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 .
Specification
The disclosure is objected to because of the following informalities:
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract contains more than 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Appropriate correction is required.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 recites the limitation “the operator” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
Claims 1 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liscio (WO 2019/086443 A1).
Regarding claim 1, Liscio teaches an administration device 20 (figure 2) comprising:
a needle 17 to be inserted into a living body;
a cartridge 18 capable of accommodating liquid medicine (page 6, lines 28-30) to be administered into the living body through the needle 17;
a case (case formed by elements 10, 38 and 19) having an open or openable first end (end of element 10 where element 17 is present) to be pressed against a skin, and housing (housing of element 10) therein the needle 17 and the cartridge 18 in such a manner that the needle 17 and the cartridge are movable toward the first end side, the needle 17 being capable of advancing to an outside of the first end (end of element 10 where element 17 is present) by being moved toward the first end side;
a pressing force control member 39 intervening between the cartridge 18 and the case 10, 38, 19 so as to generate a reaction force and controlling a pressing force (force generated by element 39) of the case against the skin when the needle 17 moves toward the first end side;
a needle base 21 supporting the needle 17 at a position away from the cartridge 18 (figure 3A) and being in a state of fixation (figure 3A) to the case in an initial state (state shown in figure 3A) and, becoming movable integrally with the needle 17 toward the first end side upon being released from the fixation; and
a fixation release mechanism 23, 32 configured to release the fixation after the cartridge that has moved toward the first end side is integrated with the needle (page 9, lines 1-4),
the administration device 20 being configured to insert the needle 17 into the living body by, in a state in which the first end of the case 10, 19, 38 is pressed onto the skin, causing the needle to move through an opening (opening in element 19 shown in figure 3B) of the first end so as to advance the needle to the outside of the first end, wherein
in a process of inserting the needle into the living body by causing the needle to move through the opening of the first end so as to advance the needle to the outside of the first end (page 10, lines 17-20), the administration device 20 causes the pressing force control member 39 to continue generating the reaction force and controls the pressing force of the case against the skin to be substantially constant (element 39 when compressed will still generate reaction force) so that insertion depth of the needle is substantially constant in a state in which insertion of the needle into the living body is completed, and
in a process of discharging and administering the liquid medicine in the cartridge through the needle 17 into the living body, the administration device causes the pressing force control member to continue generating the reaction force so that the insertion depth of the needle is substantially constant (page 10, lines 27-31).
Regarding claim 6, Liscio teaches further comprising a pushing member 41 configured to apply a force (page 11, lines 6-11) towards the first end side to the cartridge by moving the first end side (end of element 10 where element 17 is present) by being pushed by an operator (page 11, lines 6-11, triggering of element 40 is construed as being pushed by an operator because in order to push element 41, operator has to perform an action such as physically pushing or pushing by activation of a spring 42), wherein the cartridge 18 comprises:
a cartridge body (body of element 18) accommodating the liquid medicine (content inside element 18, page 6, lines 35-36); and
a piston 14 configured to push out the liquid medicine through the needle 17 by being pushed by the pushing member 41 and moving toward the first end side relative to the cartridge body (body of element 18).
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.
Claim(s) 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Liscio (WO 2019/086443 A1) in view of Fuke et al. (US 2015/0374922 A1).
Regarding claim 2, Liscio discloses the claimed invention substantially as claimed, as set forth above in claim 1. Liscio is silent regarding wherein in response to the cartridge being released from a force applied toward the first end side, the pressing force control member causes the cartridge to move integrally with the needle toward a side opposite to the first end relative to the case. Since Liscio is silent regarding operation of the administration device after the completion of the medication delivery, Liscio does not disclose the claimed limitation. However, one can construe that Liscio’s administration device is capable of wherein in response to the cartridge being released from a force applied toward the first end side, the pressing control member causes the cartridge to move integrally with the needle toward a side opposite to the first end relative to the case because element 39 can push the elements 18 and 17 in upward direction.
