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 disclosure is objected to because of the following informalities: Paragraph [0001] refers to parent application no. 17/158,868; since this application was issued as US Patent No. 11,786,659 on 10/17/2023, paragraph [0001] should be updated to indicate this. Appropriate correction is required.
Claim Objections
Claim 20 is objected to because of the following informalities: A comma and the term “wherein” should be inserted after the number “19” on line 1. 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 1-13, 19 and 20 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 1 recites “a movable sleeve comprising: an outer surface, a flower located on the outer surface, and a delivery member cover”. However, the specification and drawings set forth that the delivery member cover 6 is not a component of the movable sleeve 5. Since the language of the claim contradicts the rest of the disclosure, it is unclear how to interpret the claim in light of the specification. For the sake of examination, the claim is interpreted as reciting the delivery member cover as a member different from the movable sleep (since this was is supported by the specification and the drawings, see Fig 3 for example). Accordingly, it is suggested to amend claim 1 to recite “a movable sleeve comprising: an outer surface, and a follower located on the outer surface[[,]]; and a delivery member cover”. Claims 2-13 are rejected due to their dependence on claim 1.
Claim 2 recites “the delivery member cover comprises two legs” and Claim 4 recites “the delivery member cover comprises four arms”. Since claim 1 already introduces one “leg” and one “arm”, it is unclear if the “two legs” are intended to include the “leg” of claim 1 or be in addition to the “leg” of claim 1 and if the “four arms” are intended to include the “arm” of claim 1 or be in addition to the “arm” of claim 1; additionally, because of this, it is unclear if the “two legs” are required to have all the same features as the “leg” of claim 1 or if the “four arms” are required to have all the same features as the “arm” of claim 1. For the sake of examination, the “two legs” are interpreted as including and having all the same features as the “leg” of claim 1 and the ”four arms” are interpreted as including and having all the same features as the “arm” of claim 1. Accordingly, it is suggested to amend claim 1 to recite “[[a]] at least one distally extending leg” (on line 8) and “[[an]] at least one arm” (on line 10), amend claim 2 to recite “the at least one leg comprises two leg”, and amend claim 4 to recite “the at least one arm comprises four arms”. If the amendment to claim 1 were to be made, lines 9 and 10 of claim 1 should be amended to recite “the at least one leg”, claim 12 should be amended to recite “the at least one leg”, and claim 13 should be amended to recite “the at least one arm” to match the amended language. Claim 3 is rejected due to its dependence on claim 2.
Claim 19 recites “the delivery member cover comprises two distally extending legs and each leg comprises two arms”. Since claim 14 already introduces one “leg” and one “arm”, it is unclear if the “two distally extending legs” are intended to include the “leg” of claim 14 or be in addition to the “leg” of claim 14 and if the “two arms” on each leg are intended to include the “arm” of claim 14 or be in addition to the “arm” of claim 14; additionally, it is unclear if the “two distally extending legs” are required to have all the same features as the “leg” of claim 14 and if the “two arms” on each leg are required to have all the same features as the “arm” of claim 14. For the sake of examination, the “two distally extending legs” are interpreted as including and having all the same features as the “leg” of claim 14 and the “two arms” of each leg are interpreted as including and having all the same features as the “arm” of claim 14. Accordingly, it is suggested to amend claim 14 to recite “a distal portion comprising [[a]] at least one distally extending leg” (on line 9) and “[[an]] at least one arm” (on line 11) and amend claim 19 to recite “the at least one distally extending leg comprises two distally extending legs and the at least one arm comprises four arms, wherein each leg comprises two of the arms [[that]] and each of the arms proximally and circumferentially extend from an edge of each respective leg”. If the amendment to claim 14 were to be made, lines 10, 11 and 18 should also be amended to recite “the at least one leg” to match the amended language. Claim 20 is rejected due to its dependence on claim 19.
Claim Rejections - 35 USC § 103
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.
Claims 1, 2, and 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (PG PUB 2011/0082428) in view of Walker et al. (US Pat 4,932,940).
