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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 86’. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 23, 28, and 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.
Claims 23, 28, and 35 contains the trademark/trade name “Bluetooth”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe wireless personal area network technology and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 24-35 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. In accordance with the two-step 101 analysis (MPEP 2106), each of Claims 24-35 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 1 per MEPE 2106:
Claims 24-28 disclose a process, and claims 29-35 disclose a machine.
Step 2A, Prong 1 per MPEP 2106.04(a):
Each of the independent claims 24 and 29 recites at least one step or instruction for generating injection event information, which is grouped as a mental process in MPEP 2106.04(a)(2)(III). The claimed limitations involving the generation of injection event information, given their broadest reasonable interpretation, can be practically performed in the human mind. Specifically, the generation of injection event information would involve a human observing, judging, or evaluating the aspects of and around the injection event, and subsequently recording them. These processes of observing, judging, and/or evaluating constitute as mental processes (see MPEP 2106.04(a)(2)(III)). Accordingly, each of claims 24 and 29 recites an abstract idea.
Specifically, claim 24 recites a computerized method for execution by a controller (additional element) of a medication delivery device (additional element), wherein the controller is in communication with a wireless communication module (additional element), the method comprising: generating injection event information (abstract idea: observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)) for the medication delivery device (additional element); connecting (additional element), using the wireless communication module (additional element), to a remote computing device (additional element) to wirelessly communicate (additional element) with the remote computing device over an unencrypted wireless communication channel (additional element); and transmitting (additional element), using the wireless communication module, encrypted data (additional element) to the remote computing device over the unencrypted wireless communication channel (additional element) wherein the encrypted data comprises data indicative of the injection event information.
Claim 29 recites a computing device (additional element) comprising at least one processor (additional element) in communication with a memory (additional element) configured to store machine-readable instructions (additional element) that cause the at least one processor to: connect (additional element) to a wireless communication module (additional element) of a medication delivery device (additional element) to wirelessly communicate with the medication delivery device over an unencrypted wireless communication channel (additional element), wherein the medication delivery device comprises (a) a housing (additional element) comprising a reservoir sized sufficiently to hold medication (additional element), (b) a dose button being rotatable relative to the housing to select a dose size of the medication for an injection (additional element), and (c) a controller in communication with the wireless communication module (additional element); and receive (additional element), from the medication delivery device using the wireless communication channel, encrypted data (additional element) over the unencrypted wireless communication channel, wherein the encrypted data comprises injection event information generated by the medication delivery device (abstract idea: observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III); here, “wherein” implies the action of the generating step must occur for the preceding limitations of the data transmitting and receiving to be met).
Further, dependent claims 25-28 and 30-35 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the claimed functions/steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
Step 2A, Prong 2 per MPEP 2106.04(d):
The above-identified abstract idea in each of independent claims 24 and 29 (and their respective dependent claims 25-28 and 30-35) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent claims 24 and 29), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) or represent insignificant extra-solution activity according to MPEP 2106.05(g). More specifically, the additional elements of: a controller, a wireless communication module, a remote computing device, a wireless communication channel, an identifier, and an advertising packet, as recited in independent claim 24 and its dependent claims; and a computing device, a processor, a memory, machine-readable instructions, a wireless communication module, and a wireless communication channel, as recited in independent claim 29 and its dependent claims are generically recited computer elements which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). The additional elements of a medication delivery device merely generally link the abstract idea to a particular technological environment. Additionally, the limitations of wherein the medication delivery device comprises (a) a housing comprising a reservoir sized sufficiently to hold medication, (b) a dose button being rotatable relative to the housing to select a dose size of the medication for an injection, as recited in claim 29, is not required structure for the abstract idea of generating the injection event information or transmitting or receiving that associated data. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent claims 24 and 29 (and their respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (mental process) using rules (computer instructions) executed by a computer (a computing device, a processor, a memory, machine-readable instructions, a controller, a wireless communication module, a wireless communication channel, an identifier, and an advertising packet, as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). Thus, for these additional reasons, the abstract idea identified above in independent claims 24 and 29 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent claims 24 and 29 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B per MPEP 2106.05:
None of claims 24-35 include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons.
