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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5, 6, 14, 15, and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 5, the recitation of "the user interface comprises a graphical user interface configured for input of a sole parameter being the user's weight" appears to be new matter. It is noted that the instant disclosure only provides sufficient support for the user interface comprising a graphical user interface (instant [0110], Figs. 1, 5A, 5B) for input from the user including user's weight (instant [0117]) but not that the graphical user interface being configured for input of only one parameter. Moreover, the instant disclosure appears to require that the graphical user interface being configured for input of multiple parameters (instant [0117]). Therefore, the newly added limitation is still considered to be new matter.
Regarding claims 6 and 18, the recitation of "the at least one processor is operable to initialize closed loop delivery solely responsive to input of the user's weight" appears to be new matter because the instant specification does not provide sufficient support for this feature. It is noted that the instant disclosure only provides sufficient support for the user's weight as one of the parameters of a PWD to estimate one or more user-specific dosage parameters (instant [0117]) and that the closed loop delivery is initiated based on glucose measurements (instant [0099], [0104], [0123]). It is noted that the user's weight is only recited in instant [0117]. Therefore, the newly added limitation is still considered to be new matter.
Regarding claims 14 and 15, the recitation of require that the controller operable to set a user-specific dosage parameter solely based on the user's weight appears to be new matter. It is noted that the instant disclosure only provide sufficient support for the user's weight as one of the parameters of a PWD to estimate one or more user-specific dosage parameters (instant [0117]) and that the controller set user-specific dosage parameters based on blood glucose (instant [0095]-[0096], [0112]). Again, it is noted that the user's weight is only recited as one of the factors in determining the user-specific dosage parameters. Therefore, the newly added limitation is still considered to be new matter.
Further regarding claims 6, 14, 15, and 18, it is noted that since the instant disclosure does not disclose the specifics of the limitations of “solely based on the user's weight” or “solely based on a value that is based on the user's weight,” it is unclear how the claimed at least one processor (as per claims 6 and 15) is configured to initialize (as per claim 6), to determine and to provide (as per claim 15) or the controller is configured to initialize (as per claim 18) are required by the respective claims.
Claim 4 is rejected for incorporating the above issue of new matter through its claim dependency.
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 5 is 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 5 recites the limitation "the sole parameter" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Additionally regarding claim 5, the recitation of “the sole parameter comprises” is confusing because the limitation of “sole” requires only a single one but it is followed by a recitation of "comprises" that is open to a scope of additional parameters in addition to the user's weight. Therefore, it is unclear whether the claim is requiring only one parameter or requiring that the GUI being configured for input only one parameter and that this parameter including the user's weight but may also comprise other parameters. Since the instant disclosure does not disclose how the user's weight is received, it is unclear how the limitations should be interpreted and supported by the instant disclosure. However, for the purpose of continuous examination, the limitation is interpreted as requiring that the graphical user interface configured for input of a sole parameter (such as a field or object on the graphical user interface for inputting only one parameter), wherein the sole parameter is the user's weight.
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 2-18, 20, and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Each of claims 2-18, 20, and 21 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of the claims 2-16 recites at least one processor; and a memory to store instructions and, upon execution of the instructions, the at least one processor is operable to: present a user interface for input of one or more parameters for automated insulin delivery; receive, via the user interface, an input of at least one parameter useable to determine one or more user-specific dosage parameters, the at least one parameter comprising a user's weight; and provision a control algorithm for automated delivery of insulin by the delivery system at least partially based on the user's weight (lines 6-11 of claim 2) and each of the claims 17, 18, 20, and 21 recites to present a user interface for input of one or more parameters for automated medicament delivery; receive, via the user interface, an input of at least one parameter useable to determine one or more user-specific dosage parameters, the at least one parameter comprising a user's weight; and provision a control algorithm for a closed loop medicament delivery system at least partially based on the user's weight (lines 5-11 of claim 17) which is grouped as a mental process under the 2019 PEG. It is noted that these steps are concepts performable by the human mind because a person of ordinary skill in the art would have been able to perform the claimed steps of presenting a user interface for input of one or more parameters (via visualizing a mental image of parameters required for automated insulin delivery); receive via the user interface (via mentally fill in the parameter types including the user's weight in the mental image, since it is well-known in the art that the patient's weight affects the diabetes treatment); and provision a control algorithm (via mentally drafting of a control algorithm). Accordingly, each of claims 2-18, 20, and 21 recites an abstract idea.
