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.
Claim(s) 4, 10 is/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 4 recites the limitation " the metallic arm body" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the sake of compact prosecution, Examiner is interpreting the limitation as “the metallic alarm body”.
Claim 10 recites the limitation "the needles" in lines 2 and 3. There is insufficient antecedent basis for this limitation in the claim. For the sake of compact prosecution, Examiner is interpreting the limitation as “the needle”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-8, 10-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fourt et al. (US 2016/0001004).
Regarding claim 1, Fourt et al. discloses
A drug delivery device comprising: a housing (32/34/35); a needle (27) having a retracted position (Figs. 1-2) and an extended position (Figs. 3 and 16); a needle actuator body (70) received within (Fig. 5) the housing (32/34/35) and configured to move from a pre-use position (Figs. 1-2) where the needle (27) is in the retracted position (Figs. 1-2), to a use position (Figs. 3 and 16, Paragraphs 0066-0067) where the needle (27) is in the extended position (Figs. 3 and 16), and to a post-use position (Figs. 4 and 17, Paragraph 0042) where the needle (27) is in the retracted position (Figs. 1-2); a container (25) received within the housing (32/34/35), the container (25) configured to hold a dose of medicament (Figs. 3 and 15-17); a drive assembly (205/230) configured to move a dose of medicament (Figs. 5 and 15-16, Paragraph 0058) from the container (25) to the needle (27); and an alarm indicator (42) received within (Fig. 5) the housing (32/34/35), the needle actuator body (70) actuating the alarm indicator (42) when the needle actuator body (70) is in the post-use position (Figs. 4 and 17, Paragraph 0042).
Regarding claim 2, Fourt et al. discloses
The drug delivery device of claim 1, wherein the alarm indicator (42) comprises an audible indicator (Paragraph 0042).
Regarding claim 3, Fourt et al. discloses
The drug delivery device of claim 2, wherein the alarm indicator (42) comprises an actuator member (42, Fig. 5, Paragraph 0042), the needle actuator body (70) engaging the actuator member (42, Fig. 5, Paragraph 0042) when the needle actuator body (70) moves from the use position (Figs. 3 and 16, Paragraph 0066-0067) to the post-use position (Figs. 4 and 17, Paragraph 0042).
Regarding claim 5, Fourt et al. discloses
The drug delivery device of claim 3, wherein the needle actuator body (70) comprises a cross rib (78), the cross rib (78) engaging the actuator member (42) when the needle actuator body (70) moves from the use position (Figs. 3 and 16, Paragraph 0066-0067) to the post-use position (Figs. 4 and 17, Paragraph 0042).
Regarding claim 6, Fourt et al. discloses
The drug delivery device of claim 1, wherein the container (25) comprises a body (352), a closure (364), and a stopper (356) moveable within (Fig. 5) the body (352), and wherein the drive assembly (205/230) is configured to engage (Figs. 5 and 15-16, Paragraph 0053) the stopper (356).
Regarding claim 7, Fourt et al. discloses
The drug delivery device of claim 1, further comprising an actuator button (21) moveable relative to (Figs. 3-4 and 15-17, Paragraph 0031) the housing (32/34/35) from a first position (Figs. 3-4 and 15-17, Paragraph 0031) to a second position (Figs. 3-4 and 15-17, Paragraph 0031) to actuate the needle actuator body (70) from the pre-use position (Fig. 1-2) to the use position (Figs. 3 and 16, Paragraph 0066-0067).
Regarding claim 8, Fourt et al. discloses
The drug delivery device of claim 7, wherein the actuator button (21) is configured to actuate (Figs. 3-4 and 15-17, Paragraphs 0031, 0058, and 0062-0063) the drive assembly (205/230).
Regarding claim 10, Fourt et al. discloses
The drug delivery device of claim 1, wherein the needle (27) at least partially extends (Fig. 16) from the housing (32/34/35) when the needles (27) is in the extended position (Fig. 17), and wherein the needle (27) is entirely positioned within the housing (32/34/35) when the needles (27) is in the retracted position (Fig. 17).
Regarding claim 11, Fourt et al. discloses
The drug delivery device of claim 1, wherein the drive assembly (205/230) comprises at least one spring (205).
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fourt et al. (US 2016/0001004) in view of Weber (US 2006/0258990).
Regarding claim 4, Fourt et al. discloses the drug delivery device of claim 3 as seen above.
However, Fourt et al. fails to disclose wherein the alarm indicator comprises a metallic alarm body and a helical spring, the helical spring configured to engage the metallic arm body when the alarm indicator is actuated.
Weber teaches a similar device (Abstract) wherein the alarm indicator (884) comprises a metallic alarm body (884) and a helical spring (382), the helical spring (382) configured to engage the metallic arm body (884) when the alarm indicator (884) is actuated (Fig. 32, Paragraph 0172).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claim invention to have modified Fourt et al. to incorporate the metallic body and spring teachings of Weber. The motivation for the modification would have been to allow simple mechanical reverberation and control volume/tone as desired. (Weber Paragraph 0172).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fourt et al. (US 2016/0001004) in view of Edwards et al. (US 2018/0304017).
Regarding claim 9, Fourt et al. discloses the drug delivery device of claim 1 as seen above.
However, Fourt et al. fails to disclose wherein the alarm indicator is electro- mechanical.
Edwards et al. teaches a similar device (Abstract) wherein the alarm indicator is electro- mechanical (speaker, Paragraph 0190).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claim invention to have modified Fourt et al. to incorporate the electro-mechanical teachings of Edwards et al. The motivation for the modification would have been to allow the use of recorded messages and/or a recorded speech (Edwards et al. Paragraph 0190).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-6pm.
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/DUNG T ULSH/Examiner, Art Unit 3783
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