DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed before March 16, 2013, is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment and Request for Continued Examination (RCE) filed on 12/12/25 have been entered in the case. Claims 1-2, 4-6, 11-12, 14-16, 21-23, 25-28 are pending for examination and claims 3, 7-10, 13, 17-20 & 24 are cancelled.
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 1-2, 4-6, 11-12, 14-16, 21-23, 25-28 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.
Nowhere in the original specification has described that limitation that: at least one process configured to: receive travel information of the user including a travel destination for the user prior to the user traveling to the travel destination, as recited in the claims 1 & 11.
The para [0097] of the original specification states that the user interface 1415 may include one or more keys or buttons for the user to enter the time change information. Having said that, it does not mean that the process receives the travel information before/prior to the user travelling to the travel destination.
PNG
media_image1.png
306
446
media_image1.png
Greyscale
The para [0098] of the original specification states below that the change in time zones the travel will involve. However, the para [0098] does not mention that the process receives the travel information before/prior to the user travelling to the travel destination, as recited in the claimed invention.
PNG
media_image2.png
214
466
media_image2.png
Greyscale
Based on the statement in para [0098] above, the time module is shifted in time of a destination time when the user is present at the new destination. It does not say that the time is being changed (at home place) before the user travelling to a new destination.
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 1-2, 4-6, 11-12, 14-16, 21-23, 25-28 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 limitation “at least one process configured to: receive travel information of the user including a travel destination for the user prior to the user traveling to the travel destination, as recited in the claims 1 & 11, is unclear. Based on the para [0098] of the current application above, it states that: the time module shifts the delivery pattern of basal insulin in time according to a destination time zone indicated in the travel information. When the process receives the travel information of user before the user traveling to the travel destination, at this time, the user still at home location, but the time is to be changed to new local time at travel destination, and the delivery pattern of basal insulin is shifted based on time change while the user is still at home time. By doing so, it will mess up the insulin delivery and will create more issue to the user. A person skilled in the art would not shift the delivery insulin pattern (when time change to match with travel destination) while the patient is still at home with home-local time. It will create either hypoglycemic or hyperglycemic to the patient.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4-6, 11-12, 14-16, 21-23, 25-28 are rejected under pre-AIA 35 U.S.C. 102 (e) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over by Estes et al. (US 7,717,903).
Regarding claim 1, Estes discloses an ambulatory infusion pump system 10, in Figs. 1-18, comprising:
a pump mechanism 100 configured to deliver insulin to a patient;
a memory (inside the control circuit 240, col. 17, lines 40-555) configured to store a delivery pattern of basal insulin that varies a basal rate of insulin delivered to a user according to a time of day (col. 18, lines 1-10); and
at least one processor 243 configured to:
cause the pump mechanism 100 to deliver insulin to the user according to the delivery pattern of basal insulin by the time of day, see Fig. 15, col. 20, line 30-col. 21, line 22;
receive travel information of the user including a travel destination for the user prior to the user traveling to the travel destination (e.g., the user can anticipate a time change and can initiate a dosing schedule adaptation prior to the time change. For example, the user may be preparing for a trip to a different time zone and can initiate a change in the dosing schedule prior to departing on the trip, col. 23, lines 17-21);
Note: the change in time zone is interpreted as a travel destination for the user. For example: travelling from East to West region in United States or traveling from one country to another country that considered as change in time zone. One skilled in the art would recognize that the time zone is changed when the user travels to a new region destination.
determine time change information indicating a change to the time of day based on a time zone of the travel destination, see Fig. 16, col. 22, lines 23-37; and
cause a shift in the delivery pattern of basal insulin in time based on the time change information (e.g., the external reference system 230 can be implemented to automatically adjust the dosing schedule in the case of a time change to the new time zone, col. 22, lines 22-37).
Regarding claim 2, wherein the time change information relates to a change in time zone, Fig. 16, col. 22, lines 23-37.
Regarding claim 4, wherein shifting the delivery pattern of basal insulin in time includes shifting the pattern by a plurality of time increments (e.g., the dosing rate is gradually adjusted based on the time change. For example, the dosing schedule is shifted X minutes per hours until the dosing schedule corresponds with the new time. The value X increases based on the time change, col. 22, lines 55-63).
Regarding claim 5, wherein shifting the pattern by a plurality of time increments includes shifting by one increment after a predetermined period of time in X mins/hour (e.g., the dosing schedule is shifted X minutes per hours until the dosing schedule corresponds with the new time. The value X increases based on the time change, col. 22, lines 55-63; For example: a significant time change occurs when the time is shifted by at least a threshold amount, e.g., greater than 15mins, greater than 30mins or 1hour. A time change due to daylight savings time and/or a time change due to a transition between time zones, col. 23, lines 30-36).
