DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 9, 10, 12 and 18 are objected to because of the following informalities:
Regarding claim 9, line 2, the recitation “a dose of the medicament” appears to be amended to recite “the dose of the medicament” in order to refer to “a dose of the medicament” recited in claim 8, line 11.
Regarding claim 10, lines 2-3, the recitation “a dose of the medicament” appears to be amended to recite “the dose of the medicament” in order to refer to “a dose of the medicament” recited in claim 8, line 11.
Regarding claim 12, line 1, the recitation “the second criteria” appears to be amended to read “the second criterion” in order to refer to the same limitation consistently in all the claims.
Claim 18 recites the limitation “the electromechanical assembly” in line 11. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
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 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,017,053. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim in the instant application is broader than the patented claim.
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,017,053. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim in the instant application is broader than the patented claim.
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 1-3, 5, 8-10 and 12-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fahrer (US 2010/0305506 A1) in view of Kohlbrenner et al. (US 2007/0021715 A1) and further in view of Kolln (US 4,722,734).
Regarding claim 1, Fahrer discloses a drug injection medical device (figure 1) for delivering a medicament to a patient, the medical device comprising:
an electromechanical assembly (assembly that facilitates the injection of the fluid into the patient, paragraph 0013) configured to eject a fluid comprising the medicament from a reservoir (hollow portion inside elements 20a, 20b that comprises medicament) of the medical device into a patient;
a first detector (paragraph 0016, lines 3-9, the component that tracks “elapsed time since the injector or one or more particular components thereof were placed into service”) that detects a first use of the medical device;
a second detector (paragraph 0016, lines 3-12, components that track the number of injections performed or cumulative duration of injections performed) but is silent regarding a second detector determine whether a safety criterion associated with the electromechanical assembly is met; an indicator that indicates when the safety criterion has been met.
However, Kohlbrenner teaches a design of determining the service life timer comprising a second detector (paragraph 0008, 0068, detecting operation of the device) determine whether a safety criterion associated with the electromechanical assembly is met; an indicator (paragraph 0013, lines 1-9) that indicates when the safety criterion has been met for the purpose of stopping the operation of the device when the device is inoperable under safety conditions and notifying the user regarding the unsafe usage of the device (paragraph 0013, lines 1-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made to modify the second detector of Fahrer to incorporate a second detector determine whether a safety criterion associated with the electromechanical assembly is met, an indicator that indicates when the safety criterion has been met as taught by Kohlbrenner for the purpose of stopping the operation of the device when the device is inoperable under safety conditions and notifying the user regarding the unsafe usage of the device (paragraph 0013, lines 1-9).
Fahrer is further silent regarding a timer to reversibly limit use of the medical device temporarily in response to the first detector detecting the first use of the medical device and to cancel the reversible limit to enable injection of the medicament when the timer reaches or exceeds a time limit.
However, Kolln teaches a design of a medical device comprising a timer (column 5, lines 11-18, a timer would determine when the device needs to pause or operate based on the time after the device is turned on the first time) to reversibly limit use of the medical device temporarily in response to the first detector detecting the first use of the medical device and to cancel the reversible limit to enable injection of the medicament when the timer reaches or exceeds a time limit for the purpose of delivering the medicament in an intermediatory manner as required by the medical procedure (abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made to have modified a first detector of Fahrer to incorporate a timer to reversibly limit use of the medical device temporarily in response to the first detector detecting the first use of the medical device and to cancel the reversible limit to enable injection of the medicament when the timer reaches or exceeds a time limit as taught by Kolln for the purpose of delivering the medicament in an intermediatory manner as required by the medical procedure (abstract).
Regarding claim 2, Fahrer/Kolln does not explicitly disclose wherein the time limit is approximately a day.
