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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1, 8, 15, and dependents is/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.
Regarding Claim(s) 1, 8, and 15, Applicant recites “the drum portion of the leadscrew contains a rotary indicator that is visible to a user”. However, there is a lack of clear import from the specification such that the metes and bounds of this limitation are unclear, particularly in Claims 1 and 15 which are directed toward the drive assembly, per se.
Specifically, the specification provides antecedent basis for a “rotary indicator” identified by reference numeral (607). Here the rotary indicator is recited as being a collective component which comprises a drum portion (616) and a threaded shaft (618) extending from the drum portion and a threaded shaft/outer surface of the drum portion. The specification is therefore suggestive that the “drum portion” is constituent part of the “rotary indicator”, whereas the instant claim would appear to suggest that the “rotary indicator” is a distinctive component which is provided IN the drum (re: “the drum portion of the leadscrew contains a rotary indicator…”).
Secondly, the function of being “visible to a user” is never recited in association with the identified “rotary indicator”. The specification does discuss “vanes 520” which are “visible through a window 534 housing”, but this appears to be a different embodiment than the one which identifies the “rotary indicator”. In the instant case while the vanes (520) are clearly disclosed as providing a function of being visible during use to indicate to a user that rotation is occurring (Par. 218 – re: “[t]his window 534 indicates progress of the screw…” and this function does appear to be consistent with the function of the “rotary indicator” as recited in Claim 8 (where the window, and its function, is claimed), the “vanes” are recited in an entirely different embodiment from the identified “rotary indicator”. In the embodiment in which the “rotary indicator” is identified, the housing (and window) are never specified (or illustrated) and it is unclear if the “rotary indicator” (particularly the threaded surface of the drum portion) is intended to, or performs, the same function as the “vanes” in the alternative embodiment and would therefore be understood to be placed in an equivalent housing having an equivalent window through which the threaded surface of the drum might be visible in order to convey rotation to an observer.
Without the function of the “rotary indicator” with respect to it being “visible” being discussed in the specification and not being recited in the claims (particularly claims 1 and 15 which lack the housing and window – even in functional recitation) the metes and bounds of “visible to the user” is unclear and presents the potential for confusion. Specifically, it is unclear as to whether the “rotary indicator” being “visible to the user” means the indicator is intended to be visible to the user during assembled and operative use of the device (like the vanes 520 of the alternative embodiment) OR if being “visible to the user” requires the elements to be visible to the user when the drive assembly is assembled but not received in the housing - see Fig. 91 – where the drum is received within a housing element (611) which is generally semi-circular (note that this housing is likewise not recited in Claims 1 and 15) OR if being “visible to the user” only requires that the “rotary indicator” is a tangible component which is capable of being see by the user (e.g. not invisible to the naked eye) in a state of disassembly…etc.
For the sake of prosecution the instant claims will be read in a manner more consistent with the embodiment of species (500) as it pertains to the identification of the drum component as the dominant component – contrasted to species (600) where the “rotary indicator” is the dominant component – where there presents a drum (518) which contains the constant force spring (526), the surface of the drum having a surface element (i.e. vanes 520) which can be observed by a user as rotating during activation of the drive assembly, whereby movement of these surface elements about an axis of rotation provides an indication to the user that the drum (and lead screw which depends from the drum) are actively rotating.
Regarding Claims 2, 9, and 15, Applicant recites “the drum portion of the leadscrew causes the rotary indicator to move in a rotational manner…” However, this verbiage is inconsistent with that used in the specification and creates confusion over the relationship of the drum and the rotary indicator. Specifically, the phrase “causes” would appear to content that the rotary indicator and the drum are two completely separate and distinct components. However, the specification is suggestive that the “rotary indicator” (as understood through consideration of the specification and the claims to resolve the inconsistencies in language therebetween) is an integral part of the drum and is provided on the surface of the drum. Examiner submits that “causes” would not ordinarily be used to describe such integral rotation.
