DETAILED ACTION
Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the system of claim 39, which may comprise (among other features already depicted) “a first button rod comprising: a first drive button; and a first wing, a first length of the first button rod between the first wing and a distal end of the first button rod corresponding to a first volume of fluid expelled from the cartridge; and a second button rod comprising: a second drive button; and a second wing, a second length of the second button rod between the second wing and a distal end of the second button rod corresponding to a second volume of fluid expelled from the cartridge, wherein the first length is shorter than the second length, and wherein the first volume is less than the second volume, and a foot attachable to a distal end of the first button rod or the second button rod and comprising a pusher” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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, 10, 15, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Galbraith (U.S. Pat. Pub. No. 2013/0310739 A1).
Regarding claim 1, Galbraith discloses a multi-chamber injector fluid delivery device for mixing and administering an active substance subcutaneously to a patient (see Fig. 1A-6B, [0007-0009], and [0040-0045]), comprising: a housing (1) comprising an internal thread (guide cam 5b); a cartridge holder (holder element 2) mechanically coupled to the housing (via threaded connection 5a/5b) and comprising an external thread (guide groove 5a) extending at least partially along a length of the cartridge holder (see Fig. 1A and 2-4A, and [0042]), at least a portion of the external thread wrapping 360° around the cartridge holder (see Fig. 1A and 2-4A, and [0042]); a cartridge (two-chamber carpule/product reservoir 4) disposed within a cartridge holder internal cavity (see Fig. 1A-6A and [0041-0043]); and a button rod (drive element 3) comprising: a retaining hook (retaining element 6); a demounting stop (shoulder 6a) extending at a non-zero angle from a longitudinal axis of the button rod (see Fig. 1A and [0045-0051]); a holding snapper (lock element 10); a bypass snapper (activator element 7) extending at a non-zero angle from the longitudinal axis of the button rod (see Fig. 1A-6A and [0045-0051]); and a drive button (drive knob 8), and a foot (expanded distal end portion of the drive element 3) coupled (integrally) to a distal end of the button rod and comprising a pusher (tapered tip of the expanded distal end portion of the drive element 3, comprising a contact surface which pushes upon stopper 4d during retraction of the cartridge holder and during injection) (see Fig. 1A, [0043], and [0050-0055]).
Regarding claim 10, Galbraith further discloses that the cartridge holder is rotatable with respect to the housing (see Fig. 1A-6A, [0042], and [0050]), and wherein the retaining hook is inwardly deflectable by a proximal end of the cartridge holder (see Fig. 3-4A and [0051-0052]).
Regarding claim 15, Galbraith further discloses that the housing comprises an axial stop sized to engage a proximal end of the cartridge holder (see Fig. 4A-4B, 5B, and 6A, and [0052], wherein it is clear that each of the distal end surfaces of housing projection 9 and projection 11 are positioned and sized to engage a proximal end of the cartridge holder if the cartridge holder is retracted beyond its intended fully retracted position), wherein the cartridge holder has an extended configuration (see Fig. 1A and [0047]) and a retracted configuration (see Fig. 4A and [0052]) with respect to the housing (see Fig. 1A-4B and [0047-0052[), and the axial stop is positioned to inhibit the cartridge holder from sliding proximally beyond a predetermined position (the intended fully retracted position, or approximately that position) thereby reducing underdosing (see Fig. 4A-4B, 5B, and 6A, and [0052]). Here, the intended retracted position, or “third insertion distance”, determines the stroke distance of the button rod, and therefore the dosage delivered by the device. The distal end surfaces of housing projection 9 and projection 11 serve as stops to prevent the cartridge holder from retracting too far into the housing, which may result in premature expulsion of fluid from the cartridge. Such may occur if the cartridge holder is retracted beyond its intended retracted position, since the button arm is held in place relative to the housing by contact between the shoulder 6a and the housing projection 9 (see Fig. 4A), thus retraction of the cartridge holder with respect to the housing and button arm beyond its intended retracted position would drive the button rod axially further through the cartridge than intended, thereby driving fluid within the cartridge to either escape through a needle end, around the stoppers 4b and 4d, or through some other rupture in the cartridge caused as a result of the excessive pressure applied to the fluid by the button rod. The end result would be an underdosing of the patient at the time of injection due to escaped fluid from the cartridge.
Regarding claim 21, Galbraith further discloses that the cartridge holder further comprises a radial snap (catch arm 17) sized and positioned to engage a snap groove (first catch groove 14) in the housing when the cartridge holder is in an extended configuration (initial”, or fully extended, position of Fig. 1) (see Fig. 1 and 6A, [0047-0050] and [0058], ln 1-27).
