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
Applicant’s election without traverse of Invention I and Species I in the reply filed on 05/07/2026 is acknowledged.
Claims 6 & 8-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/07/2026.
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.
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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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 as follows.
“medicament delivery system” in Claim 1, where the generic placeholder is system, the functional language is “medicament delivery” or “configured to deliver a medicament to a user”, and sufficient modifying structure is not provided; instant application Paragraph 0021 describes a medicament delivery system as an insulin pump, providing sufficient modifying structure
“delivery device control system” in Claim 1, where the generic placeholder is system, the functional language is “delivery device control” or “configured to… control the medicament delivery system”, and sufficient modifying structure is not provided; the instant application fails to provide sufficient modifying structure
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (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) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-5 & 7 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.
As to Claim 1, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims a delivery device control system which controls the medicament delivery system. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately explain what the delivery device control system is or how the delivery device control system is capable of controlling the medicament delivery system.
The original disclosure only states the delivery device control system may be comprised of engines, and interact with electronic devices and signals. However, no structure is provided for any of the engines either, and simply interacting with electronic devices does not inherently make the delivery device control system a controller. As such, one of ordinary skill in the art would not be able to inherently determine the structure of the delivery device control system or how the delivery device control system is capable of controlling the medicament delivery system.
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 1-5 & 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.
As to Claim 1, the limitation “a delivery device control system configured to: control the medicament delivery system…”, in Lines 4-11, is indefinite. As described in the 112(a) rejection above, the term “delivery device control system” lacks sufficient written description. As such, it is not clear what the delivery device control system is comprised of or how the delivery device control system is capable of controlling the medicament delivery system to perform the functions described in Claim 1, rendering the claim indefinite.
As to Claim 2, the limitation “the delivery device control system is further configured to control the medicament delivery system to automatically suspend delivery of the medicament to the user based on the first sensor data indicating performance of an activity by the user”, in Lines 1-4, is indefinite. It is not clear if the function in Lines 1-4 is the same function as described in Claim 1, Lines 8-9, or if the two respective functions are different functions. The function in Lines 1-4 is very similar to the function in Claim 1, except the function in Lines 1-4 appears to further limit the function of Claim 1 to be an activity. As such, one of ordinary skill in the art would conclude the two functions are the same function. However, the function in Lines 1-4 is also written in a manner which would lead one of ordinary skill in the art to determine the function is a new function, separate from the function in Claim 1. If the two functions are separate, the original disclosure does not adequately describe how the two functions are different. For the purpose of examination, the function in Lines 1-4 will be interpreted as the same function as in Claim 1, Lines 8-9, where the function in Claim 1 is further limited in Claim 2.
The limitation “to automatically resume delivery of the medicament to the user based on the second sensor data indicating that performance of the activity is completed”, in Lines 4-5, is indefinite. It is not clear if the function in Lines 4-5 is the same function as described in Claim 1, Lines 10-11, or if the two respective functions are different functions. The function in Lines 4-5 is very similar to the function in Claim 1, except the function in Lines 4-5 appears to further limit the function of Claim 1 to be an activity. As such, one of ordinary skill in the art would conclude the two functions are the same function. However, the function in Lines 4-5 is also written in a manner which would lead one of ordinary skill in the art to determine the function is a new function, separate from the function in Claim 1. If the two functions are separate, the original disclosure does not adequately describe how the two functions are different. For the purpose of examination, the function in Lines 4-5 will be interpreted as the same function as in Claim 1, Lines 10-11, where the function in Claim 1 is further limited in Claim 2.
As to Claim 3, the limitation “the delivery device control system is further configured to control the medicament delivery system to automatically suspend delivery of the medicament to the user based on the first sensor data indicating that the user is at a location”, in Lines 1-3, is indefinite. It is not clear if the function in Lines 1-3 is the same function as described in Claim 1, Lines 8-9, or if the two respective functions are different functions. The function in Lines 1-3 is very similar to the function in Claim 1, except the function in Lines 1-4 appears to further limit the function of Claim 1 to be a location. As such, one of ordinary skill in the art would conclude the two functions are the same function. However, the function in Lines 1-3 is also written in a manner which would lead one of ordinary skill in the art to determine the function is a new function, separate from the function in Claim 1. If the two functions are separate, the original disclosure does not adequately describe how the two functions are different. For the purpose of examination, the function in Lines 1-3 will be interpreted as the same function as in Claim 1, Lines 8-9, where the function in Claim 1 is further limited in Claim 2.
