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 Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
a. The following claim limitations
i. “activation mechanism” in claim 1 and 15
ii. “detection elements” in claim 1 and 15
has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder
i. “mechanism” is the generic placeholder for “activation mechanism”
ii. “elements” is the generic placeholder for “detection elements”
coupled with functional language
i. “is movable between certain predetermined states when interacting with the drive unit” in claim 1 and 15
ii. “operably connected to the recording unit and positioned such as to detect when the activation mechanism has been moved between certain predetermined states” in claim 1 and 15
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 1 and 15 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
i. instant paragraph [0066] describes portions of plunger rod 152 and cut out 184 and passage 186 as parts of the activation mechanism.
ii. see the 112(b) rejection below for “detection elements”
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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 1-19 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.
Claims 1 and 15 recite “detection elements” (see 112f interpretation above), however the specification does not provide any disclosure about the specific structure of the “detection elements”. For purposes of examination, any structure that meets the functional limitation of “operably connected to the recording unit and positioned such as to detect when the activation mechanism has been moved between certain predetermined states” is considered to meet the structural elements of “detection elements”.
Claims 2-14 and 16-19 are rejected due to their dependency on claims 1 and 15.
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) 1-4 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krulevitch (WO 2010098931).
Regarding Claim 1, Krulevitch teaches (fig 3) A medicament delivery device (100) comprising:
a housing (151) configured to accommodate a medicament container (150) filled with medicament;
a drive unit comprising a plunger rod (154) operable to act on the medicament container (150);
a mechanical activation mechanism (156) configured to interact with the drive unit and wherein the mechanical activation mechanism is movable between certain predetermined states when interacting with the drive unit (see [0034] which teaches that 156 guides rod 154; the examiner interprets that the movement of the piston rod 154 along the axis results in different predetermined states, one is the beginning before dispensing and one after dispensing);
a recording unit (168) capable of recording status changes of the medicament delivery device including the status of the mechanical activation mechanism (See [0037] teaching memory 168, it is interpreted that there must be some 'recording unit' since the sensor information is saved in this memory; also see [0033] teaching that sensors detect movement of the rod which interacts with the mechanical activation mechanism, therefore it is interpreted that 168 can record the status of the mechanical activation mechanism); and
detection elements (174) operably connected to the recording unit and positioned such as to detect when the activation mechanism has been moved between certain predetermined states (See [0033] teaching that device 100 has sensors detect linear motion of rod 154).
Regarding Claim 2, Krulevitch teaches the medicament delivery device according to claim 1, wherein the mechanical activation mechanism (156) comprises a section of the plunger rod (154; see Fig 3, it appears 154 is a portion of 156).
Regarding Claim 3, Krulevitch teaches the medicament delivery device according to claim 1, further comprising a manually operated actuator (104) that, when operated, alters the drive unit from a locked state (see [0044]; the "sleep mode" is considered to be a 'locked state') to a release state (See [0045], depressing the knob 104 to inject the dose is considered to be the 'release state').
Regarding Claim 4, Krulevitch teaches the medicament delivery device according to claim 3, wherein, in the release state, the plunger rod (154) of the drive unit is released and moved to exert a pressure on the medicament inside the medicament container (movement of rod in a distal direction in the container would necessarily exert a pressure on the medicament inside the medicament container), and wherein the detection elements are arranged to detect the movement (see [0045] teaching that when the knob 104 is depressed the sensors detect movement of the plunger and the actual injection of the dose).
Regarding Claim 14, Krulevitch teaches the medicament delivery device according to claim 1, wherein the recording unit further comprises data storage elements (See memory 168, this is considered the recording unit and also the ‘storage’; also see [0035] teaching an RFID tag for storage of data).
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) 1-4 and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giambattista (WO 2011126439) in view of Jespersen (US 20110009821).
Regarding Claim 1, Giambattista teaches (Fig 1a) a medicament delivery device comprising:
a housing (110) configured to accommodate a medicament container (130) filled with medicament;
a drive unit comprising a plunger rod (116) operable to act on the medicament container (130);
a mechanical activation mechanism (235) configured to interact with the drive unit (see Fig 2B where 235 interacts with plunger rod 116) and wherein the mechanical activation mechanism is movable between certain predetermined states when interacting with the drive unit (See Pg. 11 lines 1-11).
Giambattista does not teach a medicament delivery device comprising a recording unit capable of recording status changes of the medicament delivery device including the status of the mechanical activation mechanism; and detection elements operably connected to the recording unit and positioned such as to detect when the activation mechanism has been moved between certain predetermined states.
