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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/06/2026 has been entered.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 05/06/2026 has/have been considered by the Examiner.
Status of the Claims
Claim 8 is cancelled. Claim 1 is currently amended. Claims 1-7 and 9-11 are currently pending. Claims 1-7 and 9-11 are currently rejected.
Response to Arguments
Applicant’s arguments with respect to claim(s) 05/06/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The amendments to claim 1 overcome the previous 112(b) rejection, which is not extended to the claims as amended.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
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 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by a first embodiment of Bengtsson et al (US 20180140776 A1; hereafter Bengtsson1) or, in the alternative, under 35 U.S.C. 103 as obvious over Bengtsson1 in view of a different embodiment of Bengtsson (hereafter Bengtsson240).
Regarding claim 1, Bengtsson discloses a pre-filled injection device (pen device shown in fig. 1) for delivering a liquid drug ([0065] pen device expels a drug from a drug-filled cartridge 89 through the distal end of the distal housing component 2), comprising;
a housing structure (proximal housing component 1 and distal housing component 2; fig. 1; [0065]) extending along a longitudinal axis (X) defining a distal and a proximal direction ([0065] a proximal housing component 1 in which a drug expelling mechanism is arranged or integrated, and a distal housing component 2 forming a cartridge holder portion) and permanently embedding ([0067] The device is designed to irreplaceably accommodate a cartridge 89) a cartridge (cartridge 89, fig. 1) having a movable plunger (piston described in [0068] piston rod 7 transfers a force in the distal direction forcing the piston of the cartridge 89 to move distally for expelling a quantity equal to size of the set dose),
a piston rod structure (piston rod 7 and piston washer 9, fig. 1, [0072] piston rod 7 is in close proximity with the piston washer 9 which is located adjacent the piston of cartridge 89), comprising a piston rod (piston rod 7, fig. 1, [0072]) and a piston rod foot (piston washer 9, fig. 1, [0072]), for advancing the movable plunger (piston of cartridge 89 noted in [0068]) during dispensing ([0068] piston rod 7 transfers a force in the distal direction forcing the piston of the cartridge 89 to move distally for expelling a quantity equal to size of the set dose), the piston rod structure (7/9) having an outer thread (outer thread noted in [0068], fig. 1, [0068] piston rod 7 includes an outer thread adapted to engage the inner thread of the nut element 40) and a longitudinal track structure (longitudinal recessed track 6, fig. 1, [0068] piston rod 7 further includes a longitudinal recessed track 6),
a rotatable drive element (driver tube 85, fig. 1, [0068]) engaging the longitudinal track structure (6) ([0068] The piston rod 7 further includes a longitudinal recessed track 6, a pair of flattened surfaces or similar longitudinal extending geometry for cooperating with a mating geometry of a driver tube 85) of the piston rod structure (7/9) such that rotation of the drive element (85) is transferred to a rotation of the piston rod ([0068] mating geometry enables relative axial movement between the piston rod 7 and the driver tube 85 but prevents relative rotation; Examiner notes that since the drive element 85 and piston rod 7 cannot rotate relative to one another, rotation of the drive element 85 must also rotate the piston rod 7),
a nut element (nut element 40, fig. 1, [0068]) having an inner thread (inner thread noted in [0068]) engaging the outer thread (outer thread noted in [0068]) of the piston rod structure (7/9) ([0068] piston rod 7 includes an outer thread adapted to engage the inner thread of the nut element 40), wherein the nut element (40) operates in two different states;
a first state ([0072] piston rod 7 is provided in an already threadedly engaged state relative to nut element 40 as part of formation of distal subassembly) wherein the nut (40) element is arranged axially slidable in relation to the housing structure ([0072] “In distal subassembly, the nut element 40 is secured relative to the distal housing component 2 at a particular predefined axial position by means of an axial snap fit.”; Examiner notes that prior to the nut reaching the particular predefined axial position, the nut element is slidable relative to the distal housing component), and
a second state wherein the piston rod structure (7/9) abuts the movable plunger (piston of cartridge 89 noted in [0072]) ([0072] the piston washer being located adjacent the piston of cartridge 89; [0067] piston washer 9 may be located between the piston rod and the piston for transferring axial forces exerted by the piston rod to the piston; Examiner notes that since the piston rod structure 7/9 transfers forces through the piston rod 7 through the piston rod foot 9 to the movable plunger/piston of cartridge 89, then the piston rod structure 7/9 must abut the movable plunger in order to transfer force) and the nut element is permanently secured to the housing structure (1/2) ([0072] the nut element 40 is secured relative to the distal housing component 2 at a particular predefined axial position by means of an axial snap fit),
wherein, the nut element in the first state engages the housing structure via a resilient interface (axial snap fit described in [0072]) capable of urging the nut element axially in relation to the housing structure (nut element 40 transitions from first slidable state to second fixed state by engagement of the axial snap fit described in [0072]; Examiner notes that since the snap fit occurs at a “particular predefined axial position” relative to the housing, then the resilient interface is necessarily capable of urging the nut element axially relative to the housing before, during, and after the snap fit axial position is reached), such that the piston rod structure abuts the movable plunger ([0072] describes formation of axial snap fit occurring simultaneous with the piston washer being located adjacent the piston of cartridge 89; note also [0067] describes piston washer 9 transferring axial forces in the fully assembled state), and
the nut element (40) in the second state is permanently secured to the housing structure ([0072] the nut element 40 is secured relative to the distal housing component 2 at a particular predefined axial position by means of an axial snap fit), such that the piston rod structure (7/9) is moved helically relatively to the nut element (40) and the housing structure (1/2) when rotated ([0068] The driver tube 85 acts to rotate the piston rod 7 through the nut element 40, and the piston rod 7 moves distally).
