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
Claims 8 and 11-18 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/31/2026.
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.
Claim(s) 1-4, 6 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 00/74763 A2 to Prausnitz et al. (hereinafter, Prausnitz).
Regarding Claim 1, Prausnitz discloses a method for collecting a biological fluid sample (see Abstract), the method comprising inter alia:
applying a dermal patch (device 10) comprising a microneedle array (microneedles 12) to a skin location (p. 24, ll. 1-3 “Figure 9 is a side elevational view of a schematic of an embodiment of the microneedle device inserted into undeformed skin. The device 10 includes an upper portion or substrate 11 from which a plurality of microneedles 12 protrude.”) in proximity to at least one lymph node in a subject or patient (p. 8, ll. 10-14 “…useful in transport of material into or across biological barriers including … lymphatic vessels…”) (p. 8, ll. 30-31 “Beneath the viable epidermis is the dermis, which is between 1 and 3 mm thick and contains … lymphatics…”) (Especially as broadly claimed, any portion of the human body is in proximity to at least one lymph node, because the claims fail to set forth a specific “proximity distance”. Considering lymph nodes are located throughout the human body, including a high concentration in the neck, armpits, ground, check and abdomen, and directly interact with the lymphatic system, any part of the body the dermal patch is attached to is “proximate” to at least one lymph node);
contacting the microneedle array intradermally to access a biological fluid (p. 46, lines 5-7 “The device 10 is applied to the skin such that the microneedles 12 penetrate through the stratum corneum and enter the viable epidermis so that the tip of the microneedle at least penetrates into the viable epidermis.)”;
allowing the microneedle array to take up a biological fluid sample (p. 55, l1. 12-18 “The device is applied to the skin or other biological barrier at the site where the sample is to be collected or measured. Then biological fluid, or a component thereof is drawn into or through the pores or bores of the microneedles…”);
collecting the biological fluid sample into a sampling chamber housed within the dermal patch (p. 55, l1. 12-18 “Then biological fluid, or a component thereof is… collected in the collection chamber.”).
Regarding Claim 2, Prausnitz discloses the method of claim 1, further comprising activating the microneedle array by applying pressure or electric current (p. 46, ll. 11-13 “To control the transport of material… into the device through the microneedles, a variety of forces or mechanisms can be employed. These include pressure gradients…”).
Regarding Claim 3, Prausnitz discloses the method of claim 1, wherein the lymph node is a cervical, clavical, pectoral, axillary, brachial, mediastinal, hilar, spleen, paraaortic, mesenteric, iliac, inguinal, femoral or popliteal lymph node (Especially as broadly claimed, any portion of the human body is in proximity to at least one cervical, clavical, pectoral, axillary, brachial, mediastinal, hilar, spleen, paraaortic, mesenteric, iliac, inguinal, femoral or popliteal lymph node, because the claims fail to set forth a specific “proximity distance”. Considering lymph nodes are located throughout the human body, including a high concentration in the neck, armpits, ground, check and abdomen, and directly interact with the lymphatic system, any part of the body the dermal patch is attached to is “proximate” to at least one cervical, clavical, pectoral, axillary, brachial, mediastinal, hilar, spleen, paraaortic, mesenteric, iliac, inguinal, femoral or popliteal lymph node).
Regarding Claim 4, Prausnitz discloses the method of claim 3, wherein the lymph node is a paraaortic, mesenteric, or iliac lymph node (Especially as broadly claimed, any portion of the human body is in proximity to at least one paraaortic, mesenteric, or iliac lymph node, because the claims fail to set forth a specific “proximity distance”. Considering lymph nodes are located throughout the human body, including a high concentration in the neck, armpits, ground, check and abdomen, and directly interact with the lymphatic system, any part of the body the dermal patch is attached to is “proximate” to at least one paraaortic, mesenteric, or iliac lymph node).
Regarding claim 5, Prausnitz discloses where the subject or patient is female (p. 56, lines 28-29 “Microneedles may also be inserted into… vaginal… to facilitate transport… out of… those tissues…”).
Regarding claim 6, Prausnitz discloses the method of claim 1, further comprising detecting a trigger analyte in the biological fluid sample ex vivo or in situ (p. 19, ll. 22-25 “The device can include means for assaying the amount of analyte extracted. For example. an assay method that results in a color change could be used. The change in color could be detected using a light beam that enters into a disposable collection chamber through a window on top.”).
Regarding Claim 10, Prausnitz discloses the method of claim 6, wherein the detection step is in situ and further comprises emitting a colorimetric or fluorescent detection signal when a trigger analyte is detected in the biological fluid sample (p. 19, ll. 22-25 “The device can include means for assaying the amount of analyte extracted. For example. an assay method that results in a color change could be used. The change in color could be detected using a light beam that enters into a disposable collection chamber through a window on top.”).
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.
Claim(s) 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz in view of Vaginal self-sampling is a cost-effective way to increase participation in a cervical cancer screening programme: a randomised trial to Haguenoer et al. (hereinafter, Haguenoer).
Prausnitz discloses the claimed invention as set forth and cited above in Claim 1 except for expressly disclosing (Claims 7 and 9) where the trigger analyte correlates to cervical cancer and wherein detecting a trigger analyte comprises PCR. However, Haguenoer teaches vaginal self-screening using a self-sampling device (Background, Methods, Results, p. 2187) wherein the subject or patient is female and where the skin location is a pelvic region of the subject or patient (see Settings and participants and Interventions at p. 2188 that describe the Pap smear tests performed by women in the pelvic region (e.g., vagina)) and the trigger analyte correlates to cervical cancer (Title “cervical cancer”) and wherein detecting a trigger analyte comprises PCR (Methods “PCR-based HPV testing”).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the dermal patch of Prausnitz to be placed in the pelvic region to perform a test/collecting of a trigger analyte correlating to cervical cancer and PCR of Haguenoer because Prausnitz discloses their dermal patch may be inserted into the vagina for the collection of vaginal fluid (p. 56, lines 28-29 “Microneedles may also be inserted into… vaginal… to facilitate transport… out of… those tissues…”) and discloses that analytes such as tumor antigens in the collected sample (p. 57, ll. 24-27 “Examples of typical analytes that can be measured include… tumor antigens…”) and Haguenoer teaches in Conclusions at p. 2187 that in-home vaginal tests are more effective and cost-effective in increasing participation in cervical cancer screening. Since Prausnitz already discloses a device that can collect fluid from the vagina, the addition of Haguenoer would be an obvious design choice to utilize Prausnitz at-home dermal patch for the identifying of specific cervical cancer biomarkers as set forth in Haguenoer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/ Primary Examiner, Art Unit 3791