Jespersen teaches (Figs 1-3a) a medicament delivery device (1) comprising:
a housing (interpreting the line where 2 is point to be the housing) configured to accommodate a medicament container (3) filled with medicament;
a drive unit comprising a plunger rod (5) operable to act on the medicament container;
a recording unit capable of recording status changes of the medicament delivery device including the status of the mechanical activation mechanism (0073] teaches that sensor information is recorded therefore it is interpreted that there is a recording unit in the circuitry);
and detection elements (see position sensors referenced in [0073]) operably connected to the recording unit and positioned such as to detect when the activation mechanism has been moved between certain predetermined states (See [0073] which teaches the position sensors detect changes in plunger rod movement).
It would have been obvious to one of ordinary skill in the art to have combined the medicament delivery device of Giambattista with the recording unit capable of recording status changes of the medicament delivery device including the status of the mechanical activation mechanism; and detection elements operably connected to the recording unit and positioned such as to detect when the activation mechanism has been moved between certain predetermined states as taught by Jespersen. One of ordinary skill in the art would have been motivated to do so in order to reduce the risk of imprecise or incorrect dose delivery (Jespersen [0013]).
Regarding Claim 2, the combination of Giambattista and Jespersen teaches all elements of claim 1 as described above. Giambattista further teaches the medicament delivery device wherein the mechanical activation mechanism (235) comprises a section of the plunger rod (see Fig 2B where 235 is on a section of plunger rod 116).
Regarding Claim 3, the combination of Giambattista and Jespersen teaches all elements of claim 1 as described above. Giambattista further teaches the medicament delivery device further comprising a manually operated actuator (160) that, when operated, alters the drive unit from a locked state to a release state (Pg. 11 lines 17-18; the locked state is interpreted as the state before the plunger is released from 160).
Regarding Claim 4, the combination of Giambattista and Jespersen teaches all elements of claim 3 as described above. Giambattista further teaches the medicament delivery device wherein, in the release state, the plunger rod of the drive unit is released and moved to exert a pressure on the medicament inside the medicament container (Giambattista Pg. 11 lines 1-11), and wherein the detection elements are arranged to detect the movement (sensors of Jespersen [0073]; from the combination above, the sensors of Jespersen would be able to detect the movement of the plunger rod).
Regarding Claim 14, the combination of Giambattista and Jespersen teaches the medicament delivery device according to claim 1, wherein the recording unit further comprises data storage elements (See Jespersen [0099] teaching the device includes storage).
Regarding Claim 15, Giambattista teaches (Fig 1a) a medicament delivery device (100) comprising:
a housing (110) configured to accommodate a medicament container (130) filled with medicament;
a drive unit comprising a hollow plunger rod (116; Pg. 9 lines 12-13 teaches that there is a member inside plunger rod) operable to act on the medicament container (130), where the drive unit has a locked state and a released state (there is a locking member 119; therefore there must be a locked state and a released state; Pg. 11 lines 17-18, the locked state is interpreted as the state before the plunger is released from 160);
a manually operated actuator (160) that operatively causes the drive unit to change from the locked state to the released state (Pg. 11 lines 17-18, the locked state is interpreted as the state before the plunger is released from 160);
a mechanical activation mechanism (235) configured to interact with the drive unit (see Fig 2B where 235 interacts with plunger rod 116) and wherein the mechanical activation mechanism is movable between certain predetermined states when interacting with the drive unit (Pg. 11 lines 1-11).
Giambattista does not specify a recording unit capable of recording status changes of the medicament delivery device including the status of the mechanical activation mechanism; and detection elements operably connected to the recording unit and positioned such as to detect when the activation mechanism has been moved between certain predetermined states.
Jespersen teaches a medicament delivery device (1) comprising:
a housing (interpreting the line where 2 is point to be the housing) configured to accommodate a medicament container (3) filled with medicament;
a drive unit comprising a hollow plunger rod (5) operable to act on the medicament container;
a recording unit capable of recording status changes of the medicament delivery device including the status of the mechanical activation mechanism (0073] teaches that sensor information is recorded therefore it is interpreted that there is a recording unit in the circuitry);
and detection elements (see position sensors referenced in [0073]) operably connected to the recording unit and positioned such as to detect when the activation mechanism has been moved between certain predetermined states (See [0073] which teaches the position sensors detect changes in plunger rod movement).