These claims require the additional elements of: a controller, a wireless communication module, a remote computing device, a wireless communication channel, an identifier, and an advertising packet, as recited in independent claim 24 and its dependent claims; and a computing device, a processor, a memory, machine-readable instructions, a wireless communication module, and a wireless communication channel, as recited in independent claim 29 and its dependent claims.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the controller as generically described in paragraph [0118] of the specification and depicted as 2508 in the schematic drawing Fig. 26A; the computing device as described in paragraph [0118] of the specification as the generic examples of a computer, smartphone, or computing could, and depicted as 2509 in the schematic drawing Fig. 26A; the processor as generically described in paragraph [0118] of the specification; the memory as generically described in paragraph [0078] of the specification and depicted as “Memory” in the schematic drawing Fig. 26A; the wireless communication module as generically described in paragraph [0047] of the specification as merely connect to the controller and transmit data; the wireless communication channel as generically described in paragraph [0166] of the specification with the example of the commercially available product Bluetooth; the identifier as generically described in paragraph [0167] of the specification with the example of a serial number; the advertising packet as generically described in paragraph [0174] of the specification as including “various data”; and the machine-readable instructions as merely generically recited in paragraph [0009] of the specification. The Applicant’s specification generically describes these additional elements such that the written disclosure lacks any specific structure for them, and the drawings provide no additional structures or details. The degree of generality that these elements are described as in the specification, as well as the disclosed examples of commercially used/available products for some of them as listed above, serves as evidence that these elements are all well understood, routine and conventional elements used for transmitting/receiving data in the art.
Accordingly, in light of Applicant’s specification, the claimed terms a computing device a processor, a memory, machine-readable instructions, a controller, a wireless communication module, a wireless communication channel, an identifier, and an advertising packet are reasonably construed as a elements of generic computing devices. It is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available technology, with their already available basic functions, to use as tools in executing the claimed process (MPEP 2106.05(f)).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the computing device or controller and their elements as listed above. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activities’ previously known to the industry” will not make claims patent-eligible (MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in claims 24-35 amount to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., storing or displaying the data) does not provide significantly more (MPEP 2106.05(f)). Moreover, implementing an abstract idea on a generic computer, does not add significantly more.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more (MPEP 2106.05(a)). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the process of claims 24-28 and the machine of claims 30-35 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent claims 24 and 29 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Therefore, for at least the above reasons, none of the claims 24-35 amounts to significantly more than the abstract idea itself. Accordingly, claims 24-35 are not patent eligible and rejected under 35 U.S.C. 101.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 17, 20, 23, 29, 32, and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20160239610) in view of Schleicher (US 20190022328).
Regarding claim 17, Anderson discloses a medication delivery device (2); a wireless communication module (page 5, para. [0118], lines 1-2); connect[ing], using the wireless communication module, to a remote computing device (4, 6, 8) to wirelessly communicate with the remote computing device (page 7, para. [0165], sentence 3) over an unencrypted wireless communication channel (page 2, para. [0026], sentence 2, and [0028]); and transmit, using the wireless communication module, encrypted data to the remote computing device (Figs. 1A-1C: 14; page 6, para. [0129], sentence 1) over the unencrypted wireless communication channel. However, Anderson fails to explicitly disclose the details of the mediation delivery device used in the system, including its rotatable dose-selection button and controller. Additionally, Anderson teaches that the wireless communication module is integrated in the remote computing device, as opposed to being a part of the medication delivery device as claimed.
Schleicher teaches an analogous medication delivery device in wireless communication with a remote computing device, wherein the medication delivery device comprises a housing (107) comprising a reservoir (111) sized sufficiently to hold medication; a dose button (150 with 109) being rotatable relative to the housing to select a dose size of the medication for an injection (page 2, para. [0031], lines 4-7); a wireless communication module (transceiver: page 3, para. [0043]); and a controller (371; Fig. 3C) in communication with the wireless communication module (page 3, para. [0043], sentence 3) configured to: generate injection event information for the medication delivery device (page 3, para. [0044], sentences 5-6, and para. [0043], sentence 3). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Anderson by incorporating the components and details of the medication delivery device taught by Schleicher into the generic medication delivery device disclosed by Anderson, in order to allow patients to accurately select their specific dosage and accurately track their dosing (page 2. Para. [0028], sentences 1-2; and the drug delivery control wheel). It directly follows that the resultant combination would result in the transfer of data from the medication delivery device to the remote computing device (Anderson: 14) wherein the encrypted data comprises data indicative of the injection event information.
