DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 3, 5, 6, 8, 10, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feasibility of Fine Needle Aspiration to Assess Response to Chemotherapy in Metastatic Nodes Marked with Clips in Breast Cancer: A Prospective Registry Study in to Caudle et al. (hereinafter, Caudle) in view of WO 00/74763 A2 to Prausnitz et al. (hereinafter, Prausnitz).
Caudle discloses a method for collecting a biological fluid sample, the method comprising inter alia:
(Claims 1 and 19) applying a needle to a skin location within 2 cm of at least one lymph node in a subject of a patient, contacting the needle intradermally to access a biological fluid, allowing the needle to take up and collect a biological fluid sample (Methods “Participants had a fine needle aspiration performed of the clipped node before seed-localized lymph node excision.”);
(Claim 3) where the lymph node is axillary (Objective “Clips are often placed to mark axillary nodes with biopsy-confirmed metastases in breast cancer patients.”);
(Claim 5) where the subject or patient is a female (Table 1 “Gender / Female);
(Claim 6) detecting a trigger analyte in the biological fluid sample ex vivo or in situ (Objective: “The goal of this study was to determine if preoperative fine needle aspiration of clipped nodes after neoadjuvant chemotherapy could predict the presence of residual disease.”) (Results “Of the 36 (72%) with residual disease on surgical pathology, 3 (8%) had a nondiagnostic aspirate, carcinoma was seen in 14 (39%), and 19 (53%) had a false negative result.”);
(Claim 8) wherein the skin location is an underarm region of the subject or patient (Objective “Clips are often placed to mark axillary nodes with biopsy-confirmed metastases in breast cancer patients.”) and the trigger analyte correlates to breast cancer (Objective “Clips are often placed to mark axillary nodes with biopsy-confirmed metastases in breast cancer patients.”); and
(Claim 20) wherein the trigger analyte correlates to the skin location (Objective “Clips are often placed to mark axillary nodes with biopsy-confirmed metastases in breast cancer patients.”).
Caudle discloses the claimed invention except for expressly disclosing (Claim 1) where a dermal patch comprising a microneedle array is applied to the one lymph node, contacting the microneedle array intradermally to access a biological fluid, allowing the microneedle array to take up a biological fluid sample and collecting the biological fluid sample into a sampling chamber housed within the dermal patch, (Claim 2) activating the microneedle array by applying pressure or electric current and (Claim 10) 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.
However, Prausnitz teaches:
(Claim 1) 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.”);
(Claim 2) 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…”); and
(Claim 10) 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.”).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the needle sampling system of Caudle to be the microneedle system of Prausnitz because Prausnitz teaches “needle techniques also generally require administration by one trained in its use, and are not preferred for frequent routine use due to the vascular damage caused by repeated puncture” (p. 1, ll. 24-26) and the microneedle system would have provided a “controlled sampling or sensing of biological fluids in a minimally-invasive, painless, and convenient manner” (p. 3, ll. 29-30). Caudle discloses that clinically valuable sampling means going back to the same lymph node repeatedly over time with a needle, and Prausnitz establishes that such techniques are not preferred because repeated punctures result in pain – the minimally invasive microneedles of Prausnitz worn by the patient would have resulted in the same type of sampling overtime with reduced pain. Therefore, a skilled artisan would have found the combination of Caudle and Prasunitz obvious.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caudle in view of Prausnitz as applied to claim 6 above, and further in view of US 20120277629 A1 to Bernstein et al. (hereinafter, Bernstein).
Caudle in view of Prausnitz disclose the claimed invention except for expressly disclosing wherein detecting a trigger analyte comprises: PCR, ELISA, LAMP, or synthetic riboregulator detection. However, Bernstein teaches a microneedle array (paragraphs 0091 and 0093) that can collect body fluid (paragraph 0066), where the fluid can be analyzed using ELISA. One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the method of Caudle in view of Prausnitz with the teachings of Bernstein because Bernstein teaches that ELISA is a bodily fluid analysis technique known in the art (paragraph 0060).
Allowable Subject Matter
Claims 4 and 7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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 SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791
Prosecution Insights