It would have been obvious to one of ordinary skill in the art to have combined the medicament delivery device of Giambattista with the recording unit capable of recording status changes of the medicament delivery device including the status of the mechanical activation mechanism; and detection elements operably connected to the recording unit and positioned such as to detect when the activation mechanism has been moved between certain predetermined states as taught by Jespersen. One of ordinary skill in the art would have been motivated to do so in order to reduce the risk of imprecise or incorrect dose delivery (Jespersen [0013]).
Regarding Claim 16, the combination of Giambattista and Jespersen teaches the medicament delivery device according to claim 15, wherein, in the released state, the plunger rod of the drive unit is released and moves proximally to exert a pressure on the medicament inside the medicament container (Giambattista Pg. 11 lines 1-11), and wherein the detection elements are arranged to detect the movement of the plunger rod (sensors of Jespersen [0073] are arranged to detect the movement of the plunger rod).
Regarding Claim 17, the combination of Giambattista and Jespersen teaches the medicament delivery device according to claim 15, further comprising a drive spring (Giambattista 115) in a tension state inside the plunger rod (Pg. 9 lines 12-13) when the drive unit is in in the locked state (interpreting the pretensioned state as the locked state).
Claim(s) 5-8 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krulevitch (WO 2010098931) as applied to claim 1 above, and further in view of Despa et al. (US 20160213856 hereinafter “Despa”).
Regarding Claim 5, Krulevitch teaches the medicament delivery device according to claim 1, wherein the recording unit (168) further comprises: orientation elements capable of detecting angular positions of the medicament delivery device after activation (See [0069] teaching that the device may have a various combination of elements, where one example includes an encoder to measure angular position), and information elements capable of providing a user with information regarding correct angular positions of the medicament delivery device for a priming operation (See [0069-0070] teaching how this is used with the sensors to detect if the device has been primed properly before injection).
Krulevitch does not specify that the orientation elements are activated by the detection elements detecting movement of the plunger rod.
Despa teaches [0046] that a syringe can have sensors and an accelerometer that can detect position/movement of the plunger rod and orientation/angular position of the device. Despa also teaches that the orientation elements may be activated by the detection elements (sensors) detecting movement of the plunger rod (See [0047] “the processor 185 can be configured to accept sensor data if it is detected in the most recent motion of the plunger that the plunger was advancing into the barrel of the syringe, that the orientation of the syringe was generally so that the needle was pointed downward below a certain angle, and that there were no sudden syringe motions associated with the travel of the plunger.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Krulevitch such that the orientation elements are activated by the detection elements detecting movement of the plunger rod as taught by Despa. One of ordinary skill in the art would have been motivated to do so in order to detect and correlate if any sudden movement are associated with eh device while the plunger was moving/injection was occurring (Despa [0047]). One of ordinary skill in the art would recognize this would help alert the user if there was any misuse of the device or mishandling of the device during use if the injection occurred at an incorrect angle.
Regarding Claim 6, the combination of Krulevitch and Despa teaches all elements of claim 5 as described above. Krulevitch further teaches the medicament delivery device wherein the information elements are capable of providing a user with information regarding erroneous angular positions of the medicament delivery device for a priming operation (See Krulevitch [0069-0070] teaching how the device may include an encoder to alert the user regarding angular positions and how the device may alert the user regarding improper priming of the device).
Regarding Claim 7, the combination of Krulevitch and Despa teaches all elements of claim 5 as described above. Krulevitch further teaches the medicament delivery device wherein the information elements comprise any or combinations of light emitting elements, sound emitting elements, vibration emitting elements, visual display elements (See [0069-0070] teaching how there is a display and LEDS to alert the user).
Regarding Claim 8, the combination of Krulevitch and Despa teaches all the elements of claim 5 as described above. The combination further teaches the medicament delivery device wherein the plunger rod is moved during priming, which movement is detected by the detection elements, whereby the recording unit switches off the orientation elements (See Despa [0046-0047] teaching how there is detection of the plunger rod moving during the priming function, and how the recording unit determines the difference between a priming function and an actual injection movement).
Regarding Claim 13, the combination of Krulevitch and Despa teaches the medicament delivery device according to claim 5, wherein the recording unit further comprises a micro control unit programmed to handle data obtained from the detection elements and to provide information via the information elements (See Krulevitch [0041] teaching the device comprises a micro processor, it is interpreted that the microprocessor processes the information prior to storing/recording the information in memory 168; further see Despa [0064] teaching how the processor includes various types of software/instructions for handling the data from the recording unit) .
Claim(s) 5, 9-13 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giambattista and Jespersen as applied to claim 1 above, and further in view of Despa (US 20160213856).
