that verifies that the testing kit has not become contaminated during storage or use due to moisture and the another of the indicating elements 108 used to indicate that a sufficient volume of the sample has been collected overlap since it conserves space.
With respect to claim 1, the combination teaches or suggest an apparatus comprising:
a diffuser (the diffuser 120 of Gilbert) having:
a connection tube section (the connection tube 132 of Gilbert) forming a tubular fluid passage extending from a proximal end (the proximal end 146 of Gilbert) of the diffuser toward a distal end (the distal end 148 of Gilbert) of the diffuser along at least a part of a distance between the proximal end and the distal end;
a first indicating element section (one of the indicating elements 108; paragraphs 0105, 0110, 0152, and 0192-0193 of Gilbert) disposed between the distal end and the connection tube section, the first indicating element section configured to indicate a measurement related to a body fluid;
a second indicating element section (another of the indicating elements 108; paragraphs 0105, 0110, 0152, and 0192-0193 of Gilbert), the second indicating element section configured to: indicate that the first indicating element section is adequately exposed to and/or saturated by the body fluid for the measurement to be relied upon (the another of the indicating elements 108 used to indicate that a sufficient volume of the sample has been collected, as suggested by Irina), and indicate that the first indicating element section is unusable responsive to the second indicating element section being exposed to water (the use of the indicating element section to verify that the testing kit has not become contaminated during storage or use due to moisture overlapping with the another of the indicating elements 108 used to indicate that a sufficient volume of the sample);
an indicator window (the indicator window portion 118 of Gilbert; paragraphs 0007, 0085, 0087, 0094, 0107, and 0110 of Gilbert) configured to provide an observable indication that sufficient body fluid has been collected to facilitate cessation of the body fluid collection to reduce a volume of the body fluid collected and reduce a risk of washing off and/or removing components of a respective indicator element of the first indicating element section and/or the second indicating element section; and
one or more structures (the control of vacuum or suction or a valve to stop the flow once sufficient fluid is observed; paragraphs 0161 and 0167-0169 of Gilbert) configured to regulate and/or stop flow of the body fluid proximate the respective indicator element of the first indicating element section and/or the second indicating element section to reduce the risk of washing off and/or removing the components of the respective indicator element;
a housing (the housing 110 of Gilbert) having a tubular body, the diffuser being at least partially disposed in the tubular body (FIG. 1A of Gilbert);
a micro-needle collector (the microneedle array of Prausnitz) attachable to a distal end of the housing, the micro-needle collector configured to draw the body fluid from a source to the distal end of the housing; and
a fluid chamber (the fluid passage 138 of Gilbert) cooperatively defined by the housing and the diffuser between a portion of the distal end of the diffuser and the proximal end, the fluid chamber adapted to receive the body fluid at the distal end of the diffuser,
wherein: the first indicating element section (the one of the indicating elements 108; paragraphs 0105, 0110, 0152, and 0192-0193 of Gilbert) is disposed in a first section of the housing (the indicator window portion 118 of Gilbert), having a tubular and/or cylindrical shape axially aligned with the tubular body of the housing and the connection tube section of the diffuser, and positioned to contact the body fluid from the tubular fluid passage at a radially inner surface of the first indicating element section and to display the indication of the measurement related to the body fluid at a radially outer surface of the first indicating element section (paragraphs 0104-0106 of Gilbert);
the first section of the housing allows visibility of the first indicating element section from outside of the housing (paragraph 0085 of Gilbert);
the second indicating element section (the another of the indicating elements 108 used to indicate that a sufficient volume of the sample has been collected, as suggested by Irina) is disposed within the fluid chamber, having a tubular and/or cylindrical shape axially aligned with the tubular body of the housing and the connection tube section of the diffuser, positioned further from the distal end of the housing than the first indicating element section and in fluid communication with the first indicating element section to contact the body fluid after the first indicating element section contacts the body fluid, and positioned to display the indication of the second indicating element section at a radially outer surface of the second indicating element section (paragraphs 0104-0106 of Gilbert; the 103 analysis regarding the placement of the another indicating element and the one indicating element relative to each other and the collector),
the observable indication that sufficient body fluid has been collected is visible from outside the housing (paragraphs 0007, 0085, 0087, 0094, 0107, and 0110 of Gilbert).
