DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
As set forth in the last Office Action, the effective filing date for claims 17-29 is the filing date of the present application (which is 1/4/2023).
Specification
The amendments to the Specification filed 5/27/2026 is acceptable and overcomes the objection set forth in the last Office Action.
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 23 is 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 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”.
This rejection was set forth in the last Office Action but no amendments were made to the claim nor were any arguments directed to this rejection presented.
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, and 26 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 1-5 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), 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)), and wherein a portion of the actuation locking member (the radially inward-facing surface of the actuation locking member 4 between step 19 and notch 18) moves over and directly contacts the protrusion of the lever during actuation of the medicament delivery device (as seen in Fig 3).
Re claim 18, Carrel discloses that the actuation locking 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).
Claims 17, 19, and 21-29 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Lavi et al. (PG PUB 2003/0105430).
Re claim 17, Lavi discloses a medicament delivery device (seen in Fig 59-73b; all reference characters cited below refer to Fig 59,60 unless noted), comprising: a guard 506 movable between a proximal position (seen in Fig 59) and a distal position (seen in Fig 65-70); an actuation locking member 204; a medicament container holder 502 arranged within the guard (as seen in Fig 59, lever 514 extends radially inward so that it is “within the guard”); and a locking mechanism 514 comprising a lever (“latches 514” are moved radially outward”, Para 215), wherein a distal end of the lever includes a protrusion (seen in Fig 59 and labeled in Fig A below) that directly contacts the actuation locking member to thereby restrict movement of the actuation locking member in a proximal direction prior to actuation of the medicament delivery device (as seen in Fig 59; Para 215,217), wherein the lever is pivotally mounted directly to the medicament container holder (as seen in Fig 59,73B) such that the lever pivots around a pivot axis (at the proximal-most end of the lever, labeled in Fig A below) of the lever in two directions (Para 215,217 disclose that the lever pivots outwards and Para 223 discloses that the lever pivots inward), and wherein a portion of the actuation locking member (the lower portion of 204) moves over (as seen in the movement from Fig 63 to 65) and directly contacts (as seen in Fig 65) the protrusion of the lever during actuation of the medicament delivery device (Para 219).
PNG
media_image1.png
245
647
media_image1.png
Greyscale
Re claim 19, Lavi discloses that the lever is formed integral with the medicament container holder (as seen in Fig 73B).
Re claim 21, Lavi discloses that the lever is connected to a middle portion of the medicament container holder (as seen in Fig 73B, all components of the medicament container holder are “connected to” each other either directly or indirectly).
Re claim 22, Lavi discloses that the lever is put in a tensioned state by the guard when the guard is moved in a distal direction (as seen in Fig 65; Para 218).
Re claim 23, Lavi discloses that the tensioned state of the lever enables the guard to transition from the proximal position to the distal position (Para 218).
Re claim 24, Lavi discloses that the guard and the actuation locking member are configured to contact less than the entire lever (as seen in Fig 59,65, for example, the radially-outer surface of the lever is not contacted by the guard or the actuation locking member).
Re claim 25, Lavi discloses that the actuation locking member comprises at least one proximally extending tongue ** (flange ** is considered “proximally extending” because it has a width in the longitudinal direction), 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 (the contact is indirect through the body of the actuation locking member 204).
Re claim 26, Lavi discloses that the lever comprises a longitudinally extending beam (as seen in Fig 73B).
Re claim 27, Lavi discloses that the guard comprises at least two distally directed tongues (tongue 512 and the tongue labeled in annotated Fig B below), wherein each of the at least two distally directed tongues includes a proximal end (to the right in Fig 73B) directly attached to the guard and a distal free end (to the left in Fig 73B) extending away from the guard in a distal direction (as seen in Fig 73B).
PNG
media_image2.png
187
469
media_image2.png
Greyscale
Re claim 28, Lavi discloses that the at least two distally directed tongues are integral with a distal end of the guard (as seen in Fig 73B, the guard is one integrally-formed piece).
Re claim 29, Lavi discloses that the lever is at least partly overlapped by the actuation locking member when the medicament delivery device is actuated, and wherein a proximal end of the lever directly contacts the guard to thereby restrict movement of the guard in the distal direction after actuation of the medicament delivery device.
Response to Arguments
Applicant's arguments filed 5/27/2026 have been fully considered.
The arguments directed to the rejection of claim 17 by Carrel are not persuasive. Applicant asserts that Carrel fails to teach the “locking mechanism” as claimed and specifically argues that the sleeve 4 (reading upon the “actuation locking member”) does not translate in the proximal direction and the tooth 15 (reading upon the “protrusion” of the “lever”) blocks movement of the ring 8 (reading upon the “medicament container holder”) not the sleeve 4 – meaning that the claimed limitation of protrusion of the lever “restrict[ing] movement of the actuation locking member in a proximal direction prior to actuation of the medicament delivery device” and the new claimed limitation of “a portion of the actuation locking member moves over and directly contacts the protrusion of the lever during actuation of the medicament delivery device” are not disclosed by Carrel.
The Examiner respectfully disagrees because Para 78 of Carrel (quoted by Applicant in their argument) states that the tooth 15 “block[s] translational movement of the said intermediate ring 8 with respect to said sleeve 4”. Proximal movement of the ring 8 relative to the sleeve 4 is distal movement of the sleeve 4 relative to the ring 8. Additionally, the change in position of Fig 2 to Fig 3 shows the sleeve 4 “mov[ing] over and directly contact[ing]” the tooth 15 of the lever “during actuation of the medicament delivery device”.
The arguments directed to the rejection of claim 29 by Carrel are moot in the present Office Action which no longer rejects this claim with Carrel. Claim 29 is no longer rejected by Carrel due to the amendment made to claim 29 in the 5/27/2026 Reply overcoming Carrel.
The arguments directed to the rejection of claims 17 and 29 by Grunhut are moot in view of the present Office Action which no longer rejects this claim with Grunhut. Claims 17 and 29 are no longer rejected by Grunhut due to the amendment made to claim 17 in the 5/27/2026 Reply overcoming Grunhut.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
Prosecution Insights