Regarding Claim(s) 3, 10, and 15, Applicant “the drum portion comprise a screw portion extending from the drum portion”. However, as understood in light of the specification this “a screw portion” appears to be the already claimed “leadscrew” (see Fig. 90).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-19 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-5 of U.S. Patent No. 12,048,834. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claim(s) 1, 8, and 15, the ‘834 reference patent claims, inter alia,
a drug delivery system for injecting a medicament (Clm. 1), the system comprising:
a container (Clm. 1) configured to receive a medicament, the container comprising a stopper configured to move within the container and a closure;
a drive assembly (Clm. 1) comprising:
a plunger member (Clm. 1) configured to engage and move a stopper within a container, with the plunger member having a first position and a second position axially spaced from the first position;
a constant force spring (Clm. 1) configured to move the plunger member from the first position to the second position; and
a leadscrew (Clm. 1), the leadscrew comprising a drum portion such that the constant force spring is contained within the drum portion of the leadscrew and is configured to bias the leadscrew in a rotational direction, wherein rotational movement of the leadscrew causes axial displacement of the plunger member from the first position to the second position;
a housing (Clm. 1) configured to receive at least a portion of the container and the drive assembly; and
a needle actuator (Clm. 1) assembly comprising a needle configured to be placed in fluid communication with the container, the needle moveable from a first position and a second position spaced from the first position,
wherein the housing further comprises at least one window through which at least some portion of the drum portion is visible to a user (Clm. 1).
In the instant case the claims of the reference patent fail to identify a “rotary indicator”, rather this function is attributed to the drum, per se. However, as understood in the instant claims (in light of the specification) the “rotary indicator” merely constitutes the exterior surface of the rotatable drum, as such the visibility of the drum in the claims of the ‘834 patent anticipate the structure and function of the “rotary indicator” and therefore the instant claims are not distinctive over those of the issued reference patent.
Regarding Claim(s) 2 and 9 and 15, see Clm. 1 and 15 of the reference patent.
Regarding Claim(s) 3 and 10 and 15, see Clm. 1 of the reference patent.
Regarding Claim(s) 4, 11, and 16, see Clm. 1 and 4 of the reference patent.
Regarding Claim(s) 5, 12, and 17, see Clm. 1 of the reference patent.
Regarding Claim(s) 6, 13, and 18, see Clm. 1 of the reference patent.
Regarding Claim(s) 7, 14, and 19, see Clm. 1 of the reference patent.
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.
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.
Claim(s) 1-4, 8-11, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2003/0055380 (“Flaherty”) in view of U.S. Publication No. 2016/0038677 (“Kiilerich”) and U.S. Patent No. 1,984,206 (“Zielinski”).
Regarding Claims 1 and 8, Flaherty discloses a drive assembly (310) for a drug delivery system, the assembly comprising:
A plunger member (204) configured to engage and move a stopper within a container (see generally 30 – note that the stopper and container and not required and as such the drive mechanism of Flaherty could be used in association with a container which comprises a two component pusher/stopper arrangement – see generally 204, 236 – without modification to the particular drive assembly – although such a modification would have been obvious – see Par. 83 – in order to provide better sealing by providing a separate rotating pusher, but a non-rotating stopper), with the plunger member having a first position (e.g. withdrawn position) and a second position (e.g. advanced position) axially spaced from the first position;
a constant force spring (312 - Par. 80) configured to move the plunger member from the first position to the second position; and
a leadscrew (202), the constant force spring being configured to bias the leadscrew in a rotational direction, wherein rotational movement of the leadscrew causes axial displacement of the plunger member from the first position to the second position (Par. 80).
Flaherty discloses the invention substantially as claimed except that that the leadscrew comprises a “drum portion” within which the constant force spring is contained, the drum portion of the leadscrew including a “rotary indicator”. Rather, Flaherty only provides a basic, schematic iteration of the constant force spring as generalized rectangular (see Fig. 19).
However, Kiilerich discloses a related drug delivery device (1) likewise including a related clock spring type biasing member (15, 16) wherein the biasing member is retained within a drum (22, 48) affixed to the proximal end of a leadscrew (21, 6 - see Fig. 1 and Fig. 2). Such a drum is used to rotationally fixate the outer end of the biasing member (Par. 75). Additionally, one having ordinary skill in the art that the drum (formed by the combination of 22 and 48) would also serve the distinct benefit of sealing the spring from intrusion by dust or other debris which could impede its function. For example, Zielinksi discloses a clock spring (56) which is received within a "suitable casing or housing 70" in order to "exclude dust and dirt therefrom" (Pg. 2, Col. 2, Ln. 24-27). While the clock spring of Zielinski is used for non-medical purposes, Examiner submits that the teachings establish a clear understanding of a utility that would be immediately understood and recognized by the drum of the Kiilerich reference.
