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 .
Acknowledgments
In the reply, filed on April 8, 2024, Applicant cancelled claims 1-15.
Applicant added new claims 16-35.
Specification
The abstract of the disclosure is objected to because:
In line 7, “the sensor arrangement” should be changed to “a sensor arrangement”
Line 7 recites “the sensor arrangement”. Line 4 previously recites “an optical sensor”. It is unclear whether the two recitations are the same or different
In line 12, “measurement light pulses” should be changed to “the measurement light pulses”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 17-20, 22, 25-26, 29, 32, and 34-35 are objected to because of the following informalities:
In regards to claim 17, line 1, “configuring” should be changed to “the configuring”.
In regards to claim 18, line 2, “the priming and measurement light pulses” should be changed to “the at least one priming light pulse and the measurement light pulses”.
In regards to claim 18, line 3, “the priming and measurement light pulses” should be changed to “the at least one priming light pulse and the measurement light pulses”.
In regards to claim 19, line 5, “measurement light pulses” should be changed to “the measurement light pulses”.
In regards to claim 19, line 6, “each priming light pulse” should be changed to “each priming light pulse of the at least one priming light pulse”.
In regards to claim 19, lines 6-7, “a subsequent measurement light pulse” should be changed to “a subsequent measurement light pulse of the measurement light pulses”.
In regards to claim 20, line 1, “configuring” should be changed to “the configuring”.
In regards to claim 22, line 2, “a generation” should be changed to “the generation”.
In regards to claim 22, line 3, “the first” should be changed to “the first pulse rate”.
In regards to claim 25, line 1, “altering” should be changed to “the altering”.
In regards to claim 26, line 2, “the first” should be changed to “the first pulse rate”.
In regards to claim 29, line 2, “comprising” should be changed to “comprising:”.
In regards to claim 32, line 2, “a generation” should be changed to “the generation”.
In regards to claim 34, line 2, “one or more optical sensors wherein” should be changed to “one or more optical sensors, wherein”.
In regards to claim 35, line 2, “a generation” should be changed to “the generation”.
In regards to claim 35, line 2, “a first” should be changed to “a first pulse rate”.
Appropriate correction is required.
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 16-35 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.
In regards to claim 16, line 7 recites “a sensor arrangement”. Claim 16, line 1 previously recites “an optical sensor”. It is unclear whether the two recitations are the same or different. Claims 17-28 are rejected by virtue of being dependent upon claim 16.
In regards to claim 19, line 2 recites “a first pulse rate”. Claim 19 depends upon claim 16. Claim 16, lines 3-4 previously recite “at least one predefined pulse rate”. It is unclear whether the two recitations are the same or different. Claims 20-28 are rejected by virtue of being dependent upon claim 19.
In regards to claim 19, line 2 recites “at least one secondary pulse rate”. Claim 19 depends upon claim 16. Claim 16, lines 3-4 previously recite “at least one predefined pulse rate”. It is unclear whether the two recitations are the same or different. Claims 20-28 are rejected by virtue of being dependent upon claim 19.
In regards to claim 20, line 3 recites “the pulse rate”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 20 depends upon claim 19. Claim 19, line 2 recites “a first pulse rate” and “at least one secondary pulse rate”. Claim 19 depends upon claim 16. Claim 16, lines 3-4 previously recite “at least one predefined pulse rate”. It is unclear whether “the pulse rate” is the same or different from one of “at least one predefined pulse rate”, “a first pulse rate”, or “at least one secondary pulse rate”. Claims 21-28 are rejected by virtue of being dependent upon claim 20.
In regards to claim 22, line 1 recites “a single secondary pulse rate”. Claim 22 depends upon claim 21, which depends upon claim 20. Claim 20, line 3 recites “the pulse rate”. Claim 20 depends upon claim 19. Claim 19, line 2 recites “a first pulse rate” and “at least one secondary pulse rate”. Claim 19 depends upon claim 16. Claim 16, lines 3-4 previously recite “at least one predefined pulse rate”. It is unclear whether “a single secondary pulse rate” is the same or different from one of “at least one predefined pulse rate”, “a first pulse rate”, “at least one secondary pulse rate”, or “the pulse rate”. Claim 23 is rejected by virtue of being dependent upon claim 22.
