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 .
Claims 1,3-6,9-12 are under examination.
Response to Applicants Arguments/Amendments
The examiner has considered all of applicants arguments and amendments. The examiner has withdrawn the former art rejections and put forth new rejections that address the amendments. The examiner will address all art rejection arguments involving references that are still used in the current art rejections.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1,3-6,9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Bernstein (US 20110105952), Yukio (EP0140589), and Gupta (US 20040043376)
Bernstein teaches a device for detecting ketones (Paragraph 213 of Bernstein), the device comprising: a collection apparatus for collecting a sample amount of interstitial fluid (Fig 1B and Paragraph 19 of Bernstein), wherein the collection apparatus comprises at least one hollow microneedle for penetrating skin of an individual (Paragraph 99 of Bernstein), a collection indicator having an initial state and a completed state when contacted by the sample amount of the interstitial fluid (Paragraph 197 of Bernstein), a ketone body indicator having an initial negative state and having a positive state when at least a threshold value of the ketone body is collected in the sample amount (Paragraphs 102, 191,196 and 213 of Bernstein—results can be read on test strips and/or a color change can occur as mentioned in paragraph 102); and a capillary flow path connecting the collection apparatus to the ketone body indicator (Figure 1B, #99 is the capillary flow path and paragraph 213 mentions ketone indicator).
Paragraph 213 of Bernstein indicates that ketones can be detected using Bernstein’s device. Paragraphs 102, 191, 196, and 213 indicate that colorimetric sensors such as test strips can be used. Paragraph 197 discusses access/collection indicators. It appears that these paragraphs can be part of the embodiment that encompasses Figure 1B. A access/collection indicator can also be placed in #92 of Figure 1B as in instant Claim 1.
Although Bernstein indicates that substances such as ketones can be detected from interstitial fluid using colorimetric reagents/test strips (Paragraphs 102,191,196, and 213), Bernstein fails to elaborate on the specific ketones that are detected and also the specific reagents used to detect those ketones. Yukio teaches that beta-hydroxybutyrate/3-hydroxybutyrate (levels used to assess ketones) can be detected in interstitial fluid (Page 12). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have measured that particular ketone since it is present in interstitial fluid as taught by Yukio (Page 12). An artisan would have been motivated to have measured beta-hydroxybutyrate/3-hydroxybutyrate levels to monitor dangerous conditions such as diabetes (Page 1 of Yukio). There would be a high expectation for success since Yukio discloses that measuring the levels of beta-hydroxybutyrate/3-hydroxybutyrate can be used to successfully monitor dangerous conditions such as diabetes as in instant Claims 1.
Bernstein does not teach the specific reagents used to measure beta-hydroxybutyrate/3-hydroxybutyrate levels. Gupta teaches ketones such as beta-hydroxybutyrate can be measured by using a test strip that contains beta hydroxybutyrate dehydrogenase (enzyme), NAD (enzyme cofactor), a tetrazolium dye, and an electron mediator (1-Methoxy-5-methylphenazinium) (Paragraphs 38-42 and 45 of Gupta). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used such a detection test strip because it can successfully detect beta-hydroxybutyrate (Paragraphs 38-42, and 45 of Gupta). Because these components can successfully detect beta-hydroxybutyrate/3-hydroxybutyrate levels, there would have been a high expectation for success (Paragraphs 38-42 and 45 of Gupta) as in instant Claims 1,3-5.
Dependent Claims taught by Bernstein
Bernstein teaches wherein the collection apparatus comprises at least one hollow microneedle for penetrating skin of an individual (Paragraph 99 of Bernstein), the device further comprising: an adhesive layer adapted to bond to skin of an individual (Paragraph 13 of Bernstein); a sensor layer disposed over the adhesive layer and including the ketone body indicator, wherein sensor layer accumulates interstitial fluid that migrates through the microneedle, and wherein the ketone body indicator is located in and/or on the sensor layer (Figure 1B); and a cover layer disposed over the sensor layer, wherein the cover layer comprises a window that allows viewing of the indicator(Figure 1B, #100) as in instant Claim 9. Bernstein teaches a collection layer located between the sensor layer and the adhesive layer, wherein the collection layer includes a port in fluid communication with the microneedle (Figure 1B and Paragraph 99 of Bernstein) as in instant Claim 10. Bernstein teaches wherein the sensor layer includes a feed channel in fluid communication with the port in the collection layer, and wherein the sensor layer is formed with fluidic capillary channels in fluid communication with the feed channel (Figure 1B) as in instant Claim 11. Bernstein teaches a collection indicator having an initial state and a completed state when contacted by the sample amount of the interstitial fluid, wherein the collection indicator is located in and/or on the sensor layers (Figure 1B, Paragraph 197 of Bernstein) as in instant Claim 12.
