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 .
Election/Restrictions
Applicants’ election with traverse of Group I directed to claims 1-13 in the reply filed on 24th June 2026 is acknowledged. The traversal is on the ground(s) that insulin infusion does not correspond to a multi-injected. Insulin infusion is performed continuously whereas administration via multi-injection is performed at discrete intervals at key times of the day. This is found persuasive.
The restriction requirement dated 29th April 2026 is withdrawn.
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7 utilizes quotations for calling a blood glucose level before a meal a pre-prandial blood glucose, and a post-prandial blood glucose for a blood glucose level after a meal. The quotations can be removed, optionally, the claim can be amended to simply read ‘determining a pre-prandial blood glucose’ and ‘determining a post-prandial blood glucose’, as these terms are well-understood in the art.
Claim 14, ‘characterised’ should read ‘characterized’.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Such claim limitation(s) is/are:
Claim 1:
a means for automatically acquiring multiple blood glucose levels during a first day and the day following the first day (means interpreted as item 21 blood glucose meter, in view of the disclosure)
a means for automatically labelling each acquired blood glucose level according to the time of the first day and the day following the first day (means interpreted as item 32 algorithm, in view of the disclosure)
a means for determining a blood glucose level assigned to going to bed for the first day (means interpreted as item 32 algorithm, in view of the disclosure)
a means for determining a blood glucose level assigned to a fasting state or getting up for the day following the first day (means interpreted as item 32 algorithm, in view of the disclosure)
a means for calculating the difference in blood glucose levels between the blood glucose level for this going to bed and the blood glucose level for this getting up or fasting state (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure)
a means for determining if a predetermined event has occurred between this going to bed and this getting up or fasting state (means interpreted as item 22 watch, 24 terminal, 25 user interface, 42 keyboard, 43 speech recognition module, in view of the disclosure)
a means for determining, if no predetermined event has occurred, a hyperglycaemia or a hypoglycaemia depending on the difference in blood glucose levels (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure)
a means for determining if at least a predetermined number of hyperglycaemias or hypoglycaemias has occurred in a predetermined period of time (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure)
a means for modifying the slow insulin dose to be injected if at least the predetermined number of hypoglycaemias or hyperglycaemias has occurred in the first predetermined period of time (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure)
a means for indicating to the user a numerical value of the modified slow insulin dose to be injected (means interpreted as item 25 user interface, in view of the disclosure)
Claim 2:
a means for detecting an increase in the numerical value of the modified slow insulin dose to be injected (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure)
a determination means, activated by the detection means, for determining whether at least a predetermined number of hypoglycaemias greater than or equal to one has occurred in a second predetermined period of time, the second period of time being less than the first period of time (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure)
a correction means for correcting the numerical value of the slow insulin dose to be injected if at least the predetermined number of hypoglycaemias has occurred in the second period of time, the correction means being configured to transmit to the indication means a corrected numerical value of the slow insulin dose to be injected (correction means interpreted as item 26 calculator directed to software on a web server & indication means interpreted as item 25 user interface, in view of the disclosure)
Claim 3:
the means for determining if a predetermined event has occurred between this going to bed and this getting up is configured to determine the occurrence of at least one event from amongst: having a meal between going to bed and getting up, or fasting state (means interpreted as item 22 watch, 24 terminal, 25 user interface, 42 keyboard, 43 speech recognition module, in view of the disclosure)
Claim 4:
a means for determining the occurrence of an event from amongst an illness of the user, the user's menstruation, and carrying out a physical activity (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure)
a means for determining whether at least a predetermined number, greater than or equal to one, of hypoglycaemias or hyperglycaemias has occurred in a predetermined period of time specific to this event, the means for determining the number of hypoglycaemias or hyperglycaemias being activated by the occurrence of a said event (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure)
a means for modifying the slow insulin dose to be injected by a specific slow insulin dose, if at least the predetermined number of hypoglycaemias or hyperglycaemias has occurred in the predetermined specific period of time (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure),
the indication means indicating to the user a numerical value of the specific slow insulin dose to be injected if the occurrence of a said event is determined (indication means interpreted as item 25 user interface, in view of the disclosure)
Claim 5:
a means for determining a correction bolus or a meal bolus, based on: the last blood glucose level measured in the user's blood; a correction factor; an upper target blood glucose level; and a lower target blood glucose level, if the occurrence of an event, from amongst an illness of the user, the user’s menstruation, and carrying out a physical activity, is determined (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure).
Claim 6:
a means for determining whether the correction bolus is higher than a minimum injectable insulin dose; and: if it is, transmitting to the user the value of the correction bolus to be injected; and if not, transmitting to the user a value representative of a physical activity making it possible to obtain the same effect as the corrective insulin dose (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure).
Claim 7:
a means for determining a blood glucose level of the user before a meal, called the "pre-prandial blood glucose", the pre-prandial blood glucose being labelled by the assignment means (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure, the assignment means interpreted as item 32 algorithm)
a means for determining a blood glucose level of the user after a meal, called the "post-prandial blood glucose", the post-prandial blood glucose being labelled by the assignment means (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure, the assignment means interpreted as item 32 algorithm)
a means for receiving a description of a meal (means interpreted to as item 24 terminal, 25 user interface, 42 keyboard, 43 speech recognition module, in view of the disclosure)
a means for determining an insulin active at the time of the injection (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure)
a means for determining a new glucose ratio (ICR) for a meal timeslot between the acquisition instants labelled as pre-prandial blood glucose level and those labelled as post- prandial blood glucose level, as a function of the following factors: a pre-prandial blood glucose level; a post-prandial blood glucose level; an amount of carbohydrates absorbed during the meal; a bolus; a level of active insulin; a value of a correction factor; an upper target blood glucose level; and a lower target blood glucose level (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure;
a means for replacing a glucose ratio used by the device for determining a fast-acting insulin dose to be injected, representative of a number of carbohydrates absorbed by the user, if at least a predetermined number, greater than or equal to two, of new glucose ratios were determined in a predetermined period of time, the replacement glucose ratio being an average, possibly weighted, of the new glucose ratios (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure)
Claim 8:
the determining means determines a new specific glucose ratio for a meal timeslot as a function, additionally, of the following factors:- an illness of the user; - the user's menstruation; and/or - carrying out a physical activity (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure),
the device also comprising a means for replacing a glucose ratio by a specific glucose ratio used by the device for determining a specific fast-acting insulin dose to be injected, the replacement specific glucose ratio being determined as a function of the presence of an illness and/or menstruation (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure).
