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 .
Applicant’s amendments and remarks, filed on 12/09/2024, are acknowledged. Applicant’s arguments have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn.
Examiner’s Comment
After further consideration of the claimed invention and an updated search of the prior art, the following rejections are newly applied. As a result, this is a “non-final” Office Action because these rejections were not necessitated by applicant’s amendment. Applicant is invited to contact the examiner to discuss potential after-final amendments that could serve to put the claims into condition for allowance.
Status of Claims
Claims 1-5, 8-15, 18-20 are under examination.
Claims 6, 7, 16, 17 are cancelled.
Priority
The instant application is a continuation of, and claims priority under 35 U.S.C. §120 from, U.S. Patent Application 17/474,001, filed on September 13, 2021, which is a continuation of U.S. Patent Application 15/862,819, filed on January 5, 2018, which is a continuation of U.S. Patent Application 13/610,287, filed on September 11, 2012.
Claim Rejections - 35 USC § 112 – Scope of Enablement
The following is a quotation of the first paragraph of 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.
This is a newly applied scope of enablement rejection.
Claims 1-5, 8-15, 18-20 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized in Ex parte Forman, 230 USPQ 546 (BPAI 1986) and reiterated by the Court of Appeals in In re Wands, 8 USPQ2d 1400 at 1404 (CAFC 1988). These factors include, but are not limited to: A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See also MPEP § 2164.01(a).While all of these factors are considered, a sufficient amount for a prima facie case are discussed below which leads to the determination that the above claim lacks enablement due to undue experimentation being required to make and use the invention.
The nature of the invention; the level of one of ordinary skill in the art:
The instantly claimed invention is directed to directed to a computational method and system for administering basal doses of insulin to a patient. Therefore, the nature of the invention, as claimed, is complex in that it requires knowledge of specific biological measurement data, patient parameters, disease/health parameters, and mathematical correlations capable of integrating said parameters to treat a patient with insulin.
The breadth of the claims; the amount of direction or guidance presented; the presence or absence of working examples:
First, in view of the concerns about ambiguity of the claim language expressed in the rejections under 35 U.S.C. 112(b), it is not clear how to make the invention as claimed. Claims 1 and 11 are directed to a computational method and system for administering basal doses of insulin to a patient. However, the claims are not limited to any particular disease, time periods, glucose ranges, measurement amounts, adjustment factors, basal doses, insulin amounts, insulin types, or treatment time periods associated with administering insulin. As such, the claims broadly encompass all known conditions/diseases, time periods associated with meals, dosage amounts, and types of patients. The invention claims to be able to calculate “new basal dosages” simply by multiplying a previous day basal dose by a generic “adjustment factor” (arbitrarily determined from a range of previous pre-meal glucose measurements).
The test of enablement is whether one reasonably skilled in the art could make or use the invention from the disclosures in the specification coupled with information known in the art without undue experimentation. See MPEP 2164.
Claims 1 and 11 are directed to a computational method and system for administering basal doses of insulin to a patient (who is notably not required to be a diabetic patient). The invention, as best understood, claims to achieve this result by: (i) receiving a current glucose measurement of a patient; (ii) determining that a measurement time for the received current glucose measurement falls within a pre-defined pre-meal time period; (iii) determining that a corresponding meal type for the pre-defined pre-meal time period is breakfast; (iv) retrieving a previous day basal dose that was administered to the patient and a previous pre-breakfast glucose measurement of the patient from memory hardware associated with the data processing hardware; (v) identifying a particular pre-configured range of glucose measurement values of a plurality of pre-configured ranges of glucose measurement values that includes the previous pre-breakfast glucose measurement; (vi) setting an adjustment factor to a preconfigured adjustment factor associated with the identified particular pre-configured range of glucose measurement values; and (vii) calculating a new basal dose of insulin for the patient by multiplying the previous day basal dose times the adjustment factor; (viii) retrieving a configured time interval for administering the calculated new basal dose of insulin to the patient from the memory hardware; and (ix) administering the calculated new basal dose of insulin to the patient by transmitting instructions comprising the calculated new basal dose to an administering system having a patient display at the configured time interval, the instructions causing the patient display to display the calculated new basal dose of insulin and the administering system to administer the calculated new basal dose of insulin to the patient.