Regarding claim 6, wherein shifting by one increment after a predetermined period of time includes shifting by one increment per day (e.g., the dosing schedule is shifted X minutes per hours until the dosing schedule corresponds with the new time. The value X increases based on the time change, col. 22, lines 55-63. For example: a significant time change occurs when the time is shifted by at least a threshold amount, e.g., greater than 15mins, greater than 30mins or 1hour. A time change due to daylight savings time and/or a time change due to a transition between time zones, col. 23, lines 30-36).
Regarding claim 11, Estes discloses an ambulatory infusion pump system 10, in Figs. 1-18, comprising:
a pump mechanism 100 configured to deliver insulin to a patient;
a memory (inside the control circuit 240, col. 17, lines 40-555) configured to store a delivery pattern of basal insulin that varies a basal rate of insulin delivered to a user according to a time of day (col. 18, lines 1-10); and
at least one processor 243 configured to:
cause the pump mechanism 100 to deliver insulin to the user according to the delivery pattern of basal insulin by the time of day, see Fig. 15, col. 20, line 30-col. 21, line 22;
receive travel information of the user including a travel destination for the user prior to the user traveling to the travel destination (e.g., the user can anticipate a time change and can initiate a dosing schedule adaptation prior to the time change. For example, the user may be preparing for a trip to a different time zone and can initiate a change in the dosing schedule prior to departing on the trip, col. 23, lines 17-21)
Note: the change in time zone is interpreted as a travel destination for the user. For example: travelling from East to West region in United States or traveling from one country to another country that considered as change in time zone. One skilled in the art would recognize that the time zone is changed when the user travels to a new region destination.
determine time change information indicating a change to the time of day based on a time zone of the travel destination, see Fig. 16, col. 22, lines 23-37; and
incrementally shift the delivery pattern of basal insulin in time to match the local time for the user (e.g., the external reference system 230 can be implemented to automatically adjust the dosing schedule in the case of a time change to the new time zone, col. 22, lines 22-37; the dosing schedule, which is controlled by the controller device 2000, is incrementally shifted to adjust the time change. For example, the dosing schedule is shifted X mins/hour until the dosing schedule corresponds with the new time. The value X increases based on the time change, col. 22, lines 55-62. For example: a significant time change occurs when the time is shifted by at least a threshold amount (e.g., greater than about 15 minutes, greater than about 30 minutes, and about 1 hour). Exemplary significant time changes include, but are not limited to, … a time change due to a transition between time zones, col. 23, lines 30-36).
Regarding claim 12, wherein the time change information relates to a change in time zone, Fig. 16, col. 22, lines 23-37.
Regarding claim 14, wherein incrementally shifting the delivery pattern of basal insulin in time includes shifting the pattern by a plurality of time increments until the pattern matches the local time (e.g., the dosing rate is gradually adjusted based on the time change. For example, the dosing schedule is shifted X minutes per hours until the dosing schedule corresponds with the new time. The value X increases based on the time change, col. 22, lines 55-63).
Regarding claim 15, wherein shifting the pattern by a plurality of time increments includes shifting by one increment after a predetermined period of time in X mins/hour (e.g., the dosing schedule is shifted X minutes per hours until the dosing schedule corresponds with the new time. The value X increases based on the time change, col. 22, lines 55-63; For example: a significant time change occurs when the time is shifted by at least a threshold amount, e.g., greater than 15mins, greater than 30mins or 1hour. A time change due to daylight savings time and/or a time change due to a transition between time zones, col. 23, lines 30-36).
Regarding claim 16, wherein shifting by one increment after a predetermined period of time includes shifting by one increment per day (e.g., the dosing schedule is shifted X minutes per hours until the dosing schedule corresponds with the new time. The value X increases based on the time change, col. 22, lines 55-63. For example: a significant time change occurs when the time is shifted by at least a threshold amount, e.g., greater than 15mins, greater than 30mins or 1hour. A time change due to daylight savings time and/or a time change due to a transition between time zones, col. 23, lines 30-36).
Regarding claim 21, wherein the travel information further includes a schedule travel departure time and a schedule travel return time (as mentioned in the claims 1 & 11 above, the user can anticipate a time change and can initiate a dosing schedule adaptation prior to the time change. For example, the user may be preparing for a trip to a different time zone and can initiate a change in the dosing schedule prior to departing on the trip, col. 23, lines 17-21. Estes further states that: in some instances, the time zone change may be for a brief time period, such as when a user travels out of his/her home time zone for a brief period and then returns, col. 22, lines 32-35. Therefore, a person skilled in the art would recognize that the process is configured to receive travel information (via manual input from the user) to set up any time such as schedule travel departure time or schedule travel return time).
