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 .
Election/Restrictions
Applicant's election with traverse of Group 1, drawn to the process of analyzing blood samples, and without traverse of Species 1B and 2A, microneedle array embodiment drawn to Figures 1A-1C and blood collection device embodiment drawn to Figure 2, in the reply filed on 3/20/26 is acknowledged.
The traversal is on the ground(s) that “the groups of invention would likely be subject to the same search, and accordingly the simultaneous examination of both alleged invention groups does not present a serious search and/or examination burden”.
This is not found persuasive because, as set forth in the restriction requirement mailed 9/5/25, see especially pages 2-3, the mere fact that the inventions contain related subject matter does not preclude the inventions from (i) being independent and/or distinct, (ii) having different classifications necessitating different fields of search and/or search techniques therefor, and/or (iii) the likelihood of raising different non-prior art issues such that a search and examination is present.
The requirement is still deemed proper and is therefore made FINAL.
Claims 4, 5, 14-19, 22, and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions and/or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/20/26.
Regarding the withdrawn claims not indicated by Applicant, the Examiner respectfully notes the following:
Claims 4, 5: the “extracting dried blood” from absorbent material portion 116 is solely drawn to non-elected Species B, Figures 1D, and the instant Specifications description thereof.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Claim Objections
Claim 1 is objected to because of the following informalities: the positive recitation of “a blood sample” in line 2 should apparently read “the blood sample”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3 and 6-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Plante et al. (US 2013/0018279 A1, hereinafter Plante).
For claim 1, Plante discloses a method of analyzing a blood sample from an animal (Figs 2,8) ([0006-0008,0030-0053,0062-0063]), the method comprising inter alia:
extracting a blood sample from a blood collection device (Figs 2,8) ([0006-0008,0030-0053,0062-0063]), wherein the blood collection device comprises: (i) a microneedle array (microneedles 25) (Fig 2); and (ii) a blood storage layer (absorbent pad 23) (Fig 2) ([0030-0053]), and wherein the microneedle array transports the blood sample from the animal to the blood storage layer, and wherein the microneedle array comprises one or more microneedles;
conducting at least one test on the extracted blood sample ([0006-0008,0062-0063]); and
reporting results from the at least one test to a customer ([0006-0008,0062-0063]).
For claim 2, Plante discloses the method of claim 1, wherein the microneedle array comprises a plurality of microneedles (plurality of 25, Fig 2).
For claim 3, Plante discloses the method of claim 1, wherein extracting the blood sample comprises extracting the blood sample from a chamber defined by the blood collection device (extraction in laboratory from 23) Figs 2,8) ([0006-0008,0030-0053,0062-0063]).
For claim 6, Plante discloses the method of claim 1, wherein the blood collection device further comprises an outer layer (outer main body 21) (Fig 2) ([0030-0053]) surrounding one or more microneedles of the microneedle array (Fig 2) ([0030-0053]), and wherein the outer layer restricts movement of the one or more microneedles of the microneedle array with respect to the blood storage layer (especially via adhesive 22) (Fig 2) ([0030-0053]).
For claim 7, Plante discloses the method of claim 6, wherein the outer layer comprises a polymer (Fig 2) ([0030-0053]).
For claim 8, Plante discloses the method of claim 6, wherein the outer layer provides a pharmaceutical agent to the animal ([0030-0053, especially 0049-0053]).
For claim 9, Plante discloses the method of claim 1, wherein the blood collection device further comprises a pressure indicator (color change indicating window 28) (Fig 2) ([0030-0053]), and wherein the pressure indicator comprises a compressible button configured to provide haptic feedback to a user of the blood collection device when a predetermined pressure is applied to the compressible button by the user (upon compressing window with sufficient application pressure to pierce the skin haptic feedback is provided and further sampling causes color change indication) (Fig 2) ([0030-0053]).
For claim 10, Plante discloses the method of claim 1, wherein the blood collection device further comprises a peel-to-expose package (85,87) surrounding, at least, the microneedle array and the blood storage layer of the blood collection device (Figs 2,8) ([0006-0008,0030-0053,0062-0063]).