With respect to claim 3, the combination teaches or suggest that the body fluid is a fluid selected from the group consisting of blood, plasma, urine, and gastric aspirates (paragraphs 0006, 0012, 0083, 0092, 0194, 0155, and 0183 of Gilbert).
With respect to claim 4, the combination teaches or suggest that the housing further comprising a surface treatment (the surface texture or treatment 142 of Gilbert) on the distal end of the housing to form a seal with a fluid transport source (paragraph 0089 of Gilbert).
With respect to claim 5, the combination teaches or suggest that the first indicating element section and the second indicating element section being visible through the indicator window (paragraphs 0007, 0085, 0087, 0094, 0107, and 0110 of Gilbert).
With respect to claim 7, the combination teaches or suggest that the fluid chamber is configured to minimize the volume of the body fluid to saturate one or both of the first and second indicating element sections (“Each of the newly-introduced embodiments is modified from the referenced embodiment in that its size is reduced, and the volumes of fluid-transfer passages, conduits, chambers, lumina, and other interstitial spaces which fluid under test may occupy, are reduced or minimized. In addition to the reducing the volume of fluid needed to accomplish a measurement, this modification also reduces both the amount of distance the fluid must travel to reach and saturate the indicating element, and the elapsed time of such travel (compared to those required in connection with the earlier-described indicators)”; paragraph 0131 of Gilbert; “The shape of distal transition section 422 is selected to minimize the internal volume so as to maximize the amount of available fluid that is routed to the indicating element. In addition to the reducing the volume of fluid needed to accomplish a measurement, this feature also reduces both the amount of distance the fluid must travel to reach and saturate the indicating element, and the elapsed time of such travel (compared to those required in connection with the earlier-described indicators”; paragraph 0132 of Gilbert).
With respect to claim 12, the combination teaches or suggest that the first indicating element section comprises a medium that changes color when exposed to the body fluid, the color being associated with the measurement related to the body fluid (paragraph 0085 of Gilbert).
With respect to claim 13, the combination teaches or suggest that the first indicating element section comprises the medium on the radially outer surface of the first indicating element section (paragraphs 0105, 0110, 0152, and 0192-0193 of Gilbert; FIGS. 11A-11E and 13D- 13E of Gilbert).
With respect to claim 14, the combination teaches or suggest that the source comprises a skin surface and the micro-needle collector is configured to make punctures in the skin surface to draw the body fluid from the source (the collection blood at the skin using the microneedle array of the combination).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable Gilbert, in view of Irina, and further in view of Millenson, and further in view of Prausnitz, and further in view of Barstis, and further in view of Choi, and further in view of WO 02/05890 (Lastovich)(previously cited).
The combination teaches a housing (the housing 110 of Gilbert) having a tubular body, the diffuser being at least partially disposed in the tubular body (FIG. 1A of Gilbert) and a micro-needle collector (the microneedle array of Prausnitz) attachable to a distal end of the housing.
Millenson teaches that a microneedle matrix may be connected to a plurality of tubes terminating at the combined transport portion in which (1) each of the tubes may correspond to a single microneedle and (2) such an arrangement is an equivalent to a single tube connected between the microneedle matrix 142 and the combined transport portion (paragraph 0078 of Millenson). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the plurality of tubes for connecting the microarray to the fluid passage 138 of Gilbert since it is a simple substitution of one known element for another to obtain predictable results.
Lastovich teaches a support 12 for supporting a microneedle array 14 (pages 7-8 and FIG. 2 of Lastovich). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the support 12 for supporting the microneedle array of the combination since (1) it is a simple substitution of one known element for another to obtain predictable results and/or (2) it provides support for to better protect the microneedle array.
With respect to claim 10, the combination teaches or suggest that the micro-needle collector comprises: a plurality of pipettes to draw the body fluid from the source to the distal end of the housing (the plurality of tubes connected to microneedle array); a divergent shape having a first end with a first cross-sectional area and a second end with a second cross-sectional area that is larger than the first cross-sectional area (the support of Lastovich); and a plate having a plurality of holes to retain a respective one of the pipettes into a respective one of the holes, the plate disposed at the second end (the substrate to which the microneedles are supported (see FIG. 25 of Gilbert and base 46 of Lastovich) and the plurality of tubes of Millenson is connected).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gilbert, in view of Irina, and further in view of Millenson, and further in view of Prausnitz, and further in view of Barstis, and further in view of Choi, and further in view of Lastovich, and further in view of U.S. Patent No. 9,987,427 (Polsky)(previously cited).