Regarding claim(s) 1 and 11, steps (v)-(ix), it is unclear how one of skill in the art would be able to predictably practice the claimed invention given the broad nature of the claims and without any regard for a particular disease, patient state/condition, particular pre-configured ranges of glucose values, particular meal intake information (i.e. carbohydrate amounts), particular dosage amounts, and/or particular time intervals (for administering insulin). More specifically, it is unclear how the artisan would be able to set a preconfigured adjustment factor associated with a particular range, and then calculate a new basal dose of insulin for the patient based on a simple linear equation (multiplying the previous day basal dose times the generically recited adjustment factor) for the full scope of time intervals, diseases, and patient conditions being claimed. It is also unclear how the artisan would know the appropriate configured time interval for administering the calculated new basal dose of insulin to said patient for the full scope of time intervals, diseases, and patient conditions being claimed. Indeed, such a simplistic equation does not account for the mathematical complexity required for insulin therapy (which is based on human glucose-insulin interactions).
The skilled practitioner would first turn to the instant specification for guidance on making and using the claimed system in order to develop a patient specific treatment protocol as claimed. Given the breadth of the claims, which is clearly relying on a suitably programmed computer to perform the above functions, applicant must provide a sufficient number of well-defined mathematical models and/or equations capable of performing the claimed functions and bearing a reasonable correlation to the entire scope of the claim. See also LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1345 [76 USPQ2d 1724] (Fed. Cir. 2005). A review of the specification does teach plurality of “if-else” decision block calculations using specific blood glucose ranges, blood glucose levels, and specific adjustment values, [0066-0070, Figures 4 and 7], which suggests some type of rule-based control algorithm. However, such disclosures are much narrower than what is claimed and therefore not sufficient for satisfying the enablement requirement given the full scope of what is being claimed presently. The specification also teaches specific equations for calculating current bolus (for patient on a fixed meal plan with equal carbohydrate amounts ingested at each meal time) [0078] and TTD and CIR amounts [0079], which suggests some type of model-based control algorithms. However, such disclosures are not commensurate in scope with what is being claimed and therefore not sufficient for satisfying the enablement requirement given the full scope of what is being claimed presently. Therefore, the specification fails to provide evidence that applicant has actually identified the necessary data parameters and ranges associated with all known patient conditions, diseases, and treatment outcomes. The specification also fails to provide well-defined and sufficiently validated models/equations for integrating all of the claimed parameters for calculating ‘new basal doses’ for the full scope of diseases and patient conditions being claimed (such that the calculated doses are in fact suitable for patients).
As a result, it is unclear how one of ordinary skill in the art would be able to predictably identify the appropriate time criteria, calculate the appropriate amount for a basal dose of insulin amount to be administered, and determine how long to administer it to a patient (in order for it to be therapeutic). The specification fails to provide any sufficient relationships between insulin and glucose at different times of the day, or any correlation between the amount of carbohydrates consumed and an appropriate basal dose insulin amount for administering to a patient. At best, the specification does provide generic basal dose distribution referring to the frequency and distribution of basal doses for a particular day such as (1) once a day (SID); (2) twice a day (BID); or, (3) three times a day (TID) [0038] and teach limited examples of amounts given to a subject (e.g. if there is IV access or not) [0073-0074]. Therefore, one of skill in the art would not know how to make and use the claimed system for all administering insulin basal doses for the full scope of what is being claimed without undue experimentation.
With regards to working examples, the specification does not provide any working examples that demonstrate a real-world application of the instant invention. With regards to the block diagrams (Figures 1-7), it is well settled that merely disclosing functional “block diagrams” for achieving the claimed results are insufficient for enabling a person skill in the art to practice the claimed invention with only a reasonable degree of experimentation. In re Ghiron, 442 F.2d 985, 991-92, 169 USPQ 723, 727-28 (CCPA 1971). As such, the instant specification fails to disclose the requisite computational steps and/or program code that must be practiced in order to realize the claimed functionality. For at least these reasons, it is unclear how one of skill in the art could make and use the claimed system without undue experimentation.