Re claim 1, Huang discloses administration mechanism 1+2 (Fig 1) for a medicament delivery device (it is noted that the italicized text constitutes a functional limitation and, therefore, “a medicament delivery device” is not a part of the claimed invention; this limitation is met in view of Fig 1 and Para 24 that discloses that 1+2 is mounted to a syringe 3), where the administration mechanism comprises: a movable sleeve 2 (Fig 1) comprising: an outer surface (upon which follower 21 is directly formed, as seen in Fig 1), and a follower 21 located on the outer surface (as seen in Fig 1); and a delivery member cover 1 (Fig 1) comprising: a longitudinal axis (extending vertically in Fig 1); a distal1 portion (the distal half of cover 1) comprising a distally extending leg (labeled in Fig A below and seen in Fig 1 to be located in the distal half of cover 1); a guide surface (labeled as “end face” in Fig A below) located at a distal end of the leg (as seen in Fig 4A and Fig A below); and an arm 172 that proximally and circumferentially extends from an edge (labeled in Fig A below) of the leg at an obtuse angle relative the longitudinal axis (as seen in Fig 4A), where the delivery member cover is configured to be axially displaceable relative to the movable sleeve between a first position (seen in Fig 4A), a second position (seen in Fig 4B) and a third position (seen in Fig 5); wherein the guide surface comprises an end face (labeled in Fig A below) that is slidably engaged with the follower when the delivery member cover moves from the first position to the second position (as seen in the movement from Fig 4A to 4B, Para 21). Huang does not disclose a first resilient member that biases the delivery member cover in a proximal direction. Walker, however, teaches a substantially similar administration mechanism (as seen in Fig 1) comprising a movable sleeve 8 (Fig 1) with a follower 22 (Fig 1,2) thereon (comparable to sleeve 2 and follower 21 of Huang) and a delivery member cover 4 (Fig 1) with a pathway 24 (Fig 1) formed therein (comparable to cover 1 and pathway 11+12+15+16 of Huang), wherein a resilient member 16 (Fig 1) is provided that biases the delivery member cover in a proximal direction (Col 6, Lines 45-48) for the purpose of extending the delivery member cover into a locked and safe position at the end of use (Col 6, Lines 45-48). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Huang to include a resilient member, as taught by Walker, for the purpose of automatically extending the delivery member cover into its locked and safe position (i.e. the third position of Huang) at the end of use (Col 6, Lines 45-48).
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Re claim 2, Huang discloses that the delivery member cover comprises two legs (as seen in Fig 4A and labeled in Fig A above).
Re claim 7, Huang discloses that the guide surface is oblique with respect to the longitudinal axis of the delivery member cover (as seen in Fig 4A and Fig A above).
Re claim 8, Huang discloses that the oblique surface defines an angle that is less than 90 degrees as measured relative to the longitudinal axis (as seen in Fig 4A and Fig A above).
Re claim 9, Huang discloses that the follower comprises a radial projection (as seen in Fig 1, the follower itself is a radial projection).
Re claim 10, Huang discloses that the follower is a circumferentially extending rib projecting outward from the outer surface of the movable sleeve (as seen in Fig 1, the follower itself is an outward-projecting rib and, because it extends a distance around the circumference of the outer surface of the sleeve 2, it is “circumferentially extending” as claimed).
Re claim 11, Huang as modified by Walker in the rejection of claim 1 above discloses all the claimed features with Walker teaching that the moveable sleeve rotates relative to the first resilient member when the delivery member cover moves from the first position to the second position (because the resilient member is directly engaged in notch 46 of the delivery member cover 6 – as seen in Fig 7 and Col 6, Lines 43-52 – and the delivery member cover rotates with respect to the movable sleeve 8 as the follower 22 travels along the pathway 24, at least a portion of the resilient member must rotate relative to the moveable sleeve; A rotating relative to B means that B also rotates relative to A depending on the frame of reference and, therefore, the moveable sleeve 8 rotates relative to the resilient member 16 as claimed). The motivation cited in the rejection of claim 1 above also applies to this claim.
Re claim 12, Huang discloses that an inside surface of the leg covers a proximal part of the outer surface of the movable sleeve (when in the third position, as seen in Fig 5).
Re claim 13, Huang discloses that the arm is located at a distance that is proximal to the guide surface (as seen in Fig 4A and Fig A above).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (PG PUB 2011/0082428)/Walker et al. (US Pat 4,932,940) in view of Yang et al. (PG PUB 2004/0116863).
Re claim 3, Huang as modified by Walker in the rejection of claim 1 above discloses all the claimed features except that each of the two legs has two arms. However, Yang teaches providing an administration mechanism 1+3 (Fig 11) with two followers 12 (Fig 11; comparable to follower 21 of Huang) and two corresponding pathways 323 (Fig 11; comparable to pathway 11+12+15+16) wherein one follower+pathway combination is on one side of the administration mechanism and the other follower+pathway is on the opposite side of the administration mechanism (as seen in Fig 11) for the purpose of providing a stronger locking of the delivery member cover and the movable sleeve (Para 57). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Huang/Walker to include a second follower and a second pathway on the opposite side of the administration mechanism from the first follower and the first pathway, as taught by Yang, for the purpose of providing a stronger locking of the delivery member cover and the movable sleeve (Para 57). Duplicating the pathway 11+12+15+16 on the opposite side of the administration mechanism (as indicated in annotated Fig B below) would result in the delivery member cover having two distally-extending extensions with one of the extensions extending from the right of portion 11+12 of first pathway 11+12+15+16 to the left of portion 11+12 of the second pathway 11+12+15+16 and the second of the extensions extending from the left of right of portion 11+12 of the second pathway 11+12+15+16 to the left of portion 11+12 of the first pathway 11+12+15+16; each of these extensions would be a “leg” and each of these extensions would include one arm 171 and a second arm 172, resulting in the modified delivery member cover having two legs each with two arms, as claimed.