Gilbert teaches a filter 932 disposed concentrically on the outside of the diffuser in the indicator section where the fluid under test is whole blood, and only plasma reaches the indicating element 108, substantially excluding red blood cells therefrom (paragraph 0149 of Gilbert). Polsky teaches that such filters may be placed in the channels between the needle and the active element (col. 15, lines 5-41 of Polsky). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the filter of Gilbert in the tubes of Millenson leading from the needle since it is a simple substitution of one known element (i.e., location) for another (i.e., another location) to obtain predictable results.
With respect to claim 11, the combination teaches or suggest that the body fluid comprises blood, and the plurality of pipettes are configured to filter whole blood cell components of the body fluid and pass a plasma component of the body fluid (the filters of Gilbert in the tubes of Millenson, as suggested by Polsky).
Claims 15-21, 24-25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Gilbert, in view of Irina, and further in view of Millenson, and further in view of Prausnitz, and further in view of Barstis, and further in view of Choi, and further in view of U.S. Patent Application Publication No. 2016/0054229 (Jia)(previously cited).
Gilbert teaches a diffuser (the diffuser 120 of Gilbert); a connection tube section (the connection tube 132 of Gilbert); a first indicating element section (one of the indicating elements 108; paragraphs 0105, 0110, 0152, and 0192-0193 of Gilbert); and a second indicating element section (another of the indicating elements 108; paragraphs 0105, 0110, 0152, and 0192-0193 of Gilbert).
Gilbert teaches that a sufficient amount of fluid should be collected (paragraphs 0168 of Gilbert). Irina teaches that a test trip may be used with a dye indicator that indicates that a sufficient amount of sample has been collected. The optical change may be detected by an optical system, or by visual inspection (paragraphs 0091 and 0108 of Irina). Once the test strip has collected a sufficient volume of the sample, the test strip can be used to determine the analyte in the sample (paragraph 0109 of Irina). This helps ensure accurate testing (paragraph 0089 of Irina). Further, Irina teaches that such an arrangement is suitable to evaluate the concentration of any analyte or analytes in any body fluid sample (e.g., sweat, blood, serum, urine, saliva, amniotic fluid, etc.(paragraph 0009 of Irina). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a second indicating element section to indicate that a sufficient volume of the sample has been collected, as suggested by Irina, since it ensures accurate testing.
As to the placement of the indicators 108 of Gilbert, Gilbert teaches that the rearrangement of the indicating elements may overlap or be adjacent or any other arrangement (paragraph 0157 of Gilbert). According to one example, the indicating elements are at the same distance from the collection area (FIG. 13E of Gilbert). Millenson teaches that indicating elements may have one in front of the other such that one indicating element is closer to the collection area than the other indicating element (the test zones 144 in FIG. 2 of Millenson; test zones 144a and 144b in FIG. 12 of Millenson; the test zones 144a in FIG. 28 of Millenson; paragraphs 0063, 0071, 0077, and 0122 of Millenson). It would have been obvious to position the indicating elements 108 one after the other such that one indicating element is closer to the collection area than the other indicating element since (1) Gilbert teaches other arrangements may be used and Millenson teaches such arrangements and/or (2) it is a simple substitution of one known element for another to obtain predictable results.
Also, it would have been obvious to position the another of the indicating elements 108 used to indicate that a sufficient volume of the sample has been collected further from the source of the body fluid than the one indicating element since the another indicating element is used to indicate that a sufficient volume of the sample has been collected for analysis using the one indicating element and placing the another indicating element closer to the source than the one indicating element would make such an indication less reliable.
Alternatively, it would have been obvious to position the another of the indicating elements 108 used to indicate that a sufficient volume of the sample has been collected further from the source of the body fluid than the one indicating element since a sequence of the two indicating elements is required; there is a finite number of solutions to this problem (the another indicating element is closer to the source of the body fluid than the one indicating element or the one indicating element is closer to the source of the body fluid than the another indicating element); and one of ordinary skill in the art would have pursued the known potential solutions with a reasonable expectation of success to arrive at the arrangement that provides the best results for the another indicating element to indicate that a sufficient volume of the sample has been collected for analysis using the one indicating element.
