DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Applicant’s claim for the benefit of a prior-filed application is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications – Swedish application SE1150300-0, US provisional application 61/471,886, PCT/SE2012/050355, and US nonprovisional applications 14/009,942, 15/601,742 and 16/687/181 – fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, newly presented independent claim 17 recites that “a distal end of the lever includes a protrusion that directly contacts the guard to thereby restrict movement of the guard in the proximal position prior to actuation of the medicament delivery device”. This arrangement – wherein direct contact between the protrusion at the distal end of lever and the guard restricts movement of the guard in the proximal position prior to actuation of the device – is not disclosed in any of the prior applications. Therefore, none of the claims receive the benefit of the prior-filed applications. Accordingly, the effective filing date for claims 17-29 is the filing date of the present application (which is 1/4/2023).
Specification
The disclosure is objected to because of the following informalities: The preliminary amendment to the Specification filed 1/4/2023 is objected to because (a) the term “March” is incorrectly spelled as “Ma4rch” and (b) the three US patent applications listed (14/009,942, 15/601,742 and 16/687,181) have been issued as US patents, but their issued patent numbers (9,737,668, 10,653,849 and 11,571,521, respectively) have not been listed. The preliminary amendment should be further amended to correct the spelling of the term “March” and include the issued patent numbers of the listed patent applications.
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 17-29 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 17 recites that “a distal end of the lever includes a protrusion that directly contacts the guard to thereby restrict movement of the guard in the proximal position prior to actuation of the medicament delivery device”1 on lines 5-7. Although the specification and drawings support an arrangement where the distal end of the lever 16 includes a protrusion 22 that directly contacts the guard 10 (as seen in Fig 4 and 5), this arrangement is not disclosed as or suggested as “restrict[ing] movement of the guard in the proximal position prior to actuation of the medicament delivery device” as claimed. Additionally, because the guard 10 moves in the distal direction toward (and over) the protrusion 22, it is unclear how direct contact between these two elements can “restrict movement of the guard in the proximal position prior to actuation of the medicament delivery device” as claimed. Because the specification and drawings appear to disclose an arrangement that contradicts the arrangement claimed, it is unclear how to interpret claim 17 in light of the specification.
It appears that this limitation may have intended to refer to the “actuation locking member” instead of the “guard” since the specification sets forth that direct contact between the protrusion 22 and the actuation locking member 24 restricts movement of the actuation locking member in a proximal direction prior to actuation of the medicament delivery device (Page 19, Lines 1-8). For the sake of examination, claim 17 is interpreted in the manner supported by the specification; that is, claim 17 is interpreted as reciting “a distal end of the lever includes a protrusion that directly contacts the actuation locking member to thereby restrict movement of the actuation locking member in [[the]] a proximal direction prior to actuation of the medicament delivery device”.
Claims 18-29 are rejected due to their dependence on claim 17.
Claim 23 recites that “the tensioned state of the lever [caused by the guard when the guard is moved in a distal direction, as set forth in claim 22] causes the lever to release the guard to thereby enable the guard to transition from the proximal position to the distal position”. It is unclear how the lever can release the guard when the guard itself put the lever in the tensioned state. Additionally, lines 15-17 on page 19 state that the “distal position” of the guard 10 is the position shown in Fig 4 where “the guard 10 will overlap the ledge 22” and “exert a force on the ledge 22 and thus on the distal end 20 of the beam”; thus, the Specification appears to set forth that the guard 10 and lever 16 are still in direct contact (and not “released”) when the guard is in the distal position. Because the language of the claim contradicts the specification and drawings, it is unclear how to interpret claim 23 in light of the specification.
Lines 10-17 on page 19 recites that “tongues 12 [of the guard 10] will slide onto the ledge 22 [of lever 16]” and that “as shown in Fig 4, the guard 10 will overlap the ledge 22 when it reaches a distal position”. For the sake of examination, claim 23 is interpreted in the manner supported by the specification; that is, claim 23 is interpreted as reciting “the tensioned state of the lever s the guard to transition from the proximal position to the distal position”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 17, 18, 20, 21, 24, 26 and 29 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Carrel et al. (PG PUB 2011/0245770).
