DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
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Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 9,408,972. Although the claims at issue are not identical, they are not patentably distinct from each other because the cited patent discloses substantially similar structural limitations and/or method steps as those disclose at least in claim 1 of this application. Claim 5 of the cited patent discloses:
“[a] needle-free injection device comprising: an outer housing; an inner housing, receiving a needle-free syringe in one end, the inner housing being moveable within the outer housing between a syringe loading position and a firing position; an activation button operatively associated with the inner and outer housing; and a housing lock engaged by the activation button to prohibit movement of the inner housing from the syringe loading position to the firing position when the activation button is activated in the syringe loading position; a hammer within the inner housing communicating with a plunger within the needle-free syringe; a release mechanism engaged by the activation button to release stored energy to power the hammer, wherein the activation button can only engage the release mechanism when the housing is in the firing position; and a syringe mount to receive a needle-free syringe at one end of the inner housing, the syringe mount comprising an interlocking structure cooperating with the inner housing and outer housing to prevent the placement of a needle-free syringe into engagement with the syringe mount unless the inner housing is in the syringe loading position.”
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bingham et al. (WO2008063995A2; hereinafter “WO '995”) in view of Parsons (WO1987003494A1; hereinafter “WO '494).
In relation to claim 1, WO '995 discloses a needle-free injection device comprising:
an outer housing; (Abstract: "An outer housing (28) slideably supports the inner
housing.")
an inner housing, the inner housing being moveable within the outer housing;
(Abstract: "The device includes an inner housing (12) having opposed ends... An outer
housing (28) slideably supports the inner housing.")
a syringe mount to receive a needle-free syringe at one end of the inner housing;
(Abstract: "A syringe (18) is disposed in one end of the inner housing.")
WO '995 does not explicitly disclose the inner housing being moveable between a "syringe loading position" and a "firing position," nor does it disclose an "interlocking structure cooperating with the inner housing and outer housing to prevent placement of the needle free syringe into engagement with the syringe mount unless the inner housing is in the syringe loading position."
WO '494 discloses a needleless hypodermic injection device with a safety interlocking
mechanism. This reference teaches:
A pivotal keyway on the power supply mechanism that is pivotal from a first
loading position to a second holding position. (page 3, starting in line 23: "The safety interlocking means includes a key on the syringe and a pivotal keyway on the end of the power
supply mechanism for receiving the syringe. The keyway is pivotal from a first loading
position for receiving the key on the syringe so that the syringe can be inserted into and
removed from the power supply mechanism. The keyway is pivotal to a second holding
position for holding the syringe so that the syringe is irremovably held in the power
supply mechanism so long as the keyway is in the holding position.")
A mechanism that prevents movement from the loading position to the holding position unless the syringe is fully inserted. (page 3, starting in line 33: "The power supply mechanism further includes means for preventing the pivotal keyway from moving from the loading position to the holding position unless the syringe is fully inserted into the power supply mechanism.")
Based on the above comments, it would have been obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of WO '995 and WO '494. Both references are in the field of needle-free injection devices and address the need for safe and reliable operation. One of ordinary skill would have been motivated to incorporate the safety interlocking mechanism
of WO '494 into the device of WO '995 to prevent improper syringe loading and to ensure the device is only operated when a syringe is properly secured. The "loading position" and "holding position" of WO '494 are analogous to the "syringe loading position" and "firing position" of the present application. Therefore, the combination of these references teaches all the limitations of claim 1.
In relation to claim 10, claim 10 is a method claim that substantially mirrors the apparatus of claim 1. The analysis for the rejection of claim 1 applies equally to claim 10. WO '995 teaches the step of
providing a needle-free injection device with an inner and outer housing, and a syringe mount. WO '494 teaches the step of providing an interlocking structure (the pivotal keyway) that prevents engagement unless the device is in a specific loading position. The motivation to combine the teachings to arrive at the claimed method is the same as for claim 1: to enhance the safety and reliability of the injection device. Therefore, the combination of these references teaches all the steps of claim 10.
Claims 2-5, 8, 9, 11-14, 17, and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bingham et al. (WO2008063995A2; hereinafter “WO '995”) in view of Parsons (WO1987003494A1; hereinafter “WO '494”), as discussed above, and in further view of Rice et al. (US 6,673,035; hereinafter “US '035”).
In relation to claim 2, as established in the rejection of claim 1, the combination of WO '995 and WO '494 teaches a needle-free injection device with an interlocking structure. Claim 2 further specifies that the interlocking structure comprises a pawl that rotates to an outward position by contact with the syringe and is biased to a mounted position. WO '494 discloses a "pivotal keyway," which is a rotating mechanism, but does not explicitly disclose a "pawl" or a biasing mechanism. US '035 discloses a medical injector with a medicament loading system that includes an adapter with resilient tabs:
"The first side of the adapter has a plurality of resilient tabs that flex outward upon insertion of the medicament cartridge into the adapter and flex inward after the seal is substantially flush with the wall for locking the medicament cartridge into the adapter" (see column 1, starting in line 66 to column 2, line 4).