Regarding Claim 5, the combination of Giambattista and Jespersen teaches all elements of claim 1 as described above. The combination does not specify wherein the recording unit further comprises: orientation elements capable of detecting angular positions of the medicament delivery device after activation, wherein the orientation elements are activated by the detection elements detecting movement of the plunger rod; and information elements capable of providing a user with information regarding correct angular positions of the medicament delivery device for a priming operation.
Despa teaches [0046-0047] that a syringe can have sensors and an accelerometer that can detect position/movement of the plunger rod and orientation/angular position of the device. Despa also teaches that the orientation elements may be activated by the detection elements (sensors) detecting movement of the plunger rod (See [0047] “the processor 185 can be configured to accept sensor data if it is detected in the most recent motion of the plunger that the plunger was advancing into the barrel of the syringe, that the orientation of the syringe was generally so that the needle was pointed downward below a certain angle, and that there were no sudden syringe motions associated with the travel of the plunger.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Giambattista such that the recording unit further comprises: orientation elements capable of detecting angular positions of the medicament delivery device after activation, wherein the orientation elements are activated by the detection elements detecting movement of the plunger rod; and information elements capable of providing a user with information regarding correct angular positions of the medicament delivery device for a priming operation as taught by Despa. One of ordinary skill in the art would have been motivated to do so in order to detect and correlate if any sudden movement are associated with eh device while the plunger was moving/injection was occurring (Despa [0047]). One of ordinary skill in the art would recognize this would help alert the user if there was any misuse of the device or mishandling of the device during use if the injection occurred at an incorrect angle.
Regarding Claim 9, the combination of Giambattista, Jespersen and Despa teaches the medicament delivery device according to claim 5, further comprising a medicament delivery member guard (Giambattista 120) movably arranged in the housing (Giambattista 110) between a retracted position (Giambattista Fig 8b) and an extended position (Giambattista Figs 8a, 8c) covering the medicament delivery member (Giambattista 4242) after a priming operation.
Regarding Claim 10, the combination of Giambattista, Jespersen and Despa teaches the medicament delivery device according to claim 9, wherein the medicament delivery member guard (Giambattista 120) is movable from the extended position (Giambattista Fig 8a) to the retracted position (Giambattista Fig 8b) during a penetration operation at a dose delivery site, that the medicament delivery member guard is operably connected to the drive unit wherein the medicament delivery member guard releases the plunger rod in the retracted position, causing a dose of medicament to be delivered through the medicament delivery member (See Pg. 11 lines 12-28), wherein the detection elements are arranged to detect when the plunger rod has been released (See Jespersen [0073] teaching detection of plunger rod movement).
Regarding Claim 11, the combination of Giambattista, Jespersen and Despa teaches all elements of claim 10 as described above. Giambattista does not specify the medicament delivery device, wherein the recording unit comprises a timer that is activated when the plunger rod has been released.
Despa teaches [0041] that a device could include a timer (130) that could record the time at which the sensors are detecting certain orientations of the device, and [0046] teaches the timer can be associated with sensors detecting linear motion of the plunger rod.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Giambattista such that it includes a timer that is activated when the plunger rod has been released as taught by Despa. One of ordinary skill in the art would have been motivated to do so in order to determine which portion of the linear movement of the plunger is associated with an injection event, at what time the injection event occurred, and the time over which the injection event occurred (Despa [0046]).
Regarding Claim 12, the combination of Giambattista, Jespersen and Despa teaches the medicament delivery device according to claim 11, wherein the recording unit activates the information elements when the timer has counted a pre-set time period to indicate that the medicament delivery device can be removed from the dose delivery site (See Despa [0041] teaching that there can be an associated time for each set of sensors; also see [0020] teaching “The amount of dose and the time associated with an injection event can then be recorded and displayed to a user on a user interface of the external device.”).
Regarding Claim 13, the combination of Giambattista, Jespersen and Despa teaches the medicament delivery device according to claim 5, wherein the recording unit further comprises a micro control unit programmed to handle data obtained from the detection elements and to provide information via the information elements (See Despa [0064] teaching how the processor includes various types of software/instructions for handling the data from the recording unit).
Regarding Claim 18, the combination of Giambattista and Jespersen teaches all elements of claim 15 as described above. The combination does not specify the medicament delivery device wherein the recording unit comprises a timer that is activated when the plunger rod has been released, and wherein the recording unit activates information elements when the timer has counted a pre-set time period to indicate that the medicament delivery device can be removed from a dose delivery site.