Gilbert teaches a housing (the housing 110 of Gilbert) having a tubular body, the diffuser being at least partially disposed in the tubular body (FIG. 1A of Gilbert). Gilbert further teaches that blood can be collected using needles (paragraph 0092 of Gilbert). Prausnitz teaches that microneedle array (page 16 and FIGS. 25-26 of Prausnitz). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the microneedle array of Prausnitz as the fluid collector of the combination since (1) it is a simple substitution of one known element for another to obtain predictable results, (2) it causes less trauma to the patient; and/or (3) it permit blood collection at the skin surface.
Gilbert teaches that one of the indicating element may be used to measure a chemical property such as pH and other substances (paragraphs 0108 and 0152-0156 of Gilbert). Prausnitz teaches that blood glucose is a suitable substance to monitor (pages 19-20, 22, and 56 of Prausnitz). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an indicating element section for determining glucose level since Gilbert teaches that chemical substances may be determined in blood and Prausnitz teaches one such substance. Barstis teaches a detector kit that uses an indicating element section (called a control) used to verify that the testing kit has not become contaminated during storage or use (paragraph 0053 of Barstis). Choi teaches that outside moisture is one such contaminant (abstract, paragraph 0008, 0013-0014, and 0184 of Choi). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an indicating element section to verify that the testing kit has not become contaminated during storage or use due to moisture since it would provide a greater confidence in the test results of the glucose.
Also, Gilbert teaches that the indicating elements may overlap (paragraph 0157 of Gilbert). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the indicating element section that verifies that the testing kit has not become contaminated during storage or use due to moisture and the another of the indicating elements 108 used to indicate that a sufficient volume of the sample has been collected overlap since it conserves space.
Gilbert teaches the use of a reference indicator 116 provided on the outside of the indicator to allow comparison of the appearance or condition of the indicating element with reference examples corresponding to measurement results or other indicating element states of clinical significance (paragraphs 0007, 0107-0110, 0140, 0151, 0158, 0163, and 0171 of Gilbert). Jia teaches that a comparison can be done using images (paragraphs 0009, 0019-0021, 0034, 0045-0047, 0049, 0056-0057, and 0062-0063 of Jia) and image analysis which is more reliable and user-friendly (paragraphs 0032 and 0036 of Jia). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform an image comparison of the color indicators, as suggested by Jia, using the camera and processor of Jia since image analysis is more reliable and user-friendly.
With respect to claim 15, the combination teaches or suggest a method comprising:
preparing a skin surface for a sample (ensuring the skin is clean identifying a skin surface for application; page 46 of Prausnitz; it would have been obvious to clean the skin to prevent infection and present contamination);
attaching a micro-needle collector to an indicator (the microneedle array of Prausnitz is attached to the diffuser 120 of Gilbert);
applying the micro-needle collector to the skin surface (applying the microneedle array of Prausnitz to the skin);
capturing an image of the indicator (capturing the image of Jia), the indicator having:
a housing (the housing 110 of Gilbert) having a tubular body; and
a diffuser (the diffuser 120 of Gilbert) having:
a tip section (the tip 112 of Gilbert) at a distal end (the distal end 148 of Gilbert) of the diffuser;
a connection tube section (the connection tube 132 of Gilbert) forming a tubular fluid passage extending from a proximal end (the proximal end 146 of Gilbert) of the diffuser toward the distal end along at least a part of a distance between the proximal end and the distal end;
a first indicating element section (one of the indicating elements 108; paragraphs 0105, 0110, 0152, and 0192-0193 of Gilbert) disposed in a first section of the housing between the tip section and the connection tube section, the first indicating element section visibly indicating a measurement related to a body fluid; the first indicating element section having a tubular and/or cylindrical shape axially aligned with the tubular body of the housing and the connection tube section of the diffuser; the first indicating element section positioned to contact the body fluid from the tubular fluid passage at a radially inner surface of the first indicating element section and to display the indication of the measurement related to the body fluid at a radially outer surface of the first indicating element section; and
a second indicating element section (another of the indicating elements 108; paragraphs 0105, 0110, 0152, and 0192-0193 of Gilbert), the second indicating element section visibly indicating: that the first indicating element section is adequately exposed to and/or saturated by the body fluid for the measurement to be relied upon (the another of the indicating elements 108 used to indicate that a sufficient volume of the sample has been collected, as suggested by Irina), and that the first indicating element section is unusable responsive to the second indicating element section being exposed to water (the use of the indicating element section to verify that the testing kit has not become contaminated during storage or use due to moisture overlapping with the another of the indicating elements 108 used to indicate that a sufficient volume of the sample); a
