DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 ("BRI") 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 BRI 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(I), claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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), 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), 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) 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: an/the analyte monitoring device recited as performing various functions throughout the pending claimed methods (1-20).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f), it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof (e.g., programmed processor(s), as described in ¶ [0024], ¶ [0112], etc.).
If Applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f), Applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (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).
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 pre-AIA 35 U.S.C. 112, second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 1, claim 11 and claims dependent thereon, the limitation "recommending, by the analyte monitoring device, performing one or more analyte management procedures from the list of analyte management procedures based on the level of completeness" of claim 1 and the limitation "recommending, by the analyte monitoring device, performing one or more analyte management procedures of the plurality of analyte management procedures based on the level of completeness" of claim 11 are indefinite. Applicant discloses, "It should be appreciated that specific statuses may be provided, e.g., for completed procedures only, for incomplete procedures only, or for combinations or subsets thereof. In some instances, only the complete procedures with low confidence level scores or levels of completeness may be displayed. In one embodiment, the remaining procedures of the plurality may be provided for the user to enable the user to select another procedure. All of the procedures and their statuses may be displayed, for example. In one embodiment, the analyte monitoring device recommends procedures from the plurality for the user to select. For example, incomplete procedures may be recommended since they have not been performed yet. Other procedures, such as completed procedures with low confidence level scores and/or levels of completeness may also be recommended to provide better results. […] Recommendations may encourage the user to perform more procedures and further assist the user to keep track of which procedures to do, and which are currently available or unavailable to run" (¶¶ [0040]-[0042]).
In view of the above, the scope of "recommending" is unclear. Specifically, it is unclear if "recommending" management procedures encompasses displaying only procedures of a certain status (e.g., incomplete) and/or that are available to run for selection by a user (e.g., as described in ¶ [0040]), or if "recommending" requires more than limiting a display to certain procedures, such as the example of displaying all procedures along with a recommendation of which of the displayed procedures to select/run.
For the purpose of this Office action, claims 1 and 11 will be further discussed with the understanding that displaying only a certain status or statuses of procedures as available to run or select sufficiently suggests/recommendations selection/running of said procedures to the user, as no other procedures would be available for selection/running.
Regarding claim 5 and claims dependent thereon, the limitation "ranking the analyte management procedures by the level of completeness for each of the analyte management procedures" is indefinite. The only apparent reference to ranking in the application as filed states, "The various levels of completeness may be indicated in any variety of manners-e.g., color-coded (e.g., red for incomplete, yellow for reasonably complete, and green for best completion), graphics, symbols (e.g. zero to three stars), characters, numbering or ranking system, etc." (¶ [0039]). In view of this disclosure, it is unclear how "ranking" differs from a determination of the level of completeness and/or what is further required by the limitations of claim 5. It is further unclear to what analyte management procedures (e.g., that are being ranked) refers, the procedures of the previously-recited list, the recommended analyte management procedures, etc.
Regarding claim 11 and claims dependent thereon, the limitation "recommending, by the analyte monitoring device, performing one or more analyte management procedures of the plurality of analyte management procedures based on the level of completeness" is indefinite. The prior limitation ("determining, by the analyte monitoring device, a level of completeness for the estimation of each analyte management parameter of the plurality of analyte management parameters upon completion of each analyte management procedure") recites determining a plurality of levels of completeness (i.e., for the estimation of each analyte management parameter upon completion of each analyte management procedure), such that it is unclear to which level of completeness the limitation "based on the level of completeness" refers.
Regarding claim 17 and claims dependent thereon, the limitation "wherein recommending performing one or more analyte management procedures comprises recommending an analyte management procedure having an incomplete level of completeness" is indefinite. Claim 11, on which claim 17 depends, indicates the level of completeness is determined "upon completion of each analyte management procedure." It is unclear how, under what circumstances, etc. the level of completeness can/will be "incomplete" if said level is determined "upon completion."
