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 .
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 10/29/2024, has been considered by the examiner.
Claim Objections
Claim 28 is objected to because of the following informalities: The claim appears to be missing a comma between the words “established” and “a” in the 2nd to last line of the claim. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “dose setting and drive mechanism” in claims 16 and 22.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
[Claim 16] The claim recites the limitation of “An electronic device for a drug delivery device comprising: a dose setting and drive mechanism configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device and a dose delivery operation for delivering the set dose.” The examiner is unable to determine the metes and bounds of the claim, since it is unclear if the “dose setting and drive mechanism” is intended to be part of the “electronic device” or the functionally recited “drug delivery device.” For purposes of examination, it is interpreted that the “dose setting and drive mechanism” is intended to be part of the functionally recited “drug delivery device.”
[Claim 16] The claim recites the limitation of “the other device” in the 13th and 14th lines of the claim. There is a lack of antecedent basis for this limitation in the claim. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation refers to the previously recited “another device,” or if a new structure is being introduced into the claim language. For purposes of examination, it is interpreted that “the other device” refers to the previously recited “another device.”
[Claim 22] The claim recites the limitation of “A system comprising: a drug delivery device comprising: a dose setting and drive mechanism configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device; and a dose delivery operation for delivering the set dose.” The examiner is unable to determine the metes and bounds of the claim, since it is unclear if the limitation after the semicolon is intended to be a functionality of the claimed “dose setting and drive mechanism,” or if the limitation is somehow intended to be another structure within the “drug delivery device.” For purposes of examination, it is interpreted that the semicolon is in error and that the limitation of “a dose delivery operation for delivering the set dose” is a functional limitation of the “dose setting and drive mechanism.”
[Claim 23] The claim recites the limitation of “the communication unit” in the 2nd line of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation refers to the communication unit introduced in claim 22 as part of the “electronic device,” or if it is intended to refer to the “another communication unit” introduced in claim 23. For purposes of examination, it is interpreted that the limitation refers to the communication unit introduced in claim 22 as part of the “electronic device.”
[Claim 23] The claim recites the limitation of “the other communication unit” in the 3rd line of the claim. There is a lack of antecedent basis for this limitation in the claims. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation refers to the communication unit introduced in claim 22 as part of the “electronic device,” or if it is intended to refer to the “another communication unit” introduced in claim 23. For purposes of examination, it is interpreted that the limitation refers to “another communication unit” introduced in claim 23.
[Claim 23] The claim recites the limitation of “the other device” in the 3rd and 4th lines of the claim. There is a lack of antecedent basis for this limitation in the claim. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation refers to the previously recited “another device,” or if a new structure is being introduced into the claim language. For purposes of examination, it is interpreted that “the other device” refers to the previously recited “another device.”
[Claim 28] The claim recites the limitation of “the other device” in the 11th line of the claim. There is a lack of antecedent basis for this limitation in the claim. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation refers to the previously recited “another device,” or if a new structure is being introduced into the claim language. For purposes of examination, it is interpreted that “the other device” refers to the previously recited “another device.”
[Claim 28] The claim recites the limitation of “the communication units” in the 13th line of the claim. There is a lack of antecedent basis for this limitation in the claim. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation collectively refers to the previously recited “first communication unit” and “second communication unit,” or if new structures are being introduced into the claim limitations. For purposes of examination, it is interpreted that the limitation collectively refers to the previously recited “first communication unit” and “second communication unit.”
[Claim 30] The claim recites the limitation of “the data” in the 1st line of the claim. There is a lack of antecedent basis for this limitation in the claims. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this refers to the previously recited “measurement data,” the “data” introduced in the 11th line of claim 28, or if new “data” is being introduced. For purposes of examination, it is interpreted that the limitation refers to the “data” introduced in the 11th line of claim 28.
[Claim 34] The claim recites the limitation of “after transferring the data to the other device, stopping transmission of data from the first communication unit to the second communication unit.” The examiner is unable to determine the metes and bounds of the claim, since it is unclear how transmission of data can be “stopped” if transmission has already been completed (“after transferring the data”). For purposes of examination, it is interpreted that any transferring of data is considered to satisfy “stopping the transmission of data.”