n indicator window (the indicator window portion 118 of Gilbert; paragraphs 0007, 0085, 0087, 0094, 0107, and 0110 of Gilbert) configured to provide an observable indication that sufficient body fluid has been collected to facilitate cessation of the body fluid collection to reduce a volume of the body fluid collected and reduce a risk of washing off and/or removing components of the respective indicator element of the first indicating element section and/or the second indicating element section; and
one or more structures (the control of vacuum or suction or a valve to stop the flow once sufficient fluid is observed; paragraphs 0161 and 0167-0169 of Gilbert) configured to regulate and/or stop flow of the body fluid proximate a respective indicator element of the first indicating element section and/or the second indicating element section to reduce the risk of washing off and/or removing the components of the respective indicator element; wherein: the housing and the diffuser cooperatively define a fluid chamber (the fluid passage 138 of Gilbert) between a portion of the distal end and the proximal end; the fluid chamber is adapted to receive the body fluid at the distal end from the micro-needle collector (the fluid passage 138 of Gilbert is so adapted); the first section of the housing allows visibility of the first indicating element section from outside of the housing (paragraph 0085 of Gilbert); the second indicating element section is disposed within the fluid chamber (the another of the indicating elements 108; paragraphs 0105, 0110, 0152, and 0192-0193 of Gilbert), having a tubular and/or cylindrical shape axially aligned with the tubular body of the housing and the connection tube section of the diffuser, positioned further from the source of the body fluid than the first indicating element section and in fluid communication with the first indicating element section to contact the body fluid after the first indicating element section contacts the body fluid, and positioned to display the indication of the second indicating element section at a radially outer surface of the second indicating element section (paragraphs 0104-0106 of Gilbert; the 103 analysis regarding the placement of the another indicating element and the one indicating element relative to each other and the collector); and the observable indication that sufficient body fluid has been collected is visible from outside the housing (paragraphs 0007, 0085, 0087, 0094, 0107, and 0110 of Gilbert);
transmitting the image (transmitting the image to the processor of Jia); and
receiving test results, the test results comprising an interpretation of the visible indications provided by the first indicating element section and the second indicating element section (the determinations of pH and the indication that a sufficient volume of the sample has been collected performed by the processor of Jia).
With respect to claim 16, the combination teaches or suggest interpreting the image to generate the test results (the determinations of pH and/or glucose and the indication that a sufficient volume of the sample has been collected performed by the processor of Jia using the images).
With respect to claim 17, the combination teaches or suggest that interpreting the image to generate the test results comprises determining a location of the first indicating element section and mapping the location with indicator mapping information (paragraph 0049 of Jia).
With respect to claim 18, the combination teaches or suggest that interpreting the image to generate the test results comprises compensating for light levels, colors, and/or camera optics based on an appearance within the captured image of a control image proximate the first indicating element section, the control image having known shapes and colors (the image processing of Jia; paragraphs 0009, 0019-0021, 0033-0034, 0045-0049, 0056-0057, and 0062-0063 of Jia).
With respect to claim 19, the combination teaches or suggest that: the first section of the housing further allows visibility of the second indicating element section from the outside of the housing (paragraph 0085 of Gilbert), capturing the image of the indicator comprises capturing an image of the first indicating element section and the second indicating element section (the image capturing of Jia; paragraphs 0009, 0019-0021, 0033-0034, 0045-0049, 0056-0057, and 0062-0063 of Jia), and interpreting the image to generate the test results comprises interpreting the image of the first indicating element section and the second indicating element section(the image processing of Jia; paragraphs 0009, 0019-0021, 0033-0034, 0045-0049, 0056-0057, and 0062-0063 of Jia).
With respect to claim 20, the combination teaches or suggest that: the first indicating element section comprises a medium that changes a color when exposed to the body fluid received from the micro-needle collector (paragraph 0085 of Gilbert), the color of the medium being associated with the measurement related to the body fluid, and interpreting the image to generate the test results comprises interpreting the color of the medium of the first indicating element section (the image processing of Jia; paragraphs 0009, 0019-0021, 0033-0034, 0045-0049, 0056-0057, and 0062-0063 of Jia).
