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 abstract of the disclosure is objected to because:
In line 2, “threadably” should be changed to “the dose set member threadably”
In line 8, “dose setting” should be changed to “the dose setting”
In line 9, “dose correcting” should be changed to “the dose correcting”
In line 9, “an injection” should be changed to “the injection”
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).
The disclosure is objected to because of the following informalities:
In paragraph [0001], “which is a continuation of U.S. Nonprovisional Application No. 16/358,036, filed February 16, 2016” should be changed to “which is a continuation of U.S. Nonprovisional Application No. 16/358,036, filed March 19, 2019”.
Appropriate correction is required.
Claim Objections
Claims 1, 10, and 17-19 are objected to because of the following informalities:
In regards to claim 1, lines 3-4, “a first led screw end” should be changed to “a first lead screw end”.
In regards to claim 1, line 6, “the first protrusion” should be changed to “the first lead screw protrusion”.
In regards to claim 1, line 7, “threadably” should be changed to “the dose set member threadably”.
In regards to claim 10, line 11, “the teeth of the dose set member” should be changed to “the first teeth of the dose set member”.
In regards to claim 10, line 12, “the teeth of the dose set member” should be changed to “the first teeth of the dose set member”.
In regards to claim 10, line 14, “an injection” should be changed to “the injection”.
In regards to claim 10, line 17, “the teeth of the dose set member” should be changed to “the first teeth of the dose set member”.
In regards to claim 17, line 1, “maintain” should be changed to “maintains”.
In regards to claim 18, lines 2-3, “the first protrusion” should be changed to “the first lead screw protrusion”.
In regards to claim 18, line 4, “the second spring end” should be changed to “the second spring member end”.
In regards to claim 19, line 3, “the second protrusion” should be changed to “the second lead screw protrusion”.
In regards to claim 19, line 4, “spinner” should be changed to “the spinner”.
Appropriate correction is required.
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 9-10, 12, and 15 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.
In regards to claim 9, line 6 recites: the dose set member comprises “teeth”. Claim 9 depends upon claim 1. Claim 1, lines 7-8 recite: a dose set member… having “a first mating feature”. It is unclear whether “a first mating feature” and “teeth” are the same or different.
In regards to claim 10, line 5 recites: the setback member comprises… “teeth”. Claim 10 depends upon claim 7. Claim 7, line 2 recites: the second mating feature includes “at least one second tooth”. It is unclear whether “at least one second tooth” and “teeth” are the same or different.
In regards to claim 10, line 6 recites “the internal shoulder”. There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 10, line 14 recites: “a push button”. Claim 10 depends upon claim 7, which depends upon claim 1. Claim 1, line 10 recites: “a push button”. It is unclear the two recitations are the same or different.
In regards to claim 10, line 15 recites “the retract nut”. There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 12, line 2 recites “the driver”. There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 15, line 1 recites: “a cartridge holder”. Claim 15 depends upon claim 8. Claim 8, line 1 recites: “a cartridge holder”. It is unclear the two recitations are the same or different.
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 1-3 and 5-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bush et al (US 6,936,032).
In regards to claim 1, Bush et al teaches an injection pen (Figures 1-12), comprising:
a housing (5)
a lead screw (9) axially moveable in the housing, the lead screw having a first led screw end (91) and a second lead screw end (92) opposite the first lead screw end, the first lead screw end having a first lead screw protrusion (92)
a lead screw cap (9A) receiving the first protrusion of the lead screw
a dose set member (7) for dose setting and dose correcting, threadably connected to the housing and having a first mating feature (78)
a setback member (6) having a second mating feature (65) for engaging the first mating feature
a push button (71) operatively connected to the setback member to cause the second mating feature to engage the first mating feature during an injection
a spring member (99) comprising a first spring member end disposed in a proximal direction toward the push button, and a second spring member end opposite the first spring member end disposed in a distal direction
wherein the spring member biases the lead screw in the distal direction (Figures 10-11)
In regards to claim 2, Bush et al teaches wherein the first mating feature is disengaged from the second mating feature during the dose setting and the dose correcting and engaged with the second mating feature during the injection (column 5, lines 4-23).
In regards to claim 3, Bush et al teaches a clicker (64/73) that generates an audible or tactile indication during operation, the clicker being operatively connected to the dose set member.
In regards to claim 5, Bush et al teaches a rotatable driver (8) rotationally locked to the setback member.
In regards to claim 6, Bush et al teaches wherein the dose set member is rotated out of the housing in a first direction to set a dose (Figures 9-10)(column 5, lines 24-26), and the dose set member is freely rotatable in a second direction to correct the set dose (column 5, lines 34-47).
In regards to claim 7, Bush et al teaches wherein the first mating feature includes a set of first teeth (78) and the second mating feature includes at least one second tooth (65).