Alternatively, Bengtsson1 is silent to the nut being slidable in the first state, the piston rod structure abutting the movable plunger and the nut element being permanently secured to the housing structure in the second state, and the resilient interface.
Bengtsson240, directed to a similar but an improved drug delivery device and assembly method (Bengtsson [0087]), teaches
a first state (described in [0088]) wherein the nut (improved nut element 240 includes a plurality of teeth 240c adapted to cooperate with the inner protrusions 202c so that a rotational detent mechanism is formed, fig. 8, [0087]) element is arranged axially slidable in relation to the housing structure ([0088] describes nut element 240 moving axially relative to distal housing component 202; [0091] describes nut element 240 moving axially relative to proximal housing component 201), and
a second state wherein the piston rod structure (piston rod 207 and piston washer 209, fig. 10, [0088] piston washer 209 has been positioned adjacent the piston 299 of a held cartridge 289) abuts the movable plunger ([0088] piston 299 of a held cartridge 289; see fig. 10) ([0089] The rotation between nut element 240 and distal housing component 202 is performed until a predetermined axial clearance or abutment between the piston rod 207 and the piston washer 209 is obtained.) and the nut element is permanently secured to the housing structure ([0091] describes nut element 240 being prevented from rotation relative to housing and [0087] describes axial locking of nut element 240 to distal housing component 202; [0093] describes nut element 240 being locked relative to the distal housing component 202 by additional means such as adhesive, ultrasonic welding, or laser radiation),
wherein, the nut element (240) in the first state engages the housing structure via a resilient interface (axial snap fit between outwards protruding ledge 240d of nut element 240 and circumferential groove 202d of distal housing component 202, fig. 10, [0087]; Examiner further notes resilient interface formed between annular sections 202b of distal housing component 202 and teethed surface 240d of nut 240 described in [0087] and [0091]) capable of urging the nut element axially in relation to the housing structure ([0087] When the nut element 240 is properly axially positioned relative to the distal housing component 202 the ledge 240d snaps into groove 202d), such that the piston rod structure abuts the movable plunger (see fig. 10, [0089] rotation between nut element 240 and distal housing component 202 is performed until a predetermined axial clearance or abutment between the piston rod 207 and the piston washer 209 is obtained).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Bengtsson1 to have the elements taught by Bengtsson240 since both embodiments are directed to similar devices and Bengtsson240 is described as an “improved drug delivery device” ([0087]) to Bengtsson1’s “a prior art pen-formed drug delivery device” ([0064]). One would have been motivated to make the modification because Bengtsson [0076] notes that a potential air gap can be eliminated between the piston rod and piston of the cartridge, Bengtsson [0089] similarly describes how Bengtsson240 can achieve a predetermined axial clearance or abutment, as desired, and this modification would allow for more immediate delivery of drug upon activation of the device, since the device is already appropriately primed for delivery.
Regarding claim 2, Bengtsson1, or Bengtsson1 modified by Bengtsson240 discloses the injection device according to claim 1, including wherein the nut element (40) is permanently secured to the housing structure (1/2) ([0072] the nut element 40 is secured relative to the distal housing component 2 at a particular predefined axial position by means of an axial snap fit).