It would have been obvious for a person having ordinary skill in the art at the time
the invention was made to provide the leadscrew/screw portion of the device of the
modified invention of Flaherty with a drum for housing the biasing member, as disclosed by Killerich, such a drum serving as a useful point to anchor the outer end of the spring to permit winding while also serving the function of sealing the spring within a cassette to prevent infiltration of dust or debris which could impede functioning of the spring.
In providing such a modification to Flaherty the external surface of the drum, which is visible, may serve as a rotatory indicator whereby a user will be able to confirm rotation of the drum and leadscrew based on visible rotation of the drum surface.
Regarding Claims 2 and 9, Flaherty (as modified by Kiilerich) discloses the leadscrew is engaged with the plunger member such that when the constant force spring biases the leadscrew in a rotational direction, the drum portion of the leadscrew causes the rotary indicator to move in a rotational manner (Par. 80).
Regarding Claims 3 and 10, Flaherty discloses the drum portion (as modified by Kiilerich) comprises a screw portion (i.e. the leadscrew) extending from the drum portion.
Regarding Claims 4 and 11, Flaherty discloses a drive nut (i.e. the plunger insert 210) positioned about the leadscrew, the drive nut configured to engage the plunger member to move the plunger member from the first position to the second position.
Regarding Claim 15, Flaherty discloses a drive assembly (310) for a drug delivery system, the assembly comprising:
A plunger member (204) configured to engage and move a stopper within a container (see generally 30 – note that the stopper and container and not required and as such the drive mechanism of Flaherty could be used in association with a container which comprises a two component pusher/stopper arrangement – see generally 204, 236 – without modification to the particular drive assembly – although such a modification would have been obvious – see Par. 83 – in order to provide better sealing by providing a separate rotating pusher, but a non-rotating stopper), with the plunger member having a first position (e.g. withdrawn position) and a second position (e.g. advanced position) axially spaced from the first position;
a constant force spring (312 - Par. 80) configured to move the plunger member from the first position to the second position; and
a leadscrew (202), the constant force spring being configured to bias the leadscrew in a rotational direction, wherein rotational movement of the leadscrew causes axial displacement of the plunger member from the first position to the second position (Par. 80).
Flaherty discloses the invention substantially as claimed except that that the leadscrew comprises a “drum portion” within which the constant force spring is contained, the drum portion of the leadscrew including a “rotary indicator”. Rather, Flaherty only provides a basic, schematic iteration of the constant force spring as generalized rectangular (see Fig. 19).
However, Kiilerich discloses a related drug delivery device (1) likewise including a related clock spring type biasing member (15, 16) wherein the biasing member is retained within a drum (22, 48) affixed to the proximal end of a leadscrew (21, 6 - see Fig. 1 and Fig. 2). Such a drum is used to rotationally fixate the outer end of the biasing member (Par. 75). Additionally, one having ordinary skill in the art that the drum (formed by the combination of 22 and 48) would also serve the distinct benefit of sealing the spring from intrusion by dust or other debris which could impede its function. For example, Zielinksi discloses a clock spring (56) which is received within a "suitable casing or housing 70" in order to "exclude dust and dirt therefrom" (Pg. 2, Col. 2, Ln. 24-27). While the clock spring of Zielinski is used for non-medical purposes, Examiner submits that the teachings establish a clear understanding of a utility that would be immediately understood and recognized by the drum of the Kiilerich reference.
It would have been obvious for a person having ordinary skill in the art at the time
the invention was made to provide the leadscrew/screw portion of the device of the
modified invention of Flaherty with a drum for housing the biasing member, as disclosed by Killerich, such a drum serving as a useful point to anchor the outer end of the spring to permit winding while also serving the function of sealing the spring within a cassette to prevent infiltration of dust or debris which could impede functioning of the spring.
In providing such a modification to Flaherty the external surface of the drum, which is visible, may serve as a rotatory indicator whereby a user will be able to confirm rotation of the drum and leadscrew based on visible rotation of the drum surface.