There is no evidence of record that establishes that changing the time limit would result in a difference in function of Fahrer/Kolln device. Further, a person having ordinary skill in the art, being faced with modifying the time limit of Fahrer/Kolln would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed time limit. Lastly, applicant has not disclosed the claimed value solves any stated problem, indicating that the time limit “may” be the claimed value, offering other acceptable values (e.g. “15 minutes” in paragraph 0033) and therefore there appears to be no criticality placed on the value as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art, at the time the invention was made to modify the time limit of Fahrer/Kolln to have the time limit of approximately a day as an obvious matter of design choice within the skill of the art.
Regarding claim 3, Fahrer discloses wherein the first detector (paragraph 0016, lines 3-9, the component that tracks “elapsed time since the injector or one or more particular components thereof were placed into service”) detects switching on the medical device for the first time.
Regarding claim 5, Fahrer discloses wherein the electromechanical assembly (assembly that facilitates the injection of the fluid into the patient, paragraph 0013) comprises a telescoping piston rod (paragraph 0030, lines 10-13) to eject the fluid.
Regarding claim 8, Fahrer discloses a method for delivering a medicament implemented by a medical device (figure 1) that is a drug injection device, the method comprising:
detecting a first use (paragraph 0016, lines 3-9) of the medical device;
starting a timer (paragraph 0016, lines 3-9) of the medical device in response to detecting the first use of the medical device;
determining whether a first criterion is met (paragraph 0016, lines 3-9) but is silent regarding determining whether a second criterion is met, where the second criterion is met, providing by the medical device, an indication that a limit of use of the medical has been reached in response to determining that the second criterion is met.
However, Kohlbrenner teaches a design and method of determining the service life timer comprising determining whether a second criterion (paragraphs 0008, 0068, detecting operation of the device) is met, where the second criterion is met, providing by the medical device, an indication (paragraph 0013, lines 1-9) that a limit of use of the medical device has been reached in response to determining that the second criterion is met for the purpose of stopping the operation of the device when the device is inoperable under safety conditions and notifying the user regarding the unsafe usage of the device (paragraph 0013, lines 1-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made to modify the second detector of Fahrer to incorporate determining whether a second criterion is met, where the second criterion is met, providing by the medical device, an indication that a limit of use of the medical has been reached in response to determining that the second criterion is met as taught by Kohlbrenner for the purpose of stopping the operation of the device when the device is inoperable under safety conditions and notifying the user regarding the unsafe usage of the device (paragraph 0013, lines 1-9).
Fahrer is further silent regarding wherein the first criterion is that the time reaches or exceeds a time limit, in response to determining that the first criterion is met, placing the medical device in an armed condition, wherein when the medical device is in the armed condition, the medical device can be used to dispense a dose of the medicament.
However, Kolln teaches a design of a medical device comprising wherein the first criterion is that the time reaches or exceeds a time limit (column 5, lines 11-18, determine when the device needs to pause or operate based on the time after the device is turned on the first time), in response to determining that the first criterion is met, placing the medical device in an armed condition (column 5, lines 11-18), wherein when the medical device is in the armed condition, the medical device can be used to dispense a dose of the medicament for the purpose of delivering the medicament in an intermediatory manner as required by the medical procedure (abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made to have modified a first detector of Fahrer to incorporate wherein the first criterion is that the time reaches or exceeds a time limit, in response to determining that the first criterion is met, placing the medical device in an armed condition, wherein when the medical device is in the armed condition, the medical device can be used to dispense a dose of the medicament as taught by Kolln for the purpose of delivering the medicament in an intermediatory manner as required by the medical procedure (abstract).
While Fahrer/Kolln fails to disclose in response to determining that the first criterion is met and the second criterion is not met but instead discloses in response to determining that the first criterion is met, Fahrer/Kolln/Kohlbrenner will result in a modified method comprising a step of in response to determining that the first criterion is met and the second criterion is not met, placing the medical device in an armed condition, wherein when the medical device is in the armed condition, the medical device can be used to dispense a dose of the medicament because Kolln discloses dispensing dose when the first criterion is met and Kohlbrenner discloses turning off the device when the second criterion is met (see paragraph 0013, lines 10-23 in Kohlbrenner).