In regards to claim 22, lines 1-2 recite “a single threshold”. Claim 22 depends upon claim 21, which depends upon claim 20. Claim 20, lines 3-4 recite “at least one predefined threshold”. It is unclear whether the two recitations are the same or different. Claim 23 is rejected by virtue of being dependent upon claim 22.
In regards to claim 22, line 3 recites “the second pulse rate”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 22, line 1 previously recites “a single secondary pulse rate”. Claim 22 depends upon claim 21, which depends upon claim 20. Claim 20, line 3 recites “the pulse rate”. Claim 20 depends upon claim 19. Claim 19, line 2 recites “a first pulse rate” and “at least one secondary pulse rate”. Claim 19 depends upon claim 16. Claim 16, lines 3-4 previously recite “at least one predefined pulse rate”. It is unclear whether “the second pulse rate” is the same or different from one of “at least one predefined pulse rate”, “a first pulse rate”, “at least one secondary pulse rate”, “the pulse rate”, or “a single secondary pulse rate”. Claim 23 is rejected by virtue of being dependent upon claim 22.
In regards to claim 23, line 4 recite “or vice versa”. It is unclear which limitations are encompassed by “or vice versa”.
In regards to claim 26, line 2 recites “the second pulse rate”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 26 depends upon claim 20. Claim 20, line 3 recites “the pulse rate”. Claim 20 depends upon claim 19. Claim 19, line 2 recites “a first pulse rate” and “at least one secondary pulse rate”. Claim 19 depends upon claim 16. Claim 16, lines 3-4 previously recite “at least one predefined pulse rate”. It is unclear whether “the second pulse rate” is the same or different from one of “at least one predefined pulse rate”, “a first pulse rate”, “at least one secondary pulse rate”, or “the pulse rate”.
In regards to claim 27, lines 1-2 recite: “wherein the first pulse rate is about 2 milliseconds and the second pulse rate and the time shift are about 250 microseconds”. First, a pulse rate is understood to have units of pulse/time. However, “about 2 milliseconds” and “about 250 microseconds” only have units of time. It is unclear how the first pulse rate and the second pulse rate can only have units of time. Second, claim 27 depends upon claim 20, which depends upon claim 19. Claim 19, lines 2-3 recite “wherein the first pulse rate is lower than the at least one secondary pulse rate”. In claim 27, “about 2 milliseconds” is more than “about 250 microseconds”, which means that the first pulse rate is more than the second pulse rate, which is opposite to that which is recited in claim 19. Thus, reading claims 19-20 and 27 together, it is unclear how the first pulse rate can be both lower than the at least one secondary pulse rate and more than the second pulse rate (assuming that the at least one secondary pulse rate and the second pulse rate are the same).
In regards to claim 27, line 2 recites “the second pulse rate”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 27 depends upon claim 20. Claim 20, line 3 recites “the pulse rate”. Claim 20 depends upon claim 19. Claim 19, line 2 recites “a first pulse rate” and “at least one secondary pulse rate”. Claim 19 depends upon claim 16. Claim 16, lines 3-4 previously recite “at least one predefined pulse rate”. It is unclear whether “the second pulse rate” is the same or different from one of “at least one predefined pulse rate”, “a first pulse rate”, “at least one secondary pulse rate”, or “the pulse rate”.
In regards to claim 29, lines 1-2 recite: “a drug delivery device” or “a drug delivery add-on device”. Claim 29 , line 1 previously recites “A device”. It is unclear whether “a drug delivery device” or “a drug delivery add-on device” are the same or different from “A device”. Claims 30-33 are rejected by virtue of being dependent upon claim 29.
In regards to claim 29, line 7 recites “a sensor arrangement”. Claim 29, line 1 previously recites “an optical sensor”. It is unclear whether the two recitations are the same or different. Claims 30-33 are rejected by virtue of being dependent upon claim 29.