Claim 9:
the means for replacing a glucose ratio is configured to inhibit the replacement of the glucose ratio if the replacement glucose ratio is within a predefined range of values around the glucose ratio to be replaced (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure).
Claim 10:
a means for calculating nutriments corresponding to the meal described, number of calories, carbohydrates, lipids and proteins (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure)
a means for determining a correlation between the presence of the foods described and a tendency to hypoglycaemia or hyperglycaemia after meals (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure)
a means for triggering an alert for the user, if a sufficiently high correlation is detected (means interpreted to as item 24 terminal, 25 user interface, 42 keyboard, 43 speech recognition module, in view of the disclosure);
a means for determining a meal bolus dose, as a function of the glucose ratio and correction factor values (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure).
Claim 11:
a means for the daily determination of a new correction factor (CF) corresponding to a factor lowering blood glucose levels for a unit of insulin received (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure)
a means for replacing a correction factor for determining a fast-acting insulin dose to be injected (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure)
Claim 12:
the daily determining means determines a new specific correction factor as a function (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure)
a means for replacing a correction factor by a specific correction factor for determining a specific fast-acting insulin dose to be injected (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure)
Claim 13:
the means for replacing a correction factor is configured to inhibit the replacement of the correction factor if the replacement correction factor is within a predetermined range of values around the correction factor to be replaced (means interpreted as item 26 calculator directed to software on a web server, in view of the disclosure).
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 1-13 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. The claims recite the limitations of a means for:
‘automatically labelling each acquired blood glucose level according to the time of the first day and the day following the first day’
‘determining a blood glucose level assigned to going to bed for the first day’
‘determining a blood glucose level assigned to a fasting state or getting up for the day following the first day’
‘determining if a predetermined event has occurred between this going to bed and this getting up or fasting state’;
‘determining, if no predetermined event has occurred, a hyperglycaemia or a hypoglycaemia depending on the difference in blood glucose levels’;
‘determining if at least a predetermined number of hyperglycaemias or hypoglycaemias has occurred in a predetermined period of time’;
‘modifying the slow insulin dose to be injected if at least the predetermined number of hypoglycaemias or hyperglycaemias has occurred in the first predetermined period of time; detecting an increase in the numerical value of the modified slow insulin dose to be injected’;
‘activated by the detection means, for determining whether at least a predetermined number of hypoglycaemias greater than or equal to one has occurred in a second predetermined period of time, the second period of time being less than the first period of time’;
‘correcting the numerical value of the slow insulin dose to be injected if at least the predetermined number of hypoglycaemias has occurred in the second period of time, the correction means being configured to transmit to the indication means a corrected numerical value of the slow insulin dose to be injected’;
‘determining the occurrence of an event from amongst an illness of the user, the user's menstruation, and carrying out a physical activity’;
‘determining whether at least a predetermined number, greater than or equal to one, of hypoglycaemias or hyperglycaemias has occurred in a predetermined period of time specific to this event, the means for determining the number of hypoglycaemias or hyperglycaemias being activated by the occurrence of a said event’;
‘modifying the slow insulin dose to be injected by a specific slow insulin dose, if at least the predetermined number of hypoglycaemias or hyperglycaemias has occurred in the predetermined specific period of time’;
‘determining a correction bolus or a meal bolus, based on: the last blood glucose level measured in the user's blood; a correction factor; an upper target blood glucose level; and a lower target blood glucose level, if the occurrence of an event, from amongst an illness of the user, the user’s menstruation, and carrying out a physical activity, is determined’;
‘determining whether the correction bolus is higher than a minimum injectable insulin dose; and: if it is, transmitting to the user the value of the correction bolus to be injected; and if not, transmitting to the user a value representative of a physical activity making it possible to obtain the same effect as the corrective insulin dose’;
‘determining a blood glucose level of the user before a meal’;
‘determining a blood glucose level of the user after a meal’;
‘determining an insulin active at the time of the injection’;
‘determining a new glucose ratio (ICR) for a meal timeslot between the acquisition instants labelled as pre-prandial blood glucose level and those labelled as post- prandial blood glucose level, as a function of the following factors: a pre-prandial blood glucose level; a post-prandial blood glucose level; an amount of carbohydrates absorbed during the meal; a bolus; a level of active insulin; a value of a correction factor; an upper target blood glucose level; and a lower target blood glucose level’;
‘replacing a glucose ratio used by the device for determining a fast-acting insulin dose to be injected, representative of a number of carbohydrates absorbed by the user, if at least a predetermined number, greater than or equal to two, of new glucose ratios were determined in a predetermined period of time, the replacement glucose ratio being an average, possibly weighted, of the new glucose ratio’;
‘determines a new specific glucose ratio for a meal timeslot as a function, additionally, of the following factors:- an illness of the user; - the user's menstruation; and/or - carrying out a physical activity’;
‘replacing a glucose ratio by a specific glucose ratio used by the device for determining a specific fast-acting insulin dose to be injected, the replacement specific glucose ratio being determined as a function of the presence of an illness and/or menstruation’;
‘replacing a glucose ratio is configured to inhibit the replacement of the glucose ratio if the replacement glucose ratio is within a predefined range of values around the glucose ratio to be replaced’;
‘calculating nutriments corresponding to the meal described, number of calories, carbohydrates, lipids and proteins’;
‘determining a correlation between the presence of the foods described and a tendency to hypoglycaemia or hyperglycaemia after meals’;
‘determining a meal bolus dose, as a function of the glucose ratio and correction factor values’;
‘daily determination of a new correction factor (CF) corresponding to a factor lowering blood glucose levels for a unit of insulin received’;
‘replacing a correction factor for determining a fast-acting insulin dose to be injected’;
‘daily determining means determines a new specific correction factor as a function’;
‘replacing a correction factor by a specific correction factor for determining a specific fast-acting insulin dose to be injected’;
‘replacing a correction factor is configured to inhibit the replacement of the correction factor if the replacement correction factor is within a predetermined range of values around the correction factor to be replaced’;
all allegedly performed by a calculator directed to software (algorithms) on a web server with several modules according to the disclosure. The specification fails to disclose how these limitations are accomplished with any specificity, rather merely generally citing modules of the calculator with repeated claimed step language. Thus, the specification is insufficient to convey to one skilled in the art that the inventor had possession of the claim invention.
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 1-14 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.
