DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The examiner acknowledges the reply filed on 12/03/2025 in which claim 1, was amended. Claims 16-20 are previously withdrawn. Currently, claims 1-15 are pending for examination in this application.
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1 and 3-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lav et al. (USPN 6,302,855), in view of Rasdal et al. (PGPub 2005/0154271).
[Claim 1] Lav teaches an integrated system for treating diabetes (figure 9), the integrated system comprising:
a first medicament injection pen (figure 9, item 80) configured to deliver short-acting insulin to a host (column 6, lines 3-7), wherein a dose of the short-acting insulin is determined based at least in part on glucose data obtained from a glucose sensor worn by the host (the examiner notes that the “insulin” is only recited functionally; thus, this is not considered to be a positively recited claim limitation); and
a second medicament injection pen (figure 9, item 90) configured to deliver long-acting insulin to the host (column 6, lines 3-7) (again, the examiner notes the recited “insulin” is not a positively recited claim limitation).
Although disclosing a single point glucose monitor (figure 9, item 30) that is configured to measure glucose of a host (column 3, lines 54-57), Lav does not specifically disclose a glucose sensor configured to be worn by a host.
However, Rasdal teaches an integrated system (figure 1) to treat diabetes which utilizes information from both a single point glucose monitor (figure 1, item 14) and a glucose sensor (“continuous glucose sensor”) (figure 1, item 10) configured to be worn by a host (figure 1; paragraphs [0098], [0102]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the structure taught by Lav, to have utilized a glucose sensor, as taught by Rasdal, in order to provide increased functionality, versatility, and control, by allowing for a means by which continuous glucose measurements might be obtained, as well as utilizing the single point glucose monitor as a secondary verification and calibration means (Rasdal; figure 1; Abstract; paragraph [0006]).
[Claims 3, 4, and 7] Lav and Rasdal teach the limitations of claim 1, upon which claims 3, 4, and 7, depend. In addition, Lav discloses the first medicament injection pen (figure 9, item 80) comprises
a housing that includes a display screen (figure 9, item 84);
wherein the display screen (figure 9, item 84) of the first medicament injection pen (figure 9, item 80) is configured to display a representation of the dose of short-acting insulin (column 5, lines 28-30); and
wherein the housing of the first medicament injection pen (figure 9, item 80) further comprises a button (figure 9, item 85) to toggle through information displayed by the display screen (figure 9, item 84) (column 5, lines 24-28).
[Claims 5 and 6] Lav and Rasdal teach the limitations of claim 4, upon which claims 5 and 6 depend. Although disclosing a display screen (figure 9, item 84) on the first medicament injection pen (figure 9, item 80), Lav does not specifically disclose the screen is configured to display a representation of a current glucose value of the host based on the glucose data obtained from the glucose sensor.
However, Lav does teach the system comprises a single point glucose monitor (figure 9, item 30) which is configured to display (figure 9, item 32) a current glucose value of a host (column 3, lines 54-57).
It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the functionality of the display screen of the first medicament injection pen, to be configured to display a proximate representation of a current glucose value of the host, as shown on the associated single point glucose monitor taught by Lav, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
[Claims 8, 9, and 12] Lav and Rasdal teach the limitations of claim 3, upon which claims 8, 9, and 12, depend. Lav further discloses the second medicament injection pen (figure 9, item 90) comprises
an additional housing that includes an additional display screen (figure 9, item 94; identical to item 84);
wherein the additional display screen (figure 9, item 94) is configured to display a representation of an additional dose of long-acting insulin (column 5, lines 28-30); and
wherein the additional housing of the second medicament injection pen (figure 9, item 90) further comprises a button (figure 9, item 95; identical to item 85) to toggle through information displayed by the additional display screen (figure 9, item 94) (column 5, lines 24-28).
[Claims 10 and 11] Lav and Rasdal teach the limitations of claim 9, upon which claims 10 and 11 depend. Lav also discloses the additional dose of the long-acting insulin is determined based at least in part on the glucose data obtained from the glucose sensor worn by the host; and wherein the dose of short-acting insulin comprises a bolus dose, and wherein the additional dose of long-acting insulin comprises a basal dose. (Again, the examiner notes the “insulin” is only functionally recited; as such the limitations of claims 10 and 11 are only functional in nature. Given this, the structures taught by Lav and Rasdal meet the recited claim limitations.)
Claims 2 and 13-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lav et al. (USPN 6,302,855), in view of Rasdal et al. (PGPub 2005/0154271), in further view of Brauker et al. (PGPub 2005/0192557).
[Claims 2 and 13-15] Lav and Rasdal teach the limitations of claim 1, upon which claims 2 and 13-15 depend. Although disclosing a single point glucose monitor (figure 9, item 30) that is configured to measure glucose of a host (column 3, lines 54-57), Lav does not specifically disclose a receiver.
However, Brauker teaches an integrated system for treating diabetes comprising a receiver (figure 6b, item 14), a first medicament injection pen (figure 6b, item 16/60), and a single point glucose monitor (figure 46, item 18), that are in wireless communication with one another, such that the single point glucose monitor (figure 6b, item 18) is configured to communicate the measured glucose of the host to a receiver (figure 6b, item 14) and is configured to communicate the measured glucose of the host to the first medicament injection pen (figure 6b, item 16/60) (paragraphs [0110], [0128], [0129], [0130], [0142], [0159]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the system taught by Lav and Rasdal, to have utilized a receiver that is wirelessly coupled to other system components, as taught by Brauker, in order to provide increased functionality and versatility, by allowing for a means by which data from each device could be collectively shared, as well as eliminating the need for a user to simultaneously carry all components of the system.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's representative’s arguments, filed 12/03/2025, with regards to claims 7 and 12, have been fully considered but they are not persuasive. Applicant’s representative asserts that the prior art of record does not disclose the invention as claimed.
The examiner has fully considered the applicant’s representative’s arguments but they are not persuasive. It is the examiner’s position that given a careful reading, the claims do not distinguish over the prior art of record.
Regarding claims 7 and 12, applicant’s representative asserts the prior art to Lav does not disclose a “button” as claimed. The examiner respectfully disagrees. Lacking any explicit definition within applicant’s specification or further limitations within the claims, the examiner is required to provide the term “button” with the broadest reasonable interpretation. As such, a “button” can simply be interpreted as any structure used for activation/deactivation; or, in terms of the claimed limitation, “to toggle through information displayed by the display screen.” Given this, the structure taught by Lav, as indicated in the rejection above, clearly meets the claimed limitation.
In light of the remarks and standing rejection above, the examiner asserts the prior art of record teaches all elements as claimed and these elements satisfy all structural, functional, operational, and spatial limitations currently in the claims. Therefore, the standing rejections are proper and maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 02/27/2026