Regarding claim 9, Fahrer is silent regarding wherein when the medical device is not in the armed condition, the medical device cannot be used to dispense a dose of the medicament.
However, Kolln teaches wherein when the medical device is not in the armed condition, the medical device cannot be used to dispense a dose of the medicament (column 5, lines 11-18) for the purpose of delivering the medicament in an intermediatory manner as required by the medical procedure (abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified the method of Fahrer to incorporate wherein when the medical device is not in the armed condition, the medical device cannot be used to dispense a dose of the medicament as taught by Kolln for the purpose of delivering the medicament in an intermediatory manner as required by the medical procedure (abstract).
Regarding claim 10, Fahrer is silent regarding when the second criterion is met prior to injection of the medicament, preventing the medical device from dispensing a dose of the medicament.
However, Kohlbrenner teaches when the second criterion is met prior to injection of the medicament, preventing the medical device from dispensing a dose of the medicament (paragraphs 0008, 0068, paragraph 0013, lines 10-23) for the purpose of delivering the medicament in an intermediatory manner as required by the medical procedure (abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the method of Fahrer to incorporate when the second criterion is met prior to injection of the medicament, preventing the medical device from dispensing a dose of the medicament as taught by Kohlbrenner for the purpose of delivering the medicament in an intermediatory manner as required by the medical procedure (abstract).
Regarding claim 12, Fahrer is silent regarding wherein the second criteria can be fulfilled independently of the first criterion.
As explained in the rejection of claim 8 above in view of Kohlbrenner and Kolln, the modified method will result in having wherein the second criteria can be fulfilled independently of the first criterion because the modified method would involve meeting both criteria independently.
Thus, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made to have modified the method of Fahrer to incorporate wherein the second criteria can be fulfilled independently of the first criterion as taught by Kohlbrenner and Kolln (as explained in the rejection of claim 8 above) for the purpose of delivering the medicament in an intermediatory manner as required by the medical procedure (abstract in Fahrer) and stopping the operation of the device when the device is inoperable under safety conditions and notifying the user regarding the unsafe usage of the device (paragraph 0013, lines 1-9 in Kohlbrenner).
Regarding claim 13, Fahrer is silent regarding wherein the time limit is predefined.
However, Kolln teaches wherein the time limit is predefined (column 5, lines 11-18) for the purpose of delivering the medicament in an intermediatory manner as required by the medical procedure (abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made to have modified the method of Fahrer to incorporate wherein the time limit is predefined as taught by Kolln for the purpose of delivering the medicament in an intermediatory manner as required by the medical procedure (abstract).
Regarding claim 14, Fahrer/Kolln does not explicitly disclose wherein the time limit is approximately a day.
There is no evidence of record that establishes that changing the time limit would result in a difference in function of Fahrer/Kolln device. Further, a person having ordinary skill in the art, being faced with modifying the time limit of Fahrer/Kolln would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed time limit. Lastly, applicant has not disclosed the claimed value solves any stated problem, indicating that the time limit “may” be the claimed value, offering other acceptable values (e.g. “15 minutes” in paragraph 0033) and therefore there appears to be no criticality placed on the value as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art, at the time the invention was made to modify the time limit of Fahrer/Kolln to have the time limit of approximately a day as an obvious matter of design choice within the skill of the art.
Regarding claim 15, Fahrer is silent regarding wherein providing the indication comprises outputting, by an indicator of the medical device, a signal that indicates that the limit of use of the medical device has been reached.
However, Kohlbrenner teaches wherein providing the indication (paragraph 0013, lines 1-9) comprises outputting, by an indicator of the medical device, a signal that indicates that the limit of use of the medical device has been reached for the purpose of notifying the user regarding the unsafe usage of the device (paragraph 0013, lines 1-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made to have modified the method of Fahrer to incorporate wherein providing the indication comprises outputting, by an indicator of the medical device, a signal that indicates that the limit of use of the medical device has been reached for the purpose of notifying the user regarding the unsafe usage of the device (paragraph 0013, lines 1-9).
