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 09/24/2025, 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 Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn.
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.
Withdrawn Rejections
The rejection of claims 1-5, 8-15, 18-20 under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement is withdrawn in view of applicant’s amendments.
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.
Amended claims 1 and 11 recite “identifying which 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, wherein each pre-configured range of glucose measurement values is associated with a respective pre-configured adjustment factor.” In this case, the identifying step is not associated with any particular acts or operations and broadly encompasses looking at data. A review of the specification does not describe, to any appreciable extent, any computational process that corresponds to the function of the claimed “identifying”. The specification does disclose a “calculation blocks” and a ‘logic flow’ diagram and describes “calculating” an adjustment factor based upon current blood glucose levels [Figure 7, 0025, 0066-0067]. However, this is not commensurate in scope with what is being claimed and 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.
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 “based on receiving the current pre-breakfast glucose measurement: retrieving…a basal dose distribution for the patient representing how a basal dose of insulin is to be administered to the patient.” In this case, it is unclear what limiting effect is intended by the phrase “representing how a basal dose of insulin is to be administered to the patient”. In other words, while the artisan would recognize that information relating to a “base dose distribution” is being “retrieved”, the above phrase is confusingly referencing information directed to “future intended use” that has not been previously obtained or determined and thus does not impose any limiting effect on the nature or type of dose distribution data. It is noted that the specification [Figure 6] does show a recommended basal dose (to be administered to a patient). However, this occurs after a new base dose has been calculated and therefore is clearly different from what is presently claimed. Clarification is requested via amendment.
Claims 1 and 11 recite “identifying which 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, wherein each pre-configured range of glucose measurement values is associated with a respective pre-configured adjustment factor.” Firstly, it is unclear what limiting effect is intended by said “identifying” such that the artisan would recognize what computational limitations is/are intended, i.e. this limitation reads on simply “looking” at data. Secondly, it is unclear what limiting effect is intended by the claimed “wherein” clause. In other words, it is unclear in what way the measurement values are “associated” with the adjustment factor and how the adjustment factor being calculated (if they are indeed being calculated). 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 explicitly calculating the adjustment factor using “if-else” type block calculations [0066, Figure 7, Figure 6]. However, this is not commensurate in scope with what is being claimed and 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 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 consistent with the specification.
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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PABLO S WHALEY whose telephone number is (571)272-4425. The examiner can normally be reached between 1pm-9pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anita Coope can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PABLO S WHALEY/Primary Examiner, Art Unit 3619
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