Flaherty (as modified by Kiilerich) discloses the leadscrew is engaged with the plunger member such that when the constant force spring biases the leadscrew in a rotational direction, the drum portion of the leadscrew causes the rotary indicator to move in a rotational manner (Par. 80).
Flaherty discloses the drum portion (as modified by Kiilerich) comprises a screw portion (i.e. the leadscrew) extending from the drum portion.
Regarding Claim 16, Flaherty discloses a drive nut (i.e. the plunger insert 210) positioned about the leadscrew, the drive nut configured to engage the plunger member to move the plunger member from the first position to the second position.
Claim(s) 1-3, 8-10, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,485,465 (“Moberg”) in view of U.S. Publication No. 2003/0055380 (“Flaherty”), U.S. Publication No. 2016/0038677 (“Kiilerich”), and U.S. Patent No. 1,984,206 (“Zielinski”).
Regarding Claim(s) 1 and 8, Moberg discloses a drive assembly (see e.g. Fig. 4) for a drug delivery system, the drive assembly comprising:
a plunger member (405) configured to engage and move a stopper (406) within a container (407), the plunger member having a first position (i.e. retracted, see generally Fig. 4) and a second position axially spaced from the first position (i.e. an advanced position, not shown, wherein the plunger has been advanced distally within the container to thereby expel the retained medicament); and
a leadscrew (404), the lead screw being biased by a motive component (412, 403, 401) in a rotational direction, wherein rotational movement of the leadscrew causes axial displacement of the plunger member from the first position to the second position.
Moberg discloses the invention substantially as claimed except that the plunger member is moved via a “constant force spring”. Rather Moberg discloses using motorized gearing mechanisms (401, 403; see Fig. 4). However, Flaherty discloses a related drive assembly comprising a leadscrew (202, 312 in combination) comprising a screw portion (202) configured to advance a plunger member (204) via rotation thereof. Flaherty discloses that the leadscrew can be rotated via a variety of mechanisms inclusive to motors (40; Par. 61) or a biasing member (312) when can be envisaged as a constant force “clock spring” (Par. 80). It would have been obvious for a person having ordinary skill in the art at the time the invention was made to modify the drive assembly of Moberg with a constant force clock spring as an alternative to the motor, as disclosed by Flaherty, as the prior art (see Flaherty) recognizes the two means to be suitable, art recognized alternatives to one another, whereby it has been held that simple substitution of known, suitable equivalent means requires only routine and customary skill in the art, see KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Moberg, as modified, discloses a leadscrew (see e.g. 404 – Moberg) engaged with the plunger member, the constant force spring (as replacing motor 401 – see Flaherty which pairs such a means with a leadscrew) configured to bias the leadscrew in a rotational direction, wherein rotational movement of the leadscrew causes axial displacement of the plunger member from the first position to the second position (see generally Col. 8, Ln. 19-39, Moberg; see also Flaherty, Par. 61 and 80).
Moberg, as modified, discloses the invention substantially as claimed except that the biasing member is received within a drum portion provided at the proximal end of the screw portion of the lead screw such that the screw portion extends distally therefrom. Rather Flaherty only provides a basic schematic visualization of the leadscrew/biasing member configuration (see Fig. 19). However, Kiilerich discloses a related drug delivery device (1) likewise including a related clock spring type biasing member (15, 16) wherein the biasing member is retained within a drum (22, 48) affixed to the proximal end of a leadscrew (21, 6 – see Fig. 1 and Fig. 2). Such a drum is used to rotationally fixate the outer end of the biasing member (Par. 75). Additionally, one having ordinary skill in the art that the drum (formed by the combination of 22 and 48) would also serve the distinct benefit of sealing the spring from intrusion by dust or other debris which could impede its function. For example, Zielinksi discloses a clock spring (56) which is received within a “suitable casing or housing 70” in order to “exclude dust and dirt therefrom” (Pg. 2, Col. 2, Ln. 24-27). While the clock spring of Zielinski is used for non-medical purposes, Examiner submits that the teachings establish a clear understanding of a utility that would be immediately understood and recognized by the drum of the Kiilerich reference.
