Detailed Action
Abstract
The abstract of the disclosure is objected to because the abstract was recited as part of the specification in page 23 or in page 22 of the clean copy. The abstract must be separate from the specification. The abstract must be written on a separate page numbered with the number 1. 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 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.
Claim(s) 15-35 is/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 pre-AIA the applicant regards as the invention.
In regards to claim 15, the claim recites in lines 1-2 “A method of operating an electronic unit of a drug delivery device or a drug delivery add-on device”. The way the claim is written it appears that the claim is directed to two inventions. The first invention is directed to a method of operating an electronic unit of a drug delivery device, and the second invention is directed to a method of operating an electronic unit of a drug delivery add-on device. The claims must recite one single invention. Therefore, it is unclear which invention the claim is trying to recite. For this reason, the claim is indefinite. The examiner has interpreted lines 1-2 of claim 15 in the following way in order to advance prosecution: “A method of operating an electronic unit, the electronic unit being part of a drug delivery device or of a drug delivery add-on device”.
In regards to claim(s) 16-26, the claim(s) is/are indefinite due to its/their dependency on indefinite claim 15.
In regards to claim 16, the claim recites in line 3 “configuring and/or testing the device”. Claim 15 defines a drug delivery device and a drug delivery add-on device. It is unclear to which of the previously defined devices the limitation of line 3 is referring. For this reason, the claim is indefinite. The examiner has interpreted the claim in the following way in order to advance prosecution: “configuring and/or testing the drug delivery device or the drug delivery add-on device”.
In regards to claim(s) 17-26, the claim(s) is/are indefinite due to its/their dependency on indefinite claim 16.
In regards to claim 17, the claim recites in line 1 “wherein the one or more components comprise”. Claim 15 defines one or more components in line 5, in line 7 and in line 9. It is unclear to which of the previously defined one or more components the limitation of line 1 is referring. For this reason, the claim is indefinite. The examiner has interpreted claim 15 and 17 in the following way in order to advance prosecution:
Lines 5-10 of claim 15:
“a shutdown mode in which one or more components of the electronic unit are operated for minimum power consumption;
a dose capture and recording mode in which one or more of the components of the electronic unit are operated to perform the dose measurement function; and
a communication mode in which one or more of the components of the electronic unit are operated to perform the data transmission function”.
Line 1 of claim 17: “where the of the electronic unit comprise”.
In regards to claim(s) 18-25, the claim(s) is/are indefinite due to its/their dependency on indefinite claim 17.
In regards to claim 19, line 1 of the claim has the same issues described in the rejection of claim 17 above. For this reason, the claim is indefinite.
In regards to claim(s) 20-23, the claim(s) is/are indefinite due to its/their dependency on indefinite claim 19.
In regards to claim 20, the claim recites in line 2 “switching the at least one processor, comprising the main controller, into”. Even though claim 18 defines at least one processor, and claim 19 defines a main controller, claims 18 and 19 does not recites that the main controller is part of the at least one processor. Therefore, there is lack of antecedent basis for the limitation of “the at least one processor, comprising the main controller”. For this reason, the claim is indefinite. The examiner has interpreted the claim in the following way in order to advance prosecution: “switching [[the]] at least one processor, comprising the main controller, into”.
In regards to claim 23, the claim recites a list of steps of the method. However, lines 3, 4 and 5 recites two steps in the same line. It is unclear if the second step recited in the same line is part of the list of the steps recited in claim 23 or is part of the first step recited in the same line. For this reason, the claim is indefinite.
Also, line 5 of the claim recites “(A1.9)” and “(A1.19)”. It is unclear what the meaning of the limitations inside the parenthesis is. For this reason, the claim is indefinite.
The examiner has interpreted lines 3-5 of the claim in the following way in order to advance prosecution:
“determining a device state;
determining a reported dose;
reading a real time counter value;
determining a dose time;
determining a flags value
generating at least one dose record;”.
In regards to claim 27, the claim recites in line 1 “An electronic unit of a drug delivery device or a drug delivery add-on device”. The way the claim is written it appears that the claim is directed to two inventions. The first invention is directed to an electronic unit of a drug delivery device, and the second invention is directed to an electronic unit of a drug delivery add-on device. The claims must recite one single invention. Therefore, it is unclear which invention the claim is trying to recite. For this reason, the claim is indefinite. The examiner has interpreted line 1 of claim 27 in the following way in order to advance prosecution: “An electronic unit of a drug delivery apparatus, the electronic apparatus being part of a drug delivery device of the drug delivery apparatus or of a drug delivery add-on device of the drug delivery apparatus”.