In regards to claim 31, line 2 recites “a first pulse rate”. Claim 31 depends upon claim 29. Claim 29, lines 3-4 previously recite “at least one predefined pulse rate”. It is unclear whether the two recitations are the same or different.
In regards to claim 31, lines 3-4 recite “the at least one secondary pulse rate”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 31 depends upon claim 29. Claim 29, lines 3-4 previously recite “at least one predefined pulse rate”. It is unclear whether the two recitations are the same or different.
In regards to claim 32, line 1 recites “a single secondary pulse rate”. Claim 32 depends upon claim 29. Claim 29, lines 3-4 previously recite “at least one predefined pulse rate”. It is unclear whether the two recitations are the same or different. Claim 33 is rejected by virtue of being dependent upon claim 32.
In regards to claim 32, line 3 recites “the first pulse rate”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 32 depends upon claim 29. Claim 29, lines 3-4 previously recite “at least one predefined pulse rate”. It is unclear whether the two recitations are the same or different. Claim 33 is rejected by virtue of being dependent upon claim 32.
In regards to claim 32, line 4 recites “the output signal”. There is insufficient antecedent basis for this limitation in the claim. Claim 33 is rejected by virtue of being dependent upon claim 32.
In regards to claim 33, lines 4-5 recite “or vice versa”. It is unclear which limitations are encompassed by “or vice versa”.
In regards to claim 34, line 5 recites “the optical sensor”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 34, line 2 previously recites “one or more optical sensors”. It is unclear whether the two recitations are the same or different. Claim 35 is rejected by virtue of being dependent upon claim 34.
In regards to claim 34, line 9 recites “a sensor arrangement”. Claim 34, line 1 previously recites “A sensor unit” and line 2 previously recites “one or more optical sensors”. It is unclear whether “a sensor arrangement” is the same or different from one of “A sensor unit” or “one or more optical sensors”. Claim 35 is rejected by virtue of being dependent upon claim 34.
In regards to claim 35, line 2 recites “a first”. Claim 35 depends upon claim 34. Claim 34, lines 5-6 previously recite “at least one predefined pulse rate”. It is unclear whether the two recitations are the same or different.
In regards to claim 35, lines 2-3 recites “a second pulse rate”. Claim 35 depends upon claim 34. Claim 34, lines 5-6 previously recite “at least one predefined pulse rate”. It is unclear whether the two recitations are the same or different.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 27 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In regards to claim 27, lines 1-2 recite: “wherein the first pulse rate is about 2 milliseconds and the second pulse rate and the time shift are about 250 microseconds”. Claim 27 depends upon claim 20, which depends upon claim 19. Claim 19, lines 2-3 recite “wherein the first pulse rate is lower than the at least one secondary pulse rate”. In claim 27, “about 2 milliseconds” is more than “about 250 microseconds”, which means that the first pulse rate is more than the second pulse rate, which is opposite to that which is recited in claim 19. Assuming that “the at least one secondary pulse rate” and “the second pulse rate” are the same, claim 27 is of improper dependent form for failing to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 16-26 and 28-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schabbach et al (WO 2019/101962).
In regards to claim 16, Schabbach et al teaches a method for driving an optical sensor (215a/215b) of a drug delivery device (2), the method comprising:
configuring the optical sensor to generate measurement light pulses with at least one predefined pulse rate (page 36, lines 12-14: the second optical sensor is configured to operate in a strobe-sampling mode along a second time series of strobe pulses, the… second time series having the pulse density per time unit) and to generate at least one priming light pulse before one or more of the measurement light pulses (page 36, lines 10-11: the first optical sensor is configured to operate in a strobe-sampling mode along a first time series of strobe pulses), wherein the drug delivery device comprises a movable dosage programming component (205/70) and the optical sensor is configured to detect movement of the movable dosage programming component relative to a sensor arrangement (215) during dosing of a drug by generating the measurement light pulses and detecting reflections of the measurement light pulses from the movable dosage programming component (page 5, lines 21-25: sensor arrangement comprising a light emitter arranged to emit a light beam directed to a light reflector of the encoder ring and two light receivers arranged to receive a light beam reflected by the light reflector of the encoder ring, wherein the sensor arrangement is configured to detect movement of the movable dosage programming component relative to the sensor arrangement during dosing of a medicament), wherein the at least one priming light pulse is generated with one of the at least one predefined pulse rate (page 36, line 14: the first… time series having the pulse density per time unit)
In regards to claim 17, Schabbach et al teaches wherein configuring the optical sensor to generate the at least one priming light pulse comprises generating the at least one priming light pulse comprising one or more parameters differing from a corresponding parameter for generating the measurement light pulses (page 12, lines 4-9).