[Claim 34] The claim recites the limitation of “the data” in the 1st line of the claim. There is a lack of antecedent basis for this limitation in the claims. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this refers to the previously recited “measurement data,” the “data” introduced in the 11th line of claim 28, or if new “data” is being introduced. For purposes of examination, it is interpreted that the limitation refers to the “data” introduced in the 11th line of claim 28.
[Claims 17-21, 23-27, and 29-35] The claims are rejected based upon their dependency from independent claims 16, 22, and 28.
Claim Rejections - 35 USC § 112
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 30 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. The claim recites the limitation of “further comprising encrypting the data transferred to the other device.” However, as claim 28 establishes an encrypted communication link between the “electronic device” and the “another device,” the limitations of claim 30 are not further limiting. 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
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.
Claims 22, 23, and 26, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rehbein et al. (PGPub 2019/0192778).
[Claim 22] Rehbein teaches a system (figure 1) comprising:
a drug delivery device (figure 1, item 1) comprising:
a dose setting and drive mechanism (figure 3, items 11/12) configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device (figure 3, via item 12; paragraphs [0058], [0069], [0085]); and
a dose delivery operation for delivering the set dose (see 112b interpretation above) (figure 3, via item 11; paragraphs [0062], [0072], [0097]); and
an electronic device (figure 2, item 20) configured to be coupled to the drug delivery device (figure 1, item 1) (figure 2), the electronic device (figure 2, item 20) comprising:
at least one processor (figure 8, item 50; paragraph [0101]);
a memory (figure 8, items 52a/52b) coupled to the at least one processor (figure 8, item 50) (paragraphs [0101], [0105]);
a sensor arrangement (figure 8, items 32/34) connected to the at least one processor (figure 8, item 50) and configured to generate measurement data indicative of the dose setting operation (figure 3, via item 12) or the dose delivery operation (figure 3, via item 11) (paragraphs [0074], [0101]); and
a communication unit (figure 8, item 57) comprising a wireless communication interface (paragraph [0107]) connected to the at least one processor (figure 8, item 50) and configured to establish an encrypted wireless communication (Bluetooth®) (figure 9, item 61) (paragraph [0107]).
[Claim 23] Rehbein teaches the limitations of claim 22, upon which claim 23 depends. In addition, Rehbein discloses another device (figure 9, item 60) comprising another communication unit (paragraph [0107]), wherein the communication unit (see 112b interpretation above) (figure 8, item 57) is configured to establish the encrypted wireless communication (Bluetooth®) (figure 9, item 61) with the other communication unit (see 112b interpretation above) (paragraph [0107]) and to transfer data to the other device (see 112b interpretation above) (figure 9, item 60) (paragraph [0107]).
[Claim 26] Rehbein teaches the limitations of claim 22, upon which claim 26 depends. Rehbein also teaches the electronic device (figure 2, item 20) further comprises a battery (figure 8, item 54) (paragraph [0102]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 16-21, 24, 25, and 27-35, are rejected under 35 U.S.C. 103 as being unpatentable over Rehbein et al. (PGPub 2019/0192778), in view of Srinivasan et al. (PGPub 2019/0134305).
[Claims 16 and 18] Rehbein teaches an electronic device (figure 2, item 20) for a drug delivery device (figure 1, item 1) comprising:
a dose setting and drive mechanism (see 112b interpretation above) (figure 3, items 11/12) configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device (figure 3, via item 12; paragraphs [0058], [0069], [0085]) and a dose delivery operation for delivering the set dose (figure 3, via item 11; paragraphs [0062], [0072], [0097]),
the electronic device (figure 2, item 20) comprising:
at least one processor (figure 8, item 50; paragraph [0101]);
a memory (figure 8, items 52a/52b) for storing measurement data (paragraphs [0101], [0105]);
a power source (figure 8, item 54) connected to the at least one processor (figure 8, item 50) (paragraph [0102]);
a sensor arrangement (figure 8, items 32/34) connected to the at least one processor (figure 8, item 50) and operable to generate measurement data indicative of the dose setting operation (figure 3, via item 12) and/or the dose delivery operation (figure 3, via item 11) (paragraphs [0074], [0101]); and
a first communication unit (figure 8, item 57) comprising a wireless communication interface (Bluetooth®) (paragraph [0107]) connected to the at least one processor (figure 8, item 50) and configured to establish an encrypted wireless communication (Bluetooth®) (figure 9, item 61) (paragraph [0107]) with a second communication unit of another device (figure 9, item 60) and to transfer data to the other device (see 112b interpretation above) (figure 9; paragraph [0107]).
