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 § 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.
(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) 1-9, 12-16, 18-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nielsen et al. (US 2014/0194825).
Regarding claim 1, Nielsen discloses
A supplemental device (110, fig. 1) for attachment to an injection device (Examiner notes: the limitation “for attachment to an injection device” is interpreted as functional limitation, and the limitation “an injection device” is not positively recited in claim 1. See fig. 1 for device 110 attaching to device 100), the supplemental device (110) comprising:
a housing (housing of 110, see fig. 1) containing optical sensors (232/233, figs. 4A-4B and par. 0051) arranged to detect optical features on a rotatable surface of the injection device while the supplemental device is attached to the injection device (Examiner notes: the limitation “arranged to detect optical features on a rotatable surface of the injection device while the supplemental device is attached to the injection device” is interpreted as functional limitation, and the limitations “optical features”, “a rotatable surface” and “the injection device” are not positively recited in claim 1. See figs. 4A-4B and pars. 0044-0057 for the sensors detecting optical features of the injection device); and
a processor arrangement (electronic detection means/switch means disclosed in par. 0041) configured to:
detect a change in state of each of the optical sensors (pars. 0041, 0044-0057); and
determine a direction of rotation of the rotatable surface of the injection device from the detected state changes (Examiner notes: the limitations “the rotatable surface” and “the injection device” are not positively recited in claim 1. See par. 0039 for the pen device comprises a rotation dose setting ring member to allow a user to set and adjust a variable dose size of give increments being indicated by numbers shown in a window, and par. 0041 for the data capture unit 110 being used for capturing data representing a property related to the amount of drug expelled from the reservoir. Therefore, the processor of 110 is capable of doing the claimed functional limitation when the data capture unit 110 is attached to an injection device in order to detect the correct dialed dosage of the injection device).
Regarding claim 2, Nielsen discloses
The supplemental device according to claim 1, wherein the optical sensors (232/233, figs. 4A-4B) are arranged to detect optical features on a first portion of the rotatable surface that is closer to a dosage knob of the injection device than a second portion of the rotatable surface (Examiner notes: the limitation “to detect optical features on a first portion of the rotatable surface that is closer to a dosage knob of the injection device than a second portion of the rotatable surface” is interpreted as functional limitation, and the limitations “optical features”, “a first portion”, “the rotatable surface”, “a dosage knob”, “the injection device”, and “a second portion” are not positively recited in claim 2. As shown in figs. 4A-4B, sensors 232 and 233 are used to detect optical features of member 230, it is capable of doing the claimed functional limitation when the data capture unit 110 is attached to an injection device).
Regarding claim 3, Nielsen discloses
The supplemental device according to claim 2, wherein the dosage knob is distal from a needle of the injection device (Examiner notes: the limitations “the dosage knob”, “a needle”, and “the injection device” are not positively recited in claim 3. See fig. 1 for the injection device 100).
Regarding claim 4, Nielsen discloses
The supplemental device according to claim 2, wherein a portion of the rotatable surface extends axially beyond an axial end of a housing of the injection device when a dosage knob of the injection device is in a zero dose position (Examiner notes: the limitations “a portion”, “the rotatable surface”, “an axial end”, “a housing”, “the injection device”, “a dosage knob”, and “a zero dose position” are not positively recited in claim 4. See fig. 1 for the data capture unit 110 is attached to an injection device).
Regarding claim 5, Nielsen discloses
The supplemental device according to claim 1, wherein the rotatable surface is arranged to rotate relative to a housing of the injection device and extend axially beyond the housing of the injection device during dose dialing, and the optical sensors are arranged to detect optical features on the rotatable surface of the injection device during dose dialing (Examiner notes: the limitations “the rotatable surface”, “a housing”, “the injection device”, “dose dialing”, and “optical features” are not positively recited in claim 5. And the limitation “to detect optical features on the rotatable surface of the injection device during dose dialing” is interpreted as functional limitation. See pars. 0044-0057 for the function of the optical sensors of the data capture unit 110).