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 pre-AIA 35 U.S.C. 112, first paragraph:
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1 and claims dependent thereon, the limitation "recommending, by the analyte monitoring device, performing one or more analyte management procedures from the list of analyte management procedures based on the level of completeness" is further indefinite. As noted above, Applicant discloses, "In one embodiment, the remaining procedures of the plurality may be provided for the user to enable the user to select another procedure. All of the procedures and their statuses may be displayed, for example. In one embodiment, the analyte monitoring device recommends procedures from the plurality for the user to select. For example, incomplete procedures may be recommended since they have not been performed yet. Other procedures, such as completed procedures with low confidence level scores and/or levels of completeness may also be recommended to provide better results" (¶ [0041]). Accordingly, Applicant appears to disclose a recommendation (or limiting to display) of a particular procedure is based on the status of that particular procedure. However, the above-noted limitation recites/encompasses recommending other analyte management procedures based on the level of completeness of a different analyte management procedure. Alternatively stated, claim 1 recites/encompasses estimating a first analyte management parameter based on data collected during a first analyte management procedure; determining a level of completeness to the estimation of the first analyte management parameter; and recommending performing a second (and/or third, fourth, etc.) analyte management procedure from the list for estimating a different, second (and/or third, etc.) analyte management parameter based on the level of completeness determined for the estimation of the first analyte management parameter. Applicant fails to disclose determining a level of completeness to the estimation of an analyte management parameter based on data collected during a given collection procedure, then recommending different analyte management procedures from a list based on said level of completeness as is encompassed by claim 1.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception(s) without significantly more.
Claims 1-20 recite the steps of estimating a plurality of analyte management parameters based on analyte data collected by a transcutaneous analyte sensor in communication with the analyte monitoring device during a plurality of analyte management procedures; determining a level of completeness for the estimation of each analyte management parameter of the plurality of analyte management parameters upon completion of each analyte management procedure; identifying one or more analyte management procedures that should be performed/reperformed based on the levels of completeness; and calculating a medication dosage based on the estimated analyte management parameter.
These limitations, as drafted, are a process that, under a broadest reasonable interpretation (BRI), covers performance of the limitation in the mind but for the recitation of generic computer components (e.g., monitoring device). That is, other than reciting the limitations are performed by a monitoring device, nothing in the claim elements precludes the steps from practically being performed in the mind. For example, estimating the analyte management parameter encompasses a user mentally/manually estimating at least one of carb ratio, target glucose, etc. in any manner he/she desires from acquired analyte data; determining a level of completeness encompasses the user mentally/manually deciding if the data is sufficient, optimal, etc. for his/her estimation of the parameter; identifying one or more analyte management procedures that should be performed and/or repeated based on said decision; and calculating a medication dosage encompasses the user mentally/manually considering his/her estimated parameter in making therapy (medication) decisions, such as calculating an insulin bolus based on a meal to be consumed and an estimated carb ratio. If claim limitations, under a BRI thereof, cover performance of the limitations in the mind but for the recitation of generic computer components, then they fall within the "mental processes" grouping of abstract ideas. Additionally, the steps of selecting a procedure, and outputting instructions for performing said procedure, including taking a meal or fasting, or taking a medication dose or delaying a medication dose, are comparable to concepts identified by the courts as managing personal behavior, such as following instructions. Accordingly, the pending claims recite an abstract idea(s).
This judicial exception is not integrated into a practical application. The pending claims recite the additional elements of a generic computer component (i.e., monitoring device) for performing the abstract idea(s); a generic sensor and collection step for acquiring analyte data; and outputting a generic "recommendation" or indication based on the result of performing the mental processes. The computer is recited at a high level of generality (i.e., a generic monitoring device performing generic computer functions of analyzing data, performing calculations, evaluations, etc.), such that it amounts no more than mere instructions to apply the exception using a generic computer component. The sensor and collecting step are recited only for acquiring the analyte data necessary to estimate the management parameter(s), and are therefore comparable to concepts identified by the courts as mere data gathering, or insignificant extrasolution activity (MPEP 2106.05(g), e.g., performing clinical tests on individuals to obtain input for an equation, determining the level of a biomarker in blood, etc.). Lastly, the recommending steps encompass generically outputting an indication of procedures identified as needing to be performed/repeated, and/or the calculated medication dosage, i.e., necessary outputting, or an insignificant application comparable to concepts identified by the courts (MPEP 2106.05(g), e.g., printing generated menus). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims, therefore, are directed to an abstract idea(s).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform both the ranking and determining steps amounts to no more than mere instructions to apply the exception using a generic computer component. Further, there is sufficient evidence that transcutaneous implanted analyte sensors were well-understood, routine and/or conventional at the time the application was made (see, e.g., Bender et al, mailed herewith, pgs. 2-3). Even when considered in combination, the claimed steps do no more than merely invoke computers or machinery as a tool to perform an existing process (i.e., estimating, tuning, etc. of management parameters performed by clinicians and/or patients in management of, e.g., diabetes) by requiring the use of software to tailor information and provide it to a user on a generic computer. Accordingly, claims 1-20 are not patent eligible.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claim(s) 1-6, 8 and 10-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0218132 A1 (Soni '132); or Soni '132 in view of US 2009/0063402 A1 (Hayter).