More specifically, claim 2 recites a system comprising: an insulin delivery system; at least one processor; and a memory to store instructions and, upon execution of the instructions, the at least one processor is operable to: present a user interface for input of one or more parameters for automated insulin delivery; receive, via the user interface, an input of at least one parameter useable to determine one or more user-specific dosage parameters, the at least one parameter comprising a user's weight; and provision a control algorithm for automated insulin delivery at least partially based on the user's weight (additional elements).
While claim 17 recites a system, comprising: an analyte monitor; a medicament delivery device; and a controller, the controller configured to: present a user interface for input of one or more parameters for automated medicament delivery; receive, via the user interface, an input of at least one parameter useable to determine one or more user-specific dosage parameters, the at least one parameter comprising a user's weight; and provision a control algorithm for closed loop delivery of medicament at least partially based on the user's weight (additional elements).
It is noted that the additional limitations with at least one processor and a memory in claims 2-16 and a controller in claims 17, 18, 20, and 21 are merely recitations drawn to a computer being used to perform the abstract idea while the other additional elements of an insulin delivery system of claim 2; a wearable insulin delivery device of claim 11; a display of claim 16; and an analyte monitor; a medicament delivery device of lines 2-3 of claim 17 are well-known elements of an insulin delivery system (see below for additional details).
Further, dependent claims 3-9, 12-15, 18, 20, and 21 merely include additional limitations that either further define the abstract idea (and thus do not make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technology environment or field of use because they are merely incidental or token additions to the claims that do not alter or affect how the steps are performed, including the limitations of the type of user interface, further specifying how the at least one processor is operable to or the controller configured to.
Step 2A, Prong 2
With regards to claims 2-18, 20, and 21, the above-identified abstract ideas of independent claims 2 and 17 (and their respective dependent claims) are not integrated into a practical application under 2019 PEG because the additional element (identified above in independent claims 2 and 17 and dependent claims 10, 11, and 16) because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of at least one processor and a memory in claims 2-16; a display of claim 16; and a controller in claims 17, 18, 20, and 21; are merely recitations drawn to a computer being used to perform the abstract idea while the other additional elements of an insulin delivery device system of claim 2; a wearable insulin delivery device of claim 11; and an analyte monitor; a medicament delivery device of claim 17 do not improve the functioning of a system (as per claims 2-16 and claims 17, 18, 20, and 21) with a generic computer element with claimed at least one processor, memory, controller, display or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation 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. 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. For at least these reasons, the abstract idea identified above in independent Claims 2 and 17 (and their respective dependent claims) are not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and device merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., controller 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. 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. That is, like Affinity Labs of Tex. V. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent claims 2 and 17 (and their respective dependent claims) are not integrated into a practical application under the 2019 PEG.
Accordingly, independent claims 2 and 17 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of the claims 2-18, 20, and 21 include element that are sufficient to amount to significantly more than the abstract idea because the additional elements of: the insulin delivery system of claim 2, the wearable insulin delivery device of claim 11, the analyte monitor and medicament delivery device of claim 17 are considered well-understood, routine, and conventional for insulin delivery apparatus or systems. See for examples [0028] of Harris (US Pub. No. 2016/0030669 A1), Fig. 8 and [0161] of Bashan (US Pub. No. 2011/0319322 A1), Fig. 12 and [0233] of Kovatchev (US Pub. No. 2012/0059353 A1), and Fig. 1 and [0069] of Kircher, Jr. Therefore, None of claims 2-18, 20, and 21 include additional elements that are sufficient to amount to significantly more than the abstract idea.
Moreover, the above-identified additional elements are generically claimed infusion device comprising computer component (claimed at least one processor, memory, and controller) which enable the above-identified abstract idea(s) 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, 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.
Furthermore, Applicant's specification does not describe any special programming or algorithms required for the controller. 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 Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs "well understood, routine, conventional activit[ies]' previously known to the industry" will not make claims patent-eligible (TLI Communications).
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., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs V. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC V. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016)(computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. V. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC V. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). 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, 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, as in Affinity Labs of Tex. V. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), 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 claims 2-16 are directed to apparatuses of an abstract idea (e.g., mental process or certain method of organizing human activity) while the claims 17, 18, 20, and 21 are directed to systems of an abstract idea (e.g., mental process or certain method of organizing human activity) on a general purpose computer without (i) improving the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) providing a technical solution to a problem in a technical field (as in DDR). In other words, none of claims 2-18, 20, and 21 provide 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.