Dependent Claims taught by Yukio
Yukio teaches wherein the ketone body indicator comprises an enzyme 3-hydroxybutrate dehydrogenase that catalyzes a reaction of the ketone body (Page 4), an enzyme cofactor that is reduced to a reduced cofactor during the reaction of the ketone body (NAD) (Page 4), and colorimetric agent exhibiting a first optical property and configured to change to a second optical property, different from the first optical property, when the threshold value of the ketone body is collected in the sample amount and a colorimetric agent that is reduced to a visible compound during oxidation of the reduced cofactor form in the presence of the electron mediator (tetrazolium salt—Page 6, In 7), an electron mediator (Page 6, In 7—1-methoxy-5-methylphenazium methyl sulfate Mpms— Page 6, In 16-17) as in instant Claims 3-5. Coenzymes are mentioned on pages 4-8 and the enzymes are successfully stabilized by the other components present in pages 4-8 as in instant Claim 6.
Dependent Claims taught by Gupta
Gupta teaches that diaphorase enzymes (co-enzymes) can be used (Paragraph 43 of Gupta) along with enzyme stabilizers (buffers serve as enzyme stabilizers in paragraphs 36-41 of Gupta) as in instant Claim 6.
Bernstein teaches a device that can be attached to the skin of a subject and used to measure ketones. Bernstein further states that its device can contain test strips/colorimetric compositions to measure compounds such as ketones. Bernstein does not specify what type of ketones are measured and/or what particular reagents are used in the measurement of such ketones. An artisan of ordinary skill would have been motivated to have measured beta-hydroxybutyrate/3-hydroxybutyrate since that can be used to monitor diabetes as discussed in Yukio (Page 1). Gupta further teaches the reagents that can be incorporated into a test strip used to detect beta-hydroxybutyrate/3-hydroxybutyrate. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in skin wearable monitoring devices and ketone measurement. Therefore, the level of ordinary skill in this art is high.
Response to Applicants Arguements
The examiner has considered applicants’ arguments and amendments. Applicants argue the combination of Bernstein and Yukio. Applicants argue the following.
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Applicants are arguing that because of the differences in how testing is carried out (principles of operation) between the Bernstein patch device and Yukio’s testing materials, these teachings cannot be combined. The examiner was not persuaded by these arguments. Yukio is being applied in the rejection to teach the testing materials themselves and not the method of analyzing the biological samples (principle of operation). Paragraph 102 of Bernstein mentions that detection sensors can be present in the patches. Paragraph 191 of Bernstein states that these detection sensors can be colorimetric sensors. Paragraph 213 of Bernstein recites, “the sensor may be a test strip, for example, test strips that can be obtained commercially….A test strip will typically include a band, piece, strip of paper or other material and contain one or more regions able to determine an analyte, e.g. via binding of the analyte to a diagnostic agent or a reaction entity……The test strip may be able to determine, for example, glucose, cholesterol, creatine, ketones, blood, protein, nitrite, pH….” Bernstein is establishing that indicator test strips can be used in its patch device. Like Bernstein, Yukio is describing test strip material containing reagents that can be used to detect substances such as ketones.
The testing materials of Yukio detect molecules such as ketones just by having a biological sample come into contact with the reagents present on Yukio’s test strips. Bernstein and Yukio are combinable in a rejection because they both teach test strips that can detect ketones. Placing the test strip material of Yukio with detection reagents in the patch device of Bernstein would still allow the biological specimen to successfully contact Yukio’s test strip material and allow one to see how the reagents on Yukio’s test strip material responded to the biological sample. Since Bernstein already teaches that test strips can be used to detect substances such as ketones, an artisan would have been further motivated to have used other test strips which can also detect ketones taught by other secondary references.
Applicants further argue the application of Gupta in the most recent office action rejection. Applicants state specifically the following:
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Similarly, Gupta is not being applied to teach a principle of operation, method of using a patch device, or a method of reagent testing using a dipstick structure. Gupta is being used to teach the testing materials and their reagents. Gupta also teaches test strip material that can detect ketones. An artisan would have been motivated to have used the test strip material of Gupta in the place of the test strip material mentioned in Bernstein since Gupta’s test strips can successfully detect ketones. An artisan would have been motivated to have used Gupta’s testing materials in place of the test strips taught by Bernstein in the patch device of Bernstein since Gupta’s testing materials are able to indicate the presence of a substance such as a ketone just by coming into direct contact with a biological specimen. The device of Bernstein is designed so that sensor results can be easily viewed.
Conclusion
All claims stand rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638