Regarding claims 1, 6 and 8, Soni '132 discloses/suggests a method of determining analyte management parameters, the method comprising:
receiving, by an input of an analyte monitoring device (Fig. 3, collection device 24 and/or computer 36; e.g., ¶ [0085]), a user selection of an analyte management procedure from a list of analyte management procedures (¶ [0077] selecting a structured collection procedure 70 by receiving a selection from a menu list provided in the display 108 from the user interface 146);
outputting, by a display of the analyte monitoring device, user instructions associated with the analyte management procedure (¶ [0092] providing guidance 230 for the user during collection, e.g., Fig. 6B);
collecting analyte data, by a transcutaneously implanted analyte sensor in communication with the analyte monitoring device, during an analyte management procedure for estimation of an analyte management parameter (¶ [0124] receiving resulting measurement at the processor in response to a request to take a bG leveL e.g., events 240a-c, 240f-k; ¶ [0065] where the collection device 24 is implemented as a continuous glucose monitor (CGM) (e.g., ¶ [0051]));
estimating, by the analyte monitoring device, the analyte management parameter based on the collected analyte data during the analyte management procedure (¶ [0087] determining an insulin to carbohydrate ratio, determining insulin sensitivity, etc.; ¶ [0090]-[0091]); and
determining, by the analyte monitoring device, a level of completeness to the estimation of the analyte management parameter, wherein the levels of completeness comprise at least an incomplete level of completeness (¶ [0185] marking a procedure as complete or incomplete; ¶ [0183] state condition (dormant, authorized, pending, active or completed) of each collection procedure 70 can be tracked by the software 34).
As noted above, Soni '132 discloses the analyte sensor may comprise a transcutaneously implanted analyte sensor (e.g., incorporated-by-reference US 7,389,133 B1 to Kotulla, in which at least a portion of sensor (1) is an implantable catheter (10) positioned in the subcutaneous fatty tissue for collecting interstitial fluid for analysis. Alternatively/Additionally, Hayter discloses and/or suggests continuously collecting analyte data by a transcutaneously implanted analyte sensor in communication with an analyte monitoring device (e.g., ¶¶ [0014]-[0019]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Soni '132 with the transcutaneously implanted analyte sensor as taught/suggested by Hayter as a simple substitution of one suitable/known type of continuous analyte/glucose sensor for another to yield no more than predictable results. See MPEP 2143(I)(B).
Soni '132/Soni '132 as modified does not expressly disclose recommending, by the analyte monitoring device, performing one or more analyte management procedures from the list of analyte management procedures based on the level of completeness. However, Soni '132 does disclose a list of analyte management procedures that may be seen by a user/patient may be limited to those available to him/her (¶ [0095], ¶ [0183], etc.), and further discloses and/or suggests, once a procedure has been run, it cannot be run again until reauthorized by a clinician (e.g., ¶ [0206]), thereby indicating only authorized but incomplete procedures are provided to the user for selection. Additionally, Soni '132 discloses notice that a collection procedure is available may be provided in any standard fashion (e.g., ¶ [0138]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Soni '132 with recommending, by the analyte monitoring device, performing one or more analyte management procedures from the list of analyte management procedures based on the level of completeness, such as incomplete procedures that are available to be run, in order to facilitate encouraging and/or improving compliance with prescribed (e.g., available, uncompleted) analyte management procedures.