In regards to claim 8, Bush et al teaches a cartridge holder (2) and a retract nut (4) connected to the housing and receiving the lead screw.
In regards to claim 9, Bush et al teaches a retract nut (4) having flat sides (of 42) configured with respect to the housing, wherein the lead screw is axially moveable in the housing and engaged to the flat sides of the retract nut (column 3, lines 66-67, to column 4, lines 1-3); and the dose set member comprises teeth (78) and an internal shoulder (Figure 8).
In regards to claim 10, Bush et al teaches a clicker (64/73) operatively connected to the dose set member and the setback member; and a rotatable driver (8), wherein the setback member comprises tabs (portions of 62 between adjacent 63), an enlarged head portion (Figure 5) and teeth (64/65), the enlarged head portion being operatively connected to the internal shoulder of the dose set member during the dose setting and the dose correcting, the rotatable driver comprises grooves (portions of 8 between adjacent 86) that are operatively connected to the tabs of the setback member, the rotatable driver being operatively connected to the lead screw, and during the dose setting and the dose correcting, the driver is prevented from rotating, the teeth of the setback member slide over the teeth of the dose set member, arms (73) of the clicker pass over at least one of the teeth of the dose set member and the teeth (64) of the setback member, and the setback member is rotatably locked by engagement of the tabs of the setback member with the grooves of the rotatable driver, and during an injection, a push button (71) is depressed until the dose set member fully rotates back into the housing, the retract nut is rotationally fixed to the housing to prevent the lead screw from rotating, and the teeth (65) of the setback member engage the teeth of the dose set member, which causes the driver to rotate and axially move the lead screw via engagement of the tabs in the setback member and the grooves in the driver to push a stopper (111) and dispense medication.
In regards to claim 11, Bush et al teaches wherein the dose set member is rotated out of the housing in a first direction to set a dose (Figures 9-10)(column 5, lines 24-26), rotated into the housing in a second direction to correct the dose (column 5, lines 34-47), and rotated into the housing in the second direction during the injection (column 5, lines 29-33); and the setback member moves axially with the dose set member without rotation with respect to the housing during the dose setting and the dose correcting (column 5, lines 9-14), and rotates with the dose set member during the injection (column 5, lines 16-20).
In regards to claim 12, Bush et al teaches wherein the setback member is axially moveable with respect to the driver (column 5, lines 14-16).
In regards to claim 13, Bush et al teaches wherein the setback member mates with the dose set member to rotationally lock the setback member and the dose set member during the injection (column 5, lines 16-23).
In regards to claim 14, Bush et al teaches wherein a force applied to the push button during the injection causes the setback member to engage the dose set member (column 5, lines 29-33)(column 5, lines 16-20).
In regards to claim 15, Bush et al teaches a cartridge holder (2).
In regards to claim 16, Bush et al teaches wherein the lead screw rotates with respect to the retract nut when the cartridge holder is disconnected from the housing (column 4, lines 7-10) and the lead screw is rotationally fixed to the retract nut when the cartridge holder is connected to the housing (column 4, lines 3-6).
In regards to claim 17, Bush et al teaches wherein the spring member maintain the push button in a biased position on the dose set member, allowing the push button to be pushed into the dose set member in the distal direction to cause the second mating feature to engage the first mating feature during the injection (column 5, lines 29-33)(column 5, lines 16-20).
In regards to claim 18, Bush et al teaches wherein the lead screw cap comprises a flange having an opening therein for receiving the first protrusion of the lead screw, and an upper surface of the flange receives the second spring end of the spring member (Figure 12).
In regards to claim 19, Bush et al teaches wherein the second lead screw end has a second lead screw protrusion (91), the injection pen further comprising a spinner (3) receiving the second protrusion of the lead screw, and the spring member biases the lead screw and spinner in the distal direction (Figures 10-11).
Allowable Subject Matter
Claim 4 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.
In regards to dependent claim 4, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of an injection pen, as claimed, specifically including wherein the push button receives the clicker.
Bush et al teaches an injection pen (Figures 1-12) comprising a push button (71) and a clicker (64/73).
However, Bush et al does not teach wherein the push button receives the clicker, as Bush et al instead teaches the push button (71) being separated from the clicker (64/73), thus the push button not receiving the clicker (Figures 9-11).
Moller et al (US 2009/0012479) teaches an injection pen (Figures 1-3), wherein a push button (3) receives a clicker (5) (Figure 1). However, Moller et al does not provide a motivation for modifying the push button, of the injection pen of Bush et al, to receive the clicker.
Thus, dependent claim 4 is objected to as being dependent upon a rejected base claim 1, but would be allowable if rewritten in independent form including all of the limitations of the base claim 1 and intervening claim 3.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm EST.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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