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Re claim 4, Huang discloses a second arm 172 (Fig 4A) but Huang as modified by Walker in the rejection of claim 1 above does not disclose third and fourth arms. Huang only has a single follower 21 and a single pathway 11+12+15+16, but Yang teaches providing an administration mechanism 1+3 (Fig 11) with two followers 12 (Fig 11; comparable to follower 21 of Huang) and two corresponding pathways 323 (Fig 11; comparable to pathway 11+12+15+16) wherein one follower+pathway combination is on one side of the administration mechanism and the other follower+pathway is on the opposite side of the administration mechanism (as seen in Fig 11) for the purpose of providing a stronger locking of the delivery member cover and the movable sleeve (Para 57). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Huang/Walker to include a second follower and a second pathway on the opposite side of the administration mechanism from the first follower and the first pathway, as taught by Yang, for the purpose of providing a stronger locking of the delivery member cover and the movable sleeve (Para 57). Duplicating the pathway 11+12+15+16 would result in two of arms 171 and two of arms 172.
Allowable Subject Matter
Claim 5 and 6 are objected to as being dependent on a rejected claim, but would be allowable if claim 1 were rewritten or amended in the manner suggested above to overcome the rejection under 35 U.S.C. 112(b) and claim 5 (upon which claim 6 depends) was rewritten to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of each of dependent claim 5 (upon which claim 6 depends) could not be found nor was suggested in the prior art of record in combination with the subject matter of claim 1. Dependent claim 5 (upon which claim 6 depends) requires the movable sleeve to comprise a lock extending radially from the outer surface and configured to flex radially inward. Huang discloses that the follower 21 operates as a lock, but does not disclose any other structure that could be interpreted as a lock that extends radially from the outer surface; even if Huang were modified in the manner set forth in the rejections of claims 3 and 4 above to duplicate the follower 21 and pathway 11+12+15+16 on the opposite side of the mechanism such that one of element 21 could read on the “follower” and the other of element 21 could read on the “lock”, element 21 is not configured to flex radially inward as claimed and it would not have been obvious to one of ordinary skill in the art at the time the invention was made to modify element 21 to do so as element 21 must be rigid enough to cause the arms 171,172 to flex as element 21 moves by (as set forth in Para 22).
Claims 14-18 are allowable and claims 19 and 20 would be allowable if claim 19 were rewritten or amended to overcome the rejections under 35 U.S.C. 112(b) set forth above and claim 20 were rewritten or amended to overcome the objection set forth above.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of independent claim 14 (upon which claims 15-20 depend) could not be found nor was suggested in the prior art of record. Independent claim 14 requires an administration mechanism for a medicament delivery device comprising (a) a movable sleeve comprising (a1) an outer surface, (a2) a follower located on the outer surface and (a3) a lock positioned on a flexible tongue and extending radially from the outer surface, (b) a delivery member cover configured to be axially displaceable relative to the moveable sleeve between first, second and third positions and comprising (b1) a distal portion that comprises a distally extending leg that has an inside surface that engages pushes the long and tongue radially inward as the delivery member cover moves relative to the movable sleeve, (b2) a guide surface that is oblique with respect to a longitudinal axis of the delivery member cover, located at a distal end of the leg, and comprises an end face that is slidably engaged with the follower when the delivery member cover moves from the first position to the second position and (b3) an arm that proximally and circumferentially extends from an edge of the leg at an obtuse angle relative to the longitudinal axis, and (c) a resilient member that biases the delivery member cover in a proximal direction.
The combination of Huang and Walker set forth in the rejections of claim 1 and 7 above is the closest prior art of record for claim 14, disclosing all features except a lock positioned on a flexible tongue and extending radially from the outer surface [of the movable sleeve] that is engaged by and pushed radially inward by an inside surface of the leg [of the delivery member] as the delivery member cover moves relative to the moveable sleeve. Huang discloses that the follower 21 operates as a lock, but does not disclose any other structure that could be interpreted as a lock that extends radially from the outer surface; even if Huang were modified in the manner set forth in the rejections of claims 3 and 4 above to duplicate the follower 21 and pathway 11+12+15+16 on the opposite side of the mechanism such that one of element 21 could read on the “follower” and the other of element 21 could read on the “lock”, element 21 is not positioned on a flexible tongue and configured to be pushed radially inward by an inside surface of the leg as claimed and it would not have been obvious to one of ordinary skill in the art at the time the invention was made to modify element 21 to do so as element 21 must be rigid enough to cause the arms 171,172 to flex as element 21 moves by (as set forth in Para 22). Additionally, an administration mechanism including all of the features recited in claim 14 could not be found nor was suggested elsewhere in the prior art of record.
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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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 It is noted that, in this application, the term “distal” refers to the direction pointing away from an intended injection site and the term “proximal” refers to the direction pointing toward the intended injection site.