These resilient tabs that flex outward upon insertion and inward to lock are analogous to a
pawl that rotates to an outward position and is biased to a mounted position. The flexing action of the tabs is a form of biasing. It would have been obvious to one of ordinary skill in the art to incorporate the resilient, flexible locking tabs of US '035 into the interlocking mechanism of the combined WO '995 and WO '494 device to create a simple and effective pawl-like locking mechanism. The motivation would be to provide a reliable, self-locking mechanism for securing the syringe, which is a common design consideration in such devices. Therefore, the combination of these three references teaches all the limitations of claim 2.
In relation to claim 3, claim 3 depends on claim 2 and adds the limitation that the pawl comprises a tab extending through a corresponding opening defined by the inner housing. As established in the rejection of claim 2, the combination of WO '995, WO '494, and US '035
teaches a needle-free injection device with a pawl-like interlocking structure (the resilient
tabs of US '035) that rotates or flexes to engage and lock the syringe. The pawl must interact
with both the inner housing (where the syringe mounts) and the outer housing (which
provides the position-dependent blocking mechanism taught by WO '494).
For the pawl to cooperate with both the inner and outer housings as required by claim 1,
the pawl must necessarily have a structural connection that passes through the inner
housing to reach the outer housing. This is a fundamental mechanical requirement. The
specific implementation of this connection as "a tab extending through a corresponding
opening" is the most straightforward and obvious mechanical solution. Therefore, it would have been obvious to one of ordinary skill in the art to provide an opening in the inner housing through which a tab portion of the pawl extends, as this is the simplest way to allow the pawl (mounted on the inner housing) to interact with blocking surfaces on the outer housing. This is basic mechanical design: when a component on one housing must interact with features on another housing, a passage or opening through the intervening structure is required. The motivation is inherent in the functional requirement that the interlocking structure must cooperate with both housings, as taught by the combination of references. This represents no more than the predictable use of prior art elements according to their established functions.
In relation to claim 4, claim 4 depends on claim 3 and adds the limitation that the tab further extends into an open area defined by the outer housing when the inner housing is in the syringe loading
position.
As established in the rejection of claim 3, the tab extends through the inner housing to
allow the pawl to interact with the outer housing. For the position-dependent interlocking mechanism taught by WO '494 to function, the outer housing must provide clearance (an open area) for the tab when the inner housing is in the loading position. This allows the pawl to rotate outward to receive the syringe.
WO '494 teaches that the keyway must be able to pivot to a "first loading position for
receiving the key on the syringe so that the syringe can be inserted" (page 6, starting in line 26). For this pivoting or rotating action to occur, there must necessarily be space (an open area) in the outer housing to accommodate the movement of the tab. Without such an open area, the pawl could not rotate to the outward position required to receive the syringe. Therefore, it would have been obvious to one of ordinary skill in the art to provide an open area in the outer housing aligned with the opening in the inner housing when in the loading position. This is a straightforward mechanical requirement to enable the claimed functionality. The motivation is inherent in the need to allow the pawl to move freely when syringe loading is permitted, which is the fundamental purpose of having a loading position as taught by WO '494.
In relation to claim 5, claim 5 depends on claim 3 and adds the limitation that the tab contacts an abutment surface defined by the outer housing when the inner housing is not in the syringe loading
position, and this contact prevents the pawl from rotating to the outward position. This limitation describes the blocking mechanism that prevents syringe loading except when in the loading position. WO '494 explicitly teaches this functionality:
"The power supply mechanism further includes means for preventing the pivotal keyway from moving from the loading position to the holding position unless the syringe is fully inserted into the power supply mechanism" [see page 3, starting in line 32].
This teaching describes a mechanical blockage that prevents movement of the keyway
(analogous to the pawl) when not in the correct position. As established in claims 3 and 4,
the tab extends through the inner housing into the space defined by the outer housing.
When the inner housing moves from the loading position to the firing position, the opening
in the outer housing (the "open area" of claim 4) is no longer aligned with the tab.
It would have been obvious to one of ordinary skill in the art that when the open area is not aligned with the tab, the tab will contact the solid wall of the outer housing (an abutment surface), thereby preventing the pawl from rotating outward. This is the natural and inevitable result of the position-dependent mechanism taught by WO '494. The abutment surface is simply the portion of the outer housing that blocks the tab's movement when the inner housing is not in the loading position. This is a direct and straightforward implementation of the safety interlock mechanism taught by the combination of references.
In relation claim 8, claim 8 depends on claim 2 and adds the limitation that the inner housing is prevented from moving from the syringe loading position to the firing position if the pawl is in the outward position. This is an inherent feature of the safety interlocking mechanism taught by WO '494. If the pawl is in the outward position, it means the syringe is not properly seated. WO '494 teaches that the device cannot be operated unless the syringe is fully secured. Preventing the movement of the inner housing to the firing position when the syringe is not properly loaded (i.e., when the pawl is in the outward position) is a fundamental aspect of the disclosed safety mechanism. Therefore, this limitation is taught by the combination of the references.