Bengtsson1 modified by Bengtsson240 further already discloses wherein the attachment method is welding ([0093] describes nut element 240 being locked relative to the distal housing component 202 by additional means such as adhesive, ultrasonic welding, or laser radiation).
Bengtsson1 is silent to the attachment method being welding.
Bengtsson240 further teaches wherein the nut element (240) is permanently secured ([0093] describes nut element 240 being locked relative to the distal housing component 202 by additional means such as adhesive, ultrasonic welding, or laser radiation) to the housing structure (201/202) by welding ([0093] describes welding as an attachment method).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to utilize the welding methods of Bengtsson240 to attach the nut element and housing of Bengtsson1 since Bengtsson240 has a similar structure. One would have been motivated to make the modification because the welding methods taught by Bengtsson240 would ensure that the nut element could not be knocked or accidentally moved out of the correct axial position after assembly is completed.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as obvious over Bengtsson1 in view of Bengtsson240.
Regarding claim 3, Bengtsson1 or Bengtsson1 modified by Bengtsson240 discloses the injection device according to claim 1, as described above.
Either alternative rejection is silent to wherein the resilient interface comprises a number of flexible arms.
Bengtsson240 further teaches a resilient interface comprising a number of flexible arms (annular section 202b is resilient in the radial direction, fig. 8, [0087] and [0091]) ([0087] “The distal housing component 202 includes a peripheral wall where axially running slits divide the proximal part of the distal housing component into four annular sections 202b. Each annular section 202b is resilient in the radial direction. A plurality of inner protrusions 202c is provided at regular intervals around the circumference, the protrusions extending radially inwards from the annular sections 202b.”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to include the flexible arms of Bengtsson240 with Bengtsson1 or the previously applied combination of the two embodiments, since the embodiments both deal with fixing a nut relative to a housing. One would have been motivated to make the modification because the clamping action of the flexible arms on the nut member helps to ensure that after appropriate nut placement relative to both housing components, the nut position cannot be tampered with.
Regarding claim 4, Bengtsson1 modified by Bengtsson2 discloses the injection device according to claim 3, as described above, including wherein the flexible arms (annular section 202b, fig. 8, [0087]) have a radial resiliency ([0087] states that each annular section 202b is resilient in the radial direction and [0091] describes radial compression of the annular sections 202b) and are operational between the nut element (240, fig. 8) and the housing structure (202) ([0091] compress the annular sections 202b of distal housing component 202 radially inwards into fixed engagement with the teethed surface 240d thereby immobilizing the rotational detent mechanism).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bengtsson1 as modified and applied to claim 3, and further in view of Cronenberg et al (US 20120283647 A1; hereafter Cronenberg).
Regarding claim 5, Bengtsson1 as modified and applied to claim 3 above discloses the injection device according to claim 3, as described above, including wherein arms (Bengtsson240: [0087] a plurality of teeth 240c adapted to cooperate with the inner protrusions 202c of distal housing component 202) are provided on the nut element (240, fig. 8) and abut the housing structure (201/202) (see figs. 8-10, abutment described in [0087] and [0091]).
Bengtsson as modified is silent to the arms being flexible.
Cronenberg, in the art of injection pens, teaches wherein flexible arms (flexible ratchet arms 94, fig. 9a, [0054]) are provided on the nut element (leadscrew brake 32, fig. 9a, [0054]) and abut the housing structure (body 18, fig. 9b, [0054] “the leadscrew brake 32 comprises a pair of flexible ratchet arms 94 configured to engage the cylindrical ring of ratchet teeth 55 provided on the interior of the body 18 to define a unidirectional coupling therebetween”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the nut element of Bengtsson to have flexible arms as taught by Cronenberg, since both references deal with nut elements engaged between a housing/body and piston/leadscrew (see Cronenberg [0054] and fig. 9b). One would have been motivated to make the modification because the flexible arms would help to center the nut in the body, and thus keep the piston centered in the body and the cartridge. The flexible arms may allow for a greater tolerance in manufacturing of the nut, and the flexibility of the arms would push the nut to better keep the nut in place.
Regarding claim 6, Bengtsson1 as modified and applied to claim 5, discloses the injection device according to claim 5, wherein the inner surface abutting the flexible arms (Cronenberg: flexible ratchet arms 94) is formed as grooves (see grooves between consecutive ratchet teeth 55 in Cronenberg fig. 9b).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bengtsson1 as modified and applied to claim 6, and further in view of Atterbury et al (US 20040210199 A1; hereafter Atterbury).