It would have been obvious for a person having ordinary skill in the art at the time the invention was made to provide the leadscrew/screw portion of the device of the modified invention of Moberg (see Moberg as modified by Flaherty above) with a drum for housing the biasing member, as disclosed by Killerich, such a drum serving as a useful point to anchor the outer end of the spring to permit winding while also serving the function of sealing the spring within a cassette to prevent infiltration of dust or debris which could impede functioning of the spring.
In performing such a modification to the invention of Moberg, the drum portion will comprise an outer surface which is capable of being used as a rotary indicator whereby observance of rotation of the outer surface of the drum portion of modified Moberg is indicative of rotation of the dependent leadscrew.
Regarding Claims 2 and 9, Moberg, as modified (see Flaherty and Kiilerrich) discloses the leadscrew is engaged with the plunger member (see Moberg – Fig. 4) such that when the constant force spring biases the leadscrew in a rotational direction (see Par. 80 – Flaherty), the drum portion of the leadscrew causes the rotary indicator to move in a rotational manner (see the drum portion added to the leadscrew in view of Kiilerrich).
Regarding Claims 3 and 10, Moberg, as modified (see Flaherty and Kiilerich) discloses a screw portion extending from the drum portion (see Moberg with the motor being replaced by a constant force spring provided within a drum portion provided at the proximal end of the lead screw).
Regarding Claim(s) 15, Moberg discloses a drive assembly (see e.g. Fig. 4) for a drug delivery system, the drive assembly comprising:
a plunger member (405) configured to engage and move a stopper (406) within a container (407), the plunger member having a first position (i.e. retracted, see generally Fig. 4) and a second position axially spaced from the first position (i.e. an advanced position, not shown, wherein the plunger has been advanced distally within the container to thereby expel the retained medicament); and
a leadscrew (404), the lead screw being biased by a motive component (412, 403, 401) in a rotational direction, wherein rotational movement of the leadscrew causes axial displacement of the plunger member from the first position to the second position.
Moberg discloses the invention substantially as claimed except that the plunger member is moved via a “constant force spring”. Rather Moberg discloses using motorized gearing mechanisms (401, 403; see Fig. 4). However, Flaherty discloses a related drive assembly comprising a leadscrew (202, 312 in combination) comprising a screw portion (202) configured to advance a plunger member (204) via rotation thereof. Flaherty discloses that the leadscrew can be rotated via a variety of mechanisms inclusive to motors (40; Par. 61) or a biasing member (312) when can be envisaged as a constant force “clock spring” (Par. 80). It would have been obvious for a person having ordinary skill in the art at the time the invention was made to modify the drive assembly of Moberg with a constant force clock spring as an alternative to the motor, as disclosed by Flaherty, as the prior art (see Flaherty) recognizes the two means to be suitable, art recognized alternatives to one another, whereby it has been held that simple substitution of known, suitable equivalent means requires only routine and customary skill in the art, see KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Moberg, as modified, discloses a leadscrew (see e.g. 404 – Moberg) engaged with the plunger member, the constant force spring (as replacing motor 401 – see Flaherty which pairs such a means with a leadscrew) configured to bias the leadscrew in a rotational direction, wherein rotational movement of the leadscrew causes axial displacement of the plunger member from the first position to the second position (see generally Col. 8, Ln. 19-39, Moberg; see also Flaherty, Par. 61 and 80).
Moberg, as modified, discloses the invention substantially as claimed except that the biasing member is received within a drum portion provided at the proximal end of the screw portion of the lead screw such that the screw portion extends distally therefrom. Rather Flaherty only provides a basic schematic visualization of the leadscrew/biasing member configuration (see Fig. 19). However, Kiilerich discloses a related drug delivery device (1) likewise including a related clock spring type biasing member (15, 16) wherein the biasing member is retained within a drum (22, 48) affixed to the proximal end of a leadscrew (21, 6 – see Fig. 1 and Fig. 2). Such a drum is used to rotationally fixate the outer end of the biasing member (Par. 75). Additionally, one having ordinary skill in the art that the drum (formed by the combination of 22 and 48) would also serve the distinct benefit of sealing the spring from intrusion by dust or other debris which could impede its function. For example, Zielinksi discloses a clock spring (56) which is received within a “suitable casing or housing 70” in order to “exclude dust and dirt therefrom” (Pg. 2, Col. 2, Ln. 24-27). While the clock spring of Zielinski is used for non-medical purposes, Examiner submits that the teachings establish a clear understanding of a utility that would be immediately understood and recognized by the drum of the Kiilerich reference.