With respect to claims 21 and 24, the combination teaches a housing (the housing 110 of Gilbert) having a tubular body, the diffuser being at least partially disposed in the tubular body (FIG. 1A of Gilbert) and a micro-needle collector (the microneedle array of Prausnitz) attachable to a distal end of the housing. Millenson teaches that a microneedle matrix may be connected to a plurality of tubes terminating at the combined transport portion in which (1) each of the tubes may correspond to a single microneedle and (2) such an arrangement is an equivalent to a single tube connected between the microneedle matrix 142 and the combined transport portion (paragraph 0078 of Millenson). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the plurality of tubes for connecting the microarray to the fluid passage 138 of Gilbert since it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 21, the combination teaches or suggest obtaining a body fluid sample by the micro-needle collector through a plurality of pipettes causing the body fluid sample to be directed toward the indicator (the tubes suggested by Millenson).
With respect to claim 24, the combination teaches or suggest that causing the body fluid sample to be directed toward the indicator comprises suction (obtaining the body fluid via suction; paragraph 0083, 0089, and 0099 of Gilbert).
With respect to claim 25, the combination teaches or suggest that the applying the micro-needle collector to the skin surface comprises: making a plurality of microscopic punctures in the skin surface (applying the microneedle array of Prausnitz to the skin), and obtaining a body fluid sample by drawing the body fluid from the plurality of microscopic punctures (obtaining the body fluid via suction; paragraph 0083, 0089, and 0099 of Gilbert).
With respect to claim 27, the combination teaches or suggest that drawing the body fluid comprises suction (obtaining the body fluid via suction; paragraph 0083, 0089, and 0099 of Gilbert).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Gilbert, in view of Irina, and further in view of Millenson, and further in view of Prausnitz, and further in view of Barstis, and further in view of Choi, and further in view of Jia, and further in view of Polsky.
Gilbert teaches a filter 932 disposed concentrically on the outside of the diffuser in the indicator section where the fluid under test is whole blood, and only plasma reach the indicating element 108, substantially excluding red blood cells therefrom (paragraph 0149 of Gilbert). Polsky teaches that such filters may be placed in the channels between the needle and the measuring element (col. 15, lines 5-41 of Polsky). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the filter of Gilbert in the tubes of Millenson leading from the needle since it is a simple substitution of one known element (i.e., location) for another (i.e., another location) to obtain predictable results.
With respect to claim 22, the combination teaches or suggest that the body fluid comprises blood, and obtaining the body fluid sample further comprises the plurality of pipettes filtering whole blood cell components of the body fluid and passing plasma through to the indicator (the filters of Gilbert in the tubes of Millenson, as suggested by Polsky).
Response to Arguments
The Applicant’s arguments filed 11/28/2025 have been fully considered.
Claim objections
In view of the claim amendments filed on 11/28/2025, the previous claim objections are withdrawn except for the claim objection of claim 15, line 36 (formerly, the claim objection of claim 15, line 32 in the Office Action dates 5/27/205). The Applicant’s amendments and remarks do not directly address this claim objection and the Examiner cannot find a reason to withdraw it.
Also, there are new grounds of claim objections.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 11/28/2025, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
Also, there are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Prior art rejections
The Applicant asserts:
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This argument is not persuasive since it is not commensurate with the rejection. The claimed second indication elements section are taught by Irina, Millenson, Barstis, and Choi. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The Applicant asserts:
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This argument is not persuasive. The rationale for combining the references are provided in the above rejections. Also, the elements of the combination do perform the functions of the elements found in the claims, as articulated above.
The Applicant asserts:
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This argument is not persuasive. The rationale for combining the references are provided in the above rejections with reasoned explanations as to why one of ordinary skill in the art would have found it obvious to combine the cited references in the specific combination articulated in the above rejections.
The Applicant argues and the Declaration by Paul J. Gilbert (“the Gilbert Declaration”)1 states that the claimed invention was the product of continuous research and development by the inventor which lead to the conception of the claimed invention. These arguments and statements are not persuasive since patentability is not based on the inventor’s effort per se, but whether the invention is novel and non-obvious.