Despa teaches [0041] that a device could include a timer (130) that could record the time at which the sensors are detecting certain orientations of the device, and [0046] teaches the timer can be associated with sensors detecting linear motion of the plunger rod. Despa also teaches [0041] that there can be an associated time for each set of sensors, and that [0020] “The amount of dose and the time associated with an injection event can then be recorded and displayed to a user on a user interface of the external device.”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Giambattista such that it includes a timer that is activated when the plunger rod has been released, and wherein the recording unit activates information elements when the timer has counted a pre-set time period to indicate that the medicament delivery device can be removed from a dose delivery site as taught by Despa. One of ordinary skill in the art would have been motivated to do so in order to determine which portion of the linear movement of the plunger is associated with an injection event, at what time the injection event occurred, and the time over which the injection event occurred (Despa [0046]).
Regarding Claim 19, the combination of Giambattista, Jespersen and Despa teaches all elements of claim 18 as described above. Giambattista does not specify the medicament delivery device wherein the recording unit further comprises orientation elements capable of detecting angular positions of the medicament delivery device after activation, and wherein the orientation elements are activated by the detection elements detecting movement of the plunger rod.
Despa teaches [0046-0047] that a syringe can have sensors and an accelerometer that can detect position/movement of the plunger rod and orientation/angular position of the device. Despa also teaches that the orientation elements may be activated by the detection elements (sensors) detecting movement of the plunger rod (See [0047] “the processor 185 can be configured to accept sensor data if it is detected in the most recent motion of the plunger that the plunger was advancing into the barrel of the syringe, that the orientation of the syringe was generally so that the needle was pointed downward below a certain angle, and that there were no sudden syringe motions associated with the travel of the plunger.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Giambattista such that wherein the recording unit further comprises orientation elements capable of detecting angular positions of the medicament delivery device after activation, and wherein the orientation elements are activated by the detection elements detecting movement of the plunger rod as taught by Despa. One of ordinary skill in the art would have been motivated to do so in order to detect and correlate if any sudden movement are associated with the device while the plunger was moving/injection was occurring (Despa [0047]). One of ordinary skill in the art would recognize this would help alert the user if there was any misuse of the device or mishandling of the device during use if the injection occurred at an incorrect angle.
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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Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11235103. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application independent claims appear to be broader than the US Patent claims 1 and 10.
Regarding Claim 1, A medicament delivery device comprising:
a housing (See “housing” in claim 1 of US ‘103) configured to accommodate a medicament container filled with medicament;
a drive unit (See “drive unit” in claim 1 of US ‘103) comprising a plunger rod (See “plunger rod” in claim 1 of US ‘103) operable to act on the medicament container;
a mechanical activation mechanism (See “mechanical activation mechanism” in claim 1 of US ‘103) configured to interact with the drive unit and wherein the mechanical activation mechanism is movable between certain predetermined states when interacting with the drive unit;
a recording unit (See “recording unit” in claim 1 of US ‘103) capable of recording status changes of the medicament delivery device including the status of the mechanical activation mechanism; and detection elements (See “detection elements” in claim 1 of US ‘103) operably connected to the recording unit and positioned such as to detect when the activation mechanism has been moved between certain predetermined states.
Regarding Claim 2, The medicament delivery device according to claim 1, wherein the mechanical activation mechanism comprises a section of the plunger rod (See “plunger rod” in claim 2 of US ‘103).
Regarding Claim 3, The medicament delivery device according to claim 1, further comprising a manually operated actuator (See “actuator” in claim 1 of US ‘103) that, when operated, alters the drive unit from a locked state (See “locked state” in claim 1 of US ‘103) to a release state (See “release state” in claim 1 of US ‘103).
Regarding Claim 4, The medicament delivery device according to claim 3, wherein, in the release state, the plunger rod of the drive unit is released and moved to exert a pressure on the medicament inside the medicament container, and wherein the detection elements are arranged to detect the movement (See this limitation in claim 1 of US ‘103).
Regarding Claim 5, The medicament delivery device according to claim 1, wherein the recording unit further comprises: orientation elements (See “orientation elements” in claim 1 of US ‘103) capable of detecting angular positions of the medicament delivery device after activation, wherein the orientation elements are activated by the detection elements detecting movement of the plunger rod; and information elements (See “information elements” in claim 1 of US ‘103) capable of providing a user with information regarding correct angular positions of the medicament delivery device for a priming operation.