In regards to claim 18, Schabbach et al teaches wherein at least one of the one or more parameters comprises: an energy of the priming and measurement light pulses (page 12, lines 4-12).
In regards to claim 19, Schabbach et al teaches wherein the measurement light pulses are generated either with a first pulse rate or with at least one secondary pulse rate (page 36, line 14), wherein the first pulse rate is lower than the at least one secondary pulse rate (page 12, lines 7-9) and the at least one priming light pulse is generated with one of the at least one secondary pulse rate (page 36, line 14) and the optical sensor is configured to generate the at least one priming light pulse at least before generating measurement light pulses with the first pulse rate (page 36, lines 10-11), wherein each priming light pulse is generated at a time shift prior to a subsequent measurement light pulse corresponding to the at least one secondary pulse rate (page 36, lines 10-14).
In regards to claim 20, Schabbach et al teaches wherein configuring the optical sensor to generate the measurement light pulses either with the first pulse rate or with the at least one secondary pulse rate comprises switching the pulse rate depending on exceeding or undercutting at least one predefined threshold by an output signal of the optical sensor (page 3, lines 33-36).
In regards to claim 21, Schabbach et al teaches wherein the optical sensor is configured to generate the measurement light pulses with the first pulse rate if the output signal is below the at least one predefined threshold and to generate the measurement light pulses with the at least one secondary pulse rate if the output signal is above the at least one predefined threshold (page 3, lines 33-36).
In regards to claim 22, Schabbach et al teaches wherein a single secondary pulse rate and a single threshold are provided and the optical sensor is configured to switch a generation of the measurement light pulses between the first and the second pulse rate when the single threshold is crossed by the output signal of the optical sensor (page 3, lines 33-36).
In regards to claim 23, Schabbach et al teaches wherein the optical sensor is configured to generate the measurement light pulses with the first pulse rate when the output signal of the optical sensor is above the single threshold and to generate the measurement light pulses with the second pulse rate when the output signal of the optical sensor is below the single threshold or vice versa (page 3, lines 33-36).
In regards to claim 24, Schabbach et al teaches altering the at least one predefined threshold (page 3, lines 31-33).
In regards to claim 25, Schabbach et al teaches wherein altering the at least one predefined threshold depends on the reflections (page 3, lines 31-36).
In regards to claim 26, Schabbach et al teaches wherein the optical sensor is configured to generate the measurement light pulses with the first or the second pulse rate by default (page 36, line 14).
In regards to claim 28, Schabbach et al teaches modulating an energy of the measurement light pulses (page 12, lines 4-12).
In regards to claim 29, Schabbach et al teaches a device (Figures 2-6) for driving an optical sensor (215a/215b) of a drug delivery device (2), the device being configured to perform operations comprising
configuring the optical sensor to generate measurement light pulses with at least one predefined pulse rate (page 36, lines 12-14: the second optical sensor is configured to operate in a strobe-sampling mode along a second time series of strobe pulses, the… second time series having the pulse density per time unit) and to generate at least one priming light pulse before one or more of the measurement light pulses (page 36, lines 10-11: the first optical sensor is configured to operate in a strobe-sampling mode along a first time series of strobe pulses), wherein the drug delivery device comprises a movable dosage programming component (205/70) and the optical sensor is provided and configured to detect movement of the movable dosage programming component relative to a sensor arrangement (215) during dosing of a drug by generating the measurement light pulses and detecting reflections of the measurement light pulses from the movable dosage programming component (page 5, lines 21-25: sensor arrangement comprising a light emitter arranged to emit a light beam directed to a light reflector of the encoder ring and two light receivers arranged to receive a light beam reflected by the light reflector of the encoder ring, wherein the sensor arrangement is configured to detect movement of the movable dosage programming component relative to the sensor arrangement during dosing of a medicament), wherein the at least one priming light pulse is generated with one of the at least one predefined pulse rate (page 36, line 14: the first… time series having the pulse density per time unit)
In regards to claim 30, Schabbach et al teaches being configured to determine a dosage delivered and/or selected with the drug delivery device based on the reflections of the measurement light pulses from the movable dosage programming component (page 5, lines 21-27).