The following claim limitations invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, Claims 1-13 are indefinite, unable to be clearly interpreted and are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.:
‘determining if a predetermined event has occurred between this going to bed and this getting up or fasting state’;
‘determining, if no predetermined event has occurred, a hyperglycaemia or a hypoglycaemia depending on the difference in blood glucose levels’;
‘determining if at least a predetermined number of hyperglycaemias or hypoglycaemias has occurred in a predetermined period of time’;
‘modifying the slow insulin dose to be injected if at least the predetermined number of hypoglycaemias or hyperglycaemias has occurred in the first predetermined period of time; detecting an increase in the numerical value of the modified slow insulin dose to be injected’;
‘activated by the detection means, for determining whether at least a predetermined number of hypoglycaemias greater than or equal to one has occurred in a second predetermined period of time, the second period of time being less than the first period of time’;
‘correcting the numerical value of the slow insulin dose to be injected if at least the predetermined number of hypoglycaemias has occurred in the second period of time, the correction means being configured to transmit to the indication means a corrected numerical value of the slow insulin dose to be injected’;
‘determining the occurrence of an event from amongst an illness of the user, the user's menstruation, and carrying out a physical activity’;
‘determining whether at least a predetermined number, greater than or equal to one, of hypoglycaemias or hyperglycaemias has occurred in a predetermined period of time specific to this event, the means for determining the number of hypoglycaemias or hyperglycaemias being activated by the occurrence of a said event’;
‘modifying the slow insulin dose to be injected by a specific slow insulin dose, if at least the predetermined number of hypoglycaemias or hyperglycaemias has occurred in the predetermined specific period of time’;
‘determining a correction bolus or a meal bolus, based on: the last blood glucose level measured in the user's blood; a correction factor; an upper target blood glucose level; and a lower target blood glucose level, if the occurrence of an event, from amongst an illness of the user, the user’s menstruation, and carrying out a physical activity, is determined’;
‘determining whether the correction bolus is higher than a minimum injectable insulin dose; and: if it is, transmitting to the user the value of the correction bolus to be injected; and if not, transmitting to the user a value representative of a physical activity making it possible to obtain the same effect as the corrective insulin dose’;
‘determining a blood glucose level of the user before a meal’;
‘determining a blood glucose level of the user after a meal’;
‘determining an insulin active at the time of the injection’;
‘determining a new glucose ratio (ICR) for a meal timeslot between the acquisition instants labelled as pre-prandial blood glucose level and those labelled as post- prandial blood glucose level, as a function of the following factors: a pre-prandial blood glucose level; a post-prandial blood glucose level; an amount of carbohydrates absorbed during the meal; a bolus; a level of active insulin; a value of a correction factor; an upper target blood glucose level; and a lower target blood glucose level’;
‘replacing a glucose ratio used by the device for determining a fast-acting insulin dose to be injected, representative of a number of carbohydrates absorbed by the user, if at least a predetermined number, greater than or equal to two, of new glucose ratios were determined in a predetermined period of time, the replacement glucose ratio being an average, possibly weighted, of the new glucose ratio’;
‘determines a new specific glucose ratio for a meal timeslot as a function, additionally, of the following factors:- an illness of the user; - the user's menstruation; and/or - carrying out a physical activity’;
‘replacing a glucose ratio by a specific glucose ratio used by the device for determining a specific fast-acting insulin dose to be injected, the replacement specific glucose ratio being determined as a function of the presence of an illness and/or menstruation’;
‘replacing a glucose ratio is configured to inhibit the replacement of the glucose ratio if the replacement glucose ratio is within a predefined range of values around the glucose ratio to be replaced’;
‘calculating nutriments corresponding to the meal described, number of calories, carbohydrates, lipids and proteins’;
‘determining a correlation between the presence of the foods described and a tendency to hypoglycaemia or hyperglycaemia after meals’;
‘determining a meal bolus dose, as a function of the glucose ratio and correction factor values’;
‘daily determination of a new correction factor (CF) corresponding to a factor lowering blood glucose levels for a unit of insulin received’;
‘replacing a correction factor for determining a fast-acting insulin dose to be injected’;
‘daily determining means determines a new specific correction factor as a function’;
‘replacing a correction factor by a specific correction factor for determining a specific fast-acting insulin dose to be injected’;
‘replacing a correction factor is configured to inhibit the replacement of the correction factor if the replacement correction factor is within a predetermined range of values around the correction factor to be replaced’;
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Claim 1, ‘the day following the first day’, there is insufficient antecedent basis for this limitation in this claim.
Claim 1, ‘each acquired blood glucose level’, there is insufficient antecedent basis for this limitation in this claim. Examiner interprets the limitation to intend ‘each of the multiple blood glucose levels’.
Claim 1, ‘the time’, there is insufficient antecedent basis for this limitation in this claim.
Claim 1, ‘a blood glucose level assigned to going to bed for the first day’, it is unclear whether this is part of the ‘multiple blood glucose levels’ as previously recited or if it is a new distinct blood glucose level. Examiner interprets the limitation to intend to mean a blood glucose level of the multiple blood glucose levels.
Claim 1, ‘a blood glucose level assigned to a fasting state or getting up for the day following the first day’, it is unclear whether this is part of the ‘multiple blood glucose levels’ as previously recited or if it is a new distinct blood glucose level. Examiner interprets the limitation to intend to mean a blood glucose level of the multiple blood glucose levels.
Claim 1, ‘…difference in blood glucose levels’ day’, it is unclear whether this is part of the ‘multiple blood glucose levels’ as previously recited or if it is a new distinct blood glucose level. Examiner interprets the limitation to intend to mean blood glucose levels of the multiple blood glucose levels.
Claim 1, ‘a blood glucose level for this getting up or fasting state’, it is unclear whether this is part of the ‘multiple blood glucose levels’ as previously recited or if it is a new distinct blood glucose level. Examiner interprets the limitation to intend to mean a blood glucose level of the multiple blood glucose levels.
Claim 1, ‘the difference in blood glucose levels’, there is insufficient antecedent basis for this limitation in this claim.
Claim 1, ‘the first predetermined period of time’, there is insufficient antecedent basis for this limitation in this claim.
Claims 1-2, ‘the modified slow insulin dose’, there is insufficient antecedent basis for this limitation in this claim.
Claim 2, ‘the detection means’, there is insufficient antecedent basis for this limitation in this claim. Examiner notes this limitation should likely read ‘the means for detecting’.
Claim 2, ‘at least a predetermined number of hypoglycaemias’, it is unclear if this limitation is intending to refer to ‘at least a predetermined number of hyperglycaemias or hypoglycaemias’ as previously recited or if this is a new distinct predetermined number of hypoglycaemias.