Regarding claim 20, Anderson in view of Schleicher teaches the medication delivery device of claim 17, as described above, wherein transmitting the encrypted data further comprises transmitting an unencrypted identifier for the medication delivery device (Anderson: page 5, para. [0116], sentences 2-3).
Regarding claim 23, Anderson in view of Schleicher teaches the medication delivery device of claim17, as described above, wherein connecting to the remote computing device to wirelessly communicate with the remote computing device over the unencrypted wireless communication channel comprises connecting to the remote computing device using an unencrypted Bluetooth communication channel (Anderson: page 7, para. [156], sentence 1).
Regarding claim 36, Anderson in view of Schleicher teaches the medication delivery device of claim 17, as described above, comprising a medication disposed within said reservoir (Schleicher: page 2, para. [0030], sentence 3).
Regarding claim 29 Anderson discloses a computing device (4, 6, 8; page 3, para. [0046]) comprising at least one processor (processor present if running application software: page 9, para. [0197]) in communication with a memory (storage media: page 9, para. [0197]) configured to store machine-readable instructions (page 9, para. [0197]; page 3, para. [0050]) that cause the at least one processor to: connect to a wireless communication module of a medication delivery device to wirelessly communicate with the medication delivery device (page 9, para. [0197]; page 3, para. [0052]) over an unencrypted wireless communication channel (page 2, para. [0026], sentence 2, and [0028]), and receive, from the medication delivery device using the wireless communication channel (page 9, para. [0197]; page 3, para. [0052]), encrypted data (page 6, para. [0129], sentence 1) over the unencrypted wireless communication channel. However, Anderson fails to explicitly disclose the details of the mediation delivery device used in the system, including its rotatable dose-selection button and controller, or that the data received is injection event information generated from the medication delivery device.
Schleicher teaches an analogous medication delivery device in wireless communication with a remote computing device, wherein the medication delivery device comprises (a) a housing (107) comprising a reservoir (111) sized sufficiently to hold medication, (b) a dose button (150 with 109) being rotatable relative to the housing to select a dose size of the medication for an injection (page 2, para. [0031], lines 4-7), and (c) a controller (371; Fig. 3C) in communication with the wireless communication module (page 3, para. [0043], sentence 3); wherein the data comprises injection event information generated by the medication delivery device (page 3, para. [0044], sentences 5-6, and para. [0043], sentence 3). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Anderson by incorporating the components and details of the medication delivery device taught by Schleicher into the generic medication delivery device disclosed by Anderson, in order to allow patients to accurately select their specific dosage and accurately track their dosing (page 2. Para. [0028], sentences 1-2; and the drug delivery control wheel).
Regarding claim 32, Anderson in view of Schleicher teaches the computerized method of claim 29, as described above, wherein receiving the encrypted data further comprises receiving an unencrypted identifier (Anderson: page 5, para. [0116], sentences 2-3) for the medication delivery device.
Regarding claim 35, Anderson in view of Schleicher teaches the computerized method of any one of claim 29, as described above, wherein connecting to the medication delivery device to wirelessly communicate with the medication delivery device over the unencrypted wireless communication channel comprises connecting to the medication delivery device using an unencrypted Bluetooth communication channel (Anderson: page 7, para. [156], sentence 1).
Claims 18-19 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20160239610) in view of Schleicher (US 20190022328) and in further view of JP’274 (JP 2007529274).
Regarding claim 18, Anderson in view of Schleicher teaches the medication delivery device of claim 17, as described above, further comprising a two-dimensional barcode (Anderson: 22). However, the Anderson-Schleicher combination fails to explicitly disclose that the data stored on the barcode is encryption data for decrypting.
JP’274 teaches an analogous system for securely pairing and transferring data associated with a medical device, wherein the two-dimensional barcode encodes encryption data that can be used by a computing device to decrypt the encrypted data (page 11 of translation, sixth paragraph: “the encryption key 122 is printed as a barcode”). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the barcode on the device of Anderson-Schleicher by incorporating the storage of the encryption key in the barcode as taught by JP’274 in order to more securely authenticate the transfer and decryption of the data for improved patient data security and privacy (page 4 of translation, second paragraph).
