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 .
Claim Rejections - 35 USC § 112
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.
Claims 8, 10, 11, 12 are 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.
Claim 8 recites “a third sensor of said one or more sensors”. Claim 8 depends from claim 5 which recites “one or more sensors”. The scope of claim 8 is unclear because it is not clear if claim 8 requires at least 3 sensors, where the third sensor is a magnetic sensor, or if claim 8 requires one or more sensors, where one of the sensors is a magnetic sensor.
Regarding claim 10, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 11 recites the limitation "the computer processor” in line 3, and “the human or pet" in line 3. There is insufficient antecedent basis for these limitations in the claim.
Claim 12 calls for a needle-free injector as defined in claim 1, for use with the automatic needle-free injector container unit system of claim 1. The scope of this claim is unclear because claim 1 recites “an automatic needle-free injector container unit system” and therefore, it is not clear what portion of that comprises the recited “needle-free injector as defined in claim 1” and how any part of that would be an additional element for use with the automatic needle-free injector container unit system of claim 1 which presumably includes all of claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-5, 9, 10, 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lancaster, Jr. et al (US 4,758,227) in view of Johnston, Jr. et al (US 7,850,665) in view of Azar et al (US 8,066,662).
Regarding claim 1, Lancaster discloses an automatic injector container unit system (fig. 1), comprising an injector 34 for injecting a medicament from a cartridge to a user (col. 2, lines 57-62; fig. 1), an injector movement mechanism 38/70 for automatically and reversibly positioning the injector to one or more of a home position where the injector is retracted and positioned away from contact with the user (as shown in fig. 1), and an injecting position where the injector is in proximity to the user for injection of the medication (abstract; col. 3, lines 27-56), and a container for housing the injector and the injector movement mechanism (as shown in fig. 5).
Claim 1 differs from Lancaster in calling for the injector to be a needle-free injector. Lancaster discloses needle injectors for injecting into a bird. Johnston teaches that injector such for birds can be needle injectors or needle-free injectors (col. 4, lines 61-65). Lancaster recognizes potential drawbacks of using needles for injections are accidentally injuring or killing the bird or injury to the user (col. 1, lines 12-16). Needle-free injections are also known to be less likely to spread infection between individuals. 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 injector of Lancaster to be a needle-free injector as taught by Johnston because Johnston teaches that needle-free injectors can be used in a system in place of a needle injector, and needle-free injectors avoid drawbacks of needle injectors such as injury to the bird or the user and spread of infection.
Claim 1 further calls for the needle-free injector to comprise a cartridge chamber for receiving the cartridge. As noted above, Johnston teaches the use of needle-free injectors in place of needle injectors, but fails to disclose the specific structure of a needle-free injector. Azar teaches a needle-free injector wherein the injector 200 comprises a cartridge chamber for receiving the cartridge 260 (fig. 2A; col. 5, lines 56-60). 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 needle-free injector of Lancaster in view of Johnston to include a cartridge chamber for receiving the cartridge as taught by Azar to provide an injector that can inject multiple doses to facilitate fast and reliable injection to multiple individuals.
Regarding claim 2, Azar further teaches that the system includes a computer processor (implied) in connection with a user interface 140 for controlling the injector system (col. 5, lines 11-15; fig. 1) allowing the user to input injection parameters such as volume and speed of injection to increase injection safety. 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 Lancaster in view of Johnston in view of Azar as discussed with regard to claim 1 above to include a computer processor in communication with a user interface to control the injection and injector movement as taught by Azar to allow the user to input injection parameters to increase the safety of the device and reduce user error.
Regarding claim 3, Azar teaches that the cartridge comprises the medicament for injection by the needle-free injector (fig. 2A). ). 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 needle-free injector of Lancaster in view of Johnston in view of Azar discussed above to include medicament in the cartridge as taught by Azar to provide an injector that can inject multiple doses to facilitate fast and reliable injection to multiple individuals.
Regarding claim 4, Azar teaches that the medicament is a vaccine for providing doses to a large number of individuals (col. 6, lines 50-53). ). 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 Lancaster in view of Johnston in view of Azar as discussed above to include a vaccine in the medicament cartridge as taught by Azar so that the injector that can inject multiple doses to facilitate fast and reliable vaccination to multiple individuals.
Regarding claim 5, Azar further teaches that the system comprises one or more sensors to sense the temperature of the stored medicament to ensure that the medicament remains at a safe temperature (col. 5, lines 28-30). ). 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 needle-free injector of Lancaster in view of Johnston in view of Azar as discussed above with regard to claim 1 to include a sensor as taught by Azar to monitor the temperature of the stored medicament to ensure the medicament remains within a safe temperature.
Regarding claim 9, Lancaster discloses a horizontal arm 58 having the injector thereon for moving the injector from the first position to the second position (fig. 1).
Regarding claim 10, Azar teaches that the container is temperature controlled to provide storage of the medicament at a safe temperature (col. 5, lines 25-30). 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 needle-free injector of Lancaster in view of Johnston in view of Azar as discussed above to a temperature controlled container as taught by Azar to ensure that all the medicament doses are given at a safe temperature. The term preferably in the claim is interpreted to mean that the element listed thereafter is optional.
Regarding claim 13, the system taught by Lancaster in view of Johnston in view of Azar as discussed above with regard to claim 1 is interpreted to be a portable kiosk.
Regarding claim 14, Azar teaches that the medicament is a vaccine for providing doses to a large number of individuals (col. 6, lines 50-53). ). 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 Lancaster in view of Johnston in view of Azar as discussed above to include a vaccine in the medicament cartridge as taught by Azar so that the injector that can inject multiple doses to facilitate fast and reliable vaccination to multiple individuals.
Regarding claim 15, Azar teaches that the container is refrigerated (col. 5, lines 28-30: cooled). 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 needle-free injector of Lancaster in view of Johnston in view of Azar as discussed above to be a refrigerated container as taught by Azar to ensure that all the medicament doses are given at a safe temperature. The term preferably in the claim is interpreted to mean that the element listed thereafter is optional.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lancaster in view of Johnston in view of Azar as applied to claim 1 above, and further in view of Anquetil et al (US 2021/077728).
Claim 11 differs from the teachings above in calling for a user interface in communication with the computer processor for allowing a user to input information of the human or pet to be given the medicament. Anquetil teaches a system for giving needle-free injections to a human or pet wherein the system includes a user interface in communication with the computer to allow the user to input information regarding the human or pet to automatically update medical records for future reference (page 11, para. 0116). 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 Lancaster in view of Johnston in view of Azar as discussed above to include a user interface in communication with a computer for allowing the user to input information on the human or pet receiving the injection as taught by Anquetil to allow the medical records to be updated automatically.
Allowable Subject Matter
Claims 6-8 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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, Bhisma Mehta can be reached at 571-272-3383. 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.
LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783