Regarding claim 2, Soni '132 as modified discloses/suggests the analyte management parameter comprises a carb-ratio, insulin sensitivity factor, bolus to basal ratio, or target glucose level (e.g., ¶ [0091], ¶ [0094], ¶ [0098], ¶ [0104], etc.).
Regarding claim 3, Soni '132 as modified discloses/suggests the user instructions comprise taking a meal or fasting (e.g., ¶¶ [0126]-[0127], ¶ [0234], etc.).
Regarding claim 4, Soni '132 as modified discloses/suggests the user instructions comprise taking a medication dose or delaying a medication dose (e.g., ¶¶ [0126]-[0127], etc.).
Regarding claim 5, Soni '132 as modified discloses and/or suggests ranking the analyte management procedures by the level of completeness for each of the analyte management procedures (¶ [0183] tracking state condition (dormant, authorized, pending, active or completed) of each collection procedure 70; ¶ [0185] binary complete/incomplete flagging/ranking).
Regarding claim 10, Soni '132 as modified discloses/suggests collecting the analyte data by the transcutaneously implanted analyte sensor comprises collecting glucose data by a transcutaneously implanted glucose sensor (Soni '132, ¶ [0051]; Hayter, ¶¶ [0014]-[0019]).
Regarding claims 11 and 15-17, Soni '132 discloses/suggests a method of determining analyte management parameters, the method comprising:
estimating, by an analyte monitoring device (Fig. 3, collection device 24 and/or computer 36; e.g., ¶ [0085]), a plurality of analyte management parameters based on analyte data collected by a transcutaneous analyte sensor in communication with the analyte monitoring device during a plurality of analyte management procedures (¶ [0087] determining an insulin to carbohydrate ratio, determining insulin sensitivity, etc.); and
determining and indicating, by the analyte monitoring device, a level of completeness for the estimation of each analyte management parameter of the plurality of analyte management parameters upon completion of each analyte management procedure, wherein the levels of completeness comprise at least an incomplete level of completeness (¶ [0185] determining if a procedure is complete or incomplete and marking/flagging the procedure accordingly; ¶ [0183] state condition (dormant, authorized, pending, active or completed) of each collection procedure 70 can be tracked by the software 34).
As noted above, Soni '132 discloses the analyte sensor may comprise a transcutaneously implanted analyte sensor (e.g., incorporated-by-reference US 7,389,133 B1 to Kotulla, in which at least a portion of sensor (1) is an implantable catheter (10) positioned in the subcutaneous fatty tissue for collecting interstitial fluid for analysis. Alternatively/Additionally, Hayter discloses and/or suggests continuously collecting analyte data by a transcutaneously implanted analyte sensor in communication with an analyte monitoring device (e.g., ¶¶ [0014]-[0019]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Soni '132 with the transcutaneously implanted analyte sensor as taught/suggested by Hayter as a simple substitution of one suitable/known type of continuous analyte/glucose sensor for another to yield no more than predictable results. See MPEP 2143(I)(B).
Soni '132/Soni '132 as modified does not expressly disclose recommending, by the analyte monitoring device, performing one or more analyte management procedures of the plurality of analyte management procedures based on the level of completeness. However, Soni '132 does disclose a list of analyte management procedures that may be seen by a user/patient may be limited to those available to him/her (¶ [0095], ¶ [0183], etc.), and further discloses and/or suggests, once a procedure has been run, it cannot be run again until reauthorized by a clinician (e.g., ¶ [0206]), thereby indicating only authorized but incomplete procedures are provided to the user for selection. Additionally, Soni '132 discloses notice that a collection procedure is available may be provided in any standard fashion (e.g., ¶ [0138]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Soni '132 with recommending, by the analyte monitoring device, performing one or more analyte management procedures of the plurality of analyte management procedures based on the level of completeness, such as incomplete procedures that are available to be run, in order to facilitate encouraging and/or improving compliance with prescribed (e.g., available, uncompleted) analyte management procedures.