Regarding claim 6, Nielsen discloses
The supplemental device according to claim 1, wherein the optical sensors (232/233, figs. 4A-4B) are arranged to face the rotatable surface at different relative angular positions when the supplemental device is attached to the injection device (Examiner notes: the limitations “the rotatable surface” and “the injection device” are not positively recited in claim 6. See figs. 4A-4B for the positions of the optical sensors).
Regarding claim 7, Nielsen discloses
The supplemental device according to claim 1, wherein the processor arrangement (electronic detection means/switch means disclosed in par. 0041) is configured to determine the direction of rotation of the rotatable surface based on a relative order in which the states of the optical sensors change during rotation of the rotatable surface (Examiner notes: the limitation “configured to determine the direction of rotation of the rotatable surface based on a relative order in which the states of the optical sensors change during rotation of the rotatable surface” is interpreted as functional limitation, and the limitation “the rotatable surface” is not positively recited in claim 1. See par. 0039 for the pen device comprises a rotation dose setting ring member to allow a user to set and adjust a variable dose size of give increments being indicated by numbers shown in a window, and par. 0041 for the data capture unit 110 being used for capturing data representing a property related to the amount of drug expelled from the reservoir. Therefore, the processor of 110 is capable of doing the claimed functional limitation when the data capture unit 110 is attached to an injection device in order to detect the correct dialed dosage of the injection device).
Regarding claim 8, Nielsen discloses
The supplemental device according to claim 1, wherein the processor arrangement (pars. 0044-0057) is configured to:
determine a state of each of the optical sensors before rotation of the rotatable surface (when sensors 232/233 are off);
determine the state of each of the optical sensors after rotation of the rotatable surface (when sensors 232/233 is on to detect wheel 230, figs. 4A-4B); and
determine the direction of rotation of the rotatable surface based on the determined states of each of the optical sensors before rotation of the rotatable surface and after rotation of the rotatable surface (See par. 0039 for the pen device comprises a rotation dose setting ring member to allow a user to set and adjust a variable dose size of give increments being indicated by numbers shown in a window, and par. 0041 for the data capture unit 110 being used for capturing data representing a property related to the amount of drug expelled from the reservoir).
Regarding claim 9, Nielsen discloses
The supplemental device according to claim 1, wherein the optical features comprise black and white regions detectable by the optical sensors (Examiner notes: the limitations “the optical features”, and “black and white regions” are not positively recited in claim 9), wherein each optical sensor is in a first state when a black region of the rotatable surface is detected and a second state when a white region or the rotatable surface is detected (see figs. 4A-4B for black and white regions of wheel 230, see also pars. 0051-0057).
Regarding claim 12, Nielsen discloses
A supplemental device (110, fig. 1) for attachment to an injection device (Examiner notes: the limitation “for attachment to an injection device” is interpreted as functional limitation, and the limitation “an injection device” is not positively recited in claim 1. See fig. 1 for device 110 attaching to device 100), the supplemental device (110) comprising:
a housing (housing of 110, see fig. 1) containing sensors (see figs. 2A-4B for the sensors. See also par. 0044 for Nielsen disclosing same movements being detected by means of other detection principles such as galvanic contacts, induction, capacitive coupling, or magnetic field) arranged to detect conductive and non-conductive features on a rotatable surface of the injection device while the supplemental device is attached to the injection device (Examiner notes: the limitation “arranged to detect conductive and non-conductive features on a rotatable surface of the injection device while the supplemental device is attached to the injection device” is interpreted as functional limitation, and the limitations “conductive and non-conductive features”, “a rotatable surface” and “the injection device” are not positively recited in claim 12. See par. 0044 for the sensors being magnetic sensors, which are capable of detecting conductive and non-conductive features); and
a processor arrangement (electronic detection means/switch means disclosed in par. 0041) configured to:
detect a change in state of each of the sensors (pars. 0041, 0044-0057); and
determine a direction of rotation of the rotatable surface of the injection device from the detected state changes (Examiner notes: the limitations “the rotatable surface” and “the injection device” are not positively recited in claim 12. See par. 0039 for the pen device comprises a rotation dose setting ring member to allow a user to set and adjust a variable dose size of give increments being indicated by numbers shown in a window, and par. 0041 for the data capture unit 110 being used for capturing data representing a property related to the amount of drug expelled from the reservoir. Therefore, the processor of 110 is capable of doing the claimed functional limitation when the data capture unit 110 is attached to an injection device in order to detect the correct dialed dosage of the injection device).