Regarding claim 7, Bengtsson1 as modified and applied to claim 6 discloses the injection device according to claim 6, as described above, including wherein the grooves have a slope (see ratchet teeth 55 in fig. 9b of Cronenberg)
Bengtsson1 as modified is silent to wherein the grooves have a sloped bottom angled in the distal direction.
Atterbury, directed to a medication injector apparatus and drive assembly, teaches arms (keys 74, fig. 5, [0085]) provided on a nut element (floating nut 60, fig. 5, [0085]) and abutting an inner surface of a housing structure (housing body portion 64, fig. 3) ([0085] radially projecting keys 74 on nut body section 70 fit within axially aligned grooves or keyways 65 formed in housing body portion 64; fig. 3 shows that the keys 74 are within the housing keyways 65), and wherein the grooves (Atterbury: grooves or keyways 65; fig. 3) have a sloped bottom angled in the distal direction (see fig. 3 which shows that the grooves 65 gradually widen/narrow along the proximal/distal axis)
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the housing of the device to include the keyways formed on the inner surface of housing body portion as taught by Atterbury, and the sloped bottom of the grooves, since Atterbury is also dealing with a nut sliding within a housing as noted in Atterbury ([0085] keying allows the nut to travel in an axial direction therein while preventing rotational motion of the nut within the housing at any given axial position). One would have been motivated to make the modification because by locating the arms of the nut within the device, it is harder to tamper with the location of the nut and housing after construction is complete since the nut is more protected within the housing, and as taught by Cronenberg, the ratchet restricts relative movement to one direction, so the nut could not be moved out of alignment once it reached the desired place.
Claim(s) 3-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bengtsson1 or Bengtsson1 modified by Bengtsson240 and applied to claim 1, and further in view of Ekman et al (US 20130296795 A1; hereafter Ekman).
Regarding claim 3, Bengtsson1 or Bengtsson1 modified by Bengtsson240 discloses the injection device according to claim 1, as described above.
Either alternative rejection is silent to wherein the resilient interface comprises a number of flexible arms.
Ekman, in the art of autoinjectors, teaches wherein a resilient interface (interface between dogs 7.3 and shutter arms 10.2 shown in fig. 5) comprises a number of flexible arms (dogs 7.3, see fig. 3 and fig. 5, [0060] the dogs 7.3 of the plunger arms 7.2 are pushed inwardly thus resiliently deforming).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the nut element of Bengtsson to have flexible arms for engaging grooves in a housing as taught by Ekman (nut element 240 is modified to include dogs 7.3 and housing structure 202 is modified to include ramped protrusions), since both references deal with axially fixed engagements between a housing and a plunger. One would have been motivated to make the modification because the flexible arms would help to center the nut in the body, and thus keep the piston centered in the body and the cartridge. The flexible arms may allow for a greater tolerance in manufacturing of the nut, and the configuration of the flexible arms and ramped protrusions of the shutter arms 10.2 would ensure that the nut could only move such that the piston rod structure presses against the movable plunger, and could not be accidentally retracted, thus better ensuring no air gap is accidentally reformed during assembly of the injector device of Bengtsson1 as modified. This modification would still allow for axial fixation of the nut element relative to the housing.
Regarding claim 4, Bengtsson1 as modified by Ekman and applied above discloses the device according to claim 3, as described above, including wherein the flexible arms (Ekman: dogs 7.3) have a radial resiliency (Ekman: [0060] the dogs 7.3 of the plunger arms 7.2 are pushed inwardly thus resiliently deforming) and are operational between the nut element (Bengtsson240: nut 240, figs. 8-10) and the housing structure (Bengtsson: 201/202) (note rejection of claim 3 in view of Ekman above; nut element 240 is modified to include dogs 7.3 and housing structure 202 is modified to include ramped protrusions).
Regarding claim 5, Bengtsson1 as modified by Ekman and applied to claim 3 above discloses the injection device according to claim 3, as described above, including wherein arms (Ekman: dogs 7.3) are provided on the nut element (Bengtsson240: nut 240, figs. 8-10) and abut the housing structure (201/202) (note rejection of claim 3 in view of Ekman above; nut element 240 is modified to include dogs 7.3 and housing structure 202 is modified to include ramped protrusions; see Ekman fig. 5 which shows abutment between dogs 7.3 and ramped protrusions of 10.2).
Regarding claim 6, Bengtsson1 as modified by Ekman and applied to claim 5, discloses the injection device according to claim 5, as described above, including wherein the inner surface abutting the flexible arms (Ekman: ramped protrusions of the shutter arms 10.2, fig. 2 and fig. 5, [0065]) is formed as grooves (negative space between consecutive ramped protrusions on shutter arms 10.2 in Ekman fig. 5).
