DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-19 and 23 are under examination.
Information Disclosure Statement
2. Entries in the information disclosure statement filed October 10, 2023, fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the entry has an incorrect document number (see items 191 and 192) or does not have a publication date (see item 173). It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Rejections - 35 USC § 112
3. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 and 7 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 term “substantially real time” in claim 2 is a relative term which renders the claim indefinite. The term “substantially real time” 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.
Claim 7 recites the limitation "the measurements tagged as ‘Other’". This term was not mentioned previously in the instant claim or in the claim from which it depends (claims 8 and 1). There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
4. 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 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.
5. Claim 1-12 and 23 are rejected under 35 U.S.C. 103(a) as being unpatentable over Worthington et al. (US 5,822,715) in view of Heller et al. (US 6,560,471) in view of Miller et al. (US Registration No. H2246 H).
Regarding claims 1, 12, and 23, Worthington, et al. teaches a method for treating diabetes mellitus that includes the steps of storing one or more components of the patient’s insulin dosage regimen (abstract, column 4, column 5, lines 60-67); drawing blood samples from the patient at a plurality of times (column 4, lines 21-32; column 9, lines 17-26); ascertaining the patient’s blood glucose-level measurements in the blood samples (column 9, lines 11-32); establishing the patient’s current blood glucose-level measurements relative to a desired glycemic range (column 4); determining from the patient’s blood-glucose level measurements whether and by how much to adjust at the at least one or more components of the patient’s present insulin dosage regimen to stay within said glycemic range and administer the lowest insulin dosage (column 4, column 5, lines 60-67); adjusting the at least one component in accordance to the determination (column 14, lines 1-18); performing the steps of the method until the insulin dosage regimen required to stay within the desired glycemic range is lowered to a predetermined level (column 4).
Worthington, et al. does not teach tagging measurements with identifiers reflective of when the measurements were obtained.
Heller et al. teaches storing event markers with data of a particular event which are generated automatically or through input by the patient, (column 59, lines 36-42) and storing the drug (column 61, lines 15-60).
While Worthington et al. and Heller et al. teach adjustments of insulin regimen and glucose thresholds over time, (Worthington, column 3, lines 54-64; Heller, columns 51-52), they do not expressly teach dampens or prevents unstable oscillations, and the regimen continues to decrease as the oscillations are reduced.
Miller et al. teaches a method of predicting the effectiveness of medication-based therapy in lowering average blood glucose levels and recommending a therapy on the basis of the arithmetic average of the relative minima, (abstract). Miller et al. shows the decrease of glucose oscillations over time, and the predictability of treatment effectiveness based on the amplitudes of the oscillations, suggesting that as oscillations decrease treatment decreases, (columns 3-5).
Regarding claim 2, Heller et al. teach where the adjustment to the patient’s insulin dosage regimen is performed in real time (column 61, lines 15-60; column 62, lines 33-40).
Regarding claim 3, Heller et al. teach where the insulin dosage regimen is provided by a physician or other healthcare professional (column 50, lines 12-24; column 61, lines 45-61)
Regarding claim 4, Heller et al. teach where the method is performed without any intervention from a doctor or healthcare professional (column 61, lines 45-61).
Regarding claim 5, Worthington et al. teach where the desired glycemic range changes over time and the adjustment to the patient’s insulin dosage regimen is to get within the desired glycemic range (column 11, lines 30-40).
Regarding claim 6, Heller et al. teach generating identifiers for particular events (column 59, lines 36-42). Worthington et al. teach that insulin is taken before breakfast and bedtime (column 2, lines 27-38). One of ordinary skill in art would expect that the particular events of Heller et al. may be meals as described by Worthington et al.
Regarding claim 7, Worthington et al. teach taking previous measurements and the elapsed time (column 9, lines 1-33).
Regarding claim 8, Worthington et al. teach where the glycemic range is between 85 mg/dL and 200 mg/dL (column 10, lines 5-15).
Regarding claim 9, Worthington et al. teach where the method achieves durable glycemic balance (column 13, lines 50-57).
Regarding claim 10, Worthington et al. teach where the dosage is adjusted to include a high dose (column 14, lines 1-17).
Regarding claim 11, Worthington et al. teach where the insulin dosage regime is adjusted such that insulin is no longer administered (column 14, lines 19-35).
It would have been obvious to one of ordinary skill in the art at the time of filing to combine Heller et al. with Worthington et al., because each of the elements are known in the art and the art is in the same technology, i.e. are systems for controlling blood glucose and combinable. One of ordinary skill would have recognized that the results of the combination were predictable, because Worthington et al. predicts future blood glucose values based on measured glucose values, and corrective actions if said values are outside a range, (abstract) and Heller et al. measures a level of analyte, i.e. blood glucose, and a delivery system to help alter the level of analyte based on the measured analyte, (abstract), thus all use methods to analyze blood glucose and provide a means of altering said glucose and are combinable.
It would have been obvious to one of ordinary skill in the art at the time of filing to combine Miller et al. with Worthington et al. and Heller et al., because each of the elements are known in the art and the art is in the same technology, i.e. are methods for analyzing blood glucose are combinable. One of ordinary skill would have recognized that the results of the combination were predictable, because Worthington et al. predicts future blood glucose values based on measured glucose values, and corrective actions if said values are outside a range, (abstract), Heller et al. measures a level of analyte, i.e. blood glucose, and a delivery system to help alter the level of analyte based on the measured analyte, (abstract), and Miller et al. predicts the effectiveness of medication-based therapy in lowering blood glucose levels by monitoring the oscillation patterns of blood glucose over time, (abstract) thus all use methods to analyze blood glucose and are combinable.
Double Patenting
6. 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
7. Claims 1-19 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9,220,456. Although the claims at issue are not identical, they are not patentably distinct from each other. The U.S. Patent requires the limitations of the instant claims with additional limitations. Thus, the subject matter of the instant claims encompasses the subject matter of the U.S. Patent, and they are not patentably distinct.
8. Claims 1-19 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,624,577. Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims requires the limitations of the U.S. Patent with additional limitations. Thus, the subject matter of the U.S. Patent encompasses the subject matter of the instant claims, and they are not patentably distinct.
9. Claims 1-19 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 8,457,901. Although the claims at issue are not identical, they are not patentably distinct from each other. The U.S. Patent requires the limitations of the instant claims with additional limitations. Thus, the subject matter of the instant claims encompasses the subject matter of the U.S. Patent, and they are not patentably distinct.
10. Claims 1-19 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 8,600,682. Although the claims at issue are not identical, they are not patentably distinct from each other. The U.S. Patent requires the limitations of the instant claims with additional limitations. Thus, the subject matter of the instant claims encompasses the subject matter of the U.S. Patent, and they are not patentably distinct.
11. Claims 1-19 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No.11,723,592. Although the claims at issue are not identical, they are not patentably distinct from each other. The U.S. Patent requires the limitations of the instant claims with additional limitations. Thus, the subject matter of the instant claims encompasses the subject matter of the U.S. Patent, and they are not patentably distinct.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JERRY LIN whose telephone number is (571)272-2561. The examiner can normally be reached T-F 7am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise can be reached at (571) 272-2249. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JERRY LIN/Primary Examiner, Art Unit 1685
Prosecution Insights