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 .
Acknowledgments
In the reply, filed on June 14, 2023, Applicant cancelled claims 1-15.
Applicant added new claims 16-35.
Currently, claims 16-35 are under examination.
Specification
The abstract of the disclosure is objected to because:
In lines 4-5, “the longitudinal axis” should be changed to “a longitudinal axis”
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).
Claim Objections
Claims 16, 19, 23, 27, and 30-31 are objected to because of the following informalities:
In regards to claim 16, line 3, “the injector ;” should be changed to “the injector;”.
In regards to claim 16, lines 5-6, “the longitudinal axis” should be changed to “a longitudinal axis”.
In regards to claim 19, line 2, “a movement” should be changed to “the movement”.
In regards to claim 23, lines 4-5, “one or more movements” should be changed to “the one or more movements”.
In regards to claim 27, line 3, “rotation” should be changed to “the rotation”.
In regards to claim 30, line 1, “the magnets” should be changed to “the one or more magnets”.
In regards to claim 31, lines 5-6, “the longitudinal axis” should be changed to “a longitudinal axis”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 35 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to claim 35, lines 1-2 recite: a magnet on the rotator and a magnet “on an inner surface of the shield holder”; however, such is new matter not described in the Specification. Figure 3 instead shows a magnet 72 on an outer surface of the shield holder 70.
Claim Rejections - 35 USC § 102
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 16-19 and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Turieo et al (US 2006/0015066).
In regards to claim 16, Turieo et al teaches a mechanism (Figures 1-7) for receiving an injector having a needle and a needle shield covering the needle, the mechanism comprising:
a housing having an injector holder (150) for holding the injector
a shield holder (one needle package 500) for holding the needle shield, the shield holder being movable relative to the housing between an aligned position for holding the needle shield aligned with the longitudinal axis (Figure 2), and an offset position for holding the needle shield offset from the longitudinal axis (paragraph [0066] states “After a needle is driven into the bone, the infusion device may be lifted from the patient and the cartridge assembly 300 rotated, bringing a fresh needle package 500 into alignment with the driver tip 140” from which it is understood that the shield holder that was in the aligned position aligned with the longitudinal axis is then rotated to an offset position offset from the longitudinal axis)
a rotator (310) rotatable around the longitudinal axis from a first rotator position to a second rotator position
wherein the mechanism is configured to cause a movement of the shield holder from the aligned position to the offset position by means of a movement of the rotator from the first rotator position to the second rotator position (paragraph [0066])
In regards to claim 17, Turieo et al teaches an actuating body (130) movable relative to the housing along the longitudinal axis between a first actuating position and a second actuating position.
In regards to claim 18, Turieo et al teaches wherein the actuating body covers the needle in each of the first actuating position and the second actuating position (Figure 2).
In regards to claim 19, Turieo et al teaches a guiding member (220) for limiting a movement of the actuating body relative to the housing along the longitudinal axis, where the guiding member is arranged to move along the longitudinal axis relative to the housing and is prevented from rotating about the longitudinal axis relative to the housing.
In regards to claim 31, Turieo et al teaches a mechanism (Figures 1-7) for receiving an injector having a needle and a needle shield covering the needle, the mechanism comprising:
a housing having an injector holder (150) for holding the injector
a shield holder (one needle package 500) for holding the needle shield, the shield holder being movable relative to the housing between an aligned position for holding the needle shield aligned with the longitudinal axis (Figure 2), and an offset position for holding the needle shield offset from the longitudinal axis (paragraph [0066] states “After a needle is driven into the bone, the infusion device may be lifted from the patient and the cartridge assembly 300 rotated, bringing a fresh needle package 500 into alignment with the driver tip 140” from which it is understood that the shield holder that was in the aligned position aligned with the longitudinal axis is then rotated to an offset position offset from the longitudinal axis)
a rotator (310) rotatable around the longitudinal axis from a first rotator position to a second rotator position
an actuating body (130) slidable relative to the housing between a first actuating position and a second actuating position
a guiding member (220) that moves axially relative to the housing and is rotationally fixed relative to the housing
wherein the mechanism is configured to cause a movement of the shield holder from the aligned position to the offset position when the rotator rotates from the first rotator position to the second rotator position (paragraph [0066])
Allowable Subject Matter
Claims 20-30 and 32-34 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.