Regarding claims 22 & 26-27, wherein the at least one processor is further configured to shift the delivery pattern based on one or more of the travel departure times (e.g., external reference system 230 is be implemented to automatically adjust the dosing schedule in the case of a time change, col. 22, lines 23-25; the dosing rate is gradually adjusted based on the time change…, col. 22,lines 55-65; the dosing schedule, which is controlled by the controller device 220, may adjust to conform to the new time zone by making a step-shift…, col. 23, lines 7-12, also see col. 23, line 24-col. 24, line 6).
With aspect to the limitation, i.e., the processor is configured to shift the delivery pattern based on the travel return time, (as required in claims 22 & 27), and the limitation, i.e. the travel information includes a travel return time, (as required in claim 26), as discussed the above, the processor is configured to adjust the dosing schedule based on the time change; therefore, a person skilled in the art would recognize that when the user travels back to home base, the external reference system will update the local time, and therefore, the processor is configured to shift the delivery schedule/pattern based on the local time at home base (or travel return time).
Regarding claim 23, further comprising a user interface, and wherein the at least one processor is configured to receive the travel information through the user interface (via display update time on display 622, see Fig. 18).
Regarding claim 25, Estes discloses all claimed subject matter as required in claims 11 & 24, Estes further discloses that wherein the at least one processor is configured to determine the destination time zone based on the travel destination, see block 1606 in Fig. 16; col. 22, lines 23-25; col. 23, lines 34-42; col. 25, lines 27-37.
Regarding claim 28, Estes discloses all claimed subject matter as required in claim 11. Estes further discloses that comprising a user interface 622, and wherein the at least one processor is configured to receive the travel information (time/date signal) through the user interface 622, in Fig. 18.
Claims 1-2, 4-6, 11-12, 14-16, 21-23, 25-28 are rejected under pre-AIA 35 U.S.C. 102 (b) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over by Schnell (US 2002/0147135).
Regarding claims 1-2, Schnell discloses an ambulatory infusion pump system, in Figs. 1-3, comprising:
a pump mechanism (insulin metering device inside an insulin pump, para [0031]) configured to deliver insulin to a patient;
a memory configured to store a delivery pattern of basal insulin that varies a basal rate of insulin delivered to a user according to a time of day (para [0031], a continuous application of insulin according to a programmed basal rate. Therefore, the system is inherently including a memory is used for storing a delivery pattern of basal insulin, as required in the claimed invention);
at least one processor configured to:
cause the pump mechanism to deliver insulin to the user according to the delivery pattern of basal insulin by the time of day, para [0031];
receive travel information of the user including a travel destination for the user prior to the user traveling to the travel destination, see S3 in Fig. 3, para [0027], also see #1a) in Appendix 1-3, pages 7-18;
determine time change information indicating a change to the time of day based on a time zone of the travel destination, see S4-S5 in Fig. 3, paras [0025-0027], also see #1a) in Appendix 1-3, pages 7-18;
cause a shift in the delivery pattern of basal insulin in time based on the time change information, see S6 & S7 in Fig. 3, para [0031-0032] & see Appendix 1-3 on pages 7-18;
Note: the device 100 includes input, i.e. keyboard, for entering the departure time and arrival time (the clock time is changed), the device 100 determines a modified travel treatment plan for adapting the therapy to the time changeover caused by the long-haul journey, para [0019]. The insulin pump is an electronic handheld device, wherein the insulin pump is based on a continuous application of insulin according to a programmed basal rate that depending on the time or travel treatment plan as stated in paras [0031-0032]. Therefore, a person skilled in the art would recognize that the insulin pump includes the feature above, as provided in the device 100.
In addition, the device 100/200 is provided a processor and storage device such as a mobile telephone, or a sugar concentration measuring device, or a network system of computers, para [0005]. The insulin pump is an electronic handheld device and having processor and storage device, therefore, the insulin pump is equivalent to a mobile telephone, or one of the computers in the network system. Therefore, a person skilled in the art would recognize that the insulin pump includes the feature above, as provided in the device 100/200. Assuming that the device 100/200 is separate unit with the insulin pump; however, the processor in the device 100/200 in a part of the infusion pump system. Therefore, the processor in the device 100/200 is configured to perform functions as required in the claimed invention.