Regarding claim 13, Nielsen discloses
The supplemental device according to claim 12, wherein the sensors are arranged to protrude from the housing of the supplemental device (see figs. 2A-4B and also 5A-6B for different positions of the sensors protruding from the housing to be able to detect the features on the injection device).
Regarding claim 14, Nielsen discloses
The supplemental device according to claim 12, wherein the processor arrangement (electronic detection means/switch means disclosed in par. 0041) is configured to determine the direction of rotation of the rotatable surface based on a relative order in which the states of the sensors change during rotation of the rotatable surface (Examiner notes: the limitation “configured to determine the direction of rotation of the rotatable surface based on a relative order in which the states of the optical sensors change during rotation of the rotatable surface” is interpreted as functional limitation, and the limitation “the rotatable surface” is not positively recited in claim 1. See par. 0039 for the pen device comprises a rotation dose setting ring member to allow a user to set and adjust a variable dose size of give increments being indicated by numbers shown in a window, and par. 0041 for the data capture unit 110 being used for capturing data representing a property related to the amount of drug expelled from the reservoir. Therefore, the processor of 110 is capable of doing the claimed functional limitation when the data capture unit 110 is attached to an injection device in order to detect the correct dialed dosage of the injection device).
Regarding claim 15, Nielsen discloses
The supplemental device according to claim 12, wherein the processor arrangement (pars. 0044-0057) is configured to:
determine a state of each of the sensors before rotation of the rotatable surface (when sensors are off);
determine the state of each of the sensors after rotation of the rotatable surface (when sensors are on to detect the rotation); and
determine the direction of rotation of the rotatable surface based on the determined states of each of the sensors before rotation of the rotatable surface and after rotation of the rotatable surface (See par. 0039 for the pen device comprises a rotation dose setting ring member to allow a user to set and adjust a variable dose size of give increments being indicated by numbers shown in a window, and par. 0041 for the data capture unit 110 being used for capturing data representing a property related to the amount of drug expelled from the reservoir).
Regarding claim 16, Nielsen discloses
The supplemental device according to claim 12, wherein the sensors are magnetic sensors (see par. 0044 for means of detection principles as magnetic field).
Regarding claim 18, Nielsen discloses
The supplemental device according to claim 12, wherein the sensors are capacitive sensors (see par. 0044 for means of detection principles as capacitive coupling).
Regarding claim 19, Nielsen discloses
The supplemental device according to claim 12, wherein the sensors comprise contacts (contacts of sensors disclosed in par. 0044) configured to engage with the conductive and non-conductive features (Examiner notes: the limitation “configured to engage with the conductive and non-conductive features” is interpreted as functional limitation, and the limitation “conductive and non-conductive features” is not positively recited in claim 19. See par. 0044 for different sensors used to detect the movements to indicate the amount of drug being delivered. Therefore, the sensors are capable of engaging with the features of the injection device to indicate the amount of drug being delivered).