Rehbein does not specifically disclose the electronic device is configured to reduce a radio frequency power of the first communication unit while the encrypted wireless communication between the first communication unit and the second communication unit is being established thereby limiting a pairing distance between the electronic device and the other device.
However, Srinivasan teaches a system and method (figure 11) comprising establishing communication between an electronic device (“electronic components”) (figure 12, item 103) (for use with a drug delivery device; figure 11, item 102; paragraph [0040]) and a secondary device (figure 11, item 104), wherein a radio frequency power of a first communication unit (hybrid NFC/Bluetooth®) (figure 12, items 106/106’) is reduced (the examiner notes Srinivasan teaches a hybrid NFC/Bluetooth® system wherein NFC is utilized during the pairing process and NFC or Bluetooth® can be used during data transfer; as such, during pairing, NFC utilizes reduced radio frequency power) while encrypted wireless communication between the first communication unit (hybrid NFC/Bluetooth®) (figure 12, items 106/106’) and a second communication unit (item 104 can be a “NFC-enabled and Bluetooth™-enabled smart phone with via a NFC and/or Bluetooth™ wireless connection”; paragraph [0054]) of the secondary device (figure 11, item 104) is being established (“pairing”) thereby limiting a pairing distance (figure 11) between the electronic device (“electronic components”) (figure 12, item 103) and the secondary device (figure 11, item 104) (figure 11; paragraphs [0054], [0055], [0057]-[0059]).
It would have been obvious to one ordinary skill in the art, before the effective filing date of the invention, to have modified the first communication unit taught by Rehbein, to have utilized a hybrid communication unit, as taught by Srinivasan, in order to provide increased functionality, safety, and control, by allowing for a means by which autonomous pairing and simultaneous data download might occur, while ensuring an intended wireless connection by limiting pairing distance (Srinivasan; figure 11; paragraphs [0054], [0055], [0057]-[0059]).
[Claim 17] Rehbein and Srinivasan teach the limitations of claim 16, upon which claim 17 depends. In addition, Srinivasan teaches the radio frequency power is increased after the encrypted wireless communication between the first communication unit (hybrid NFC/Bluetooth®) (figure 12, items 106/106’) and the second communication unit (item 104 can be a “NFC-enabled and Bluetooth™-enabled smart phone with via a NFC and/or Bluetooth™ wireless connection”; paragraph [0054]) is established (figure 11; paragraphs [0054], [0055], [0057]-[0059]) (again, the examiner notes Srinivasan teaches a hybrid NFC/Bluetooth® system wherein NFC is utilized during the pairing process and NFC or Bluetooth® can be used during data transfer; as such, after pairing, when Bluetooth® is utilized, radio frequency power is increased).
[Claim 19] Rehbein and Srinivasan teach the limitations of claim 16, upon which claim 19 depends. Srinivasan further discloses the radio frequency power is reduced by software operations, electronic signal, and/or a mechanical operation (figures 11 and 12; paragraphs [0054], [0055], [0057]-[0059]).
[Claim 20] Rehbein and Srinivasan teach the limitations of claim 16, upon which claim 20 depends. Srinivasan also teaches the pairing distance is limited to be less than 3.0 meters (“10 cm”) (figure 11; paragraph [0037]; “for NFC pairing”).
[Claim 21] Rehbein and Srinivasan teach the limitations of claim 16, upon which claim 21 depends. Although teaching a battery (figure 8, item 54; paragraph [0102]), Rehbein does not specifically disclose the use of a rechargeable battery.
However, Srinivasan teaches a system and method comprising establishing communication between an electronic device (“electronic components”) (figure 12, item 103) (for use with a drug delivery device; figure 11, item 102; paragraph [0040]) and a secondary device (figure 11, item 104), wherein a rechargeable battery is utilized (figure 12, item 114) (paragraph [0041]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the battery taught by Rehbein, to a rechargeable battery, as taught by Srinivasan, in order to provide increased functionality and versatility, since such usage is conventional in reuseable medical devices to allow for cheaper and environmentally-friendly device operation.