The limitation “to automatically resume delivery of the medicament to the user based on second sensor data indicating that the user is at a subsequent location”, in Lines 4-5, is indefinite. It is not clear if the function in Lines 4-5 is the same function as described in Claim 1, Lines 10-11, or if the two respective functions are different functions. The function in Lines 4-5 is very similar to the function in Claim 1, except the function in Lines 4-5 appears to further limit the function of Claim 1 to be a location. As such, one of ordinary skill in the art would conclude the two functions are the same function. However, the function in Lines 4-5 is also written in a manner which would lead one of ordinary skill in the art to determine the function is a new function, separate from the function in Claim 1. If the two functions are separate, the original disclosure does not adequately describe how the two functions are different. For the purpose of examination, the function in Lines 4-5 will be interpreted as the same function as in Claim 1, Lines 10-11, where the function in Claim 1 is further limited in Claim 2.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosinko (U.S. PGPub 2021/0093781).
As to Claim 1, Rosinko teaches a system (Figure 16) comprising:
one or more sensors (1603/1605/3424);
a medicament delivery system (212) configured to deliver a medicament to a user (Paragraphs 0067/0073); and
a delivery device control system (202c) configured to:
control the medicament delivery system to suspend delivery of the medicament to the user responsive to a request (2702; see Figure 27) initiated by the user (Paragraph 0300), and to automatically resume delivery of the medicament to the user (2712; see Figure 27) after (as shown in Figure 27) a suspension time period has lapsed (2706; see Figure 27); and
control the medicament delivery system to automatically suspend delivery of the medicament to the user (3509; see Figure 35) based on first sensor data (3504) obtained from (Paragraphs 0419/0420/0422/0430) the one or more sensors (1603/1605/3424), and to automatically resume delivery of the medicament to the user (3518; see Figure 35) based on second sensor data (3516) obtained from (Paragraphs 0419/0420/0422/0430/0433) the one or more sensors (1603/1605/3424).
As to Claim 2, Rosinko teaches all the limitations of Claim 1, and continues to teach the delivery device control system is further configured to control the medicament delivery system to automatically suspend delivery of the medicament to the user (3509; see Figure 35) based on the first sensor data (3504) indicating performance of an activity by the user (Paragraph 0415, where being at a location –site location of medicament delivery-- is broadly interpreted as an activity), and to automatically resume delivery of the medicament to the user (3518; see Figure 35) based on the second sensor data (3516) indicating that performance of the activity is completed (Paragraph 0297, where location –location-based resumption—is a new location, indicating the being at the first location is completed).
As to Claim 3, Rosinko teaches all the limitations of Claim 1, and continues to teach the delivery device control system is further configured to control the medicament delivery system to automatically suspend delivery of the medicament to the user (3509; see Figure 35) based on the first sensor data (3504) indicating that the user is at a location (Paragraph 0415; “site location of medicament delivery”), and to automatically resume delivery of the medicament to the user (3518; see Figure 35) based on second sensor data (3516) indicating that the user is at a subsequent location (Paragraph 0297, where location –location-based resumption—is a new location).
As to Claim 4, Rosinko teaches all the limitations of Claim 1, and continues to teach an analyte monitoring device (110) that is connected to (Paragraph 0073) the medicament delivery system (212) to form a closed loop system (as shown in Figure 35, and described in Paragraphs 0297/0415, which does not rely on user interaction). The limitation was interpreted in light of instant application Paragraph 0063 which defines a closed loop system as “the combination of devices is configured to provide automatic suspension and resumption of medicament delivery in a way that eliminates or reduces user interaction involved with removing the medicament delivery system 106 temporarily, such as to bathe or participate in a physical activity, e.g., basketball.”
As to Claim 5, Rosinko teaches all the limitations of Claims 1 & 4, and continues to teach the analyte monitoring device comprises (110) a wearable glucose monitoring device (Element 110 is described as a glucose level sensor), and wherein the medicament delivery system (212) comprises a wearable (as shown in Figure 1B) insulin pump (Element 212 is described as a pump).
Claim Rejections - 35 USC § 103
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Rosinko.
As to Claim 7, Rosinko teaches all the limitations of Claims 1 & 4, but does not teach the delivery device control system is implemented at the analyte monitoring device.
Additionally, it appears the only difference between Rosinko and the instant application is the delivery device control system position with respect to the analyte monitoring device. This is merely a rearrangement of parts (see MPEP 2144.04(VI)(C)), since shifting the position of the delivery device control system with respect to the analyte monitoring device will not modify the operation of the device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Constantin (2019/0246914) describes a similar system with operation based on location and activity detection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
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