Regarding claim 20, Nielsen discloses
An injection device (100, fig. 1) comprising:
a housing (housing of 110, fig. 1) containing sensors (see figs. 2A-4B for different sensors, see also par. 0044 for Nielsen disclosing same movements being detected by means of other detection principles such as galvanic contacts, induction, capacitive coupling, or magnetic field) arranged to detect (i) optical features or (ii) conductive and non-conductive features on a rotatable surface of the injection device (Examiner notes: the limitation “to detect (i) optical features or (ii) conductive and non-conductive features on a rotatable surface of the injection device” is interpreted as functional limitation. The limitations “optical features or conductive and non-conductive features” and “a rotatable surface” are not positively recited in claim 20. See figs. 2A-4B for the sensors configured to detect optical features and see par. 0044 for the sensors being magnetic sensors configured to detect conductive and non-conductive features); and
a processor arrangement (electronic detection means/switch means disclosed in par. 0041) configured to:
detect a change in state of each of the sensors (pars. 0041, 0044-0057); and
determine a direction of rotation of the rotatable surface of the injection device from the detected state changes (Examiner notes: the limitations “the rotatable surface” and “the injection device” are not positively recited in claim 12. See par. 0039 for the pen device comprises a rotation dose setting ring member to allow a user to set and adjust a variable dose size of give increments being indicated by numbers shown in a window, and par. 0041 for the data capture unit 110 being used for capturing data representing a property related to the amount of drug expelled from the reservoir. Therefore, the processor of 110 is capable of doing the claimed functional limitation when the data capture unit 110 is attached to an injection device in order to detect the correct dialed dosage of the injection device).
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) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen et al. (US 2014/0194825) in view of Geipel et al. (US 2014/0039396).
Regarding claim 10, Nielsen discloses the supplemental device according to claim 1, as set forth above, except for wherein the supplemental device comprises one or more light emitting diodes arranged to illuminate the optical features.
However, Geipel teaches a delivery system (fig. 4) comprising a rotatable surface with black and white markings (64/65, fig. 4 and par. 0124), a light emitting element LED (56) illuminating the markings, and a photo sensor (58) detecting the light reflected by the markings (par. 0125).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Nielsen by having a light emitting element LED to illuminate the markings and a photo sensor to detect the light reflected by the markings, as taught by Geipel, for the purpose of allowing the device to better detect the changes between the markings during the rotation of the rotatable surface of the injection device.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen et al. (US 2014/0194825) in view of Nielsen et al. (US 2014/0194826).
Regarding claim 11, Nielsen 825’ discloses the supplemental device according to claim 1, as set forth above, except for wherein each of the optical sensors comprises a camera.
However, Nielsen 826’ teaches a data capture device with a light source and a digital camera (pars. 0062-0066 and fig. 7).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Nielsen 825’ by having a camera, as taught by Nielsen 826’, for the purpose of capturing the images to ensure that only the expelled dose is recorded (par. 0063 of Nielsen 826’).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen et al. (US 2014/0194825) in view of ielDan (US 2012/0041363).
Regarding claim 17, Nielsen 825’ discloses the supplemental device according to claim 12, as set forth above, except for wherein the sensors are resistive sensors.
However, ielDan teaches a number of different sensors being used to detect values of the position of the dose setting member, including capacitive, resistive, optical, mechanical, electromechanical technologies and combinations of these. The number of sensors as well as the design and patterns of the sensing areas may be modified in many ways in order to obtain the desired function (par. 0039).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Nielsen sensors to be resistive sensors, as taught by ielDan. Doing so would be a simple substitution of one know element (optical sensors) for another (resistive sensors) to obtain predictable results (determine a quantity of medicine to be delivered during injection).
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, 6-7, 9-10, 20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 13 of U.S. Patent No. 11,400,231. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the limitations of the application claims can be found in the patent claims.
Application 18460316
U.S. Patent No. 11,400,231
Claim 1
Claim 13
Claim 6
Claim 13
Claim 7
Claim 13
Claim 9
Claim 13
Claim 10
Claim 13
Claim 20
Claim 13
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-6pm.
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/DUNG T ULSH/Primary Examiner, Art Unit 3783
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