[Claim 24] Rehbein teaches the limitations of claim 22, upon which claim 24 depends. Rehbein does not specifically disclose the electronic device is configured to reduce a radio frequency power of the communication unit while the encrypted wireless communication is established.
However, Srinivasan teaches a system and method comprising establishing communication between an electronic device (“electronic components”) (figure 12, item 103) (for use with a drug delivery device; figure 11, item 102; paragraph [0040]) and a secondary device (figure 11, item 104), wherein a radio frequency power of a communication unit (hybrid NFC/Bluetooth®) (figure 12, items 106/106’) is reduced (the examiner notes Srinivasan teaches a hybrid NFC/Bluetooth® system wherein NFC is utilized during the pairing process and NFC or Bluetooth® can be used during data transfer; as such, during pairing, NFC utilizes reduced radio frequency power) while encrypted wireless communication between the communication unit (hybrid NFC/Bluetooth®) (figure 12, items 106/106’) and a second communication unit (item 104 can be a “NFC-enabled and Bluetooth™-enabled smart phone with via a NFC and/or Bluetooth™ wireless connection”; paragraph [0054]) of the secondary device (figure 11, item 104) is being established (“pairing”) thereby limiting a pairing distance (figure 11) between the electronic device (“electronic components”) (figure 12, item 103) and the secondary device (figure 11, item 104) (figure 11; paragraphs [0054], [0055], [0057]-[0059]).
It would have been obvious to one ordinary skill in the art, before the effective filing date of the invention, to have modified the first communication unit taught by Rehbein, to have utilized a hybrid communication unit, as taught by Srinivasan, in order to provide increased functionality, safety, and control, by allowing for a means by which autonomous pairing and simultaneous data download might occur, while ensuring an intended wireless connection by limiting pairing distance (Srinivasan; figure 11; paragraphs [0054], [0057]-[0059]).
[Claim 25] Rehbein and Srinivasan teach the limitations of claim 24, upon which claim 25 depends. In addition, Srinivasan teaches the radio frequency power is increased after the encrypted wireless communication between the communication unit (hybrid NFC/Bluetooth®) (figure 12, items 106/106’) and the second communication unit (item 104 can be a “NFC-enabled and Bluetooth™-enabled smart phone with via a NFC and/or Bluetooth™ wireless connection”; paragraph [0054]) is established (figure 11; paragraphs [0054], [0055], [0057]-[0059]) (again, the examiner notes Srinivasan teaches a hybrid NFC/Bluetooth® system wherein NFC is utilized during the pairing process and NFC or Bluetooth® can be used during data transfer; as such, after pairing, when Bluetooth® is utilized, radio frequency power is increased).
[Claim 27] Rehbein teaches the limitations of claim 26, upon which claim 27 depends. Although teaching a battery (figure 8, item 54; paragraph [0102]), Rehbein does not specifically disclose the use of a rechargeable battery.
However, Srinivasan teaches a system and method comprising establishing communication between an electronic device (“electronic components”) (figure 12, item 103) (for use with a drug delivery device; figure 11, item 102; paragraph [0040]) and a secondary device (figure 11, item 104), wherein a rechargeable battery is utilized (figure 12, item 114) (paragraph [0041]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the battery taught by Rehbein, to a rechargeable battery, as taught by Srinivasan, in order to provide increased functionality and versatility, since such usage is conventional in reuseable medical devices to allow for cheaper and environmentally-friendly device operation.
[Claims 28, 30, 31, and 34] Rehbein teaches a method of operating an electronic device (figure 2, item 20) for a drug delivery device (figure 1, item 1), the method comprising:
generating, by a sensor arrangement (figure 8, items 32/34) of the electronic device (figure 2, item 20), measurement data indicative of a dose setting operation (figure 3, via item 12; paragraphs [0058], [0069], [0085]) and/or a dose delivery operation (figure 3, via item 11; paragraphs [0062], [0072], [0097]) of the drug delivery device (figure 1, item 1) (paragraphs [0074], [0101]);
storing the measurement data (paragraphs [0101], [0105]) in a memory device (figure 8, items 52a/52b) coupled to the electronic device (figure 2, item 20);
establishing, with a first communication unit (figure 8, item 57) of the electronic device (figure 2, item 20), a wireless connection (Bluetooth®) (figure 9, item 61) (paragraph [0107]);
establishing an encrypted wireless communication (via the exchange of encryption keys) (Bluetooth®) (paragraph [0107]) with a second communication unit of another device (figure 9, item 60) (the examiner notes that Bluetooth® connections utilize the exchange of encryption keys); and
transferring data (see 112b interpretation above relative to claim 34) to the other device (figure 9, item 60) (figure 9; paragraph [0107]).