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.
Claim(s) 2-3, 22-23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Galbraith as modified by Staub (U.S. Pat. Pub. No. 2019/0167903 A1).
Regarding claim 2, Galbraith fails to teach that the housing further comprises a button rod groove, and the button rod further comprises a wing sized to engage the button rod groove. Such features, however, are well known within the art. For example, Staub exhibits a multi-chamber injector fluid delivery device similar to that of Galbraith (see Fig. 1-6c and associated text), wherein the housing may be configured with a longitudinally extending button rod groove (longitudinal groove 1e), and the button portion (actuation element 5) of the button rod (drive element 2) may comprise a wing (first cam 5a, and second cam 5b) sized to engage the button rod groove in order to rotationally lock the button arm relative to the housing, thereby ensuring that the button rod is not inadvertently rotated relative to the housing during use, leading to faulty handling of the device (see Fig. 3c-3d, 4c-4d, 5c-5d, and 6c, and pg. 4, Col. 2, ln 37-47). Relative rotation of the button rod with respect to the housing in Galbraith would result in misalignment of key locking/retaining features (6, 6a, 7, and 10 in Galbraith) formed on the button rod with their corresponding features formed on the housing (projections 9 and 11 in Galbraith – see Fig. 1A-6A and [0047-0055]). Proper alignment and engagement between these features governs the positioning and stroke of the button rod, thereby a significant misalignment between these features due to button rod rotation would compromise the accuracy or operability of the device. For these reasons, it would have been obvious to one of ordinary skill in the art to modify the housing and button rod of Galbraith such that the housing further comprises a longitudinally extending button rod groove, and the button rod further comprises a wing sized to engage the button rod groove, in the manner taught by Staub, in order to rotationally lock the button arm relative to the housing, thereby ensuring that the button is not inadvertently rotated relative to the housing during use, as described by Staub (pg. 4, Col. 2, ln 37-47).
Regarding claim 3, upon the modification described above, Galbraith as modified by Staub further exhibits that a first length of the button rod between the wing and a distal end of the button rod corresponds to a volume of fluid expelled from the fluid delivery device, since the button rod of Galbraith is integrally formed and not elastic (see Fig. 1A), therefore, in order for the designer to adjust the dosage delivered to the patient, the designer must modify the length of the button rod as it extends between the wing (positioned proximally of the locking/retaining features 6, 6a, 7, and 10) and a distal end of the button rod in order to accommodate a larger or smaller volume of fluid contained within the cartridge during mixing/priming.
Regarding claim 22, Galbraith further discloses that the cartridge holder further comprises a radial snap (catch arm 17) sized and positioned to engage a first radial snap groove (first catch groove 14) and a second radial snap groove (second catch groove 16) on the housing (see Fig. 6A and [0058]), wherein engaging the radial snap with the first radial snap groove and the second radial snap groove may provide an audible feedback in each case ([0058], ln 17-30).
While Galbraith does not teach that the first radial snap groove and the second radial snap groove may be configured as apertures (interpreted as through-holes within the housing), Galbraith does teach an intermediate radial snap aperture (second catch orifice 15) which is configured as such, thereby Galbraith suggests that apertures may be appropriately used to perform the same function as the first radial snap groove and the second radial snap groove. Further, it is known within the art to provide radial snap apertures at positions along the housing corresponding to the first radial snap groove and the second radial snap groove of Galbraith. For example, Staub exhibits a multi-chamber injector fluid delivery device similar to that of Galbraith, wherein the cartridge holder (holding device 6) of Staub comprises a radial snap (latching arm 6d) which engages a first radial snap aperture (latching opening 1h) or groove (latching longitudinal groove 1h’) provided on a distal end of the housing (1) when cartridge holder is positioned at a first extended position relative to the housing (see Fig. 1 and 2b, and [0051]) and engages a second radial snap aperture (latching openings 1h) provided at a proximal end of the housing when cartridge holder is positioned at a second retracted position relative to the housing (see Fig. 3b and 4b, and [0053]) in order to prevent the cartridge holder from backward rotation relative to the housing (pg. 5, Col. 1, ln 24-32). Based on these teachings of Staub, as well as the suggestions provided by Galbraith, one of ordinary skill in the art would have found it obvious to reconfigure the first radial snap groove and the second radial snap groove of Galbraith as radial snap apertures, rather than as grooves, as a matter of routine and simple substitution of one well known opening configuration (apertures) for another (grooves), both known to be suitable for engaging a radial snap of the type disclosed in Galbraith to thereby prevent the cartridge holder from backward rotation relative to the housing, as described by Staub (pg. 5, ln 24-32) and Galbraith ([0058], ln 19-24 and ln 45-50). See MPEP 2143(I)(B).