Additionally, Fuke teaches a design of liquid administration device 10 (figure 2) wherein in response to the cartridge 2 being released from a force applied toward the first end side (paragraphs 0124, 0125), the pressing force control member 13 causes the cartridge 2 to move integrally with the needle 7 toward a side opposite (side towards element 542) to the first end (end of element 6 towards element 621) relative to the case 6 for the purpose of covering the needle to thereby safely preventing needle piercing accidents after use (paragraph 0125).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the administration device of Liscio to incorporate wherein in response to the cartridge being released from a force applied toward the first end side, the pressing force control member causes the cartridge to move integrally with the needle toward a side opposite to the first end relative to the case as taught by Fuke for the purpose of covering the needle to thereby safely preventing needle piercing accidents after use (paragraph 0125).
Regarding claim 3, Liscio discloses the claimed invention substantially as claimed, as set forth above in claim 1. Liscio is silent regarding when movement of the cartridge integrated with the needle is prevented after completion of administration of the liquid medicine, the pressing force control member causes the cartridge to move integrally with the needle toward the side opposite to the first end side relative to the case. However, one can construe that Liscio’s administration device is capable of when movement of the cartridge integrated with the needle is prevented after completion of administration of the liquid medicine, the pressing force control member causes the cartridge to move integrally with the needle toward the side opposite to the first end side relative to the case because element 39 can push the elements 18 and 17 in upward direction.
Additionally, Fuke teaches when movement of the cartridge 2 integrated with the needle 7 is prevented after completion of administration of the liquid medicine, the pressing force control member 39 causes the cartridge to move integrally with the needle toward the side opposite to the first end side relative to the case (paragraphs 0124, 0125) for the purpose of covering the needle to thereby safely preventing needle piercing accidents after use (paragraph 0125).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the administrative device of Liscio to incorporate when movement of the cartridge integrated with the needle is prevented after completion of administration of the liquid medicine, the pressing force control member causes the cartridge to move integrally with the needle toward the side opposite to the first end side relative to the case as taught by Fuke for the purpose of covering the needle to thereby safely preventing needle piercing accidents after use (paragraph 0125).
Regarding claim 4, Liscio discloses the claimed invention substantially as claimed, as set forth above in claim 1. Liscio is silent regarding further comprising a notification mechanism configured to be engaged at a time of the completion of the administration of the liquid medicine to thereby provide notification of the completion of the administration of the liquid medicine to the operator.
However, Fuke teaches further comprising a notification mechanism 37, 515 (figures 6 and 21) configured to be engaged at a time of the completion of the administration of the liquid medicine to thereby provide notification of the completion of the administration of the liquid medicine to the operator (paragraph 0141, lines 1-8, notification is the stopping of the sound or vibration) for the purpose of indicating the progress and the completion of the medication delivery to the user (paragraph 0141, lines 1-8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the administration device of Liscio to incorporate further comprising a notification mechanism configured to be engaged at a time of the completion of the administration of the liquid medicine to thereby provide notification of the completion of the administration of the liquid medicine to the operator as taught by Fuke for the purpose of indicating the progress and the completion of the medication delivery to the user (paragraph 0141, lines 1-8).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Liscio (WO 2019/086443 A1) in view of Shaw et al. (US 2019/0298928 A1).
Regarding claim 7, Liscio is silent regarding wherein the administration device is used for intradermal administration. However, one of ordinary skill in the art can construe that Liscio discloses wherein the administration device 20 is used for intradermal administration (element 20 could be used for intradermal administration by controlling the insertion depth of the needle 17).
Additionally, Shaw teaches a design of an administration device (figure 1) wherein the administration device is used for intradermal administration (paragraph 0001, lines 14-19) for the purpose of using the needle length with appropriate length to perform a necessary medical procedure (paragraph 0001).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the use of administrative device of Liscio to incorporate wherein the administration device is used for intradermal administration as taught by Shaw for the purpose of using the needle length with appropriate length to perform a necessary medical procedure (paragraph 0001).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783