CTNF 18/925,897 CTNF 89964 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding Claim 7 , first, the claim recites “tubing”. It is unclear as to if this tubing is the same as the compliant tube of Claim 6 or some other tube, thus rendering the claim indefinite. Second, the claim recites “can be constructed of plastic”. It is unclear whether the limitation(s) following the phrase “can be” are part of the claimed invention, thus rendering the claim indefinite. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-12-aia AIA (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. 07-15-aia AIA Claim(s) 1 – 5 and 8 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Kalpin (US 2016/0354540) . Regarding Claim 1 , Kalpin discloses an apparatus for sensing fluid communication in a wearable medicament delivery device, in at least Figures 1, 2, and 5, having a fluid reservoir (32) for containing a medicament [0031], a fluid delivery mechanism (pump) for controlling delivery of the medicament from the reservoir to a patient [0031], a processor (46, 50) [0036], and a fluid path configured to fluidically connect the fluid reservoir with an outlet to the patient to transport the medicament from the fluid reservoir to the outlet under control of the fluid delivery mechanism [0031] (Figures 2, 5), the apparatus comprising: a chamber (44) disposed adjacent a portion of the fluid path and connected to the fluid path such that the fluid path is exposed within the chamber (Figures 2, 5); and a pressure sensor (14) having a sensing surface (flexible membrane, or surface of piezo-electric or resistive change element) [0044] and an output portion electrically connected to the processor of the wearable medicament delivery device (Figures 2, 5) [0036], wherein the chamber is dimensioned to receive the sensing surface [0044], and the sensing surface is configured to detect pressure of the fluid in the fluid path and provide a sensed pressure output electrically to the processor via the output portion [0036, 0044]. Regarding Claim 2 , Kalpin discloses the medication in the chamber applies a force to the sensing surface that corresponds to a characteristic of fluid pressure in the fluid path when the sensing surface is received within the chamber [0044]. Regarding Claim 3 , Kalpin discloses the chamber is configured to expose the medication in the fluid path, and the sensing surface directly contacts the medication in the chamber when the sensing surface is received within the chamber [0044]. Regarding Claim 4 , Kalpin discloses the pressure sensor comprises a force sensing resistor (piezo-electric effect or resistive change) and the sensing surface is a face of the force sensing resistor (membrane), and the force sensing resistor varies in conductance in response to the force applied to the sensing surface [0044]. Regarding Claim 5 , Kalpin discloses an intermediate contact element disposed within the chamber and arranged between the sensing surface and the medicament in the fluid path that is exposed within the chamber such that the sensing surface indirectly contacts the medicament (in the case of the sensing surface being the surface of piezo-electric or resistive change element, the intermediate surface would be the flexible membrane) [0044]. Regarding Claim 8 , Kaplin discloses the sensor is a force sensing resister sensor (piezo-electric effect or resistive change) and the sensing surface is an active sensing surface of an FSR sensing element (membrane) [0044] . 07-15-aia AIA Claim(s) 1 and 9 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Kamen et al. (US 2011/0144574) . Regarding Claim 1 , Kamen discloses an apparatus for sensing fluid communication in a wearable medicament delivery device, in at least Figure 21, having a fluid reservoir (118) for containing a medicament [0184], a fluid delivery mechanism (106) for controlling delivery of the medicament from the reservoir to a patient [0386], a processor (inherently present containing the processing logic) [0386], and a fluid path configured to fluidically connect the fluid reservoir with an outlet to the patient (via 138) to transport the medicament from the fluid reservoir to the outlet under control of the fluid delivery mechanism (Figure 21), the apparatus comprising: a chamber (620) disposed adjacent a portion of the fluid path and connected to the fluid path such that the fluid path is exposed within the chamber (Figure 21); and a pressure sensor having a sensing surface (628) and an output portion electrically connected to the processor of the wearable medicament delivery device [0031, 0567, 0619, 0624 – 0627], wherein the chamber is dimensioned to receive the sensing surface (Figure 21), and the sensing surface is configured to detect pressure of the fluid in the fluid path and provide a sensed pressure output electrically to the processor via the output portion [0031, 0567, 0619, 0624 – 0627]. Regarding Claim 9 , Kamen discloses the chamber and the pressure sensor are arranged along the fluid path downstream of fluid delivery mechanism (Figure 21) . Allowable Subject Matter 12-151-08 AIA 07-43 12-51-08 Claim 6 is 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 Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER MERCADO whose telephone number is (571)270-7094. The examiner can normally be reached Monday - Thursday 9am - 4pm 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, Laura Martin can be reached at (571) 272-2160. 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. ALEXANDER A. MERCADO Primary Examiner Art Unit 2855 /ALEXANDER A MERCADO/ Primary Examiner, Art Unit 2855 Application/Control Number: 18/925,897 Page 2 Art Unit: 2855 Application/Control Number: 18/925,897 Page 3 Art Unit: 2855 Application/Control Number: 18/925,897 Page 4 Art Unit: 2855 Application/Control Number: 18/925,897 Page 5 Art Unit: 2855 Application/Control Number: 18/925,897 Page 6 Art Unit: 2855 Application/Control Number: 18/925,897 Page 7 Art Unit: 2855
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