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 2 and 17 (and their respective dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, 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. 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. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, 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. Therefore, none of the claims 2-18, 20, and 21 amounts to significantly more than the abstract idea itself. Accordingly, claims 2-18, 20, 21 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. V. CLS Bank International, et al. and 2019 PEG.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2, 7-10, 12, 13, 16, 17, 20, and 21 are rejected under 35 U.S.C. 102(a)(1) as being
anticipated by U.S. Patent Publication No. 2010/0292634 to Kircher, Jr. (“Kircher”).
Regarding claim 2, Kircher discloses a system, comprising an insulin delivery system (1310); at least one processor (156); and a memory (158) to store instructions and, upon execution of the instructions, the at least one processor is operable to: present a user interface (162, 164) for input of one or more parameters for automated insulin delivery (904) ([0203]); receive, via the user interface, an input of at least one parameter useable to determine one or more user-specific dosage parameters ([0204]-[0205]), the at least one parameter comprising a user's weight ([0199]); and provision a control algorithm for automated delivery of insulin by the delivery system (i.e., insulin dispenser with control system 100) at least partially based on the user's weight (910) (Figs. 9A, 9C, [0206] and since patient's weight is information pertinent for the control system 100 to maintaining a target fasting blood glucose level).
Regarding claim 7, Kircher discloses the system of claim 2, wherein, to provision the control
algorithm for the automated insulin delivery system at least partially based on the user's weight, upon execution of the instructions, the at least one processor is operable to: set a user-specific dosage parameter (i.e., number, size and timing of doses) of the control algorithm for the automated delivery of insulin by the insulin delivery system at least partially based on the user's weight ([0199]).
Regarding claim 8, Kircher discloses the system of claim 7, wherein, upon execution of the instructions, the at least one processor is operable to: determine a value for the user-specific dosage parameter at least partially based on the user's weight and a predetermined relationship between weight and the user-specific dosage parameter ([0199]; i.e., number, size, and timing of the doses are values).
Regarding claim 9, Kircher discloses the system of claim 8, wherein, upon execution of the instructions, the at least one processor is operable to: generate an instruction to deliver insulin, an amount of insulin associated with the instruction at least partially based on the user-specific dosage parameter ([0209]).
Regarding claim 10, Kircher discloses the system of claim 9, wherein the instruction to deliver insulin is for a controller (140) of an insulin delivery device (104) (Fig. 1; i.e., via radiofrequency signals 172, 176, see [0072]).
Regarding claim 12, Kircher discloses the system of claim 2, wherein, to provision the control algorithm for automated delivery of insulin by the insulin delivery system at least partially based on the user’s weight, upon execution of the instructions, the at least one processor is operable to: provide the user's weight to a controller (160) configured to implement the control algorithm for the automated delivery of insulin by the insulin delivery system (Fig. 1; [0069]-[0070]), the controller operable to set a user-specific dosage parameter at least partially based on the user's weight ([0199]; i.e., number, size, and timing of the doses are user-specific parameters).
Regarding claim 13, Kircher discloses the system of claim 2, wherein, to provision the control algorithm for the automated delivery of insulin by the insulin delivery system at least partially based on the user's weight, upon execution of the instructions, the at least one processor is operable to: determine a value for a user-specific dosage parameter at least partially based on the user's weight and a predetermined relationship between weight and a user-specific dosage parameter ([0199]; i.e., number, size, and timing of the doses are values); and provide the value to a controller (140) configured to implement the control algorithm for the automated delivery of insulin by the insulin delivery system, the controller operable to set the user-specific dosage parameter at least partially based on the value (Fig. 1; i.e., via radiofrequency signals 172, 176, see [0072]).
Regarding claim 16, Kircher discloses the system of claim 2, comprising a display (i.e., display), wherein, upon execution of the instructions, the at least one processor is operable to present the user interface at the display ([0070]).
Regarding claim 17, Kircher discloses a system, comprising: an analyte monitor (102); a medicament delivery device (104); and a controller (106), the controller configured to: present a user interface (162, 164) for input of one or more parameters for automated insulin delivery (904) ([0203]); receive, via the user interface, an input of at least one parameter useable to determine one or more user-specific dosage parameters ([0204]-[0205]), the at least one parameter comprising a user's weight ([0199]); and provision a control algorithm for a closed loop medicament delivery system (i.e., insulin dispenser with control system 100) at least partially based on the user's weight (910) (Figs. 9A-9C, [0206] and since patient's weight is information pertinent for the control system 100 to maintaining a target fasting blood glucose level and it is noted that the method of Figs. 9A-9C forms a closed loop delivery of insulin after initializing step 902).