The state of the prior art; the quantity of experimentation needed:
Given the deficiencies of the specification, as discussed above, the skilled practitioner would turn to the prior art for guidance. However, as illustrative of the state of the art regarding the use of diabetes management systems for administering basal amounts of insulin to a patient (with diabetes), the Examiner refers to the following prior art references:
Thukral et al. (US2009/0006061) teaches a method for administering insulin to patients using the collected glucose data and other available information and a patient-specific model for purposes of determining the therapy parameters for a patient with diabetes [Abstract, 0055]. Unlike the instant claims, Thukral teaches that insulin therapy rules are defined in terms of glucose measurements, insulin sensitivity, insulin-to-carbohydrate ratio, basal insulin rate, and other factors, e.g. stress level and the effect of exercise [0007]. Unlike the instant claims/specification, Thukral also provides data showing a set point relationship between insulin and glucose at different times of the day [FIG. 5]; specific time intervals associated with different glucose amounts, carbohydrate amounts, and processing functions [FIGS. 11-15] and discloses the effects of meal type/timing in dosage calculations [0138]. Lastly, Thukral teaches that insulin treatment methods require patient-specific elements that have to developed and tuned for the overall process to work with the desired level of safety, accuracy, and robustness, and that designing therapies for diseases such as diabetes requires well-defined and validated models and plurality of different types of biological data [0008].
Weinert et al. (US2007/0179434) teaches a method and system for determining drug administration information. In particular, Weinert teaches that administering insulin to treat a patient requires specific information with regards to bolus quantity, bolus type (e.g., normal or fast-acting, e.g., Regular, Lispro, etc.), bolus delivery time, times or intervals (e.g., single delivery, multiple discrete deliveries, continuous delivery, etc.), and the like [0067]. However, neither the instant claims nor the specification provides sufficient guidance on this information for the full scope of basal dose information embraced by the claims.
Steil et al. (Diabetes, 2006, Vol. 55, pp.3344-3350) teaches a well defined mathematical model that calculates insulin delivery based on changes in measured and target amounts as well as specific time parameters [page 3345, entire]. In addition, Steil teaches that no one algorithm has been universally accepted as optimal for insulin delivery, and that lingering questions remain regarding the suitability of different glucose sensing sites (subcutaneous versus intravascular), insulin delivery sites (subcutaneous versus intravascular versus intraperitoneal), and sensor reliability [page 3344, col. 2]. Notably, the instant specification does not appear to contemplate different insulin delivery sites or mechanisms and, if so, they are not reflected in the instant claims.
Davidson et al. (Diabetes Care, 2005, Vol. 28, No. 10, pp.2418-23) teaches a computer-directed intravenous insulin system for administering boluses to patients. In particular, Davidson teaches linear equations for determining the amounts of intravenous insulin to be administered to equations that include “multipliers” (i.e. adjustment factors) and provides an efficacy analysis of their model for correcting hypoglycemia. Davidson further teaches that determining these adjustment factors requires progressively changing them whenever the multiplier does not effectively correct the glucose to specifically defined target ranges [page 2418, col. 2, page 2419, col. 1], which provides evidence that determining such adjustment factors would require undue experimentation.
Mault et al. (US2003/0208113) teaches a method/system for maintaining blood glucose levels. Unlike the instant claims, Mault teaches receiving patient blood glucose measurements over time [Figure 12, ref. claim 1]; providing a PDA loaded with a glycemic model and data relating to specific hypoglycemia thresholds and target blood glucose ranges [0140-0144, ref. claim 1]; and comparing current blood glucose levels to the hypoglycemic model levels; alerting the user when there are any deviations from the predetermined ranges; and recommending corrected insulin or glucagon dosages to the patient so as to maintain blood glucose within a predetermined range [ref. claims 1, 2, 3, and 0153, 0159]. Moreover, Mault teaches that methods for administering insulin vary depending upon the type of diabetes (e.g. Type I or Type II) [0019-0023]. As such, this provides evidence that additional experimentation would be need to practice the claimed invention for the full scope of what is being claimed.
For these reasons, the prior art supports the unpredictability of the claimed invention, since the “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. In re Marzocchi, 439 F.2d 220, 223-24, 169 USPQ 367, 369-70 (CCPA 1971). Finally, said practitioner would turn to trial and error experimentation to determine what disease to study, what glucose ranges are applicable based on the condition of the patient, what other clinical parameters are relevant for treatment, how to integrate all of the parameters in a mathematical model/equation, and then simulate and validate the model to ensure it is actually are effective for patient treatment for the specific disease. Such represents undue experimentation. Due to the unpredictability of the invention, as discussed above, coupled to the lack of guidance in either the prior art or instant specification, it would require undue experimentation to perform the method/system of the claim as broadly written.
