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.
Claims 8, 9, 11, 21, and 22 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.
The term “approximately” in claims 8, 9, 11, 21, and 22 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 7, 15-18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gravesen et al. (US 2016/0008536, hereafter “Gravesen”).
Regarding claim 1, Hawkins discloses a system (Figs. 17 and 18) for filling an on-body injector, the system comprising: the on-body injector (30) having a medicament reservoir (the reservoir defined within 30); a fill cartridge (99) having an internal chamber (the internal chamber within 99) containing a medicament (MPEP 2115 states: Claim analysis is highly fact-dependent. A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).); a filling station (170) for receiving the on-body injector and the fill cartridge, the filling station comprising: an injector socket (the adaptor for mating with the socket of the patch pump system 30; para. [0123]) for receiving the on-body injector; a cartridge socket (the opening in 170 that receives 99) for receiving the fill cartridge; a fluid path section (conduit 180; Fig. 18; para. [0125] – [0127]) providing fluid communication between the injector socket and the cartridge socket; and a pump (165) operatively engaging the fluid path section to transfer the medicament from the internal chamber of the fill cartridge to the medicament reservoir of the on-body injector (para. [0126] – [0127]).
Regarding claim 2, Gravesen further discloses the system of claim 1, wherein the pump comprises one or more rollers (189) configured to engage a resilient tubing section of the fluid path section. (Fig. 18)
Regarding claim 3, Gravesen further discloses the system of claim 1, wherein the injector socket comprises a needle (22) for piercing a septum or port of the on-body injector. (Fig. 18)
Regarding claim 4, Gravesen further discloses the system of claim 1, wherein the cartridge socket comprises a needle (181) for piercing a septum or stopper of the fill cartridge. (Fig. 18)
Regarding claim 5, Gravesen further discloses the system of claim 1, wherein the injector socket, the cartridge socket, and the fluid path section are provided on a removable transfer tray (the tray defining 31; para. [0123]; see how 170 may be coupled or decoupled from 30).
Regarding claim 7, Gravesen further discloses the system of claim 1, wherein the filling station comprises an inflation chamber (the chamber within 20f) configured to deliver a pre-fill inflation volume of air to the on-body injector.
Regarding claim 15, Gravesen discloses a filling station (Figs. 17 and 18) for filling an on-body injector, the filling station comprising: a removable transfer tray (the tray defining 31; para. [0123]; see how 170 may be coupled or decoupled from 30) comprising: an injector socket (the adaptor for mating with the socket of the patch pump system 30; para. [0123]) for receiving the on-body injector; a cartridge socket (the opening in 170 that receives 99) for receiving a fill cartridge; a fluid path section (conduit 180; Fig. 18; para. [0125] – [0127]) providing fluid communication between the injector socket and the cartridge socket; and a pump (165) operatively engaging the fluid path section to transfer the medicament from an internal chamber of the fill cartridge to a medicament reservoir of the on-body injector (para. [0126] – [0127]).
Regarding claim 16, Gravesen further discloses the filling station of claim 15, wherein the pump comprises one or more rollers (189) configured to engage a resilient tubing section of the fluid path section. (Fig. 18)
Regarding claim 17, Gravesen further discloses the filling station of claim 15, wherein the injector socket comprises a needle (22) for piercing a septum or port of the on-body injector. (Fig. 18)
Regarding claim 18, Gravesen further discloses the filling station of claim 15, wherein the cartridge socket comprises a needle (181) for piercing a septum or stopper of the fill cartridge. (Fig. 18)
Regarding claim 20, Gravesen further discloses the filling station of claim 15, further comprising an inflation chamber (the chamber within 20f) configured to deliver a pre-fill inflation volume of air to the on-body injector.
Claim(s) 1, 10, 12, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hawkins et al. (US 7,938,801, hereafter “Hawkins”).
Regarding claim 1, Hawkins discloses a system (Figs. 4-11) for filling an on-body injector, the system comprising: the on-body injector (210) having a medicament reservoir (the reservoir within 210); a fill cartridge (132) having an internal chamber (the chamber within 132) containing a medicament (MPEP 2115); a filling station (300) for receiving the on-body injector and the fill cartridge, the filling station comprising: an injector socket (the portion of 300 receiving 210) for receiving the on-body injector; a cartridge socket (332) for receiving the fill cartridge; a fluid path section (336) providing fluid communication between the injector socket and the cartridge socket; and a pump (335) operatively engaging the fluid path section to transfer the medicament from the internal chamber of the fill cartridge to the medicament reservoir of the on-body injector.
Regarding claim 10, Hawkins further discloses the system of claim 1, wherein the filling station comprises a controller (341) for actuating the pump. (Col. 5, lines 22-34)
Regarding claim 12, Hawkins further discloses the system of claim 10, wherein the controller is configured to run the pump in reverse to evacuate air from the fluid path section. (Col. 5, line 54 – Col. 6, line 3)
Regarding claim 15, Hawkins discloses a filling station (Figs. 4-11) for filling an on-body injector (210), the filling station comprising: a removable transfer tray (337) comprising: an injector socket (the portion of 300 receiving 210) for receiving the on-body injector; a cartridge socket (332) for receiving a fill cartridge; a fluid path section (336) providing fluid communication between the injector socket and the cartridge socket; and a pump (335) operatively engaging the fluid path section to transfer the medicament from an internal chamber of the fill cartridge to a medicament reservoir of the on-body injector.