Claim 2, ‘the second period of time’, there is insufficient antecedent basis for this limitation in this claim. Examiner notes the limitation should likely read ‘the second predetermined period of time’.
Claim 2, ‘the first period of time’, there is insufficient antecedent basis for this limitation in this claim. Examiner notes the limitation should likely read ‘the first predetermined period of time’.
Claim 2, ‘the indication means’, there is insufficient antecedent basis for this limitation in this claim. Examiner notes the limitation should likely read ‘the means for indicating’.
Claim 3, ‘the occurrence’, there is insufficient antecedent basis for this limitation in this claim.
Claim 4, ‘the occurrence’, there is insufficient antecedent basis for this limitation in this claim.
Claim 4, ‘the means for determining the number of hypoglycaemias or hyperglycaemias has occurred in a predetermined period of time specific to this event’, there is insufficient antecedent basis for ‘the number of hypoglycaemias or hyperglycaemias’ in this claim. Further, it is unclear what ‘this event’ is referring to, rendering claim 4 indefinite. Examiner interprets ‘this event’ as ‘the event’.
Claim 4, ‘a said event’, it is unclear what this limitation is intending to refer to, rendering claim 4 indefinite. Examiner interprets ‘this event’ as ‘the event’.
Claim 4, ‘the predetermined specific period of time’, there is insufficient antecedent basis for this limitation in this claim.
Claim 5, ‘the last blood glucose level measured’, there is insufficient antecedent basis for this limitation in this claim.
Claim 5, ‘the occurrence’, there is insufficient antecedent basis for this limitation in this claim.
Claim 5, ‘an event’, it is unclear what this limitation is referring to, whether it is attempting to refer to the same instance of ‘an event’ as previously recited in claim 4, or if it is a new distinct ‘event’. Examiner interprets the limitation to intend ‘the event’, referring to ‘an event’ as recited in claim 4.
Claim 5, ‘an illness of the user… a physical activity…’, it is unclear whether this is attempting to refer to the same instance of ‘an illness of the user… a physical activity…’ as previously recited in claim 4, or if it is a new distinct ‘an illness of the user… a physical activity…’. Examiner interprets this to intend ‘the illness of the user… the physical activity…’.
Claim 6, ‘it’, it is unclear what ‘it’ is referring to, rendering claim 6 indefinite. Examiner interprets this limitation to intend ‘if the correction bolus is higher than the minimum injectable insulin dose’.
Claim 6, ‘the value’, there is insufficient antecedent basis for this limitation in this claim.
Claim 6, ‘the same effect’, there is insufficient antecedent basis for this limitation in this claim.
Claim 6, ‘an illness of the user… a physical activity…’, it is unclear whether this is attempting to refer to the same instance of ‘an illness of the user… a physical activity…’ as previously recited in claims 4 & 5, or if it is a new distinct ‘an illness of the user… a physical activity…’. Examiner interprets this to intend ‘the illness of the user… the physical activity…’.
Claim 6, ‘the corrective insulin dose’, there is insufficient antecedent basis for this limitation in this claim.
Claim 7, ‘a blood glucose level’, it is unclear whether this is part of the ‘multiple blood glucose levels’ as previously recited or if it is a new distinct blood glucose level. Examiner interprets the limitation to intend to mean a blood glucose level of the multiple blood glucose levels.
Claim 7, ‘the pre-prandial blood glucose’, there is insufficient antecedent basis for this limitation in this claim.
Claim 7, ‘the assignment means’, there is insufficient antecedent basis for this limitation in this claim.
Claim 7, ‘the post-prandial blood glucose’, there is insufficient antecedent basis for this limitation in this claim.
Claim 7 recites ‘a meal’ several times, it is unclear whether every instance of ‘a meal’ is intending to be referring to ‘a meal’ as initially recited in claim 7, or if it is a new distinct instance of ‘a meal’, rendering claim 7 indefinite.
Claim 7, ‘determining an insulin active…’, it is unclear what is meant by this limitation, rendering claim 7 indefinite. Upon review of the specification, examiner interprets this limitation to read ‘determining a level of an active insulin’.
Claim 7, ‘the time of the injection’, there is insufficient antecedent basis for these limitations in this claim.
Claim 7, ‘the acquisition instants’, there is insufficient antecedent basis for this limitation in this claim.
Claim 7, ‘the following factors’, there is insufficient antecedent basis for this limitation in this claim.
Claim 7, ‘…a predetermined period of time’, it is unclear whether this is referring to ‘a predetermined period of time’ as previously recited or a new distinct ‘predetermined period of time’, rendering claim 7 indefinite.
Claim 7, ‘the replacement glucose ratio’, there is insufficient antecedent basis for this limitation in this claim.
Claim 7 recites multiple limitations within quotations making it unclear if each recitation is meant to be part of the claim or not.
Claim 8, ‘a meal timeslot’, it is unclear whether this is referring to ‘a meal timeslot’ as previously recited, or a new distinct ‘meal timeslot’, rendering claim 8 indefinite.
Claim 8, ‘a function’, it is unclear whether this is referring to ‘a function’ as previously recited, or a new distinct ‘a function’, rendering claim 8 indefinite.
Claim 8, ‘an illness’, it is unclear whether this is referring to ‘an illness’ as previously recited, or a new distinct ‘an illness’, rendering claim 8 indefinite.
Claim 8, ‘a means for replacing a glucose ratio’, it is unclear whether this is referring to ‘a means for replacing a glucose ratio’ as previously recited, or a new distinct ‘a means for replacing a glucose ratio’, rendering claim 8 indefinite.
Claim 8, ‘a glucose ratio’, it is unclear whether this is referring to ‘a glucose ratio’ as previously recited, or a new distinct ‘a glucose ratio’, rendering claim 8 indefinite.
Claim 8, ‘the replacement specific glucose ratio’, there is insufficient antecedent basis for this limitation in this claim.
Claim 8, ‘the presence of an illness and/or menstruation’, there is insufficient antecedent basis for this limitation in this claim.
Claim 9, ‘a glucose ratio’, it is unclear whether this is referring to ‘a glucose ratio’ as previously recited, or a new distinct ‘a glucose ratio’, rendering claim 9 indefinite.
Claim 9, ‘the replacement’, there is insufficient antecedent basis for this limitation in this claim.
Claim 9, ‘the replacement glucose ratio’, there is insufficient antecedent basis for this limitation in this claim.
Claim 10, ‘the presence’, there is insufficient antecedent basis for this limitation in this claim.
Claim 10, ‘the foods described’, there is insufficient antecedent basis for this limitation in this claim.