Rehbein does not specifically disclose wherein while the encrypted wireless communication between the first communication unit and the second communication unit is being established, a radio frequency power of at least one of the communication units is reduced.
However, Srinivasan teaches a system and method comprising establishing communication between an electronic device (“electronic components”) (figure 12, item 103) (for use with a drug delivery device; figure 11, item 102; paragraph [0040]) and a secondary device (figure 11, item 104), wherein a radio frequency power of a first communication unit (hybrid NFC/Bluetooth®) (figure 12, items 106/106’) is reduced (the examiner notes Srinivasan teaches a hybrid NFC/Bluetooth® system wherein NFC is utilized during the pairing process and NFC or Bluetooth® can be used during data transfer; as such, during pairing, NFC utilizes reduced radio frequency power) while encrypted wireless communication between the first communication unit (hybrid NFC/Bluetooth®) (figure 12, items 106/106’) and a second communication unit (item 104 can be a “NFC-enabled and Bluetooth™-enabled smart phone with via a NFC and/or Bluetooth™ wireless connection”; paragraph [0054]) of the secondary device (figure 11, item 104) is being established (“pairing”) thereby limiting a pairing distance (figure 11) between the electronic device (“electronic components”) (figure 12, item 103) and the secondary device (figure 11, item 104) (figure 11; paragraphs [0054], [0055], [0057]-[0059]).
It would have been obvious to one ordinary skill in the art, before the effective filing date of the invention, to have modified the first communication unit taught by Rehbein, to have utilized a hybrid communication unit, as taught by Srinivasan, in order to provide increased functionality, safety, and control, by allowing for a means by which autonomous pairing and simultaneous data download might occur, while ensuring an intended wireless connection by limiting pairing distance (Srinivasan; figure 11; paragraphs [0054], [0057]-[0059]).
[Claim 29] Rehbein and Srinivasan teach the limitations of claim 28, upon which claim 29 depends. In addition, Srinivasan teaches the radio frequency power is increased after the encrypted wireless communication between the first communication unit (hybrid NFC/Bluetooth®) (figure 12, items 106/106’) and the second communication unit (item 104 can be a “NFC-enabled and Bluetooth™-enabled smart phone with via a NFC and/or Bluetooth™ wireless connection”; paragraph [0054]) is established (figure 11; paragraphs [0054], [0055], [0057]-[0059]) (again, the examiner notes Srinivasan teaches a hybrid NFC/Bluetooth® system wherein NFC is utilized during the pairing process and NFC or Bluetooth® can be used during data transfer; as such, after pairing, when Bluetooth® is utilized, radio frequency power is increased).
[Claim 32] Rehbein and Srinivasan teach the limitations of claim 28, upon which claim 32 depends. In addition, Srinivasan teaches establishing the wireless connection (“pairing”) comprises bringing the electronic device (“electronic components”) (figure 12, item 103) and the other device (figure 11, item 104) within 1.0 meter of each other (“10 cm”) (figure 11; paragraph [0037]; “for NFC pairing”).
[Claim 33] Rehbein and Srinivasan teach the limitations of claim 28, upon which claim 33 depends. Srinivasan further discloses the radio frequency power of at least one of the communication units is reduced by software, an electronic signal, and/or a mechanical operation (figures 11 and 12; paragraphs [0054], [0055], [0057]-[0059]).
[Claim 35] Rehbein and Srinivasan teach the limitations of claim 34, upon which claim 35 depends. Rehbein also teaches wherein stopping of the transmission of data from the first communication unit (figure 8, item 57) to the second communication unit (figure 9, via item 60) conserves power of the drug delivery device (figure 1, item 1) (the examiner notes that stopping the transmission of data would intrinsically conserve power).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 08/18/2026
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