Regarding claim 23, Galbraith further discloses that the cartridge holder further comprises a radial snap (catch arm 17) sized and positioned to engage a first radial snap groove (first catch groove 14) and a second radial snap groove (second catch groove 16) on the housing (see Fig. 6A and [0058]); and the cartridge holder is rotatable with respect to the housing from a first position (“initial”, or fully extended, position of Fig. 1) wherein the radial snap engages the first radial snap groove (see Fig. 1 and 6A, [0047-0050] and [0058], ln 1-27) to a second position (“inserted”, or fully retracted, position of Fig. 4A and 6A) wherein the radial snap engages the second radial snap groove (see Fig. 6A and [0058], ln 52-61). While Galbraith does not teach that the first radial snap groove and the second radial snap groove may be configured as apertures (interpreted as through-holes within the housing), Galbraith may be modified according to the manner and for the reasons described above in re claim 22, whereupon the first radial snap groove and the second radial snap groove of Galbraith may be reconfigured as radial snap apertures, as claimed.
Regarding claim 25, Galbraith further discloses a method of using the fluid delivery device of claim 1, the method comprising: rotating the cartridge holder with respect to the housing causing the cartridge holder to move axially proximally through the housing from a first position (“initial”, or fully extended, position of Fig. 1) wherein a radial snap (catch arm 17) on the cartridge holder engages a first radial snap groove (first catch groove 14) on the housing (see Fig. 1 and 6A, [0047-0050] and [0058], ln 1-27) to a second position (“inserted”, or fully retracted, position of Fig. 4A and 6A) wherein the radial snap engages a second radial snap groove (second catch groove 16) on the housing (see Fig. 6A and [0058], ln 52-61); and rotating the cartridge holder with respect to the housing causing the button rod to move axially distally through the cartridge (see Fig. 1A-6A and [0047-0055]), and pushing a first stopper distally through the cartridge via the foot such that the first stopper moves axially distally toward a second stopper within the cartridge (see Fig. 1A-6A and [0047-0055]).
While Galbraith does not teach that the first radial snap groove and the second radial snap groove may be configured as apertures (interpreted as through-holes within the housing), Galbraith may be modified according to the manner and for the reasons described above in re claim 22, whereupon the first radial snap groove and the second radial snap groove of Galbraith may be reconfigured as radial snap apertures, as claimed.
Claim(s) 5, 7, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Galbraith (U.S. Pat. Pub. No. 2013/0310739 A1) in view of Hirschel (EP2252351B1).
Regarding claim 5, Galbraith exhibits the fluid delivery device of claim 1, however, Galbraith fails to teach that the foot comprises a plurality of flexible fingers radially arranged around a common axis extending along the length of the foot, wherein: the cartridge holder has an extended configuration and a retracted configuration with respect to the housing; in the extended configuration, each flexible finger of the plurality of flexible fingers extending radially from the foot engages a proximal end of the cartridge; and in the retracted configuration, each flexible finger of the plurality of flexible fingers extending radially from the foot engages an internal surface of the cartridge.
Hirschel exhibits a multi-chamber injector fluid delivery device (Fig. 6a-6b and [0050-0051]) for mixing and administering an active substance in a similar manner to that of Galbraith, comprising a housing (1) and a cartridge holder (carpule holder 2) which may be threadedly engaged to each other in the same manner taught by Galbraith (see Fig. 6a-6b, and see above description in re claim 1 regarding Galbraith). Among other similar features, Hirschel exhibits a button rod (drive element 3’) comprising a foot portion (distal end portion of the drive element 3’), the button rod being configured to drive a stopper (plug 8b) of a medicament cartridge (cartridge 7) received within the cartridge holder, with the foot portion pushing the stopper along a path internal to the cartridge (see Fig. 6a-6b and [0050]). Hirschel teaches that the foot portion of the button rod may comprise a distinct pusher portion (plunger 26) cooperating with a plurality of flexible fingers (retaining arms 4’) radially arranged around a common axis extending along the length of the foot (see Fig. 6a-6b), wherein the cartridge holder has an extended configuration (Fig. 6a) and a retracted configuration (Fig. 6b) with respect to the housing, in a similar manner to Galbraith (see in re claim 15); in the extended configuration, each flexible finger of the plurality of flexible fingers extending radially from the foot engages a proximal end of the cartridge (see Fig. 6a and [0050-0051]); and in the retracted configuration, each flexible finger of the plurality of flexible fingers extending radially from the foot engages an internal surface of the cartridge (Fig. 6b and [0050-0051]). Hirschel teaches that this configuration has the advantage of maintaining proper alignment and positioning between the button rod foot portion and the cartridge throughout the pushing stroke of the button rod by virtue of the plurality of flexible fingers holding the cartridge against sliding longitudinally within the cartridge holder within the cartridge holder ([0051]), thereby ensuring accuracy in the dose delivered by the push stroke.