The Applicant argues:
(1) that there were problems with the invention of Gilbert (that is, the disclosure of U.S. Patent Application Publication No. 2015/0168244 (“the Gilbert Application”));
(2) that these problems could not have been known or predicted prior to placing the device into practical use in the field;
(3) that these problems were long-felt in the field since the introduction of the device from the Gilbert Application; and
(4) that no one else developed or provided a solution to those problems prior to the invention of the present application.
These arguments are not persuasive. With respect to points (1) and (2), the problems with the invention of Gilbert were known and the solutions were found in the prior art.
As to the problem of the clinician did not know if fluid entered the body fluid container (point 1 on page 14 of the Applicant’s Remarks and point a on page 3 of the Gilbert Declaration), Gilbert teaches that a sufficient amount of fluid should be collected (paragraphs 0168 of Gilbert). Irina teaches that a test trip may be used with a dye indicator that indicates that a sufficient amount of sample has been collected. The optical change may be detected by an optical system, or by visual inspection (paragraphs 0091 and 0108 of Irina). Once the test strip has collected a sufficient volume of the sample, the test strip can be used to determine the analyte in the sample (paragraph 0109 of Irina). This helps ensure accurate testing (paragraph 0089 of Irina). Further, Irina teaches that such an arrangement is suitable to evaluate the concentration of any analyte or analytes in any body fluid sample (e.g., sweat, blood, serum, urine, saliva, amniotic fluid, etc.(paragraph 0009 of Irina). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a second indicating element section to indicate that a sufficient volume of the sample has been collected, as suggested by Irina, since it ensures accurate testing.
As to the placement of the indicators 108 of Gilbert, Gilbert teaches that the rearrangement of the indicating elements may overlap or be adjacent or any other arrangement (paragraph 0157 of Gilbert). According to one example, the indicating elements are at the same distance from the collection area (FIG. 13E of Gilbert). Millenson teaches that indicating elements may have one in front of the other such that one indicating element is closer to the collection area than the other indicating element (the test zones 144 in FIG. 2 of Millenson; test zones 144a and 144b in FIG. 12 of Millenson; the test zones 144a in FIG. 28 of Millenson; paragraphs 0063, 0071, 0077, and 0122 of Millenson). It would have been obvious to position the indicating elements 108 one after the other such that one indicating element is closer to the collection area than the other indicating element since (1) Gilbert teaches other arrangements may be used and Millenson teaches such arrangements and/or (2) it is a simple substitution of one known element for another to obtain predictable results.
Also, it would have been obvious to position the another of the indicating elements 108 used to indicate that a sufficient volume of the sample has been collected further from the source of the body fluid than the one indicating since the another indicating element is used to indicate that a sufficient volume of the sample has been collected for analysis using the one indicating element and placing the another indicating element closer to the source than the one indicating element would make such an indication less reliable.
Alternatively, it would have been obvious to position the another of the indicating elements 108 used to indicate that a sufficient volume of the sample has been collected further from the source of the body fluid than the one indicating element since a sequence of the two indicating elements is required; there is a finite number of solutions to this problem (the another indicating element is closer to the source of the body fluid than the one indicating element or the one indicating element is closer to the source of the body fluid than the another indicating element); and one of ordinary skill in the art would have pursued the known potential solutions with a reasonable expectation of success to arrive at the arrangement that provides the best results for the another indicating element to indicate that a sufficient volume of the sample has been collected for analysis using the one indicating element.