For claim 11, Plante discloses the method of claim 10, wherein the peel-to-expose package comprises a first tab that selectively covers the microneedle array and a second tab that selectively covers the blood storage layer (front and back of 85 and/or 87) (Figs 2,8) ([0006-0008,0030-0053,0062-0063]).
For claim 12, Plante discloses the method of claim 11, wherein the second tab comprises a transparent material (Fig 8) ([0006-0008,0030-0053,0062-0063]).
For claim 13, Plante discloses the method of claim 11, wherein at least one of the first tab and the second tab of the peel-to-expose package is re-sealable after the peel-to-expose package is peeled away (consumer seals 87 to ship) (Figs 8) ([0006-0008,0030-0053,0062-0063]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) s 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Plante in view of Sebba et al. (WO 2016/022604 A2, hereinafter Sebba).
For claim 20, Plante discloses the method of claim 1, including subsequent laboratory analysis of an extracted sample for consumer information and convenience ([0006-0008,0030-0053,0062-0063]). Plante discloses the method of claim 1, except for expressly disclosing wherein conducting the at least one test on the extracted blood sample comprises: (i) lysing the extracted blood sample to provide a lysed blood sample; (ii) measuring an activity of G6PDH in the lysed blood sample; and (iii) correlating the activity of G6PDH in the lysed blood sample to a hematocrit of the blood sample.
For claim 20, Sebba, in the same field of consumer blood analytical analysis, teaches conducting the at least one test on the extracted blood sample comprises: (i) lysing the extracted blood sample to provide a lysed blood sample ([0033-0090, especially 0081-0100]); (ii) measuring an activity of G6PDH in the lysed blood sample ([0033-0090, especially 0081-0100]); and (iii) correlating the activity of G6PDH in the lysed blood sample to a hematocrit of the blood sample ([0033-0090, especially 0081-0100]).
For claim 20, Plante and Sebba are both considered to be analogous to the claimed invention because they are in the same field of analytical blood diagnostics. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Plante to incorporate the teachings of Sebba to provide additional and/or alternate diagnostic testing on blood specimens. Doing so would aid in achieving the predictable reporting laboratory blood analysis results of quantified hematocrit in blood samples to evaluate glucose enzymatic activity to a consumer.
For claim 21, Plante discloses the claimed invention as set forth hereinabove, except for expressly disclosing, wherein measuring the activity of the G6PDH comprises: allowing the lysed blood sample to react for a predetermined reaction time; measuring a first absorption of the lysed blood sample at a beginning of a predetermined reaction time; measuring a second absorption of the lysed blood sample at a conclusion of the predetermined reaction time; calculating a rate of formation of NADPH based on a change in absorption between the second absorption and the first absorption; and correlating the rate of formation with a standard curve to determine the hematocrit of the blood sample.
For claim 21, Sebba, in the same field of consumer blood analytical analysis, teaches measuring the activity of the G6PDH comprises: allowing the lysed blood sample to react for a predetermined reaction time ([0033-0090, especially 0081-0100]); measuring a first absorption of the lysed blood sample at a beginning of a predetermined reaction time; measuring a second absorption of the lysed blood sample at a conclusion of the predetermined reaction time ([0033-0090, especially 0081-0100]); calculating a rate of formation of NADPH based on a change in absorption between the second absorption and the first absorption ([0033-0090, especially 0081-0100]); and correlating the rate of formation with a standard curve to determine the hematocrit of the blood sample ([0033-0090, especially 0081-0100]).
For claim 21, Plante and Sebba are both considered to be analogous to the claimed invention because they are in the same field of analytical blood diagnostics. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Plante to incorporate the teachings of Sebba to provide additional and/or alternate diagnostic testing on blood specimens. Doing so would aid in achieving the predictable reporting laboratory blood analysis results of quantified hematocrit in blood samples to evaluate glucose enzymatic activity to a consumer.
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for analyzing extracted animal blood samples.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
Prosecution Insights