Regarding claim 19, Anderson in view of Schleicher in further view of JP’274 teaches the medication delivery device of claim 18, as described above, wherein the encryption data comprises a private encryption key (JP’274: page 11 of translation, sixth paragraph: “the encryption key 122 is printed as a barcode”).
Regarding claim 30, Anderson in view of Schleicher teaches the computerized method of claim 29, as described above, comprising decoding (Anderson: decoding the data from the barcode achieved via scanning; page 6, para. [0137], sentences 3-4), from a two-dimensional barcode on the medication delivery device (Anderson: Fig. 3A, 22 on 2), data. However, the Anderson-Schleicher combination fails to explicitly disclose that the data stored on the barcode is encryption data for decrypting.
JP’274 teaches an analogous system for securely pairing and transferring data associated with a medical device, wherein decoding the two-dimensional barcode yields encryption data that can be used by a computing device to decrypt the encrypted data (page 11 of translation, sixth paragraph: “the encryption key 122 is printed as a barcode”). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the barcode on the device of Anderson-Schleicher by incorporating the storage of the encryption key in the barcode as taught by JP’274 in order to more securely authenticate the transfer and decryption of the data for improved patient data security and privacy (page 4 of translation, second paragraph).
Regarding claim 31, Anderson in view of Schleicher in further view of JP’274 teaches the computerized method of claim 30, as described above, wherein the encryption data comprises a private encryption key (JP’274: page 11 of translation, sixth paragraph: “the encryption key 122 is printed as a barcode”).
Claims 21-22 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20160239610) in view of Schleicher (US 20190022328) in further view of Piao (CN 105450627).
Regarding claim 21, Anderson in view of Schleicher teaches the medication delivery device of claim 17, as described above, but fails to explicitly teach an advertising packet transmitted by the device controller.
Piao teaches an analogous connection and data transmission system, which can be applied to medical device (page 5 of translation, fourth paragraph, sentence 1: “In other embodiments, the electronic device may include at least one of the following items: a medical device of any type (e.g., any type of portable medical device (such as glucose, heart rate, blood pressure or thermometer”) transmitting patient data, wherein the controller is further configured to wirelessly transmit an advertising packet to advertise the presence of the medication delivery device for connection (page 2 of translation, eight paragraph, sentence 1: “electronic device (e.g., beacon device) can encrypt the advertising packet based on the time information and broadcast the advertisement packet”). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Anderson-Schleicher system by incorporating the advertising packet generated by the controller taught by Piao, in order for the medication delivery device to be identifiable by the communication device for accurate device pairing (page 7 or translation, lines 1-2).
Regarding claim 22, Anderson in view of Schleicher teaches the medication delivery device of claim 21, as described above, wherein the controller is further configured to encrypt the advertising packet (page 2 of translation, eight paragraph, sentence 1: “electronic device (e.g., beacon device) can encrypt the advertising packet based on the time information and broadcast the advertisement packet”).
Regarding claim 33 Anderson in view of Schleicher teaches the computerized method of any one of claim 29, as described above, but fails to explicitly teach receiving advertising packet transmitted by the device controller.
Piao teaches an analogous connection and data transmission system, which can be applied to medical device (page 5 of translation, fourth paragraph, sentence 1: “In other embodiments, the electronic device may include at least one of the following items: a medical device of any type (e.g., any type of portable medical device (such as glucose, heart rate, blood pressure or thermometer”) transmitting patient data, comprising wirelessly receiving an advertising packet to advertise the presence of the medication delivery device for connection (page 2 of translation, eight paragraph, sentence 1: “electronic device (e.g., beacon device) can encrypt the advertising packet based on the time information and broadcast the advertisement packet”; page 7 or translation, lines 1-2: “when detecting that the corresponding data with the external received beacon signal, beacon data processing module 180 can perform the operation related to the data signal”).