Re claim 17, Carrel discloses a medicament delivery device 1 (Fig 1-5; it is noted that all reference characters cited below refer to Fig 105 unless otherwise noted), comprising: a guard 9 movable between a proximal position (seen in Fig 5) and a distal position (seen in Fig 2); an actuation locking member 4; a medicament container holder 8 arranged within the guard (as seen in 2-5, a proximal part of the holder 8 is arranged within the guard 9); and a locking mechanism comprising a lever 14, wherein a distal end of the lever includes a protrusion 15 that directly contacts the actuation locking member (as seen in Fig 2) to thereby restrict movement of the actuation locking member in a proximal direction prior to actuation of the medicament delivery device (Para 78), and wherein the lever is pivotally mounted directly to the medicament container holder such that the lever pivots around a pivot axis of the lever in two directions (the left lever 14 can pivot in the clockwise direction (as seen in Fig 3) or the counterclockwise direction (as seen in Fig 2).
Re claim 18, Carrel discloses that the actuation member surrounds the medicament container holder (as seen in Fig 2).
Re claim 20, Carrel discloses that the actuation locking member is a ring-shaped or sleeve-shaped member (as seen in Fig 1, the actuation locking member 4 is sleeve-shaped) surrounding the medicament container holder (as seen in Fig 2).
Re claim 21, Carrel discloses that the lever is connected to a middle portion of the medicament container holder (as seen in Fig 2; additionally, it is noted that all components of the medicament container holder are “connected to” each other either directly or indirectly).
Re claim 24, Carrel discloses that the guard and the actuation locking member are configured to contact less than the entire lever (as seen in Fig 2, the radially inner surface of the lever is not contacted by either the guard nor the actuation locking member).
Re claim 26, Carrel discloses that the lever comprises a longitudinally extending beam (as seen in Fig 2).
Re claim 29, Carrel discloses that the lever is at least partly overlapped by the actuation locking member when the medicament delivery device is actuated (as seen in Fig 3).
Claims 17, 19, and 21-29 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Grunhut et al. (PG PUB 2009/0312705).
Re claim 17, Grunhut discloses a medicament delivery device 1 (Fig 2-14, 16-17; it is noted that all reference characters cited below refer to Fig 4 unless otherwise noted), comprising: a guard 10 movable between a proximal position (seen in Fig 4) and a distal position (seen in Fig 6); an actuation locking member 26; a medicament container holder 17 arranged within the guard (as seen in Fig 5 and described in Para 116, the locking mechanism 18 of the medicament container holder extends radially through a window formed proximally of teeth 14 of the guard); and a locking mechanism comprising a lever 18, wherein a distal end of the lever includes a protrusion (the free distal end, itself) that directly contacts the actuation locking member (as seen in Fig 5) to thereby restrict movement of the actuation locking member in a proximal direction prior to actuation of the medicament delivery device (Para 106), and wherein the lever is pivotally mounted directly to the medicament container holder such that the lever pivots around a pivot axis of the lever in two directions (the lever pivots radially inward (as seen in Fig 5, for example) and pivots radially outward (as seen in Fig 10, for example)).
Re claim 19, Grunhut discloses that the lever is formed integral with the medicament container holder (as seen in Fig 1; Para 96).
Re claim 21, Grunhut discloses that the lever is connected to a middle portion of the medicament container holder (as seen in Fig 1; additionally, it is noted that all components of the medicament container holder are “connected to” each other either directly or indirectly).
Re claim 22, Grunhut discloses that the lever is put in a tensioned state by the guard when the guard is moved in a distal direction (Para 116).
Re claim 23, Grunhut discloses that the tensioned state of the lever enables the guard to transition from the proximal position to the distal position (Para 116).
Re claim 24, Grunhut discloses that the guard and the actuation locking member are configured to contact less than the entire lever (as seen in Fig 5, the radially outer surface of the lever is not contacted by either the guard nor the actuation locking member).
Re claim 25, Grunhut discloses that the actuation locking member comprises at least one proximally extending tongue (the entirety of 26 that extends proximally from rims 33, Fig 1 and Para 95), and wherein the at least one proximally extending tongue is configured to contact the lever as the guard transitions from the proximal position to the distal position (Para 116).
Re claim 26, Grunhut discloses that the lever comprises a longitudinally extending beam (as seen in Fig 5).
Re claim 27, Grunhut discloses that the guard comprises at least two distally directed tongues 13 (Para 93), wherein each of the at least two distally directed tongues includes a proximal end directly attached to the guard and a distal free end extending away from the guard in a distal direction (as seen in Fig 1).
Re claim 28, Grunhut discloses that the at least two distally directed tongues are integral with a distal end of the guard (as seen in Fig 1).
Re claim 29, Grunhut discloses that the lever is at least partly overlapped by the actuation locking member when the medicament delivery device is actuated (as seen in Fig 7).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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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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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 In the present application, the term “proximal” refers to the direction pointing toward the dose delivery site and the term “distal” refers to the direction pointing away from the dose delivery site.
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