Regarding claim 7, Bengtsson1 as modified by Ekman and applied to claim 6 discloses the injection device according to claim 6, as described above, including wherein the grooves have a sloped bottom angled in the distal direction (see fig. 5 of Ekman).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bengtsson1 modified by Bengtsson240, or alternatively over Bengtsson1 in view of Radmer et al (US-20110046567-A1; hereafter Radmer), or in a further alternative over Bengtsson1 modified by Bengtsson240 further in view of Radmer.
Regarding claim 9, Bengtsson1 or Bengtsson1 modified by Bengtsson240 discloses the injection device according to claim 1, as described above.
Bengtsson1 modified by Bengtsson240 further discloses including wherein the housing structure (201/202, fig. 8) has a passage (gaps between adjacent annular section 202b is resilient in the radial direction, fig. 8, [0087]) for a laser beam ("L") ([0093] describes nut element 240 being locked relative to the distal housing component 202 by additional means such as adhesive, ultrasonic welding, or laser radiation; Examiner notes that the gap between adjacent annular sections 202b would permit laser beam passage).
Bengtsson1 is silent to wherein the housing structure has a passage for a laser beam ("L").
Bengtsson240 further teaches wherein the housing structure (201/202, fig. 8) has a passage (gaps between adjacent annular section 202b is resilient in the radial direction, fig. 8, [0087]) for a laser beam ("L") ([0093] describes nut element 240 being locked relative to the distal housing component 202 by additional means such as adhesive, ultrasonic welding, or laser radiation; Examiner notes that the gap between adjacent annular sections 202b would permit laser beam passage).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Bengtsson1 to include the adjacent annular sections 202b with the gaps between them as shown in fig. 8, since the embodiments both deal with fixing a nut relative to a housing. One would have been motivated to make the modification because the clamping action of the flexible arms on the nut member helps to ensure that after appropriate nut placement relative to both housing components, the nut position cannot be tampered with.
Alternatively, Bengtsson1 or Bengtsson240 is silent to wherein the housing structure has a passage for a laser beam ("L").
Radmer, directed to an injection device for medical injections, teaches wherein the housing structure (main body 130, fig. 10, [0071]) has a passage (openings 131, fig. 10, [0071]) for a laser beam ("L") ([0071] “In this abutting position the laser welding is performed through openings 131 in the main body 130 thereby locking the piston rod foot 170 to the piston rod 160 in a position where the piston rod foot 170 abuts the plunger 144 such that initial priming can be avoided.”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify Bengtsson1 or Bengtsson1 modified by Bengtsson240 such that the housing had a passage explicitly suited for application of a laser beam, as taught by Radmer, since Radmer also deals with a mechanism for fixing a piston rod structure such that a piston foot abuts the plunger of a cartridge. One would have been motivated to make the modification because the opening would provide direct access to the point where the nut and the housing cooperate, as taught by Radmer, such that the juncture between the two pieces can be suitably melted together to produce a strong physical bond. The opening provides the laser beam with direct access to the two components and also may serve to permit a user to ensure that the nut member and housing are cooperating effectively prior to the laser fixation being applied. This modification thus serves to improve the integrity of the connection between the nut and the housing as well as allow for visual confirmation of the relative location of the nut and housing.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bengtsson1 modified by Bengtsson240.
Regarding claim 10, Bengtsson1 modified by Bengtsson240 discloses the injection device according to claim 1 (see 103 rejection of claim 1 above).