Based on the teachings and example of Hirschel, and since Galbraith itself does not appear to teach any means of holding the cartridge against sliding longitudinally within the cartridge holder, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the foot portion of the button rod of Galbraith to be configured in the manner taught by Hirschel, since this configuration has the advantage of maintaining proper alignment and positioning between the button rod foot portion and the cartridge throughout the pushing stroke of the button rod by virtue of the plurality of flexible fingers holding the cartridge against sliding longitudinally within the cartridge holder within the cartridge holder, as described by Hirschel ([0051]), thereby ensuring accuracy in the dose delivered by the push stroke.
Regarding claim 7, Galbraith further discloses that when in the retracted configuration, the demounting stop (shoulder 6a) abuts a housing stop (housing projection 9) positioned proximate a proximal end of the housing (see Fig. 4a).
Regarding claim 17, Galbraith discloses the fluid delivery device of claim 1, wherein the cartridge comprises: a distal tip (distal tip of the carpule/reservoir 4 at which a needle may be inserted, see Fig. 1A-6A and [0040]); a first stopper (stopper 4b); a second stopper (stopper 4d) disposed between the distal tip and the first stopper (see Fig. 1A-6A and [0041]); an active agent (a solid active substance which forms the product of the product reservoir 4a – see [0009], ln 3-5 and [0040-0041]) disposed between the distal tip and the second stopper (within the product reservoir space 4a – see Fig. 1A-6A and [0041]); and a solvent (dissolving liquid/solvent – see [0009], ln 3-5 and [0041]) disposed between the second stopper and the first stopper (see Fig. 1A-6A and [0041]). Galbraith may be modified according to the teachings of Hirschel, as described above in reclaim 5, wherein the proposed combination then exhibits the foot configuration taught by Hirschel, such that the foot comprises a plurality of flexible fingers extending radially from the foot (see in reclaim 5) and centering the pusher centrally with respect to the first stopper (see Fig. 6a-6b and [0051] of Hirschel, wherein the flexible fingers/retaining arms 4’ are pretensioned radially outward, such that in the extended position of the cartridge holder depicted in Fig. 6a, the flexible fingers/retaining arms 4’ press upon the rim of the proximal end of the cartridge 7, thereby centering the pusher 26 within the proximal end of the cartridge, as depicted in Fig. 6a, and such that in the retracted position of the cartridge holder depicted in Fig. 6b, the flexible fingers/retaining arms 4’, having been compressed to fit within the cartridge internal cavity, exert a radially outward reaction force upon the internal walls of the cartridge 7, thereby centering the pusher 26 within the internal cavity of the cartridge), thereby improving dose volume consistency by centering the foot as the foot slides distally through the cartridge (it is clear from Fig. 6a-6b and [0051] of Hirschel, as described above, that the flexible fingers/retaining arms 4’ center the foot as the foot slides distally through the cartridge, therefore having presented the structure and functionality identified by the claim as producing the benefit of improving dose volume consistency, it follows that the configuration taught by Hirschel also exhibits this benefit).
Claim(s) 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable Galbraith in view of Moser (U.S. Pat. Pub. No. 2009/259181 A1) and Elmen (U.S. Pat. Pub. No. 2019/0275255 A1).
