DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant's election with traverse of group I, claims 1-16 in the reply filed on 5/22/26 is acknowledged. The traversal is on the ground(s) that the Examiner has not established that an unduly burdensome search and examination would be required if the Restriction Requirement is not maintained. This is not found persuasive because, as stated in the restriction requirement, the apparatus as claimed can be sued to practice another and a materially different process. Therefore, a search for the apparatus claims would be different than the required search for the process claims, thus creating an undue burden on the Office should be sets of claims be examined together.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
3. 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.
4. Claim(s) 9-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yaginuma et al. (US 2019/0290383 A1) (hereafter “Yaginuma”).
Regarding claims 9 and 10, Yaginuma discloses (figure 1; para [0044]-[0055]) a sterilization device comprising: an enclosure (120); a surgical instrument (110) capable of being subjected to a sterilization process within the enclosure (120); and a sensor (temperature sensor 13) forming a portion of the surgical instrument (110) (sensor 13 is part of tag 10 that is attached to the instrument 110) and configured to measure a characteristic of an environment (ambient temperature) inside the enclosure during the sterilization process to provide data regarding a nature of the environment to which the surgical instrument is exposed (see para [0055]).
Regarding claim 11, Yaginuma discloses a surgical instrument (110) that includes a thermal mass (area where sensor tag 10 is attached – see figure 1). The sensor (13) comprises a temperature sensor (see figure 2; para [0055]) configured to measure a temperature of the thermal mass (see para [0055] – temperature sensor 13 measures the temperature of the instrument).
Regarding claims 12 and 13, Yaginuma discloses (para [0054]-[0067]) a processor (11a) in communication with the sensor (13), the processor (11a) configured to receive a signal from the sensor (13) including the data that is representative of the characteristic of the inside the enclosure during the sterilization process (ambient temperature in sterilizer 120 – see para [0055]). Yaginuma further discloses that the surgical instrument (110) that includes a thermal mass (area where sensor tag 10 is attached – see figure 1). The sensor (13) comprises a temperature sensor (see figure 2; para [0055]) configured to measure a temperature of the thermal mass (see para [0055] – temperature sensor 13 measures the temperature of the instrument). The processor (11a) is further configured to compare the temperature measured by the sensor (13) to a threshold temperature to determine that sterilization has occurred (see para [0064]-[0065]).
Regarding claim 14, Yaginuma discloses wherein the threshold value is a known peak temperature for the thermal mass (134 degrees C for the instrument) which confirms the one or more surgical instruments have been properly sterilized (see para [0065]-[0077].
Claim Rejections - 35 USC § 103
5. 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.
6. Claim(s) 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Yaginuma a in view of Coyle et al. (US 8,236,253 B2) (hereafter “Coyle”).
Regrading claim 1, Yaginuma discloses (figure 1; para [0044]-[0055]) a sterilization device comprising: an enclosure (120); a surgical instrument (110) capable of being subjected to a sterilization process within the enclosure (120); and a sensor (temperature sensor 13) forming a portion of the surgical instrument (110) (sensor 13 is part of tag 10 that is attached to the instrument 110) and configured to measure a characteristic of an environment (ambient temperature) inside the enclosure during the sterilization process to provide data regarding a nature of the environment to which the surgical instrument is exposed (see para [0055]). Yaginuma is silent with regards to the details of the sterilization enclosure (120) other than that it is an autoclave (see para [0049]).
Coyle discloses a portable sterilizing autoclave (10) for surgical and dental instruments where the instruments to be treated are placed in a sterilization container (84) formed to allow sterilant to enter and exit (see figure 2; col. 4, lines 35-46; col. 8, lines 35-55).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Yaginuma and utilize a conventional and well-known steam autoclave arrangement having an apertured cassette for holding multiple surgical or dental instruments during sterilization as taught Coyle.
Regarding claims 2 and 4-5, Yaginuma discloses (para [0054]-[0067]) a processor (11a) in communication with the sensor (13), the processor (11a) configured to receive a signal from the sensor (13) including the data that is representative of the characteristic of the inside the enclosure during the sterilization process (ambient temperature in sterilizer 120 – see para [0055]). The processor (11a) is further configured to compare the temperature measured by the sensor (13) to a threshold temperature to determine that sterilization has occurred (see para [0064]-[0065]). Yaginuma further discloses that the surgical instrument (110) includes a thermal mass (area where sensor tag 10 is attached – see figure 1). The sensor (13) comprises a temperature sensor (see figure 2; para [0055]) configured to measure a temperature of the thermal mass (see para [0055] – temperature sensor 13 measures the temperature of the instrument).
Regarding claim 3, Yaginuma discloses that the sensor (10) comprises a temperature sensor (13) (see figure 2; para [0055]).
Regarding claim 6, Yaginuma discloses wherein the threshold value is a known peak temperature for the thermal mass (134 degrees C for the instrument) which confirms the one or more surgical instruments have been properly sterilized (see para [0065]-[0077].
Allowable Subject Matter
7. Claims 7-8 and 15-16 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.
The following is a statement of reasons for the indication of allowable subject matter: the prior art, alone or in combination, fails to teach or suggest wherein the sensor comprises a temperature sensor configured to measure a plurality of temperature measurements of the thermal mass spaced over a period of time; and wherein the processor is further configured to determine a rate of change of the temperature based on the plurality of temperature measurements by the sensor and to compare the determined rate of change of the temperature of the thermal mass to a known rate of change to determine whether the sterilization process has reached predetermined sterilization threshold, in the claimed environment.
Conclusion
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN E CONLEY whose telephone number is (571)272-8414. The examiner can normally be reached on M-F, 8:30am-4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Marcheschi can be reached on 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SEAN E CONLEY/Primary Examiner, Art Unit 1799
Prosecution Insights