It would have been obvious for a person having ordinary skill in the art at the time the invention was made to provide the leadscrew/screw portion of the device of the modified invention of Moberg (see Moberg as modified by Flaherty above) with a drum for housing the biasing member, as disclosed by Killerich, such a drum serving as a useful point to anchor the outer end of the spring to permit winding while also serving the function of sealing the spring within a cassette to prevent infiltration of dust or debris which could impede functioning of the spring.
In performing such a modification to the invention of Moberg, the drum portion will comprise an outer surface which is capable of being used as a rotary indicator whereby observance of rotation of the outer surface of the drum portion of modified Moberg is indicative of rotation of the dependent leadscrew.
Moberg, as modified (see Flaherty and Kiilerrich) discloses the leadscrew is engaged with the plunger member (see Moberg – Fig. 4) such that when the constant force spring biases the leadscrew in a rotational direction (see Par. 80 – Flaherty), the drum portion of the leadscrew causes the rotary indicator to move in a rotational manner (see the drum portion added to the leadscrew in view of Kiilerrich).
Moberg, as modified (see Flaherty and Kiilerich) discloses a screw portion extending from the drum portion (see Moberg with the motor being replaced by a constant force spring provided within a drum portion provided at the proximal end of the lead screw).
Claim(s) 4-7, 11-14, and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,485,465 (“Moberg”) in view of U.S. Publication No. 2003/0055380 (“Flaherty”), U.S. Publication No. 2016/0038677 (“Kiilerich”), and U.S. Patent No. 1,984,206 (“Zielinski”) as applied above, and further in view of U.S. Publication No. 2013/0304021 (“Carbiri”).
Regarding Claim 4-7, 11-14, and 16-19, Moberg, as modified above, discloses the invention substantially as claimed except that the leadscrew includes a “drive nut” positioned about the leadscrew, the drive member configured to engage and axially move an outer plunger of the plunger member, an inner plunger received within the outer plunger being moveable relative to the outer plunger via movement of the outer plunger.
However, Cabiri discloses a related drug delivery device utilizing a leadscrew assembly configured to drive a plunger (Fig. 2A) wherein a driving mechanism (234 - equivalent to the biasing member of the modified invention of Moberg as it provides the driving force for rotating the leadscrew) is provided at the proximal end of a leadscrew screw portion (240), the leadscrew having a drive member (i.e. threads 229”) positioned about the leadscrew (see Fig. 2A), wherein the plunger member comprises an outer plunger (230) and an inner plunger (220) moveable relative to the outer plunger (see Fig. 2A and 2B), at least a portion of the inner plunger received within the outer plunger when the plunger member Is in the first position (see Fig. 2B).
Cabiri further discloses the drive member is configured to engage and axially move the outer plunger (230 – see Figs. 2A and 2B), wherein axial movement of the outer plunger is configured to cause axial movement of the inner plunger (see Figs. 2A and 2B), and wherein the outer plunger includes a threaded portion (228’) configured to engage the drive member (see Fig. 2A, 2B).
Such a telescoping arrangement would be understood by an ordinary artisan to affect a longer stroke length from a more compact piston configuration (see and compare Fig. 2A and 2B – note that because of the telescoping/nested arrangement the leadscrew/plunger arrangement can assume a much more compact configuration in the first position and a longer extended configuration in the second position).
It would have been obvious for a person having ordinary skill in the art at the time the invention was made to replace the lead screw of the modified device of Moberg with a telescoping lead screw, as disclosed by Cabiri, in order to increase the stroke length of the piston without adding significant proximal length, thereby permitting the device to take up less space while delivering a larger volume of medicament.
“About” is defined as “used to express location in a particular place”, see Oxford University Press Online Dictionary. See also Merriam-Webster’s Online Dictionary which defines about as “reasonably close to”, “in the immediate neighborhood of : NEAR”, “engaged in”, “over or in different parts of”…etc. Examiner submits that “about” the interior circumference is still “about” in accordance with the broadest reasonable interpretation of the claims.
Conclusion
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 09/22/2026
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