For the above reasons, the invention of claim(s) 1-5, 8-15, 18-20 do not comply with the enablement requirement of 35 U.S.C 112(a), since to practice the claimed invention, a person of ordinary skill in the art would have to engage in undue experimentation with no reasonable expectation of success.
Applicant is reminded that while the claims are to be interpreted in light of the specification, it does not follow that limitations from the specification may be read into the claims. On the contrary, claims must be interpreted as broadly as their terms reasonably allow. See MPEP 904.01 and Ex parte Oetiker, 23 USPQ2d 1641 (BPAI, 1992).
To obviate this rejection, the examiner suggests limiting the claims to a specific disease (presumably diabetes), particular ranges of time and glucose measurement parameters, and particular insulin dosage times/amounts that are consistent with the specification.
Claim rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(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 35 U.S.C. 112 (pre-AIA ), 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.
This is a written description rejection.
Claims 1-5, 8-15, 18-20 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
To satisfy the written-description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. Vas-Cath, 935 F.3d at 1563; see also Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention”). Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include: A) Partial structure; B) Physical and/or chemical properties; C) Functional characteristics; D) Known or disclosed correlation between structure and function; E) Method of making; and F) Combinations of A-E. See also MPEP 2163 and the 2011 Supplementary Guidelines to analysis under 35 USC 112 (Computer-Implemented Functional Claim Limitations).
Based on a consideration of the above factors, the level of skill and knowledge in the art, and the specification, the instant claims fail to meet the written description requirement for the following reasons:
The claimed invention is directed to a method for administering a newly calculated basal dose of insulin to a patient, as recited in claims 1 and 11.
Claim 1 recites “setting an adjustment factor to a pre-configured adjustment factor associated with the pre-configured ranges of values...”. In this case, the identifying step is not associated with any particular acts or operations or ranges, i.e. it covers all means or methods of performing the claimed function, i.e. it is unclear who/what is setting the ‘adjustment factor’ (e.g. a user, a computer program, or otherwise) and how this function is being achieved (e.g. user input, mathematical calculations, or otherwise). Presumably the instantly claimed invention is being performed by a suitably program computer (i.e. data processing hardware). As such, there must be an explanation of how the computer or processor performs the specialized claimed functions. However, a review of the specification does not describe, to any appreciable extent, any computational process that corresponds to the function of the claimed “setting”. In this case, neither the claims nor the specification describes to any appreciable extent, any algorithms or mathematical operations that achieve the above function for the full scope of what is being claimed. The specification does disclose a “calculation blocks” and a ‘logic flow’ diagram showing adjustment factor calculations based upon current blood glucose levels [Figure 7, 0025, 0066-0067]. However, this is not commensurate in scope with what is being claimed, as “if-else” calculations performing calculations is not equivalent to “setting” (i.e. selecting) adjustment factors without any calculations whatsoever. Furthermore, it is improper to import narrowing limitations in the claims. See MPEP 2111.01. As such, the specification does not satisfy the written description requirement with respect to the full scope of what is being claimed.
Therefore, the specification fails to support a “broad genus” claim that covers all ways of performing the claimed functions when there is no evidence that a more generic way is contemplated.” See also LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 76 USPQ2d 1724 (Fed. Cir. 2005). For the reasons discussed above, the specification does not satisfy the written description requirement with respect to the full scope of what is being claimed. For more information regarding the written description requirement, see MPEP §2161.01- §2163.07(b).
Claim rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The following rejections are maintained or newly applied.
Claims 1-5, 8-15, 18-20 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 pre-AIA the applicant regards as the invention. Claims that depend directly or indirectly from claim(s) 1 and 11 is/are also rejected due to said dependency.
Claims 1 and 11 recite the term “data processing hardware”. It remains unclear as to the metes and bounds of this term. A review of the specification does not provide any limiting definitions that would serve to clarify what structural limitations is/are intended. For example, it is unclear in what way the “data processing hardware” differs from the “memory hardware” (as data processing hardware such as a computer can routinely include memory). Clarification is again requested via amendment. Applicant has not provided any clarifying amendments or illuminating arguments on this issue. Accordingly, the rejection is maintained.
