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 .
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed 8/4/26. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow.
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 Objections
Claim 1 is objected to because of the following informalities: there appears to be an erroneous “and” in line 6. 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 7-13 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,
wherein the microneedle array comprises one or more microneedles,
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]);
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 7, Plante discloses the method of claim 1, wherein the outer layer comprises a polymer (Fig 2) ([0030-0053]).
For claim 8, Plante discloses the method of claim 1, 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.
Response to Arguments
Applicant's arguments filed 8/4/26 have been fully considered but they are not persuasive, wherein Applicant argues the following:
Instead, at most, the main body 1 or 21 of Plante refers to a structural body that, at most, provides "support and structure upon which other cooperating elements are coupled and/or integrated." Id. at para. [0031].
Instead, as illustrated in Figs. 1 and 2 of Plante, at most, these "main body" features of Plante discloses a "main body" that serves as a support structure for all other components of the of the sample collection device of Plante to couple to or integrate within like the claimed features of claim 1, this "main body" feature of Plante does not amount to or otherwise disclose or even suggest any layer that surrounds one or more microneedles of a microneedle array, much less that the outer layer restricts movement of one or more components, much less that the outer layer restricts movement of the one or more microneedles, much less that the outer layer restricts movement of the one or more microneedles with respect to the blood storage layer.
For claim 9, Instead, at most, the color change indicating window 28 of Plante amounts to a transparent portion of the device capable of displaying a change in color. See FIG. 2 of Plante. In contrast, claim 9 recites a pressure indicator that 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. As a result, Plante does not disclose a pressure indicator, much less that the pressure indicator comprises a compressible button, much less that the compressible button is configured to provide haptic feedback to a user, much less that the compressible button is configured to provide haptic feedback to a user when a predetermined pressure is applied to the compressible button, much less all of these features in combination with the additional features of claim 1
For claim 10, Instead, at most, the Office's interpretation of a peel-to-expose package amounts to a packaging capable of storing a blood collection device for transport. Claim 11 requires that 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. Therefore, Plante fails to disclose that the peel-to-expose package comprises a first tab and a second tab, much less that the first tab selectively covers the microneedle array, much less that the second tab selectively covers the blood storage layer, much less all of these features in combination with the additional features of claim 1.
The Examiner respectfully disagrees in response and notes the following:
For claim 1, the Examiner respectfully notes that as cited above, as broadly as claimed, absent any structural distinctions to the contrary, consistent with the plain meaning of the terms of the claims in light of the instant Specification, and absent any special definition upon which Applicant does not appear to rely, it is more than fair and reasonable to consider Plante’s outer main body 21 to at least surround the one or more microneedles of the microneedle array, especially in a top down direction, and particularly given that Plante explicitly discloses that the securement of the main body to a patient secures and confines the microneedle array for extracting blood, thereby restricting movement of the microneedle array and restricting movement of the blood storage layer to achieve blood sampling while the device is securely attached to a patient for collection. The mere fact that Plante’s main body serves as a support structure for all other components does not preclude it from surrounding the microneedle array when attached and/or in a top-down direction, restricting microneedle array movement when attached, and restricting microneedle array movement with respect to the blood storage layer in order to achieve the expressly disclosed blood sampling method. For example at least, the Examiner notes that, although disclosed, the claims do not recite and/or require that the outer layer directly contacts and surrounds the base of each of the microneedles of the array, which would appear to distinguish from Plante.
For claim 9, the Examiner respectfully notes that as cited above, as broadly as claimed, absent any structural distinctions to the contrary, consistent with the plain meaning of the terms of the claims in light of the instant Specification, and absent any special definition upon which Applicant does not appear to rely, it is more than fair and reasonable to consider Plante’s color indicating window 28 as a compressible haptic feedback pressure indicator button. Plante’s window necessarily has a texture, is button shaped, and application-pressure, compression-induced haptic movement that provides not only a tactile, textured-based, feel-able haptic indication of successful device application but also a status indication of blood extraction. In order to achieve the desired indication of successful blood extraction, Plante’s window must have pressure applied thereto, which the patient would haptically feel, such that once a predetermined piercing pressure is applied, successful extraction of blood is indicated therefrom via color change. This is substantially similar to the disclosed visual inspection. For example at least, the Examiner notes that, although disclosed, the claims do not recite and/or require “audible clicking”, which would appear to distinguish from Plante.
For claims 10 and 11, the Examiner respectfully notes that as cited above, as broadly as claimed, absent any structural distinctions to the contrary, consistent with the plain meaning of the terms of the claims in light of the instant Specification, and absent any special definition upon which Applicant does not appear to rely, it is more than fair and reasonable to consider Plante’s multi-sided disposable sterile envelope sleeve 85 and plastic return container 87 that holds the blood extraction therein as a peel-to-expose package not only capable of but configured for storing the blood collection device for transport both to and from the patient. The fronts and backs of 85 and/or 87 may fairly be considered at least projecting pieces or flaps that are “tabs” that selectively cover the microneedle array and the blood storage layer. For example at least, the Examiner notes that, although disclosed, the claims do not recite and/or require the tabs are configured to attached to one another when in a closed position via adhesive and/or the tabs are configured to reseal, which would appear to distinguish from Plante.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