Regarding Claim 6, The medicament delivery device according to claim 5, wherein the information elements (See “information elements” in claim 1 of US ‘103) are capable of providing a user with information regarding erroneous angular positions (See “erroneous angular positions” in claim 1 of US ‘103) of the medicament delivery device for a priming operation.
Regarding Claim 7, The medicament delivery device according to claim 5, wherein the information elements (See “information elements” in claim 3 of US ‘103) comprise any or combinations of light emitting elements, sound emitting elements, vibration emitting elements, visual display elements.
Regarding Claim 8, The medicament delivery device according to claim 5, wherein the plunger rod (See “plunger rod” in claim 4 of US ‘103) is moved during priming, which movement is detected by the detection elements (See “detection elements” in claim 4 of US ‘103), whereby the recording unit (See “recording unit” in claim 4 of US ‘103) switches off the orientation elements (See “orientation elements” in claim 4 of US ‘103).
Regarding Claim 9, The medicament delivery device according to claim 5, further comprising a medicament delivery member guard (See “delivery guard member” in claim 1 of US ‘103) movably arranged in the housing between a retracted position and an extended position covering the medicament delivery member after a priming operation.
Regarding Claim 10, The medicament delivery device according to claim 9, wherein the medicament delivery member guard (See “delivery guard member” in claim 5 of US ‘103) is movable from the extended position to the retracted position during a penetration operation at a dose delivery site, that the medicament delivery member guard is operably connected to the drive unit wherein the medicament delivery member guard (See “delivery guard member” in claim 5 of US ‘103) releases the plunger rod (See “plunger rod” in claim 5 of US ‘103) in the retracted position, causing a dose of medicament to be delivered through the medicament delivery member, wherein the detection elements guard (See “detection elements” in claim 5 of US ‘103) are arranged to detect when the plunger rod has been released.
Regarding Claim 11, The medicament delivery device according claim 10, wherein the recording unit (See “recording unit” in claim 6 of US ‘103) comprises a timer (See “timer” in claim 6 of US ‘103) that is activated when the plunger rod (See “plunger rod” in claim 6 of US ‘103) has been released.
Regarding Claim 12, The medicament delivery device according to claim 11, wherein the recording unit (See “recording unit” in claim 7 of US ‘103) activates the information elements (See “information elements” in claim 7 of US ‘103) when the timer (See “timer” in claim 7 of US ‘103) has counted a pre-set time period to indicate that the medicament delivery device can be removed from the dose delivery site.
Regarding Claim 13, The medicament delivery device according to claim 5, wherein the recording unit (See “recording unit” in claim 8 of US ‘103) further comprises a micro control unit (See “micro control unit” in claim 8 of US ‘103) programmed to handle data obtained from the detection elements and to provide information via the information elements (See “information elements” in claim 8 of US ‘103).
Regarding Claim 14, The medicament delivery device according to claim 1, wherein the recording unit (See “recording unit” in claim 9 of US ‘103) further comprises data storage elements (See “data storage elements” in claim 9 of US ‘103).
Regarding Claim 15, A medicament delivery device comprising:
a housing (See “a housing” in claim 10 of US ‘103) configured to accommodate a medicament container filled with medicament;
a drive unit (See “a drive unit” in claim 10 of US ‘103) comprising a hollow plunger rod (See “plunger rod” in claim 10 of US ‘103) operable to act on the medicament container, where the drive unit has a locked state and a released state;
a manually operated actuator (See “actuator” in claim 10 of US ‘103) that operatively causes the drive unit to change from the locked state to the released state;
a mechanical activation mechanism (See “activation mechanism” in claim 10 of US ‘103) configured to interact with the drive unit and wherein the mechanical activation mechanism is movable between certain predetermined states when interacting with the drive unit;
a recording unit (See “recording unit” in claim 10 of US ‘103) capable of recording status changes of the medicament delivery device including the status of the mechanical activation mechanism; and
detection elements (See “detection elements” in claim 10 of US ‘103) operably connected to the recording unit and positioned such as to detect when the activation mechanism has been moved between certain predetermined states.
Regarding Claim 16, The medicament delivery device according to claim 15, wherein, in the released state, the plunger rod (See “plunger rod” in claim 10 of US ‘103) of the drive unit is released and moves proximally to exert a pressure on the medicament inside the medicament container, and wherein the detection elements (See “detection elements” in claim 10 of US ‘103) are arranged to detect the movement of the plunger rod.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Karlsson et al. (US 20140228769) teaches a medicament delivery device with multiple predetermined states for the plunger including a priming state.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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