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 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) 6 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gravesen in view of Schabbach et al. (US 2016/0317737, hereafter “Schabbach”).
Regarding claim 6, Gravesen further discloses the system of claim 5, wherein the filling station comprises: a base (the base portion of 30) for receiving the transfer tray; and a lid (the panel at the top of 30 which is positioned directly below and abuts against the panel defining 31) connected to the base, but fails to disclose the lid is pivotally connected to the base.
Schabbach teaches a system comprising a lid (15) pivotally connected to a base (12). (Fig. 1; claim 11)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the application to modify the lid of Gravesen to be pivotally connected to the base as taught by Schabbach since this is combining prior art elements (pivoting connections) according to known methods (pivoting) to yield predictable results (providing a pivoting connection between a lid and a base). The motivation for doing so would be to provide a simple and easy to use means to connect the lid to the base.
Regarding claim 19, Gravesen further discloses the filling station of claim 15, further comprising: a base (the base portion of 30) for receiving the transfer tray; and a lid (the panel at the top of 30 which is positioned directly below and abuts against the panel defining 31) connected to the base, but fails to disclose the lid is pivotally connected to the base.
Schabbach teaches a system comprising a lid (15) pivotally connected to a base (12). (Fig. 1; claim 11)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the application to modify the lid of Gravesen to be pivotally connected to the base as taught by Schabbach since this is combining prior art elements (pivoting connections) according to known methods (pivoting) to yield predictable results (providing a pivoting connection between a lid and a base). The motivation for doing so would be to provide a simple and easy to use means to connect the lid to the base.
Claim(s) 8, 9, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gravesen.
Regarding claim 8, Gravesen further discloses the system of claim 7, but fails to disclose the pre-fill inflation volume of air is approximately 100 pL.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the application to modify the pre-fill inflation volume of air to be approximately 100 pL since applicant has not disclosed that having the pre-fill inflation volume of air to be approximately 100 pL solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs.
Furthermore, absent a teaching as to criticality that having the pre-fill inflation volume of air to be approximately 100 pL, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). In this case, para. [0014] of the original specification merely states:
In some embodiments, the pre-fill inflation volume of air is approximately 100 pL.
Regarding claim 9, Gravesen further discloses the system of claim 1, but fails to disclose the medicament reservoir of the on-body injector has a volume of approximately 3 mL.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the application to modify the medicament reservoir of the on-body injector to have a volume of approximately 3 mL since applicant has not disclosed that having the medicament reservoir of the on-body injector to have a volume of approximately 3 mL solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs.
Furthermore, absent a teaching as to criticality that having the medicament reservoir of the on-body injector to have a volume of approximately 3 mL, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). In this case, para. [0015] of the original specification merely states:
In some embodiments, the medicament reservoir of the on-body injector has a volume of approximately 3 mL.
Regarding claim 21, Gravesen further discloses the filling station of claim 20, but fails to disclose the pre-fill inflation volume of air is approximately 100 pL.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the application to modify the pre-fill inflation volume of air to be approximately 100 pL since applicant has not disclosed that having the pre-fill inflation volume of air to be approximately 100 pL solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs.
Furthermore, absent a teaching as to criticality that having the pre-fill inflation volume of air to be approximately 100 pL, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). In this case, para. [0014] of the original specification merely states:
In some embodiments, the pre-fill inflation volume of air is approximately 100 pL.
Claim(s) 11, 22, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hawkins.
Regarding claim 11, Hawkins further discloses the system of claim 10, but fails to disclose the controller is configured to actuate the pump to fill the medicament reservoir of the on-body injector to approximately 10 psi.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the application to modify the controller to be configured to actuate the pump to fill the medicament reservoir of the on-body injector to approximately 10 psi since applicant has not disclosed that having the controller to be configured to actuate the pump to fill the medicament reservoir of the on-body injector to approximately 10 psi solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs.
Furthermore, absent a teaching as to criticality that having the controller to be configured to actuate the pump to fill the medicament reservoir of the on-body injector to approximately 10 psi, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). In this case, para. [0017] of the original specification merely states:
In some embodiments, the controller is configured to actuate the pump to fill the medicament reservoir of the on-body injector to approximately 10 psi.
Regarding claim 22, Hawkins further discloses the filling station of claim 15, wherein the filling station comprises a controller (341) for actuating the pump (Col. 5, lines 22-34), but fails to disclose the controller is configured to actuate the pump to fill the medicament reservoir of the on-body injector to approximately 10 psi.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the application to modify the controller to be configured to actuate the pump to fill the medicament reservoir of the on-body injector to approximately 10 psi since applicant has not disclosed that having the controller to be configured to actuate the pump to fill the medicament reservoir of the on-body injector to approximately 10 psi solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs.
Furthermore, absent a teaching as to criticality that having the controller to be configured to actuate the pump to fill the medicament reservoir of the on-body injector to approximately 10 psi, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). In this case, para. [0017] of the original specification merely states:
In some embodiments, the controller is configured to actuate the pump to fill the medicament reservoir of the on-body injector to approximately 10 psi.
Regarding claim 23, Hawkins further discloses the filling station of claim 22, wherein the controller is configured to run the pump in reverse to evacuate air from the fluid path section. (Col. 5, line 54 – Col. 6, line 3)
Allowable Subject Matter
Claims 13 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL J GRAY whose telephone number is (571)270-0544. The examiner can normally be reached 9:00 am - 5:00 pm, Monday - Friday.
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/PAUL J GRAY/Primary Examiner, Art Unit 3753
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