In relation to claim 9, claim 9 depends on claim 1 and adds the limitation of an orientation structure on the needle-free syringe that engages with guides on the syringe mount to prevent rotation. The primary and secondary references teach the core device. Providing an orientation structure to prevent rotation is a well-known and obvious design consideration for any two components that need to be mated in a specific orientation. For example, WO '494 discloses a "key on the syringe and a pivotal keyway on the end of the power supply mechanism” [see page 3, lines 24-25] which inherently provides a specific orientation for the syringe. It would have been obvious to one of ordinary skill in the art to include guides and corresponding structures to ensure proper rotational alignment of the syringe within the mount, preventing improper loading and ensuring correct engagement of the interlocking mechanism. This is a matter of routine mechanical design to improve the reliability and safety of the device.
In relation to claims 11-14, claims 11-14 are method claims that correspond to the apparatus limitations of claims 2-5. The same reasoning for the rejection of claims 2-5 applies to claims 11-14:
Claim 11 (corresponding to claim 2): The step of causing a pawl to rotate to an outward
position by contact with the syringe surface and biasing it to a mounted position is taught by the combination of the resilient flexing tabs of US '035 with the interlocking mechanism of WO '494.
Claim 12 (corresponding to claim 3): The step of providing a tab extending through an opening in the inner housing is obvious as the necessary mechanical implementation to allow the pawl to interact with both the inner and outer housings, as required by the combination of references.
Claim 13 (corresponding to claim 4): The step of having the tab extend into an open area in the outer housing when in the loading position is a necessary consequence of the position-dependent mechanism taught by WO '494, which requires clearance for the pawl to move when loading is permitted.
Claim 14 (corresponding to claim 5): The step of preventing pawl rotation via tab contact with an abutment surface when not in the loading position is the direct implementation of the blocking mechanism taught by WO '494.
Based on the above comments, the combination of WO '995, WO '494, and US '035 teaches all the claimed method steps for the same reasons stated in the rejection of claims 2-5.
In relation to claim 17, claim 17 is a method claim that corresponds to the apparatus limitations of claim 8. The same reasoning for the rejection of claim 8 applies to claim 17. The step of preventing the inner housing from moving from the syringe loading position to the firing position if the pawl is in the outward position is an inherent feature of the safety interlocking mechanism taught by WO '494. Therefore, the combination of the references teaches this limitation of claim 17.
In relation to claim 18, claim 18 is a method claim that corresponds to the apparatus limitations of claim 9. The same reasoning for the rejection of claim 9 applies to claim 18. The steps of providing the
syringe with an orientation structure and engaging that structure with guides on the syringe mount to prevent rotation are taught or made obvious by the combination of the references. WO '494 discloses a "key on the syringe and a pivotal keyway," which is a form of orientation structure and guide. The motivation to include such features is to ensure proper alignment and engagement of the syringe, which is a matter of routine design for improving the safety and reliability of the device. Therefore, the combination of the references teaches the limitations of claim 18.
Claims 6-7 and 15-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bingham et al. (WO2008063995A2; hereinafter “WO '995”) in view of Parsons (WO1987003494A1; hereinafter “WO '494”) and Rice et al. (US 6,673,035; hereinafter “US '035”), as discussed above, and in further view of Parsons (US 5,569,189A).
In relation to claim 6, claim 6 depends on claim 2 and adds a release mechanism and an eject button that causes the pawl to rotate to the outward position. As discussed above, the primary and secondary references teach the core interlocking mechanism. Parsons, in the context of a cocking/carrying case, discloses a mechanism for interacting with the injector. While not an exact match for an eject button, it teaches the concept of an external component acting on the injector's mechanism. A release mechanism with an eject button is a common feature in devices that require the removal of a disposable component [see Parsons; figures 5a and 6a]. Accordingly, it would have been an obvious design choice to include an eject button to simplify the removal of the syringe. The motivation is to improve user convenience and efficiency, especially in a clinical setting where multiple injections may be administered.
In relation to claim 7, claim 7 depends on claim 6 and adds the limitation of an extension from the outer housing that shields the eject button when the inner housing is moved toward the firing position. This is a common safety feature to prevent accidental actuation of a button. The motivation
to prevent accidental actuation of triggers and buttons on medical devices is strong, as noted in the background of WO '995 which discusses the risks of inadvertent pressing of an exposed trigger [see paragraph 0007]. Therefore, it would have been obvious to one of ordinary skill in the art to add a shield to the eject button to prevent accidental ejection of the syringe, especially during the critical phase of moving the device to the firing position. This is a simple and well-known mechanical design principle for enhancing safety and would have been a matter of routine design to implement.
In relation to claims 15 and 16, claims 15-16 are method claims that correspond to the apparatus limitations of claims 6-7. The same reasoning for the rejection of claims 6-7 applies to claims 15-16. The steps of providing a release mechanism with an eject button (claim 15) and shielding the eject button (claim 16) are taught or made obvious by the combination of the references for the reasons previously stated. The combination of WO '995, WO '494, and Parsons teaches the claimed method steps.
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783