Claims 1 and 11 recite “memory hardware associated with the data processing hardware”. It is unclear as to the metes and bounds of the claimed “memory hardware”. The specification does not provide any limiting definition that would serve to clarify what structural limitation is intended. Absent any limiting definition, the term “memory hardware” also reads on both transitory and non-transitory memory, i.e. signals. Clarification is requested via amendment, e.g. replacing the term with memory or non-transitory computer readable medium.
Claims 1 and 11 recite “determining that a measurement time for the received current glucose measurement falls within a pre-defined pre-meal time period.” This phrase is problematic for the following reasons. (1) This is a conditional limitation. However, it is unclear as to the metes and bounds of a “pre-defined pre-meal time period” such that the artisan would recognize when this condition is actually met, i.e. the phrase encompasses literally any time period when food is not being consumed. The artisan would recognize that there are no universally well-defined times associated with meals (e.g. some people eat breakfast for dinner) and a review of the specification does not provide any limiting definition for this term that would serve to clarify the scope. The specification teaches manual input of “time period, meal type, and estimated carbohydrates” [Figure 1], however this is not commensurate in scope with what is being claimed. Therefore, the claim is indefinite as it fails to state the function which is to be achieved and more than one effect can be implied from the specification. As a result, it is also unclear what positive process limitation(s) is/are performed when the condition is “not” met (e.g. if the measurement time does not fall within the time period criteria). Moreover, none of the subsequent steps actually uses the “measurement time” information being determined in this step. As a result, it is unclear in what way this step is functionally related to the following steps of the claim (in order to achieve the claimed “calculating a new basal dose of insulin”). In each case, clarification is requested via amendment.
Claims 1 and 11 recite “identifying a particular pre-configured range of glucose measurement values of a plurality of pre-configured ranges of glucose measurement values that includes the previous pre-breakfast glucose measurement”. This limitation is problematic for the following reasons. (1) There is no previous mention of any step that obtains glucose measurements before breakfast (only for generically receiving a current glucose measurement). As a result, there is lack of antecedent basis for “the previous pre-breakfast glucose measurement”. (2) It is unclear what limiting effect is intended by the term “identifying” such that the artisan would recognize what computational limitation is intended, i.e. this limitation reads on simply “looking” at data. It is unclear what limiting effect is intended by the claimed “identifying” step. A review of the specification does not describe, to any appreciable extent, any algorithm or computational operations that correspond to the function of the claimed function. The specification does disclose “decision blocks” wherein ‘if-else’ “logic” is directed to make a decision as to “whether the time period at which the blood was taken is pre-meal, post-meal, bedtime, mid-sleep, or miscellaneous” [0057-59 and Figure 2]. However, this is not commensurate in scope with what is being claimed, as “if-else” calculations performing calculations is not equivalent to “identifying” measurement values. Furthermore, it is improper to import narrowing limitations in the claims. See MPEP 2111.01. As a result, the claim fails to clarify the boundaries of the mathematical/computational operations performed by the data processing hardware such that the artisan would know how to avoid infringement. Clarification is requested via amendment, e.g. including “if-else” logic statements associated with positive “calculating” steps (which is consistent with the specification).
Claims 1 and 11 recite “setting an adjustment factor to a pre-configured adjustment factor associated with the pre-configured ranges of values...”. This limitation is problematic for the following reasons. (1) It is unclear as to the metes and bounds of the term “pre-configured” such that the artisan would recognize what limiting effect is intended. The specification does not provide any limiting definition for this term that would serve to clarify the scope, i.e. in what way are the adjustment factor (i.e. a number) and a range of numbers “pre-configured”. Clarification is requested via amendment. For purposes of examination, this term is broadly interpreted as “known”. (2) It is unclear what limiting effect is intended by the claimed “setting” such that the artisan would recognize what computational limitation is intended. A review of the specification does not describe, to any appreciable extent, any computational process that corresponds to the claimed function. The specification does disclose a “calculation blocks” and a ‘logic flow’ diagram showing adjustment factor calculations based upon current blood glucose levels [Figure 7, 0025, 0066-0067]. However, this is not commensurate in scope with what is being claimed, as “if-else” calculations performing calculations is not equivalent to “setting” (i.e. selecting) adjustment factors without any calculations whatsoever. Furthermore, it is improper to import narrowing limitations in the claims. See MPEP 2111.01. As a result, the claim fails to clarify the boundaries of the mathematical/computational operations performed by the data processing hardware such that the artisan would know how to avoid infringement. Clarification is requested via amendment, e.g. replacing the term with “if-else” logic statement associated with positive “calculating” steps (which is consistent with the specification).