The term “sufficiently” in claim 10 is a relative term which renders the claim indefinite. The term “sufficiently” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. ‘a means for triggering an alert for the user, if a sufficiently high correlation is detected’.
Claim 11, ‘the daily determination’, there is insufficient antecedent basis for this limitation in this claim.
Claim 11, ‘the correction factor’, there is insufficient antecedent basis for this limitation in this claim.
Claim 11, ‘…a predetermined period of time’, it is unclear whether this is referring to ‘a predetermined period of time’ as previously recited or a new distinct ‘predetermined period of time’, rendering claim 11 indefinite.
Claim 11, ‘the replacement correction factor’, there is insufficient antecedent basis for this limitation in this claim.
Claim 12, ‘the daily determination’, there is insufficient antecedent basis for this limitation in this claim.
Claim 12, ‘a correction factor’, it is unclear if this limitation is referring to ‘a correction factor’ as previously recited or if it is a new distinct ‘a correction factor’, rendering claim 12 indefinite.
Claim 12, ‘the replacement specific correction factor’, there is insufficient antecedent basis for this limitation in this claim.
Claim 12, ‘the presence of an illness and/or menstruation’, there is insufficient antecedent basis for this limitation in this claim.
Claim 12, ‘an illness’, it is unclear whether this is referring to ‘an illness’ as previously recited, or a new distinct ‘an illness’, rendering claim 12 indefinite.
Claim 13, ‘a correction factor’, it is unclear if this limitation is referring to ‘a correction factor’ as previously recited or if it is a new distinct ‘a correction factor’, rendering claim 13 indefinite.
Claim 13, ‘the replacement’, there is insufficient antecedent basis for this limitation in this claim.
Claim 13, ‘the replacement correction factor’, there is insufficient antecedent basis for this limitation in this claim.
Claim 14, ‘it’, it is unclear what ‘it’ is referring to, rendering claim 14 indefinite. Examiner interprets ‘it’ to intend ‘the method’.
Claim 14, ‘the day following the first day’, there is insufficient antecedent basis for this limitation in this claim.
Claim 14, ‘each acquired blood glucose level’, there is insufficient antecedent basis for this limitation in this claim. Examiner interprets the limitation to intend ‘each of the multiple blood glucose levels’.
Claim 14, ‘the time’, there is insufficient antecedent basis for this limitation in this claim.
Claim 14, ‘a blood glucose level assigned to going to bed for the first day’, it is unclear whether this is part of the ‘multiple blood glucose levels’ as previously recited or if it is a new distinct blood glucose level. Examiner interprets the limitation to intend to mean a blood glucose level of the multiple blood glucose levels.
Claim 14, ‘a blood glucose level assigned to a fasting state or getting up for the day following the first day’, it is unclear whether this is part of the ‘multiple blood glucose levels’ as previously recited or if it is a new distinct blood glucose level. Examiner interprets the limitation to intend to mean a blood glucose level of the multiple blood glucose levels.
Claim 14, ‘…difference in blood glucose levels’ day’, it is unclear whether this is part of the ‘multiple blood glucose levels’ as previously recited or if it is a new distinct blood glucose level. Examiner interprets the limitation to intend to mean blood glucose levels of the multiple blood glucose levels.
Claim 14, ‘a blood glucose level for this getting up or fasting state’, it is unclear whether this is part of the ‘multiple blood glucose levels’ as previously recited or if it is a new distinct blood glucose level. Examiner interprets the limitation to intend to mean a blood glucose level of the multiple blood glucose levels.
Claim 14, ‘the difference in blood glucose levels’, there is insufficient antecedent basis for this limitation in this claim.
Claim 14, ‘the predetermined specific period of time’, there is insufficient antecedent basis for this limitation in this claim.
Claim 14, ‘the modified slow insulin dose’, there is insufficient antecedent basis for this limitation in this claim.
Claim Rejections - 35 USC § 101
Claims 1-14 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.
Each of Claims 1-14 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1-14 recites at least one step or instruction for 1-14, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG.
Accordingly, each of Claims 1-14 recites an abstract idea.
Specifically,
Claim 1: A device for dynamically determining a slow insulin dose to be injected for a user treated by multiple injections, comprising:-
a means for automatically acquiring multiple blood glucose levels during a first day and the day following the first day (Observation); -
a means for automatically labelling each acquired blood glucose level according to the time of the first day and the day following the first day (Observation, Judgement); -
a means for determining a blood glucose level assigned to going to bed for the first day (Observation, Judgement, Evaluation/Opinion); -
a means for determining a blood glucose level assigned to a fasting state or getting up for the day following the first day (Observation, Judgement, Evaluation/Opinion); -
a means for calculating the difference in blood glucose levels between the blood glucose level for this going to bed and the blood glucose level for this getting up or fasting state (Mathematical Concept); -
a means for determining if a predetermined event has occurred between this going to bed and this getting up or fasting state (Observation); -
a means for determining, if no predetermined event has occurred, a hyperglycaemia or a hypoglycaemia depending on the difference in blood glucose levels (Observation, Judgement, Evaluation/Opinion); -
a means for determining if at least a predetermined number of hyperglycaemias or hypoglycaemias has occurred in a predetermined period of time (Observation, Judgement, Evaluation/Opinion); -
a means for modifying the slow insulin dose to be injected if at least the predetermined number of hypoglycaemias or hyperglycaemias has occurred in the first predetermined period of time (Observation, Judgement, Evaluation/Opinion); and –
a means for indicating to the user a numerical value of the modified slow insulin dose to be injected (Observation).
Claim 14: A method for dynamically determining a slow insulin dose to be injected for a user treated by multiple injections, characterised in that it comprises:-
a step of automatically acquiring multiple blood glucose levels during a first day and the day following the first day (Observation, Judgement, Evaluation/Opinion); -
a step of automatically labelling each acquired blood glucose level according to the time of the first day and the day following the first day (Observation, Judgement, Evaluation/Opinion);
a step of determining a blood glucose level assigned to going to bed for the first day (Observation, Judgement, Evaluation/Opinion); -
a step of determining a blood glucose level assigned to a fasting state or getting up for the day following the first day (Observation, Judgement, Evaluation/Opinion); -
a step of calculating the difference in blood glucose levels between the blood glucose level for this going to bed and the blood glucose level for this getting up or fasting state (Observation, Judgement, Evaluation/Opinion); -
a step of determining if a predetermined event has occurred between this going to bed and this getting up or fasting state (Observation, Judgement, Evaluation/Opinion); -
a step of determining, if no predetermined event has occurred, a hyperglycaemia or a hypoglycaemia depending on the difference in blood glucose levels (Observation, Judgement, Evaluation/Opinion); -
a step of determining if at least a predetermined number of hyperglycaemias or hypoglycaemias has occurred in a predetermined period of time (Observation, Judgement, Evaluation/Opinion); -
a step of modifying the slow insulin dose to be injected if at least the predetermined number of hypoglycaemias or hyperglycaemias has occurred in the predetermined specific period of time (Observation, Judgement, Evaluation/Opinion); and –
a step of indicating to the user a numerical value of the modified slow insulin dose to be injected (Observation, Judgement, Evaluation/Opinion).