Regarding claim 12, Soni '132 as modified discloses/suggests displaying a list of analyte management procedures for user selection on a display of the analyte monitoring device (¶ [0077] displaying a selectable menu list of structured collection procedures; ¶ [0160] collection procedure 70 available for selection in a list 329 provided by the processor 102 on the display 108).
Regarding claim 13, Soni '132 as modified discloses/suggests receiving a user selection of an analyte management procedure from the list of analyte management procedures by an input of the analyte monitoring device (¶ [0077] selecting a structured collection procedure 70 by receiving a selection from a menu list provided in the display 108 from the user interface 146).
Regarding claim 14, Soni '132 as modified discloses/suggests displaying, on the display of the analyte monitoring device, user instructions associated with the analyte management procedure selected by the user (¶ [0092] providing guidance 230 for the user during collection, e.g., Fig. 6B).
Regarding claim 18, Soni '132 as modified discloses/suggests determining a confidence level score for each analyte management parameter of the plurality of analyte management parameters (¶ [0041] calculating a rate of adherence describing the extent to which a user adhered to the structured collection procedure; ¶ [0109] providing a given confidence interval with the assessment; etc.).
Claim(s) 7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Soni '132 (or Soni '132 in view of Hayter) as applied to claim(s) 6 above, and further in view of US 2011/0178820 A1 (Soni '820).
Regarding claim 7, Soni '132 as modified discloses and/or suggests the limitations of claim 6, as discussed above, but does not disclose outputting on a display of the analyte monitoring device the level of completeness for the one or more analyte management procedures.
Soni '820 discloses/suggests a comparable method comprising outputting on a display of an analyte monitoring device the level of completeness for one or more analyte management procedures (e.g., Fig. 19B; 19E-G; etc.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Soni '132 with outputting on the display of the analyte monitoring device the level of completeness for the one or more analyte management procedures as taught/suggested by Soni '820 in order to facilitate communicating to a patient how far along he/she is and/or has to go in completing a collection procedure (Soni '820, ¶ [0238]).
Claim(s) 9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Soni '132 (or Soni '132 in view of Hayter) as applied to claim(s) 6 above, and further in view of US 2010/0212675 A1 (Walling).
Regarding claim 9, Soni '132 as modified discloses and/or suggests the limitations of claim 6, as discussed above, but does not disclose the method further comprises calculating and recommending a medication dosage based on the estimated analyte management parameter.
Walling discloses/suggests a comparable method comprising completing a first procedure and thereafter providing a therapeutic recommendation to the user to administer a medication dosage based on the estimated analyte management parameter (e.g., ¶¶ [0208]-[0209] adjusting a carbohydrate to insulin (C:I) ratio during a collection procedure, wherein new insulin dose for a meal bolus is calculated based on the new C:I ratio; ¶ [0187] adjusting basal dosage based on a fasting collection procedure; etc.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Soni '132 with calculating and recommending a medication dosage based on the estimated analyte management parameter as taught/suggested by Walling in order to guide a user to optimize therapy based on data obtained during a successful management procedure(s) (Walling, ¶ [0003]).
Double Patenting
The nonstatutory double patenting ("NSDP") 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 NSDP 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 NSDP rejection 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 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 (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.
Claim(s) 1, 5-7, 10-16 and 18-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 9 of USPN 11,087,868.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 9 of USPN 11,087,868 anticipates each limitation of claims 1, 5-7, 10-16 and 18-20 of the present application.
Specifically, with respect to independent claim 1 of the present application, claim 9 of USPN 11,087,868 recites a method comprising receiving, by an input of an analyte monitoring device (claim 1, computer having a processor for executing instructions), a user selection of an analyte management procedure from a list of analyte management procedures (claim 1, receiving an indication from a user to initiate a first procedure of the plurality of analyte management procedures for determining a first parameter of the analyte management parameters); outputting, by a display of the analyte monitoring device, user instructions associated with the analyte management procedure (claim 1, displaying to the user user-instructions associated with the first procedure); collecting analyte data, by a transcutaneously implanted analyte sensor in communication with the analyte monitoring device, during an analyte management procedure for estimation of an analyte management parameter (claim 1, receiving from a continuous analyte monitoring device a plurality of actual analyte measurement data of an analyte for the first procedure, wherein a continuous analyte monitoring device encompasses a transcutaneously implanted sensor in view of the specification, e.g., col. 6, line 58 - col. 7, line 3); estimating, by the analyte monitoring device, the analyte management parameter based on the collected analyte data during the analyte management procedure (claim 1, estimating the first parameter); determining, by the analyte monitoring device, a level of completeness to the estimation of the analyte management parameter (claim 1, categorizing the level of completeness of the first procedure); and recommending, by the analyte monitoring device, performing one or more analyte management procedures from the list of analyte management procedures based on the level of completeness (claims 8-9, recommending the first set of procedures with reasonable level of completeness to the user on the display).