In regards to claim(s) 28-32, the claim(s) is/are indefinite due to its/their dependency on indefinite claim 27.
In regards to claims 28-32, each of the claims recite in line 1 “The electronic unit of claim 27”. Claim 27 defines an electronic unit of a drug delivery device and an electronic unit of a drug delivery add-on device. It is unclear to which of the previously defined units the limitation of line 1 is referring. For this reason, the claims are indefinite.
In regards to claim 33, the claim recites in line 1 “A drug delivery device or a drug delivery add-on device comprising”. The way the claim is written it appears that the claim is directed to two inventions. The first invention is directed to a drug delivery device, and the second invention is directed to a drug delivery add-on device. The claims must recite one single invention. Therefore, it is unclear which invention the claim is trying to recite. For this reason, the claim is indefinite. The examiner has interpreted line 1 of claim 33 in the following way in order to advance prosecution: “A drug delivery apparatus comprising a drug delivery device or a drug delivery add-on device comprising”.
In regards to claim(s) 34-35, the claim(s) is/are indefinite due to its/their dependency on indefinite claim 33.
In regards to claim 34 and 35, each of the claims recite in line 1 “The device of claim 33”. Claim 33 defines a drug delivery device and a drug delivery add-on device. It is unclear to which of the previously defined devices the limitation of line 1 is referring. For this reason, the claim is indefinite.
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(s) 16-26, 28-32 and 34-35 is/are 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. 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.
In regards to claims 16-26, each of the claims recite in line 1 “The method of claim”. Claim 15 defines a method of operating an electronic unit of a drug delivery device and a method of operating an electronic unit of a drug delivery add-on device. If the limitations of claims 16-26 are referring to only one of the methods defined in claim 15, the claims are failing to include all the limitations of the claim upon which it depends because the claims are not including both of the methods defined in claim 27. The examiner has interpreted lines 1-2 of claim 15 in the following way in order to advance prosecution: “A method of operating an electronic unit, the electronic unit being part of a drug delivery device or of a drug delivery add-on device”.
In regards to claims 28-32, each of the claims recite in line 1 “The electronic unit of claim 27”. Claim 27 defines an electronic unit of a drug delivery device and an electronic unit of a drug delivery add-on device. If the limitations of claims 28-32 are referring to only one of the electronic units defined in claim 27, the claims are failing to include all the limitations of the claim upon which it depends because the claims are not including both of the electronic units defined in claim 27. The examiner has interpreted line 1 of claim 27 in the following way in order to advance prosecution: “An electronic unit of a drug delivery apparatus, the electronic apparatus being part of a drug delivery device of the drug delivery apparatus or of a drug delivery add-on device of the drug delivery apparatus”.
In regards to claim 34 and 35, each of the claims recite in line 1 “The device of claim 33”. Claim 33 defines a drug delivery device and a drug delivery add-on device. If the limitations of claims 34 and 35 are referring to only one of the drug delivery devices defined in claim 33, the claims are failing to include all the limitations of the claim upon which it depends because the claims are not including both of the devices defined in claim 33.
The examiner has interpreted line 1 of claims 33, 34 and 35 in the following way in order to advance prosecution:
Claim 33 “A drug delivery apparatus comprising an integrated drug delivery device or a drug delivery add-on device comprising”.
Claim 34: “The drug delivery apparatus
Claim 35: “The drug delivery apparatus
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.
Claim(s) 15 and 27-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jorgensen et al. (US-9,186,465).
