DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The preliminary amendment to the claims filed 13 May 2025 has been entered. Claim(s) 1 is/are currently amended. New claim(s) 2-18 has/have been added. Claim(s) 1-18 is/are pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation ("BRI") using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The BRI of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) (or pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked.
As explained in MPEP § 2181(I), claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(A) the claim limitation uses the term "means" or "step" or a term used as a substitute for "means" that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term "means" or "step" or the generic placeholder is modified by functional language, typically, but not always linked by the transition word "for" (e.g., "means for") or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term "means" or "step" or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word "means" (or "step") in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word "means" (or "step") in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word "means" (or "step") are being interpreted under 35 U.S.C. 112(f), except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word "means" (or "step") are not being interpreted under 35 U.S.C. 112(f), except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word "means," but are nonetheless being interpreted under 35 U.S.C. 112(f) because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: "a communication module" (i.e., module for communication or communicating) in claim(s) 13-18.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f), it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The disclosed corresponding structure is a wired or wireless (e.g., ¶ [0035]) transmitter (e.g., ¶ [0082]).
If Applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f), Applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-18 is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, claim 7, claim 13 and claims dependent thereon, the pending claims are not limited to use with any particular type of user, e.g., collecting the signal data from any particular type of user, or deriving glucose levels from the collected signal data using the identified signal data points as a reference point for the normal physiological level of the glucose for any particular type of user, etc. However, Applicant discloses, "[In] a pre-diabetic person or in a person who has impaired glucose tolerance or non-insulin dependent type 2 diabetes, the blood glucose level corresponds to a normal physiological range during the majority of the day. In contrast, in patients with type 1 diabetes this is not the case. Specifically, in patients with type 1 diabetes, the blood glucose level does not correspond to a normal physiological range during the majority of the day" (¶ [0032]). In view of the above, while Applicant sufficiently discloses how signal data points identified as occurring most frequently to are correlated to a normal physiological level for glucose and glucose levels are derived from the collected data using the identified signal data points as a reference point for the normal physiological level of glucose for "a pre-diabetic person or […] a person who has impaired glucose tolerance or non-insulin dependent type 2 diabetes;" Applicant does not sufficiently disclose how data points identified as most frequently occurring within the time period or a subset thereof are correlated to normal level of glucose, or glucose analyte levels are derived based on said identified signal points for any/all users, which includes patients with type 1 diabetes, such that the scope of each of the above-identified claims is broader than what is sufficiently described in the specification as filed. Therefore, each of the pending claims contain and/or encompass 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.
Double Patenting
The nonstatutory double patenting ("NSDP") rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. A NSDP rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional NSDP rejection provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a NSDP rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-4, 6-10 and 12 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-22 of USPN 10,905,364.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-22 of USPN 10,905,364 recite and/or anticipate each limitation of claims 1-4, 6-10 and 12 of the present application.
Claim(s) 5, 11 and 13-18 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-22 of USPN 10,905,364 in view of US 2011/0027127 A1 (Simpson).
Claims 12-22 of USPN 10,905,364 recite and/or anticipate each limitation of claims 13-16 and 18 of the present application, with the exception of the computer being part of a system further comprising the in vivo positioned sensor; and a communication module communicatively coupled to the one or more memories.
Simpson discloses and/or suggests a system comprising an in vivo positioned sensor (continuous analyte sensor 100 having an in vivo portion, e.g., ¶ [0363]); a communication module (throughout document, sensor electronics, which may include a transmitter (e.g., ¶ [0458]); one or more processors (throughout document, sensor electronics, which may include a processor module, e.g., ¶¶ [0543]-[0543]; and/or processor of receiver for data analysis and/or processing calibration of glucose concentration as described in ¶ [0458], e.g., ¶ [0251] of US 2006/0036142 A1 to Brister); one or more memories communicatively coupled to the one or more processors, the in vivo positioned sensor, and the communication module (throughout document, sensor electronics, which may include processing memory, e.g., ¶¶ [0543]-[0543]; and/or memory of receiver for data analysis and/or processing calibration of glucose concentration as described in ¶ [0458], e.g., ¶ [0251] of Brister).
It would have been obvious to modify the system of claims 12-22 of USPN 10,905,364 to further comprise the in vivo positioned sensor; and a communication module communicatively coupled to one or more memories as disclosed/suggested by Simpson in order to facilitate continuously collecting the required signal data for glucose monitoring (e.g., Simpson, ¶ [0003]).
Claims 1-22 of USPN 10,905,364 (or said claims as modified above) recite and/or suggest each limitation of claims 5, 11 and 17 of the present application with the exception of the in vivo positioned sensor being further configured to collect data corresponding to β-hydroxybutyrate, uric acid, creatinine, or lactate. Simpson discloses the in vivo positioned sensor may be configured to collect data corresponding to multiple analytes (¶ [0437], including glucose and at least one of uric acid, creatinine, or lactate (e.g., ¶ [0029]).
It would have been obvious to modify the system of claims 12-22 of USPN 10,905,364 with the in vivo positioned sensor being further configured to collect data corresponding to β-hydroxybutyrate, uric acid, creatinine, or lactate as disclosed/suggested by Simpson in order to allow for improved accuracy in the measurement of glucose, allow for detection of certain conditions that can affect sensor accuracy, etc. (Simpson, ¶ [0437]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791