The underlined portions of which are grouped as a mental process under the 2019 PEG, annotated with abstract ideas grouped as a mental process under the 2019 PEG such as observation, judgement, evaluations and opinions. The additional elements used to perform the abstract ideas are seen as generically recited elements conducting extra solution activity and are annotated via bold text, in this case the additional elements are not positively recited, but have been considered to be the “means for” limitations as interpreted in the 112f section above: (additional element); (Observation) (Judgement) (Evaluation/Opinion)
Further, dependent Claims 2-13 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 process steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 1 & 14 (and their respective dependent Claims 2-13) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 1 & 14), 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: “means for” limitations as interpreted in the 112f section above are generically recited computer elements in independent Claims 1 & 14 (and their respective dependent claims) which do not improve the functioning of a computer, 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 1 & 14 (and their respective dependent claims) is 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 system 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., “means for” limitations as interpreted in the 112f section above 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 1 & 14 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 1 & 14 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1-14 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “means for” limitations as interpreted in the 112f section above.
The above-identified additional elements are generically claimed computer components 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.
Per Applicant’s specification, the additional elements are generically recited additional elements: “means for” limitations as interpreted in the 112f section above.
Accordingly, in light of Applicant’s specification, the claimed term means for is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the means for. 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).
The recitation of the above-identified additional limitations in Claims 1-14 amounts 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., 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 device and method of Claims 1-14 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 (ii) providing a technical solution to a problem in a technical field. None of Claims 1-14 provides 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 1 & 14 (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. 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. 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. Thus, Claims 1-14 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-14 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-14 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 7, 9, 11 & 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 11869648 B2 to Bashan et al. (hereinafter, Bashan) in view of US 20110053121 A1 to Heaton.
Claim 1:
Bashan discloses a device for dynamically determining a slow insulin dose to be injected for a user treated by multiple injections (Bashan: Abstract), comprising:
a means for automatically acquiring multiple blood glucose levels during a first day and the day following the first day (Bashan: Col. 8, lines 55-61; Col. 14, lines 17-19)
a means for automatically labelling each acquired blood glucose level according to the time of the first day and the day following the first day (Bashan: Col. 12, lines 11-18; Col. 14, lines 17-19)
a means for determining a blood glucose level assigned to going to bed for the first day (Bashan: Col. 12, lines 11-18)
a means for determining a blood glucose level assigned to a fasting state or getting up for the day following the first day (Bashan: Col. 12, lines 11-18)
a means for determining, if no predetermined event has occurred, a hyperglycaemia or a hypoglycaemia depending on the difference in blood glucose levels (Bashan: Col. 13, lines 16-24; Fig. 12, item 420)
a means for determining if at least a predetermined number of hyperglycaemias or hypoglycaemias has occurred in a predetermined period of time (Bashan: Fig. 12, item 440)
a means for modifying the slow insulin dose to be injected if at least the predetermined number of hypoglycaemias or hyperglycaemias has occurred in the first predetermined period of time (Bashan: Col. 19, lines 1-16)
a means for indicating to the user a numerical value of the modified slow insulin dose to be injected (Bashan: Col. 7, lines 4-17; Figs. 2-4)
Bashan is silent on calculating the difference in blood glucose levels between going to bed and waking up and determining the occurrence of a predetermined event between going to bed and waking up.
However, Heaton teaches a means for calculating the difference in blood glucose levels between the blood glucose level for this going to bed and the blood glucose level for this getting up or fasting state (Heaton: Para. [0067])
a means for determining if a predetermined event has occurred between this going to bed and this getting up or fasting state (Heaton: Para. [0067]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the processing steps of Bashan by including calculating a difference between glucose levels between going to bed and waking up to determine an occurrence of a predetermined event as taught by Heaton to account for individuals with an elevated evening glucose level who do not return to fasting glucose by the following morning caused by excessive nighttime overeating, either at dinner or during the night, and/or impaired metabolic function wherein the body at rest is unable to dispose of excess glucose (Heaton: Para. [0067]).
Claim 2:
Bashan in view of Heaton disclose the device according to claim 1, Bashan further discloses a means for detecting an increase in the numerical value of the modified slow insulin dose to be injected (Bashan: Col. 17, lines 17-27)
a determination means, activated by the detection means, for determining whether at least a predetermined number of hypoglycaemias greater than or equal to one has occurred in a second predetermined period of time, the second period of time being less than the first period of time (Bashan: Col. 11, lines 36-58, Col. 13, lines 25-35; Fig. 12)
a correction means for correcting the numerical value of the slow insulin dose to be injected if at least the predetermined number of hypoglycaemias has occurred in the second period of time, the correction means being configured to transmit to the indication means a corrected numerical value of the slow insulin dose to be injected (Bashan: Col. 13, lines 25-42; Fig. 12; Col. 13, line 61-Col. 14, line 3)
Claim 3:
Bashan in view of Heaton disclose the device according to claim 1, Bashan is silent on the occurrence of at least one event from amongst having a meal between going to bed and getting up, or fasting state; carrying out a physical activity between going to bed and getting up, or fasting state; and taking insulin between going to bed and getting up or fasting state.
However, Heaton teaches wherein the means for determining if a predetermined event has occurred between this going to bed and this getting up is configured to determine the occurrence of at least one event from amongst: having a meal between going to bed and getting up, or fasting state; carrying out a physical activity between going to bed and getting up, or fasting state; and taking insulin between going to bed and getting up or fasting state (Heaton: Para. [0067]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the processing steps of Bashan by including calculating a difference between glucose levels between going to bed and waking up to determine an occurrence of a predetermined event as taught by Heaton to account for individuals with an elevated evening glucose level who do not return to fasting glucose by the following morning caused by excessive nighttime overeating, either at dinner or during the night, and/or impaired metabolic function wherein the body at rest is unable to dispose of excess glucose (Heaton: Para. [0067]).