In regards to claim 15, Jorgensen teaches a method of operating an electronic unit, the electronic unit being part of a drug delivery device [fig. 1, fig. 4a element 271, col. 10 L. 41-47, col. 14 L. 21-25]. Furthermore, Jorgensen teaches that the drug delivery device comprises a dose measurement function and a data transmission function [col. 8 L. 49-57]. Also, Jorgensen teaches that the electronic unit is configured to operate in a shutdown mode in which one or more components of the electronic unit are operated for minimum power consumption [col. 8 L. 49-51]. Jorgensen further teaches that the electronic unit is configured to operate in a dose capture and recording mode in which one or more components of the electronic unit are operated to perform the dose measurement function [col. 8 L. 44-46 and L. 54-55]. Also, Jorgensen teaches that the electronic unit is configured to operate in a communication mode in which one or more components of the electronic unit are operated to perform the data transmission function [col. 8 L. 40-44 and L. 51-54]. Furthermore, Jorgensen teaches that the method comprises operating the electronic unit in the shutdown mode when the drug delivery device is parked position for a predetermined period of time (idle) [col. 9 L. 4-6 and L. 13-15] and/or after the dose capture and recording mode [col. 9 L. 4-6] and/or after the communication mode [col. 8 L. 19-22 and L. 27-28]. Also, Jorgensen teaches that the dosage sense sensor is powered up when the dosage selector is bulled out [col. 22 L. 31-40 and L. 52-56]. This teaching that when the dosage selector is bulled out a wake up signal is sent to the sensor to power up. In other words, the method comprises operating the electronic unit in the dose capture and recording mode upon receipt of a wake up signal. Jorgensen further teaches that that the electronic unit can comprise a mode in which the electronic unit operates in the communication mode and in the dose capture and recording mode at the same time [col. 8 L. 51-54]. This teaching means that the method comprises operating the electronic unit in the communication mode upon initiation from the dose capture and recording mode.
In regards to claim 27, Jorgensen, as shown in the rejection of claim 15, teaches a method comprising the operations of the claimed electronic unit. Therefore, Jorgensen also teaches the claimed electronic unit. Also, Jorgensen teaches that the electronic unit is operable in different operating modes and comprises one or more components being capable of being switched into different modes having different power requirements depending on the operating mode of the electronic unit [col. 8 L. 49-57]. Furthermore, Jorgensen teaches that the electronic unit comprises at least one processor configured the at least one processor to perform the claimed operations [fig. 11, col. 16 L. 7-9]. It is inherent that the processor is coupled to at least one non-volatile memory for storing a program configuring the at least one processor to perform the claimed operations because the processor will not function without instructions stored in memory.
In regards to claim 28, Jorgensen, as applied in the rejection of claim 27 above, further teaches that the one or more components comprise a processor (sensor controller) for dose capture [fig. 11, col. 16 L. 7-9, col. 23 L. 23-36].
In regards to claim 29, Jorgensen, as applied in the rejection of claim 27 above, further teaches that the one or more components comprise a main controller provided for dose recording and data transmission control [fig. 11, col. 16 L. 7-9, col. 23 L. 23-39].
In regards to claim 30, Jorgensen, as applied in the rejection of claim 27 above, further teaches that the one or more components comprise at least one communication interface component [col. 8 L. 16-17].
In regards to claim 31, Jorgensen, as applied in the rejection of claim 27 above, further teaches that the one or more components are connected to a printed circuit board [col. 16 L. 7-9 and L. 23-25, col. 23 L. 53-59].
In regards to claim 32, Jorgensen, as applied in the rejection of claim 27 above, further teaches that the one or more components are integrated in a distal end of the drug delivery device [fig. 1 element 275, fig. 3, fig. 4A element 271].
In regards to claim 33, Jorgensen, as shown in the rejections of claims 15 and 27, teaches the claimed limitations. Therefore, Jorgensen also teaches the claimed drug delivery device.
In regards to claim 34, Jorgensen, as shown in the rejections of claims 28-30, teaches the claimed limitations.
In regards to claim 35, Jorgensen, as shown in the rejection of claim 31, teaches the claimed limitations.
Other Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Paramanandam et al. (US-2022/0347398) teaches drug delivery device comprising a plurality of operation modes [fig. 1, fig. 3].
Allowable Subject Matter
Claim(s) 16-26 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
In regards to claim 16, the prior art cited in this office action does not teach either by anticipation or combination the following limitations: wherein the electronic unit is further configured to operate in a manufacturing mode in which the electronic unit is operated for configuring and/or testing the device; and wherein the method comprises: operating the electronic unit in the manufacturing mode upon initiation from the dose capture and recording mode and receipt of a manufacturing mode request; and operating the electronic unit in the shutdown mode after the manufacturing mode.
In regards to claims 17-26, the claims would be allowable due to their dependency on claim 16.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRANKLIN D BALSECA whose telephone number is (571)270-5966. The examiner can normally be reached 6AM-4PM EST M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, STEVEN LIM can be reached at 571-270-1210. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRANKLIN D BALSECA/Examiner, Art Unit 2688
Prosecution Insights