Similarly, with respect to independent claim 11 of the present application, claim 9 of USPN 11,087,868 recites a method comprising estimating, by an analyte monitoring device (claim 1, computer having a processor for executing instructions), a plurality of analyte management parameters based on analyte data collected by a transcutaneous analyte sensor in communication with the analyte monitoring device during a plurality of analyte management procedures (claim 1, claim 1, estimating the first parameter; claims 8-9, where multiple "completed procedures" may be recommended, logically indicating multiple procedures for estimating multiple parameters were completed); determining, by the analyte monitoring device, a level of completeness for the estimation of each analyte management parameter of the plurality of analyte management parameters upon completion of each analyte management procedure (claim 1, categorizing the level of completeness of the first procedure; claims 8-9, multiple procedures); and recommending, by the analyte monitoring device, performing one or more analyte management procedures of the plurality of analyte management procedures based on the level of completeness (claims 8-9, recommending the first set of procedures with reasonable level of completeness to the user on the display).
Claim 9 of USPN 11,087,868 further recites and/or encompasses the limitations of present-application claim 5 (claim 1, categorizing and indicating the level of completeness of the first procedure; claims 8-9, where multiple "completed procedures" are recommended); claim 6 (claim 1, reasonable level of completeness, best level of completeness); claim 7 (claim 1, displaying to the user on the display an indication of the level of completeness); claim 10 (claim 1, continuous analyte monitoring device; col. 6, line 58 - col. 7, line 3); claim 12 (claim 1, displaying for user-selection on the display a plurality of analyte management procedures for determining analyte management parameters); claim 13 (claim 1, receiving an indication from a user to initiate a first procedure of the plurality of analyte management procedures for determining a first parameter of the analyte management parameters); claim 14, displaying, on the display of the analyte monitoring device, user instructions associated with the analyte management procedure selected by the user (claim 1, displaying to the user user-instructions associated with the first procedure); claim 15 (claim 1, displaying to the user on the display an indication of the level of completeness); claim 16 (claim 1, reasonable level of completeness, best level of completeness); claim 18, determining a confidence level score for each analyte management parameter of the plurality of analyte management parameters (claim 1, associating a confidence level score to the completed first procedure); claim 19 (claims 8-9, recommending the first set of procedures with reasonable level of completeness, claim 1, where a procedure is categorized as a reasonable level of completeness based on the confidence level score being a low confidence level score); claim 20 (claim 1, categorizing the level of completeness of the first procedure based on a comparison of the confidence level score to a low confidence level score).
Claim(s) 2-4, 8-9 and 17 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 9 of USPN 11,087,868 in view of Soni '132 or Walling.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 9 of USPN 11,087,868 anticipates each limitation of claims 2-4, 8-9 and 17 of the present application with the exception of the analyte management parameter comprises a carb-ratio, insulin sensitivity factor, bolus to basal ratio, or target glucose level, the user instructions comprising taking a meal or fasting or taking a medication dose or delaying a medication dose; recommending an analyte management procedure having an incomplete level of completeness; and the method comprising calculating and recommending a medication dosage based on the estimated analyte management parameter. However, as discussed with respect to the prior art rejections above, Soni '132 and/or Walling disclose/suggest these features, such that it would have been obvious to modify the method of claim 9 of USPN 11,087,868 with said features in order to facilitate encouraging and/or improving compliance with prescribed (e.g., available, incomplete) analyte management procedures; to optimize a patient's therapy of the chronic disease; etc.
Conclusion
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/Meredith Weare/Primary Examiner, Art Unit 3791
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