Claim 7:
Bashan in view of Heaton disclose the device according to claim 1, Bashan further discloses wherein a means for determining a blood glucose level of the user before a meal, called the "pre-prandial blood glucose", the pre-prandial blood glucose being labelled by the assignment means (Bashan: Col. 11, lines 36-58)
a means for determining a blood glucose level of the user after a meal, called the "post-prandial blood glucose", the post-prandial blood glucose being labelled by the assignment means (Bashan: Col. 11, lines 36-58; Col. 14, line 60-Col. 15, line 16)
a means for receiving a description of a meal (Bashan: Col. 9, lines 50-55)
a means for determining an insulin active at the time of the injection (Bashan: Col. 7, line 62-Col. 8, line 4)
a means for determining a new glucose ratio (ICR) for a meal timeslot between the acquisition instants labelled as pre-prandial blood glucose level and those labelled as post- prandial blood glucose level (Bashan: Col. 16, lines 13-46), as a function of the following factors: a pre-prandial blood glucose level (Bashan: Col. 16, lines 13-46); a post-prandial blood glucose level (Bashan: Col. 16, lines 13-46); an amount of carbohydrates absorbed during the meal (Bashan: Col. 9, lines 37-55; Col. 23, lines 31-38); a bolus (Bashan: Col. 21, lines 1-7); a level of active insulin (Bashan: Col. 7, line 66-Col. 8, line 2); a value of a correction factor (Bashan: Col. 21, lines 43-44); an upper target blood glucose level and a lower target blood glucose level (Bashan: Col. 15, lines 29-43; Col. 16, lines 13-18);
a means for replacing a glucose ratio used by the device for determining a fast-acting insulin dose to be injected (Bashan: Col. 19, lines 60-67),
representative of a number of carbohydrates absorbed by the user (Bashan: Col. 9, lines 37-55; Col. 23, lines 31-38), if at least a predetermined number, greater than or equal to two, of new glucose ratios were determined in a predetermined period of time, the replacement glucose ratio being an average, possibly weighted, of the new glucose ratios (Bashan: Col. 21, line 1-Col. 22, line 38)
Claim 9:
Bashan in view of Heaton discloses the device according to claim 7, Bashan further discloses wherein the means for replacing a glucose ratio is configured to inhibit the replacement of the glucose ratio if the replacement glucose ratio is within a predefined range of values around the glucose ratio to be replaced (Bashan: Col. 16, lines 12-37).
Claim 11:
Bashan in view of Heaton disclose the device according to claim 1, Bashan further discloses a means for the daily determination of a new correction factor (CF) corresponding to a factor lowering blood glucose levels for a unit of insulin received (Bashan: Col. 16, lines 18-22; Col. 16, lines 38-46)
the correction factor being a function of the following factors: - a pre-correction blood glucose level (Bashan: Col. 16, lines 18-22); - a post-correction blood glucose level (Bashan: Fig. 12, pathway after updating (500 or 430) resets to receiving a new blood glucose measurement (400)); - a bolus (Bashan: Col. 21, lines 1-7); - an active insulin (Bashan: Col. 7, line 66-Col. 8, line 2); - an upper target blood glucose level and a lower target blood glucose level (Bashan: Col. 15, lines 29-43; Col. 16, lines 13-18);
a means for replacing a correction factor for determining a fast-acting insulin dose to be injected (Bashan: Col. 21, line 26-Col. 22, line 14)
Claim 13:
Bashan in view of Heaton disclose the device according to claim 11, Bashan further discloses wherein the means for replacing a correction factor is configured to inhibit the replacement of the correction factor if the replacement correction factor is within a predetermined range of values around the correction factor to be replaced (Bashan: Col. 23, lines 9-26, Col. 23, lines 43-48).
Claim 14:
Bashan discloses a method for dynamically determining a slow insulin dose to be injected for a user treated by multiple injections (Bashan: Abstract), characterised in that it comprises:-
a step of automatically acquiring multiple blood glucose levels during a first day and the day following the first day (Bashan: Col. 8, lines 55-61; Col. 14, lines 17-19); -
a step of automatically labelling each acquired blood glucose level according to the time of the first day and the day following the first day (Bashan: Col. 12, lines 11-18; Col. 14, lines 17-19); -
a step of determining a blood glucose level assigned to going to bed for the first day (Bashan: Col. 12, lines 11-18); -
a step of determining a blood glucose level assigned to a fasting state or getting up for the day following the first day (Bashan: Col. 12, lines 11-18); -
a step of determining, if no predetermined event has occurred, a hyperglycaemia or a hypoglycaemia depending on the difference in blood glucose levels (Bashan: Col. 13, lines 16-24; Fig. 12, item 420);-
a step of determining if at least a predetermined number of hyperglycaemias or hypoglycaemias has occurred in a predetermined period of time (Bashan: Fig. 12, item 440); -
a step of modifying the slow insulin dose to be injected if at least the predetermined number of hypoglycaemias or hyperglycaemias has occurred in the predetermined specific period of time (Bashan: Col. 19, lines 1-16); and –
a step of indicating to the user a numerical value of the modified slow insulin dose to be injected (Bashan: Col. 7, lines 4-17; Figs. 2-4).
Bashan is silent on calculating the difference in blood glucose levels between going to bed and waking up and determining the occurrence of a predetermined event between going to bed and waking up.
However, Heaton teaches a step of calculating the difference in blood glucose levels between the blood glucose level for this going to bed and the blood glucose level for this getting up or fasting state (Heaton: Para. [0067])
a step of determining if a predetermined event has occurred between this going to bed and this getting up or fasting state (Heaton: Para. [0067]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the processing steps of Bashan by including calculating a difference between glucose levels between going to bed and waking up to determine an occurrence of a predetermined event as taught by Heaton to account for individuals with an elevated evening glucose level who do not return to fasting glucose by the following morning caused by excessive nighttime overeating, either at dinner or during the night, and/or impaired metabolic function wherein the body at rest is unable to dispose of excess glucose (Heaton: Para. [0067]).
Claim(s) 4-6 & 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bashan in view of Heaton in view of US 20160228641 A1 to Gescheit et al. (hereinafter, Gescheit).
Claim 4:
Bashan in view of Heaton disclose the device according to claim 1, Bashan further discloses a means for modifying the slow insulin dose to be injected by a specific slow insulin dose, if at least the predetermined number of hypoglycaemias or hyperglycaemias has occurred in the predetermined specific period of time (Bashan: Col. 19, lines 1-16),
the indication means indicating to the user a numerical value of the specific slow insulin dose to be injected if the occurrence of a said event is determined (Bashan: Col. 7, lines 4-17; Figs. 2-4)
Bashan is silent on the occurrence of an event from amongst an illness of the user, the user’s menstruation, and carrying out a physical activity.