Regarding claims 4-6, wherein shifting the delivery pattern of basal insulin in time includes shifting the pattern by a plurality of time increments; wherein shifting the pattern by a plurality of time increments includes shifting by one increment after a predetermined period of time; wherein shifting by one increment after a predetermined period of time includes shifting by one increment per day, paras [0031-0032], also see #3 (proposed treatment drawn up by way of set of rules in the Appendix 1-3, on pages 8,12-14, 16-18). For example: see #4-#11 on page 8; #36-47 on pages 13-14; #36-47 on pages 17-18.
Regarding claim 11-12, 14-16, these claims are being rejected with using same analysis in the noted above with regard to claims 1-2, 4-6.
Regarding claims 21 & 26, wherein the travel information further includes a schedule travel depart time and a schedule travel return time, para [0013, 0020, 0027]. Note: the schedule travel return time is interpreted that when the user is located at a travel destination, the user enters (via keypad input) the travel date (from the travel location) to home location (as travel time of returning home).
Regarding claims 22 & 27, wherein the at least one processor is further configured to shift the delivery pattern based on one or more of travel departure time and the travel return time, paras [0031-0032].
Regarding claims 23 & 28, wherein the infusion pump system further comprising a user interface (via keypad input), and wherein the at least processor is configured to receive the information through the user interface (by storage in the memory or in the programmed basal rate based on the time of the day).
Regarding claim 25, wherein the at least one processor is configured to determine the destination time zone based on the travel destination, see S4 in Fig. 3.
Response to Arguments
Applicant's arguments filed 12/22/25 have been fully considered but they are not persuasive.
1) Applicant states that: a “travel destination” and a “time zone of the travel destination” are two different things. A time zone cannot consider a “destination”.
In response, the current application relates to shift a delivery pattern of the device in time change to a new local destination when travelling. Therefore, it is very common sense that traveling from one location to another destination, for example, travelling from East to West region in United States or traveling from one country to another country that considered as change in time zone in new region destination.
2) Applicant further states that: a travel destination is a PLACE. One of example of the processor receiving “travel information including a travel destination of user” would be the processor interfacing with an airline application on the user’s phone.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the processor interfacing with an airline application on the user’s phone) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In this case, the claim requires that: the processor is configured to receive travel information of the user including a travel destination for the user prior to the user traveling to the travel destination. Having said in the limitation above, it does not mean that the processor interfacing with an airline application on the user’s phone.
3) Applicant argues that the references never receive any information that includes a place to which the user is travelling.
In response, Estes discloses that: the user can anticipate a time change and can initiate a dosing schedule adaptation prior to the time change. For example: the user maybe preparing for a trip to a different time zone and can initiate a change in the dosing schedule prior to departing on the trip, col. 23, lines 17-22. It is noted that the term “departing on the trip” in the statement above is equivalent to a travel destination (as required in the claims 1 & 11). Estes further states: … In other instances, a user may travel between time zones, where the time change can be several hours or even an entire day. The external reference system 230 can alert the user to such time changes and assist the user in adapting the dosing schedule to the new time zone. In some instances, the time zone change may be for a brief time period, such as when a user travels out of his/her home time zone for a brief period and then returns. In such a case, the user may instruct the insulin pump system 10 to function as normal, without adjusting the dosing rate to the new time zone. See col. 22, lines 28-37.
Having said in the statements above, a person skill in the art would recognize that changing new time zone that is considered as travelling to a new place or new destination in different time zone region.
4) Applicant argues that nothing has been cited in Estes that receiving a location itself (e.g., California or London) prior to a user traveling to that destination as claimed.
In response, the claimed invention does not require the very specifically location, such as California or London, for a travel destination. The claim only broadly requires that: … receive travel information of the user including a travel destination…
In this case, Estes clearly states that: the external reference system 230 can be implemented to automatically adjust the dosing schedule in the case of a time change, … a user travels between time zones, wherein the time change can be several hours or even an entire day, col. 22, lines 23-30; see blocks 1604 & 1606 in Fig. 16. In addition, the external reference system 230 receives a GPS clock signal that transmitted from a GPS satellite 235 or other satellite, col. 21, lines 1-10; time change due to a transition between time zones, col. 23, lines 35-36. Therefore, a person skilled in the art would recognize that the processor is inherently/obviously receiving travel information of the user including a travel destination via changing new time at destination place via GPS clock signal and GPS satellite.
If the system in Estes does not include a function of receiving any travel information of a user including a travel destination or a destination time zone, as indicated by Applicant’s statement above, in that case, there is no reason for the system in Estes to update the new travel time zone and to change or shift the delivery schedule/pattern.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783