In regards to claim 20, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a mechanism for receiving an injector having a needle and a needle shield covering the needle, as claimed, specifically including a rotator force device arranged to force the rotator in a distal direction along the longitudinal axis.
Turieo et al does not teach a rotator force device arranged to force the rotator in a distal direction along the longitudinal axis.
Thus, claim 20 is objected to as being dependent upon a rejected base claim 16, but would be allowable if rewritten in independent form including all of the limitations of the base claim 16 and intervening claims 17 and 19. Claim 21 is objected to by virtue of being dependent upon claim 20.
In regards to claim 22, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a mechanism for receiving an injector having a needle and a needle shield covering the needle, as claimed, specifically including wherein the rotator is rotatable from the first rotator position to the second rotator position in response to one or more movements of the actuating body between the first actuating position and the second actuating position.
Turieo et al teaches wherein the rotator (310) is rotatable from the first rotator position to the second rotator position (paragraph [0066]) and one or more movements of the actuating body (130) between the first actuating position and the second actuating position (paragraph [0037]).
However, Turieo et al does not teach wherein the rotator is rotatable from the first rotator position to the second rotator position “in response to” one or more movements of the actuating body between the first actuating position and the second actuating position.
Thus, claim 22 is objected to as being dependent upon a rejected base claim 16, but would be allowable if rewritten in independent form including all of the limitations of the base claim 16 and intervening claim 17. Claims 23-26 are objected to by virtue of being dependent upon claim 22.
In regards to claim 27, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a mechanism for receiving an injector having a needle and a needle shield covering the needle, as claimed, specifically including at least one magnet, wherein the shield holder is magnetically forced towards the rotator by means of the at least one magnet from the aligned position to the offset position during rotation of the rotator from the first rotator position to the second rotator position.
Turieo et al does not teach at least one magnet, wherein the shield holder is magnetically forced towards the rotator by means of the at least one magnet from the aligned position to the offset position during rotation of the rotator from the first rotator position to the second rotator position.
Thus, claim 27 is objected to as being dependent upon a rejected base claim 16, but would be allowable if rewritten in independent form including all of the limitations of the base claim 16. Claims 28-30 are objected to by virtue of being dependent upon claim 27.
In regards to claim 32, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a mechanism for receiving an injector having a needle and a needle shield covering the needle, as claimed, specifically including a rotator force device engaged with the rotator and the guiding member to move the rotator distally
Turieo et al does not teach a rotator force device engaged with the rotator and the guiding member to move the rotator distally.
Thus, claim 32 is objected to as being dependent upon a rejected base claim 31, but would be allowable if rewritten in independent form including all of the limitations of the base claim 31.
In regards to claim 33, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a mechanism for receiving an injector having a needle and a needle shield covering the needle, as claimed, specifically including wherein axial movement of the actuating body causes the rotator to rotate from the first rotator position to the second rotator position.
Turieo et al teaches axial movement of the actuating body (130) (paragraph [0037]) and the rotator (310) to rotate from the first rotator position to the second rotator position (paragraph [0066]).
However, Turieo et al does not teach wherein axial movement of the actuating body “causes” the rotator to rotate from the first rotator position to the second rotator position.
Thus, claim 33 is objected to as being dependent upon a rejected base claim 31, but would be allowable if rewritten in independent form including all of the limitations of the base claim 31.
In regards to claim 34, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a mechanism for receiving an injector having a needle and a needle shield covering the needle, as claimed, specifically including a cam profile and a cam follower, where movement of the cam follower along the cam profile causes the rotator to rotate from the first rotator position to the second rotator position.
Turieo et al does not teach a cam profile and a cam follower, where movement of the cam follower along the cam profile causes the rotator to rotate from the first rotator position to the second rotator position.
Thus, claim 34 is objected to as being dependent upon a rejected base claim 31, but would be allowable if rewritten in independent form including all of the limitations of the base claim 31.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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