Regarding claim 16, Fahrer is silent regarding wherein the medicament comprises an enzyme, an antibody, an antibody fragment, a hormone, an oligonucleotide, or a combination thereof.
However, Kohlbrenner teaches wherein the medicament comprises an enzyme, an antibody, an antibody fragment, a hormone, an oligonucleotide, or a combination thereof (paragraph 0002) for the purpose of delivering the appropriate medication as needed to treat the medical condition (paragraph 0002).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made to have modified the method of Fahrer to incorporate wherein the medicament comprises an enzyme, an antibody, an antibody fragment, a hormone, an oligonucleotide, or a combination thereof as taught by Kohlbrenner for the purpose of delivering the appropriate medication as needed to treat the medical condition (paragraph 0002).
Regarding claim 17, Fahrer fails to explicitly recite a non-transitory computer readable medium having stored thereon instructions that when executed by at least one processor of the medical device, perform the method. However, one of ordinary skill in the art would construe that Fahrer is implicitly reciting a non-transitory computer readable medium having stored thereon instructions that when executed by at least one processor of the medical device, perform the method in order for the device to operate.
Additionally, Kolln teaches a non-transitory computer readable medium having stored thereon instructions that when executed by at least one processor of the medical device, perform the method (column 3, lines 9-10) for the purpose of using an electronic storage medium to store the instructions for the device operation (column 3, lines 9-10).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made to have modified the method of Fahrer to incorporate a non-transitory computer readable medium having stored thereon instructions that when executed by at least one processor of the medical device, perform the method as taught by Kolln for the purpose of using an electronic storage medium to store the instructions for the device operation (column 3, lines 9-10).
Regarding claims 18 and 19, Fahrer discloses a method for delivering a medicament implemented by a drug injection medical device (figure 1) configured to eject a fluid comprising the medicament from a reservoir (hollow portion inside elements 20a, 20b) for injection into a patient, the method comprising:
detecting a first use (paragraph 0016, lines 3-9) of the medical device;
starting a timer (paragraph 0016, lines 3-9) of the medical device in response to detecting the first use of the medical device;
determining whether a first criterion is met (paragraph 0016, lines 3-9) but is silent regarding determining whether a second criterion is met, where the second criterion is a safety criterion associated with the electromechanical assembly of the medical device; where the second criterion is met, providing by the medical device, an indication that a limit of use of the medical has been reached in response to determining that the second criterion is met.
However, Kohlbrenner teaches a design and method of determining the service life timer comprising determining whether a second criterion (paragraphs 0008, 0068, detecting operation of the device) is met where the second criterion is a safety criterion associated with the electromechanical assembly of the medical device; where the second criterion is met, providing by the medical device, an indication (paragraph 0013, lines 1-9) that a limit of use of the medical device has been reached in response to determining that the second criterion is met for the purpose of stopping the operation of the device when the device is inoperable under safety conditions and notifying the user regarding the unsafe usage of the device (paragraph 0013, lines 1-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made to modify the second detector of Fahrer to incorporate determining whether a second criterion is met where the second criterion is a safety criterion associated with the electromechanical assembly of the medical device, where the second criterion is met, providing by the medical device, an indication that a limit of use of the medical has been reached in response to determining that the second criterion is met as taught by Kohlbrenner for the purpose of stopping the operation of the device when the device is inoperable under safety conditions and notifying the user regarding the unsafe usage of the device (paragraph 0013, lines 1-9).
Fahrer is further silent regarding reversibly limiting use of the medical device temporarily; wherein the first criterion is that the time reaches or exceeds a time limit, when the first criterion is met, cancelling the reversible limit to enable injection of the medicament.