Regarding claims 8 and 9, Galbraith exhibits the fluid delivery device of claim 1. Galbraith fails to teach either that the foot is detachably attachable to the distal end of the button rod, or that such detachably attachment is accomplished by the foot comprising a foot groove sized to engage a foot snap of the button rod. However, it is well known within the art to provide a foot detachably attachable to the distal end of a button rod of the type disclosed by Galbraith. Such an attachment configuration is depicted, for example, in Fig. 1A-4B of Moser. Here, Moser exhibits a multi-chamber injector fluid delivery device similar to that of Galbraith, comprising, among other similar features, a button rod (plunger rod 1) comprising a detachably attached foot portion (contact element 1e) (see Fig. 1A-1B and [0031]). It is clear from the figures of Moser (particularly the view of Fig. 1B) that the foot portion of the button rod comprises a foot groove (groove formed in the interior wall of the contact element 1e which forms the flared out portion of the internal cavity of contact element 1e depicted in Fig. 1A and 1B) sized to engage a foot snap (the flared out portion at the distal tip of the integral shaft portion of plunger/button rod 1 depicted in Fig. 1B) of the button rod in precisely the same manner as is depicted in the applicant(s) own Fig. 2A and 2C, thereby it is clear that the foot portion of Moser must, by virtue of this structure, be detachably attachable to the distal end of the button rod in the same manner as the applicant(s) own configuration.
It is also clear from the figures of Moser that such an attachment configuration renders the foot rotatable relative to the button rod in a similar manner to the foot of Elmen (see Fig. 1-3). Elmen exhibits a multi-chamber injector fluid delivery device similar to that of Galbraith and Moser, comprising many of the same features, including a button rod (25) comprising a detachably attached disk-shaped foot portion (60) which receives a circular shaft portion (62) of the button rod within a central passage (61) of the foot, thereby rendering the foot portion rotatable relative to the button rod (see Fig. 1-3, [0035], ln 11-18). It is clear from the multiple angles presented in Fig. 1A-1D of Moser that foot groove and foot snap taught by Moser are also configured in a manner to allow rotation of the foot portion relative to the remainder of the button rod. The foot of Moser is depicted in these figures in such a manner known within the art to convey that the foot has a circular cross-section, much like the stopper, housing, cartridge, and other such features depicted. In the same manner, it is clear that the hollow interior of the foot, including the foot groove, is also circular in cross-section, thereby permitting the foot snap of the button rod, like the circular shaft portion of Elmen, to rotate relative to the foot while remaining captive within the foot groove.
Elmen further teaches that providing a foot as detachably attachable and rotatable relative to the distal end of the button rod provides the advantage of reduced friction between the button rod and the cartridge during the step of withdrawing the cartridge holder into the housing ([0042], ln 1-10). In each of Moser, Elmen, and Galbraith, the cartridge holder must be rotated relative to the housing in order to withdraw the cartridge holder into the housing and initiate the mixing of the solvent and agent (for Galbraith, see in re claim 25; for Moser, see [0030-0032]]; and for Elmen, see [0042]). During this process, the foot of the button rod is pressed into contact with the stopper of the cartridge, and potentially the interior side walls of the cartridge as well. If the foot is not rotatable relative to the cartridge (as is the case in Galbraith during the step of withdrawing the cartridge holder into the housing – see [0050]), significant friction may be incurred. Elmen teaches that providing the foot as detachably attachable and rotatable relative to the distal end of the button rod, such as in the manner taught by Moser, reduces such friction, thereby making it easier for the user to accomplish this necessary step in using the injector.
Based on these teachings and examples, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the foot portion of the button rod of Galbraith to be formed in the manner taught by Moser, such that the integrally coupled foot of Galbraith is replaced with the detachably attachable and rotatable foot of Moser, in order to thereby reduce friction between the button rod and the cartridge during the step of withdrawing the cartridge holder into the housing, thereby making it easier for the user to accomplish this necessary step in using the injector, as described by Elmen ([0042]). Upon such a modification, the button rod of Galbraith may comprise a foot that is detachably attachable and rotatable relative to the distal end of the button rod and comprises a wide pusher/contact portion, the foot further comprising a foot groove sized to engage a foot snap of the button rod, as claimed and as taught by Moser.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Galbraith in view of Mosebach (U.S. Pat. Pub. No. 2018/0154089 A1).