In regards to claim 31, Schabbach et al teaches wherein the optical sensor is configured to generate the measurement light pulses with a first pulse rate if an output signal of the optical sensor is below at least one predefined threshold and to generate the measurement light pulses with the at least one secondary pulse rate if the output signal is above the at least one predefined threshold (page 3, lines 33-36).
In regards to claim 32, Schabbach et al teaches wherein a single secondary pulse rate and a single threshold are provided and the optical sensor is configured to switch a generation of the measurement light pulses between the first pulse rate and the single secondary pulse rate when the single threshold is crossed by the output signal of the optical sensor (page 3, lines 33-36).
In regards to claim 33, Schabbach et al teaches wherein the optical sensor is configured to generate the measurement light pulses with the first pulse rate when the output signal of the optical sensor is above the single threshold and to generate the measurement light pulses with the single secondary pulse rate when the output signal of the optical sensor is below the single threshold or vice versa (page 3, lines 33-36).
In regards to claim 34, Schabbach et al teaches a sensor unit (215) (Figures 2-6) of a drug delivery device (2), the sensor unit comprising one or more optical sensors (215a/25b) wherein the sensor unit is provided and configured for integration in the drug delivery device (Figures 4-6), the drug delivery device being configured to perform operations comprising:
configuring the optical sensor to generate measurement light pulses with at least one predefined pulse rate (page 36, lines 12-14: the second optical sensor is configured to operate in a strobe-sampling mode along a second time series of strobe pulses, the… second time series having the pulse density per time unit) and to generate at least one priming light pulse before one or more of the measurement light pulses (page 36, lines 10-11: the first optical sensor is configured to operate in a strobe-sampling mode along a first time series of strobe pulses), wherein the drug delivery device comprises a movable dosage programming component (205/70) and the optical sensor is provided and configured to detect movement of the movable dosage programming component relative to a sensor arrangement (215) during dosing of a drug by generating the measurement light pulses and detecting reflections of the measurement light pulses from the movable dosage programming component (page 5, lines 21-25: sensor arrangement comprising a light emitter arranged to emit a light beam directed to a light reflector of the encoder ring and two light receivers arranged to receive a light beam reflected by the light reflector of the encoder ring, wherein the sensor arrangement is configured to detect movement of the movable dosage programming component relative to the sensor arrangement during dosing of a medicament), wherein the at least one priming light pulse is generated with one of the at least one predefined pulse rate (page 36, line 14: the first… time series having the pulse density per time unit)
In regards to claim 35, Schabbach et al teaches wherein the one or more optical sensors are configured to switch a generation of the measurement light pulses between a first and a second pulse rate (page 3, lines 33-36).
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 27 is rejected under 35 U.S.C. 103 as being unpatentable over Schabbach et al, as applied to claim 20 above.
In regards to claim 27, Schabbach et al is silent about wherein the first pulse rate is about 2 milliseconds and the second pulse rate and the time shift are about 250 microseconds. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the method, of Schabbach et al, wherein the first pulse rate is about 2 milliseconds and the second pulse rate and the time shift are about 250 microseconds, as Applicant has not disclosed that such a configuration provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the first pulse rate and the second pulse rate and the time shift varying according to the kinematical state of the movable dosage programming component, as taught by Schabbach et al (page 36, lines 14-16), as a person having ordinary skill in the art would have known how to configure the first pulse rate and the second pulse rate and the time shift in order to determine a medicament dosage dialed by movement of the movable dosage programming component.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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