As to the problem of blanching or dilution due to the draw up of too much fluid so as to flush the indication element (point 2 on page 14 of the Applicant’s Remarks and point b in page 3 of the Gilbert Declaration), the claims do not require a structure that would correct this issue. That is, claim 1 does not have an indicting element section requiring the indication of saturation of the element section since the saturation indication is an alternative to the adequately exposed indication. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
As to the problem of drawing up a very small amount of bodily fluid in the case of premature inventions (point 3 on page 14 of the Applicant’s Remarks and point c on page 3 of the Gilbert Declaration), the claims do not require a structure that would correct this issue. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
As to the problem of compromised indicators due to improper storage, exposure to cleaning products (point 4 on page 14 of the Applicant’s Remarks and point d on page 3 of the Gilbert Declaration), Gilbert teaches that one of the indicating element may be used to measure a chemical property such as pH and other substances (paragraphs 0108 and 0152-0156 of Gilbert). Prausnitz teaches that blood glucose is a suitable substance to monitor (pages 19-20, 22, and 56 of Prausnitz). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an indicating element section for determining glucose level since Gilbert teaches that chemical substances may be determined in blood and Prausnitz teaches one such substance. Barstis teaches a detector kit that uses an indicating element section (called a control) used to verify that the testing kit has not become contaminated during storage or use (paragraph 0053 of Barstis). Choi teaches that outside moisture is one such contaminant (abstract, paragraph 0008, 0013-0014, and 0184 of Choi). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an indicating element section to verify that the testing kit has not become contaminated during storage or use due to moisture since it would provide a greater confidence in the test results of the glucose. Also, Gilbert teaches that the indicating elements may overlap (paragraph 0157 of Gilbert). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the indicating element section that verifies that the testing kit has not become contaminated during storage or use due to moisture and the another of the indicating elements 108 used to indicate that a sufficient volume of the sample has been collected overlap since it conserves space.
Further, the claims do not require a structure that would correct the issue of compromised indicators due to exposure to cleaning products.
As to the problems of the complexity of instructions to attempt to work around the problems and incident and interruptions (point 5 on pages 14-15 of the Applicant’s Remarks and point e on page 3 of the Gilbert Declaration), the claims do not require a structure that would correct this issue. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With respect to the arguments with respect to the discovery of the feature, utility, and position of the second indicator on page 15 of the Applicant’s Remarks (also referred to in points 21-27 on pages 4-5 of the Gilbert Declaration), these arguments are not persuasive since the combination of the Gilbert Application, Irina, Millenson, Prausnitz, Barstis, and Choi has all the features of the claimed invention and their combination would have been obvious for the reasons provided in the above rejection.
Further, the assertion that these problems with the Gilbert Application could not have been known or predicted prior to the use of the invention of the Gilbert Application is not persuasive since the Gilbert Application and its teachings exists, contribute to the body of prior art that one of ordinary skill in the art would have had access to, and renders the claimed invention obvious in view of its own teachings and those of Irina, Millenson, Prausnitz, Barstis, and Choi. Also, the teachings of the Gilbert Application and those of Irina, Millenson, Prausnitz, Barstis, and Choi would have led to the claimed invention for the reasons provided in the above rejection.
With respect to points (3) and (4), this argument is not persuasive since no evidence had been provided showing that the long-felt need was recognized by others (see MPEP 716.04: “Establishing long-felt need requires objective evidence that an art recognized problem existed in the art for a long period of time without solution. The relevance of long-felt need and the failure of others to the issue of obviousness depends on several factors. First, the need must have been a persistent one that was recognized by those of ordinary skill in the art. In re Gershon, 372 F.2d 535, 539, 152 USPQ 602, 605 (CCPA 1967) (“Since the alleged problem in this case was first recognized by appellants, and others apparently have not yet become aware of its existence, it goes without saying that there could not possibly be any evidence of either a long felt need in the . . . art for a solution to a problem of dubious existence or failure of others skilled in the art who unsuccessfully attempted to solve a problem of which they were not aware."); Orthopedic Equipment Co., Inc. v. All Orthopedic Appliances, Inc., 707 F.2d 1376, 217 USPQ 1281 (Fed. Cir. 1983) (Although the claimed invention achieved the desirable result of reducing inventories, there was no evidence of any prior unsuccessful attempts to do so.).).
Also, there is no evidence as to when the problem is identified and articulated and what efforts, if any, to solve for the problems (See MPEP 616.04): “Long-felt need is analyzed as of the date the problem is identified and articulated, and there is evidence of efforts to solve that problem, not as of the date of the most pertinent prior art references. Texas Instruments Inc. v. Int’l Trade Comm’n, 988 F.2d 1165, 1179, 26 USPQ2d 1018, 1029 (Fed. Cir. 1993).”).
With respect to the rest of the Gilbert Declaration, statements 1-17 do not directly address the merits of the rejection based on the prior art.
For the above reasons, the rejection of claim 1 is proper.
The rejection of claim 15 is proper for the same and/or analogous reasons as those reasons provide for why the rejection of claim 1 is proper.
Conclusion
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 See point 17 on page 2 and point 21 on page 4 of the Declaration.