However, Kolln teaches a design of a medical device comprising reversibly limiting use of the medical device temporarily (column 5, lines 11-18, pause in delivery); wherein the first criterion is that the time reaches or exceeds a time limit (column 5, lines 11-18, determine when the device needs to pause or operate based on the time after the device is turned on the first time), when the first criterion is met, cancelling the reversible limit to enable injection of the medicament (column 5, lines 11-18) for the purpose of delivering the medicament in an intermediatory manner as required by the medical procedure (abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made to have modified a first detector of Fahrer to incorporate reversibly limiting use of the medical device temporarily; wherein the first criterion is that the time reaches or exceeds a time limit, when the first criterion is met, cancelling the reversible limit to enable injection of the medicament as taught by Kolln for the purpose of delivering the medicament in an intermediatory manner as required by the medical procedure (abstract).
While Fahrer/Kolln fails to disclose further comprising, when the reversible limit is cancelled and the second criterion is not met, injecting the medicament but instead discloses when the reversible limit is cancelled, injecting the medicament. Fahrer/Kolln/Kohlbrenner will result in a modified method comprising a step of when the reversible limit is cancelled and the second criterion is not met, injecting the medicament because Kolln discloses dispensing dose when the reversible limit is cancelled and Kohlbrenner discloses turning off the device when the second criterion is met (see paragraph 0013, lines 10-23 in Kohlbrenner).
Regarding claim 20, Fahrer discloses wherein the first use of the medical device comprises occurrence of a user operation associated with the reservoir of the medical device (paragraph 0016, lines 3-9).
Claim 6 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fahrer (US 2010/0305506 A1) in view of Kohlbrenner et al. (US 2007/0021715 A1) in view of Kolln (US 4,722,734) and further in view of Neer et al. (US 7,725,168 B2).
Regarding claim 6, Fahrer/Kohlbrenner/Kolln (hereinafter referred as “modified Fahrer”) discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Fahrer is silent regarding further comprising: a motor output shaft of the medical device; and an optical encoder that sends one or more electrical pulses in response to a rotation of the motor output shaft.
However, Neer teaches a design of powerhead of a power injection system (figure 1A) further comprising: a motor output shaft (column 6, lines 60-67, shaft or rod in the motor that rotates) of the medical device; and an optical encoder 166a, 166b (figure 2) that sends one or more electrical pulses in response to a rotation of the motor output shaft (column 6, lines 60-67) for the purpose of monitoring the movement of the motor to thereby accurately calibrate the motor when needed or if needed (column 6, lines 60-67, column 7, lines 5-22).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the electromechanical assembly of modified Fahrer to incorporate further comprising: a motor output shaft of the medical device; and an optical encoder that sends one or more electrical pulses in response to a rotation of the motor output shaft as taught by Neer for the purpose of monitoring the movement of the motor to thereby accurately calibrate the motor when needed or if needed (column 6, lines 60-67, column 7, lines 5-22).
Allowable Subject Matter
Claims 4, 7 and 11 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.
The closest prior art of record, Fahrer (US 2010/0305506 A1) in view of Kohlbrenner et al. (US 2007/0021715 A1) in view of Kolln (US 4,722,734), is silent regarding wherein the first detector detects that the medical device has been provided with the fluid in combination with other claimed limitations of claim 4.
The closest prior art of record, Fahrer (US 2010/0305506 A1) in view of Kohlbrenner et al. (US 2007/0021715 A1) in view of Kolln (US 4,722,734), is silent regarding wherein the first detector is configured to detect when the fluid comprising the medicament is provided to the reservoir of the medical device in combination with other claimed limitations of claim 7.
The closest prior art of record, Fahrer (US 2010/0305506 A1) in view of Kohlbrenner et al. (US 2007/0021715 A1) in view of Kolln (US 4,722,734), is silent regarding further comprising, when the second criterion is met while injecting the medicament, ceasing injection of the medicament in combination with other claimed limitations of claim 11.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Nemoto (US 2006/0151049 A1): discloses a design of an injector comprising mount detecting means to detect the mounting and includes waiting period to inject the media.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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