Regarding claim 20, Kircher discloses the system of claim 17, wherein the controller is configured to, responsive to input of the user's weight, connect to the analyte monitor, receive an analyte value from the analyte monitor ([0218]; i.e., current blood glucose level data determined by blood glucose sensor system 102, see [0071]), provision the control algorithm at least partially based on the user's weight and the analyte value ([0199]).
Regarding claim 21, Kircher discloses the system of claim 20, wherein the controller is configured to send instructions to the medicament delivery device at least partially responsive to the provisioned control algorithm (Figs. 9A-9C; [0211]-[0212]).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 3-5, as best understood for the purpose of continuous examination, are rejected under 35 U.S.C. 103 as being unpatentable over Kircher in view of WO 2013/176770 to Kamen.
Regarding claim 3, Kircher discloses the system of claim 2, wherein the input of the one or more parameter comprising the user's weight ([0223]), but does not explicitly disclose the input of the one or more parameter at the user interface being limited to user weight, interpreted as requiring the graphical user interface comprising a field or an object for inputting only the user's weight, see above for interpretation details. However, it is noted that Kamen also discloses an apparatus for medication delivery including insulin ([00579]) comprising a user interface (3300) configured for input of a sole parameter (3320), the sole parameter comprising the user's weight ([001081]; Fig. 315) to allow for user to customize the delivery for body weight based dosage ([001080]). Therefore, since both Kircher and Kamen are drawn to apparatus for drug delivery comprising a user interface with a graphical user interface for receiving user input, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify Kircher with the feature of a graphical user interface configured for input of a sole parameter, wherein the sole parameter is the user's weight as disclosed by Kamen for body weight based dosage medication delivery ([001080] of Kamen; and [0199] of Kircher).
Regarding claim 4, Kircher in view of Kamen discloses the system of claim 3, wherein Kircher further discloses that the user interface with suitable user interface for receiving such as a keypad ([0069]) and for outputting information such as a visual display ([0070]) but does not explicitly disclose of an input field to receive the at least one parameter, wherein the input field includes one or more of: a slider bar, a radio button, a touch button, or a check box. However, it is noted that Kamen further discloses that the GUI 3300 on a touch screen ([001049]) and comprising virtual buttons ([001052]) for receiving user input. Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to further modify Kircher with the feature of the user interface including an input field to receive the at least one parameter, wherein the input field includes a touch button as disclosed by Kamen ([001052]) for receiving the user input and since such user interface is known in the art for receiving input.
Regarding claim 5, Kircher in view of Kamen discloses the system of claim 3, wherein Kircher in view of Kamen discloses that the graphical user interface configured for input of the sole parameter comprises an input field to receive a value for the user's weight ([001081]; Fig. 315 of Kamen).
Claims 6, 11, 14, 15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kircher in view of U.S. Patent Publication No. 2011/0098638 to Chawla.
Regarding claim 6, Kircher discloses the system of claim 2, wherein, upon execution of the instructions, the at least one processor is operable to initialize closed loop delivery (i.e., insulin dispenser with control system 100), but does not appear to explicitly execute the instructions solely responsive to input of the user’s weight.
Chawla teaches a processor operable to initialize delivery solely responsive to input of the user’s weight ([0004]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Kircher to initiate delivery solely responsive to weight as taught by Chawla to provide a proper dosage to the user. The use of weight alone to calculate dosage is old and well-known in the art as shown by Chawla.
Regarding claim 11, Kircher discloses the system of claim 10, but does not explicitly disclose that the insulin delivery system is a wearable insulin delivery system. However, Chawla also discloses an apparatus for automated insulin delivery (Fig. 23) wherein the insulin delivery system is wearable ([0175]; i.e., patch pump worn by being placed directly on the skin of the patient). Therefore, since both Kircher, Jr. and Chawla are drawn to apparatuses for insulin delivery, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the insulin dispenser of Kircher as a wearable insulin pump as disclosed by Chawla since patch pumps are known suitable pumps for administer the insulin through subcutaneous injection ([0175] of Chawla).
Regarding claim 14, Kircher discloses the system of claim 2, wherein, to provision the control algorithm for the automated delivery of insulin by the insulin delivery system at least partially based on the user's weight, upon execution of the instructions, the at least one processor is operable to: determine a value for a user-specific dosage parameter at least partially based on the user's weight and a predetermined relationship between weight and a user-specific dosage parameter ([0199]; i.e., number, size, and timing of the doses are values); and provide the value to a controller (140) configured to implement the control algorithm for the automated delivery of insulin by the insulin delivery system (Fig. 1; i.e., via radiofrequency signals 172, 176, see [0072]), but does not appear to explicitly limiting the dosage parameter to solely be based on the user’s weight.