Bengtsson240 discloses a method for assembling an injection device, the method comprising the steps of:
threadedly engaging the nut element (nut element 240, fig. 8, [0087]) and piston rod structure (piston rod 207 and piston washer 209, fig. 10, [0087]) by rotating the nut element (240) and the piston rod structure (207/209) relatively to each other ([0088] “assembling the piston rod 207 with the nut element 240 to establish the threaded engagement there between”),
translating the nut element (240) together with the piston rod structure (207/209) relatively to the housing structure ([0089] “then assembling the piston rod 207 with the nut element 240 to establish the threaded engagement there between, and finally inserting the nut element 240 into a proper axial position relative to distal housing component 202”),
inserting at least the proximal part of the cartridge (cartridge 289, fig. 10, [0088]) together with the plunger (piston 299, fig. 10, [0088]) into the housing structure (distal housing component 202, fig. 8, [0088]) ([0088] describes cartridge insertion into housing structure portion 202 and notes that “prior to this a piston washer 209 has been positioned adjacent the piston 299 of a held cartridge 289”),
moving the cartridge (289) and therewith the plunger (299) proximally into a position wherein the plunger (299) inside the cartridge (289) abuts the piston rod structure (207/209) (see fig. 10 which shows abutment; [0089] “rotation between nut element 240 and distal housing component 202 is performed until a predetermined axial clearance or abutment between the piston rod 207 and the piston washer 209 is obtained”), and
securing the nut element (240) to the housing structure (201/202) in this position ([0091] describes the fixation of the nut element 240 relative to the housing structure 201/202).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use the method of assembly taught by Bengtsson240 to assemble the device of Bengtsson1 modified by Bengtsson240 because the form of the device is very similar to that of Bengtsson1. One would have been motivated to use the method of assembly taught by Bengtsson240 because the device and method are, as described by Bengtsson [0087], “an improved drug delivery device and assembly method”. Furthermore, one would be motivated to use this assembly method because the nut element 240 is firmly secured against axial and rotational movement relative to the housing once fully assembled, thus ensuring that all components remain in the desired position shown in fig. 10 once assembly is complete.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bengtsson1 modified by Bengtsson240 as applied to claim 10 above and further in view of Ekman or Cronenberg.
Regarding claim 11, Bengtsson1 modified by Bengtsson240 discloses the method for assembling an injection device according to claim 10, as described above, including wherein the nut element (Bengtsson1: 40, fig. 1 ; Bengtsson240: 240, fig. 8) is welded ([0093] “Alternative locking means may include using an adhesive or by joining the nut element 240 relative to the distal housing component 202 and/or to the proximal housing component 201 by using ultrasonic welding, laser radiation or like processes.”) to the housing structure (201/202, figs. 8-10) in the position wherein the plunger (299, fig. 10) inside the cartridge (289, fig. 10) abuts the piston rod structure (207/209, fig. 10) ([0089] “rotation between nut element 240 and distal housing component 202 is performed until a predetermined axial clearance or abutment between the piston rod 207 and the piston washer 209 is obtained”; [0091] describes the fixation of the nut element 240 relative to the housing structure 201/202).
Bengtsson as modified is silent to wherein the nut element has at least one flexible arm.
Ekman, in the art of autoinjectors, teaches wherein a resilient interface (interface between dogs 7.3 and shutter arms 10.2 shown in fig. 5) comprises a number of flexible arms (dogs 7.3, see fig. 3 and fig. 5, [0060] the dogs 7.3 of the plunger arms 7.2 are pushed inwardly thus resiliently deforming).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the nut element of Bengtsson as modified to have flexible arms for engaging grooves in a housing as taught by Ekman (nut element 240 is modified to include dogs 7.3 and housing structure 202 is modified to include ramped protrusions), since both references deal with axially fixed engagements between a housing and a plunger. One would have been motivated to make the modification because the flexible arms would help to center the nut in the body, and thus keep the piston centered in the body and the cartridge. The flexible arms may allow for a greater tolerance in manufacturing of the nut, and the configuration of the flexible arms and ramped protrusions of the shutter arms 10.2 would ensure that the nut could only move such that the piston rod structure presses against the movable plunger, and could not be accidentally retracted, thus better ensuring no air gap is accidentally reformed during assembly of the injector device of Bengtsson1 as modified. This modification would still allow for axial fixation of the nut element relative to the housing.
Alternatively, Bengtsson as modified is silent to wherein the nut element has at least one flexible arm.
Cronenberg, in the art of injection pens, teaches wherein flexible arms (flexible ratchet arms 94, fig. 9a, [0054]) are provided on the nut element (leadscrew brake 32, fig. 9a, [0054]) and abut the housing structure (body 18, fig. 9b, [0054] “the leadscrew brake 32 comprises a pair of flexible ratchet arms 94 configured to engage the cylindrical ring of ratchet teeth 55 provided on the interior of the body 18 to define a unidirectional coupling therebetween”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the nut element of Bengtsson to have flexible arms as taught by Cronenberg, since both references deal with nut elements engaged between a housing/body and piston/leadscrew (see Cronenberg [0054] and fig. 9b). One would have been motivated to make the modification because the flexible arms would help to center the nut in the body, and thus keep the piston centered in the body and the cartridge. The flexible arms may allow for a greater tolerance in manufacturing of the nut, and the flexibility of the arms would push the nut to better keep the nut in place.
Conclusion
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 09/21/2026
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