Regarding claim 11, Galbraith discloses the fluid delivery device of claim 1, wherein the housing comprises a holding snapper hook (projection 11) sized to engage the holding snapper (see Fig. 1B and 5B, [0048], and [0056]). Galbraith does not teach that the housing comprises a holding snapper aperture, however, it is well known within the art that for purposes of engaging a holding snapper of this kind, an aperture provided within the housing may be used in a functionally equivalent manner to a hook provided on the interior surface of the housing (see, for example, Fig. 33-34, and 38-40 of Mosebach, wherein one or two holding snappers similar in structure to that of Galbraith are provided on a button rod of the same kind as that of Galbraith, as seen in Fig. 33 and 38, with each holding snapper configured to be engaged by a holding snapper aperture provided on the housing, as seen in Fig. 34 and 39-40, rather than by a hook). For this reason, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to replace the holding snapper hook of Galbraith with a holding snapper aperture as a simple substitution of one means of engaging a holding snapper (an aperture) well known in the art for another (a hook), each being well understood within the art to be functionally equivalent. See MPEP 2143(I)(B).
Claim(s) 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Galbraith in view of Elmen.
Regarding claim 12, Galbraith discloses the fluid delivery device of claim 1, wherein the housing comprises an internal thread provided on an interior surface of the housing (see in re claim 1). Galbraith fails to teach that the internal thread wraps at least 360° around an interior surface of the housing, Galbraith providing no specific teaching regarding the extent of the internal threading. Such a configuration is, however, well known within the art for multi-chamber injector fluid delivery devices of the type disclosed by Galbraith. Elmen, for example, exhibits such a multi-chamber injector fluid delivery device (10), wherein the housing (21) comprises internal threading (22) configured to engage an external thread (18) of the cartridge holder (12) (see Fig. 1 and 4, and [0038]), and which wraps more than 360° around an interior surface of the housing (see Fig. 1 and [0038], wherein it is clear that the internal threading 22 of Elmen may be seen to complete more than six revolutions of the interior surface of the housing). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the internal threading of Galbraith such that the internal thread wraps at least 360° around an interior surface of the housing as a matter of routine design choice, wherein the designer would recognize the benefits and tradeoffs of varying the extend of internal threading within the housing (more threading improves the strength of a threaded connection but also increases rotational friction during the threading process), and wherein a configuration in which the internal thread wraps more than 360° around an interior surface of the housing is known to be suitable within the art, as shown by Elmen (see Fig. 1 and [0038]).
Regarding claim 14, Galbraith discloses the fluid delivery device of claim 1, wherein the housing comprises an internal thread provided on an interior surface of the housing (see in re claim 1). Galbraith fails to teach that the internal thread wraps at least 420° around an interior surface of the housing, Galbraith providing no specific teaching regarding the extent of the internal threading. Such a configuration is, however, well known within the art for multi-chamber injector fluid delivery devices of the type disclosed by Galbraith. Elmen, for example, exhibits such a multi-chamber injector fluid delivery device (10), wherein the housing (21) comprises internal threading (22) configured to engage an external thread (18) of the cartridge holder (12) (see Fig. 1 and 4, and [0038]), and which wraps more than 420° around an interior surface of the housing (see Fig. 1 and [0038], wherein it is clear that the internal threading 22 of Elmen may be seen to complete more than six revolutions of the interior surface of the housing). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the internal threading of Galbraith such that the internal thread wraps at least 360° around an interior surface of the housing as a matter of routine design choice, wherein the designer would recognize the benefits and tradeoffs of varying the extend of internal threading within the housing (more threading improves the strength of a threaded connection but also increases rotational friction during the threading process), and wherein a configuration in which the internal thread wraps more than 420° around an interior surface of the housing is known to be suitable within the art, as shown by Elmen (see Fig. 1 and [0038]).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Galbraith as modified by Elmen according to claim 12, and in further view of Vickers (U.S. Pat. No. 4,827,811).
Regarding claim 13, Galbraith as modified by Elmen according to claim 12 exhibits the fluid delivery device of claim 12. Galbraith fails to teach that the internal thread comprises a beveled first end and a beveled second end to reduce friction as the cartridge holder rotates with respect to the housing, however the concept of beveling the ends of a threading structure within a threaded connection in order to reduce friction (prevent binding) during threading is well known in the art. For example, Vickers exhibits a threaded fastener (10) for use in a threaded connection (with a tapped aperture) similar to the threaded connection between the housing and the cartridge holder of Galbraith (see Fig. 1 and Col. 3, ln 4-20). Vickers teaches that the threaded portion may be provided with beveled ends (22, 23) in order to facilitate proper alignment of the threaded portion with the corresponding threaded (tapped) aperture of the threaded connection, and thereby to prevent binding (i.e. reduce friction) between the threaded components due to misalignment (Col. 3, ln 13-20). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the internal thread of Galbraith to comprise a beveled first end and a beveled second end in the manner well known within the art to reduce friction between components within a threaded connection, as exemplified and described by Vickers (see Fig. 1 and Col. 3, ln 13-20). Upon such a modification, one of ordinary skill in the art would expect a reduction in friction between the housing and the cartridge holder as the cartridge holder rotates with respect to the housing.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Galbraith as modified by Hirschel according to claim 17, and in further view of USDA (“Gattex (teduglutide [rDNA origin]), for injection, for subcutaneous use”, NPL).