Chawla teaches a controller operable to set the user-specific dosage parameter solely based on the user’s weight ([0004]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Kircher to ser the user-specific dosage parameters solely based on weight as taught by Chawla to provide a proper dosage to the user. The use of weight alone to calculate dosage is old and well-known in the art as shown by Chawla.
Regarding claim 15, Kircher discloses the system of claim 2, wherein, upon execution of the instructions, the at least one processor is operable to: determine a value for the user-specific dosage parameter at least partially based on the user's weight and a predetermined relationship between weight and the user-specific dosage parameter ([0199]; i.e., number, size, and timing of the doses are values); and provide the value to a controller for the automated insulin delivery system according to the control algorithm for the automated insulin delivery system (Fig. 1; i.e., via radiofrequency signals 172, 176, see [0072]), but does not appear to explicitly limiting the dosage parameter to solely be based on the value
Chawla teaches a controller operable to set the user-specific dosage parameter solely based on a value (user’s weight, [0004]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Kircher to ser the user-specific dosage parameters solely based on a value as taught by Chawla to provide a proper dosage to the user. The use of weight alone to calculate dosage is old and well-known in the art as shown by Chawla.
Regarding claim 18, Kircher discloses the system of claim 17, wherein, upon execution of the instructions, the at least one processor is operable to initialize closed loop delivery (i.e., insulin dispenser with control system 100), but does not appear to explicitly execute the instructions solely responsive to input of the user’s weight.
Chawla teaches a processor operable to initialize delivery solely responsive to input of the user’s weight ([0004]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Kircher to initiate delivery solely responsive to weight as taught by Chawla to provide a proper dosage to the user. The use of weight alone to calculate dosage is old and well-known in the art as shown by Chawla.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer
Claims 2, 3, and 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11,738,144 B2.
Claim 2, 3, and 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11,738,144 to Lee et al. (“Lee”) in view of U.S. Patent Publication No. 2010/0292634 to Kircher, JR. et al. (“Kircher”). Claim 4 teaches all the limitations of claims 2, 3, and 13-15 but does not mention the insulin delivery system. Kircher shows an insulin delivery system (1304/1310). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used an insulin delivery system with Lee as taught by Kircher to yield the predictable result of providing the insulin calculated by Lee. Lee is intended to be used with an insulin delivery system, Kircher merely shows an example of such a system as known in the art.
Response to Arguments
Applicant's arguments and amendments with respect to 112(a) rejections have been fully considered and they are not persuasive in-part. The rejection of claim 3 has been withdrawn, however the rejection of claims 5, 6, 15, and 18 remain. Applicant argues that a single-parameter approach is not excluded, however there is still no explicit disclosure of a graphical user interface being configured for input of a sole parameter being the user's weight. The rejections stand.
Applicant's arguments and amendments with respect to 112(b) rejections have been fully considered and they are not persuasive in-part. The rejections of claims 3 and 4 have been withdrawn, however the rejection of claim 5 remains. Applicant does not appear to have presented arguments regarding the 112(b) rejection of claim 5.
Applicant's arguments and amendments with respect to 101 rejections have been fully considered but they are not persuasive. Regarding claim 2, Applicant argues that the recitation of “an insulin delivery system” integrates the abstract idea into a practical application and so satisfies prong 2. Examiner respectfully disagrees. The recitation of an insulin delivery device merely links the use of a judicial exception to a particular technological environment of field of use, as discussed in MPEP 2106.05(h). Furthermore, regarding Applicant’s new recitation in claims 2 and 12-14 of a control algorithm “for automated delivery of insulin by the insulin delivery system,” such a limitation is a functional limitation which does not positively recite any actual delivery of insulin. But even if actual delivery were specified, such a limitation would be considered applying the exception in a generic way (MPEP 2106.04(d)(2), see example a, “The particularity Or Generality of The Treatment or Prophylaxis”). The rejections stand.
Applicant's arguments and amendments with respect to art rejections have been fully considered but they are not persuasive. Applicant argues that Kircher does not teach “presenting a user interface for input… receiving… an input of a parameter… the input parameter comprising the user’s weight. Examiner respectfully disagrees. In paragraph [0199], Kircher explicitly teaches a user input device which is receives input regarding patient weight, and the user cannot receive input if it is not “presented” to the user first. The rejection stands.
Applicant’s arguments and arguments with respect to double patenting rejections have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lee and Kircher as shown above.
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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