Claims 2 and 12 recite “administering the determined correction dose of insulin to the patient by transmitting the determined correction dose to the administering system having the patient display configured to display the determined correction dose of insulin.” It is unclear in what way a correction dose is administered to the patient “by transmitting” it to a system configured to “display” the determined dose. Clearly, the artisan would appreciate that administering and displaying are entirely different processes. Clarification is requested via amendment. In order to advance prosecution, the examiner suggests amending the claim to recite “and trigger administration of the correction dose of insulin to the patient”.
Claims 8 and 18 recite “administering the determined current meal bolus to the patient by transmitting the determined current meal bolus to the administering system having the patient display, the patient display configured to display the determined current meal bolus.” It is unclear in what way a correction dose is administered to the patient “by transmitting” it to a system configured to “display” the determined dose. Clearly, the artisan would appreciate that administering and displaying are entirely different processes. Clarification is requested via amendment. In order to advance prosecution, the examiner suggests amending the claim to recite “and trigger administration of the correction dose of insulin to the patient”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 8-15, 18-20 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 2, 4, 5-28 US application 17/474,001 (now US Patent 11,733,196). The differences between the inventions defined by the conflicting claims are as follows: Reference claim(s) 1 of the ‘001 application is a species of the genus recited in instant claim(s) 1 of the instant patent application, because the cited reference claim(s) teach all of the limitations of instant claim(s) 1 and 11, plus additional features and/or limitations. Therefore, instant claim(s) 1-5, 8-15, 18-20 is/are anticipated by the narrower claims (i.e. species anticipates the genus).
Claims 1-5, 8-15, 18-20 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-12 of US Patent 9,898,585. The differences between the inventions defined by the conflicting claims are as follows: Reference claim(s) 1 of the ‘585 patent is a species of the genus recited in instant claim(s) 1 of the instant patent application, because the cited reference claim(s) teach all of the limitations of instant claim(s) 1, plus additional features and/or limitations. Therefore, instant claim(s) 1-5, 8-15, 18-20 is/are anticipated by the narrower claims (i.e. species anticipates the genus).
Claims 1-5, 8-15, 18-20 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3, 4, 10, 13, 14 of US Patent 9,897,565. The differences between the inventions defined by the conflicting claims are as follows: Reference claim(s) 1 of the ‘565 patent is a species of the genus recited in instant claim(s) 1 of the instant patent application, because the cited reference claim(s) teach all of the limitations of instant claim(s) 1 and 11, plus additional features and/or limitations. Therefore, instant claim(s) 1-5, 8-15, 18-20 is/are anticipated by the narrower claims (i.e. species anticipates the genus).
Claims 1 and 11 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 of US Patent 10,453,568. The differences between the inventions defined by the conflicting claims are as follows: Reference claim(s) 1 of the ‘568 patent is a species of the genus recited in instant claim(s) 1 of the instant patent application, because the cited reference claim(s) teach all of the limitations of instant claim(s) 1, plus additional features and/or limitations. Therefore, instant claim(s) 1 and 11 is/are anticipated by the narrower claims (i.e. species anticipates the genus).
Response to Arguments
Applicant has not argued the merits of the above double patenting rejections, but has merely stated that a terminal disclaimer in compliance with 37 C.F.R. §1.321(c) will be filed upon resolution of all other issues in this case, if at that time the referenced claims are still co-pending and this rejection has not been withdrawn. Accordingly, absent any illuminating arguments, clarifying amendments, or terminal disclaimers, the above rejections are maintained for reasons of record.
Conclusion
No claims are allowed.
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/PABLO S WHALEY/Primary Examiner, Art Unit 3619