Regarding claim 20, Galbraith as modified by Hirschel according to claim 17 exhibits the fluid delivery device of claim 17. While Galbraith teaches that the multi-chamber injector fluid delivery device may be configured for administering an active substance subcutaneously to a patient (see Fig. 1A-6B, [0007-0009], and [0040-0045]), and that this active substance may be a solid that is mixed with a liquid solvent prior to injection ([0009]), Galbraith fails to teach that the active agent/substance dispensed by the device comprises lyophilized teduglutide (Galbraith providing no specific teaching of what the active agent may be).
USDA exhibits a drug label comprising information about the drug teduglutide (brand name Gattex). USDA teaches that teduglutide injections may be administered subcutaneously (“Dosage and Administration”, bullet 1), wherein the active agent/substance is contained within a pre-filled cartridge (vial) which comprises solid teduglutide in the form of a lyophilized powder which must be mixed with sterile water prior to injection (“Dosage Forms and Strengths”, bullet 1).
Because the multi-chamber injector fluid delivery device of Galbraith is configured to administer an active substance subcutaneously to a patient, wherein the active substance may be a solid that is mixed with a liquid solvent prior to injection in the same manner as is required for lyophilized teduglutide administration, as described by USDA, it follows that one of ordinary skill in the art would have recognized the applicability of the multi-chamber injector fluid delivery device of Galbraith to lyophilized teduglutide administration based on the information taught by USDA and would have found it obvious prior to the filing date of the claimed invention to select the active substance administered by the multi-chamber injector fluid delivery device of Galbraith to be lyophilized teduglutide.
Claim(s) 39 is rejected under 35 U.S.C. 103 as being unpatentable over Galbraith in view of Franklin (U.S. Pat. Pub. No. 2013/0197449 A1), Smedley (U.S. Pat. No. 5,240,146), and Rissman (U.S. Pat. Pub. No. 2010/0249829 A1).
Regarding claim 39, Galbraith discloses a multi-chamber injector fluid delivery system for mixing two substances prior to injection (see in re claim 1) comprising: a housing comprising an internal thread (see in re claim 1); a cartridge holder mechanically coupled to the housing and comprising an external thread extending at least partially along a length of the cartridge holder and sized to engage the internal thread (see in re claim 1); a cartridge disposed within a cartridge holder internal cavity (see in re claim 1); a first button rod comprising: a first drive button (see in re claim 1); and a foot attachable to a distal end of the first button rod or the second button rod and comprising a pusher (see in re claim 1).
Galbraith fails to teach that the housing comprises a button rod groove; that the first button rod comprises a first wing, a first length of the first button rod between the first wing and a distal end of the first button rod corresponding to a first volume of fluid expelled from the cartridge, however such features are well known in the art. For example, Franklin exhibits an injector fluid delivery system (10) similar to that of Galbraith (see Fig. 1-10), comprising many similar features, such as a button rod (34) comprising a first drive button (the flange provided at the proximal end of button rod 34), the button rod being received and axially translatable within a housing (14) and the button rod comprising a foot (distal end of button rod 34) configured to push a stopper (30) to thereby drive the injection of fluid from the device into a patient (see Fig. 1 and [0035]). Franklin teaches that such a button rod may comprise a set of wing portions (protrusions 58) provided at intervals along the length of the button rod and designed to engage with a button rod groove (66) formed within the interior wall of the housing at its proximal end (see Fig. 1 and 3, and [0040]) in order to thereby provide tactile and audible feedback to the user that an increment of dose has been delivered, thereby allowing the user to accurately administer a desired amount of medication in a stepwise manner, and, in the case that the user desires to administer the entirety of the medication contained within the device, providing confirmation to the user that the full dose has been delivered ([0040]). Franklin further exhibits that a first length of the first button rod between any of the set of first wings and a distal end of the first button rod corresponds to a first volume of fluid expelled from the device proportional to that first length, since the button rod is solid in construction, therefore a wing provided closer to the proximal end of the button rod (with a larger first length) will correspond to a larger dosage delivered by the device when the user presses the button rod until the wing is engaged by the button rod groove, whereas a wing provided closer to the distal end of the button rod (with a smaller first length) will correspond to a smaller dosage delivered by the device when the user presses the button rod until the wing is engaged by the button rod groove, since the button rod has not axially translated as far within the housing (i.e. a smaller delivery stroke) as compared to the case of the wing provided closer to the proximal end of the button rod, thereby less medication is driven from the device (see Fig. 1).