However, Gescheit teaches a means for determining the occurrence of an event from amongst an illness of the user, the user's menstruation, and carrying out a physical activity (Gescheit: Para. [0062-0063])
a means for determining whether at least a predetermined number, greater than or equal to one, of hypoglycaemias or hyperglycaemias has occurred in a predetermined period of time specific to this event, the means for determining the number of hypoglycaemias or hyperglycaemias being activated by the occurrence of a said event (Gescheit: Para. [0062-0063])
Bashan supplies the means for modifying the slow insulin dose dependent on the predetermined number of hypoglycaemias or hyperglycaemias that have occurred in a predetermined period of time, Gescheit teaches the event consideration of physical activity causing hypoglycaemia events. Thus, Bashan in view of Gescheit teaches the limitations above.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the event detection of Bashan to include physical activity events as taught by Gescheit because the increased energy consumption of the body causes an increased hypoglycemic risk in diabetics (Gescheit: Para. [0063]).
Claim 5:
Bashan in view of Heaton in view of Gescheit disclose the device according to claim 4, Bashan is silent on a correction bolus.
However, Gescheit teaches wherein a means for determining a correction bolus or a meal bolus, based on: the last blood glucose level measured in the user's blood; a correction factor; an upper target blood glucose level; and a lower target blood glucose level, if the occurrence of an event, from amongst an illness of the user, the user’s menstruation, and carrying out a physical activity, is determined (Gesheit: Para. [0082]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the device of Bashan to include determining a correction bolus as taught by Gescheit as an appropriate measure in case of a hyper glycaemia tow lower the glucose level to a target level or a target range (Gescheit: Para. [0082]).
Claim 6:
Bashan in view of Heaton in view of Gescheit disclose the device according to claim 5,
Bashan further discloses transmitting insulin dosage changes to the user in numerical values (Bashan: Figs. 2-4). Bashan is silent on a correction bolus and a physical activity.
However, Gescheit teaches wherein a means for determining whether the correction bolus is higher than a minimum injectable insulin dose (Gescheit: Para. [0081-0082]);
a physical activity lowering glucose levels (Gescheit: Para. [0063] ).
Bashan in view of Heaton in view of Gescheit are silent on notifying the user of a value representative of a physical activity making it possible to obtain the same effect as the corrective insulin dose.
Bashan supplies numerical data transmission and display to the user, Gescheit teaches a correction bolus being higher than a minimum insulin dose to lower glucose levels from a hyper glycaemia event to a target level and that physical activity lowers glucose levels. Thus, Bashan in view of the teachings of Gescheit teach the limitations.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the event detection of Bashan to include a correction bolus in response to hyper glycaemia and physical activity events as taught by Gescheit because to bring glucose levels to a target level or a target range and the increased energy consumption of the body causes glucose levels to decrease (Gescheit: Para. [0063], [0082]).
Claim 8:
Bashan in view of Heaton discloses the device according to claim 7, Bashan further discloses wherein the determining means determines a new specific glucose ratio for a meal timeslot (Bashan: Col. 22, lines 6-14).
Bashan is silent on an illness of the user, the user’s menstruation and/or carrying out a physical activity.
However, Gescheit teaches a means for determining the occurrence of an event from amongst an illness of the user, the user's menstruation, and carrying out a physical activity (Gescheit: Para. [0062-0063])
Bashan supplies the means for determining a new specific glucose ratio for a meal timeslot and Gescheit teaches the event consideration of physical activity causing hypoglycaemia events. Thus, Bashan in view of Gescheit teaches the limitations above, as physical activity would trigger an update of the ratio through the processing steps of Bashan’s device.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the event detection of Bashan to include physical activity events as taught by Gescheit because the increased energy consumption of the body causes an increased hypoglycemic risk in diabetics (Gescheit: Para. [0063]).
Regarding the limitation of: the device also comprising a means for replacing a glucose ratio by a specific glucose ratio used by the device for determining a specific fast-acting insulin dose to be injected, the replacement specific glucose ratio being determined as a function of the presence of an illness and/or menstruation (Note: The list above does not require the presence of an illness or menstruation with the use of and/or prior to ‘carrying out a physical activity’ and thus is optional, No art has been applied for this limitation in this claim as a result.).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bashan in view of Heaton in view of US 20160262707 A1 to DeVries.
Claim 10:
Bashan in view of Heaton discloses the device according to claim 7, Bashan further discloses a means for determining a meal bolus dose, as a function of the glucose ratio and correction factor values (Bashan: Col. 16, lines 38-46)
While Bashan discloses an amount of carbohydrates in meals (Bashan: Col. 8, lines 46-54), Bashan is silent on specific nutriments.
However, DeVries teaches wherein a means for calculating nutriments corresponding to the meal described, number of calories, carbohydrates, lipids and proteins (DeVries: Para. [0055])
a means for determining a correlation between the presence of the foods described and a tendency to hypoglycaemia or hyperglycaemia after meals (DeVries: Para. [0055])
a means for triggering an alert for the user, if a sufficiently high correlation is detected (DeVries: Para. [0117]).
Bashan supplies the device for determining insulin dosage regimens of and displaying to a user, and DeVries supplies teaching specific meal nutriments and notifying the user of their correlation with glycemic factors. Thus, the combination of Bashan in view of Devries teaches the limitations above.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the meal data of Bashan to include specific nutriments as taught by DeVries to account for specific glycemic factors that the meal has to counteract anticipated effects of the meal on the blood glucose concentration (DeVries: Para. [0131]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bashan in view of Heaton in view of US 20170220751 A1 to Davis et al. (hereinafter, Davis).
Claim 12:
Bashan in view of Heaton disclose device according to claim 11, Bashan is silent on the correction factor being a function of illness of the user and/or the user’s menstruation.
However, Davis teaches wherein the daily determining means determines a new specific correction factor as a function, additionally, of the following factors: - an illness of the user; and/or - the user's menstruation (Davis: Para. [0100]),
a means for replacing a correction factor by a specific correction factor for determining a specific fast-acting insulin dose to be injected (Davis: Para. [0100])
the replacement specific correction factor being determined as a function of the presence of an illness and/or menstruation (Davis: Para. [0100]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the correction factors of Bashan to include specific correction factors regarding illness of the user as taught by Davis as illness is one of many factors that may drive the variation of insulin sensitivity for glucose management (Davis: Para. [0100])
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. US 20210050085 A1 to Hayter et al.
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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