Regarding claim 34 Anderson in view of Schleicher teaches the computerized method of claim 33, as described above, wherein the advertising packet is encrypted (page 2 of translation, eight paragraph, sentence 1: “electronic device (e.g., beacon device) can encrypt the advertising packet based on the time information and broadcast the advertisement packet”), and the method further comprises decrypting the advertising packet (page 7, tenth paragraph, sentence 1: “The various embodiments of the present disclosure, beacon related information receiving unit 210 can receive the beacon information (also known as beacon decryption related information in the associated context) is decrypted”).
Claims 24-25 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Schleicher (US 20190022328) in view of Anderson (US 20160239610).
Regarding claim 24, Schleicher discloses a computerized method for execution by a controller (371; Fig. 3C) of a medication delivery device (101), wherein the controller is in communication with a wireless communication module (page 3, para. [0043], sentence 3), the method comprising: generating injection event information for the medication delivery device (page 3, para. [0044], sentences 5-6, and para. [0043], sentence 3); connecting, using the wireless communication module (transceiver: page 3, para. [0043], sentence 3), to a remote computing device (121) to wirelessly communicate with the remote computing device over a wireless communication channel (Fig. 1: “WIRELESS COM.”); and transmitting, using the wireless communication module, data to the remote computing device over the wireless communication channel (transceiver: page 3, para. [0043], sentence 3; Fig. 1: “WIRELESS COM.” conveying this transmission of data over the wireless communication channel). However, Schleicher fails to explicitly disclose whether the wireless communication channel is unencrypted or whether the transmitted data is encrypted.
Anderson teaches an analogous wireless data transfer from a medication injection device over an unencrypted wireless communication channel (page 2, para. [0026], sentence 2, and [0028]) wherein the data is encrypted data (page 6, para. [0129], sentence 1) to the remote computing device over the unencrypted wireless communication channel. It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the controller disclosed by Schleicher with the teachings of the data being encrypted and the wireless communication channel being unencrypted, as taught by Anderson. It would have been obvious to incorporate Anderson’s teachings to make the injection event data transferred by Schleicher encrypted in order to increase the privacy and security of sensitive patient data (page 5, para. [0119], sentence 5). It would have been obvious to also incorporate Anderson’s teachings to make the wireless communication channel of Schleicher unencrypted in order to create a more automatic and more cost-effective data transfer system (page 2, para. [0028]).
Regarding claim 25, Schleicher in view of Anderson teaches the computerized method of claim 24, as described above, wherein transmitting the encrypted data further comprises transmitting an unencrypted identifier (Anderson: page 5, para. [0116], sentences 2-3) for the medication delivery device.
Regarding claim 28, Schleicher in view of Anderson teaches the computerized method of claim 24, as described above, wherein connecting to the remote computing device to wirelessly communicate with the remote computing device over the unencrypted wireless communication channel comprises connecting to the remote computing device using an unencrypted Bluetooth communication channel (Anderson: page 7, para. [156], sentence 1).
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Schleicher (US 20190022328) in view of Anderson (US 20160239610) in further view of Piao (CN 105450627).
Regarding claim 26 Schleicher in view of Anderson teaches the computerized method of any one of claim 24, as described above, but fails to explicitly teach an advertising packet transmitted by the device controller.
Piao teaches an analogous connection and data transmission system, which can be applied to medical device (page 5 of translation, fourth paragraph, sentence 1: “In other embodiments, the electronic device may include at least one of the following items: a medical device of any type (e.g., any type of portable medical device (such as glucose, heart rate, blood pressure or thermometer”) transmitting patient data, further comprising wirelessly transmitting an advertising packet to advertise the presence of the medication delivery device for connection (page 2 of translation, eight paragraph, sentence 1: “electronic device (e.g., beacon device) can encrypt the advertising packet based on the time information and broadcast the advertisement packet”). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Anderson-Schleicher system by incorporating the advertising packet generated by the controller taught by Piao, in order for the medication delivery device to be identifiable by the communication device for accurate device pairing (page 7 or translation, lines 1-2).
Regarding claim 27 Schleicher in view of Anderson teaches the computerized method of claim 26, as described above, further comprising encrypting the advertising packet (page 2 of translation, eight paragraph, sentence 1: “electronic device (e.g., beacon device) can encrypt the advertising packet based on the time information and broadcast the advertisement packet”).
Conclusion
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/K.A.W./Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783