Based on the teachings and example of Franklin, 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 system of Galbraith such that the first button rod comprises a set of wing portions provided at intervals along the length of the button rod and designed to engage with a button rod groove formed within the interior wall of the housing at its proximal end, in order to thereby provide tactile and audible feedback to the user that an increment of dose has been delivered, thereby allowing the user to accurately administer a desired amount of medication in a stepwise manner, and, in the case that the user desires to administer the entirety of the medication contained within the device, providing confirmation to the user that the full dose has been delivered ([0040]). Further, since Galbraith also exhibits a button rod of solid and integral construction (no elastic portion), Galbraith likewise exhibits that a first length of the first button rod between any of the set of first wings and a distal end of the first button rod corresponds to a first volume of fluid expelled from the device proportional to that first length.
Galbraith also fails to teach that the system comprises a second button rod comprising: a second drive button; and a second wing, a second length of the second button rod between the second wing and a distal end of the second button rod corresponding to a second volume of fluid expelled from the cartridge, however, injector configurations comprising two button rods are well known in the art. For example, Smedley exhibits an injector for fluid delivery (2) similar to that of Galbraith (see Fig. 1-8), wherein two button rods (36, 37) are provided for simultaneously engaging two distinct cartridges (6,7) or a single collapsable bag cartridge (see Col. 6, ln 41-45) for delivering medication to the patient, wherein the stroke length of each button rod may be adjusted in order to provide precise adjustability in regards to the total amount of medication administered (see Fig. 1-8, Col. 1, ln 28 – Col. 2, ln 3, Col. 2, ln 50 – Col. 3, ln 31, and Col. 4, ln 12 – Col. 6, ln 38). Rissman likewise exhibits an injector (100) for fluid delivery similar to that of Galbraith (see Fig. 1, [0008-0010], and [0038-0042]), wherein two button rods (132, 134) are provided in order to engage a single cylindrical cartridge (101) which is split into two parallel chambers (110, 120) (see Fig. 1, [0010], and [0038-0042]).
As such, based on the examples of Smedley and Rissman, 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 system of Galbraith to include a second button rod of the same form as the first button rod of Galbraith as modified by Franklin, the second button rod being configured to engage with a second portion or chamber of the cartridge of Galbraith in order to thereby provide the user with additional adjustability in regards to the total dosage delivered – for example, allowing the user to opt for a half-dose by only operating one of the two button rods, thereby only delivering from one of the two portions or chambers of the cartridge. Since the second button rod may be configured in the same form as the first button rod of Galbraith as modified by Franklin (i.e. as a duplicate), the second rod therefore further comprises a second drive button; and a second wing, a second length of the second button rod between the second wing and a distal end of the second button rod corresponding to a second volume of fluid expelled from the cartridge in the same manner as the first button rod of Galbraith as modified by Franklin (see above discussion in re Franklin).
Further still, it is clear that when the first length is defined as being the distance between one of the first wings provided closer to the distal end of the first button rod and the distal end of the first button rod, and the second length is defined as being the distance between one of the second wings provided closer to the proximal end of the second button rod and the distal end of the second button rod, it follows that the first length must be shorter than the second length (the first and second button rods being of identical total length), and the corresponding first volume delivered must be less than the corresponding second volume delivered as a result (the stroke length of the first button rod based upon the user pressing until engagement of the first wing within the button rod groove being shorter than the stroke length of the second button rod based upon the user pressing until engagement of the second wing within the button rod groove). Such a situation may occur, for example, if the user desires to select a dosage of 70% of the maximum available dose, for example, and opts to press the second button rod until the most proximal second wing is engaged within the button rod groove (thereby delivering a full dosage from the corresponding second portion/chamber of the cartridge, making up 50% of total available dosage in the cartridge), and opts to obtain the remainder by pressing the first button rod until one of the most distal first wings is engaged within the button rod groove (thereby delivering a partial dosage from the corresponding first portion/chamber of the cartridge, such as 20% of the total available dosage in the cartridge).
Conclusion
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/ERIC A LANGE/Examiner, Art Unit 3745
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783