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 .
Response to Amendment
The Amendments filed 02/13/2026 have been entered.
Claims 1 and 47 have thereby been amended.
Claims 1-3, 5, 26, 47-50 and 59 are being examined in this office action.
Claim Interpretation
Claims 3 and 48 recite the limitation “in response to a needle insertion input.” Claims 5, 26, 50 and 59 recite the limitation “in response to a valve input.” These inputs are not specifically defined, and are examined given their broadest reasonable interpretation of any input that also relates to either the insertion of the needle or valve, respectively.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5, 26, 47-50 and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Staub (EP 3354303) in view of Yodfat (US 20110160652).
Regarding claim 1, Staub discloses a drug delivery device (Fig. 1: 2) comprising: a housing defining a shell and an inner volume (Fig. 1: housing shell 3 defines inner volume); a container at least partially disposed within the housing (Fig. 2: container 4, within the housing 3), the container having an inner volume to contain a medicament (para. [0055], sentence 1); an activation mechanism at least partially disposed within the housing (Fig. 2: activation mechanism 16, within housing 3), the activation mechanism adapted to exert a force to urge the medicament out the container (para. [0055], sentence 1); a needle insertion mechanism at least partially disposed within the housing (Figs. 2-3: needle insertion mechanism 10+12, within housing 3), the needle insertion mechanism including: an actuation assembly (10) adapted to insert a needle (72) and/or a cannula (76) to deliver the medicament, and a valve assembly (Figs. 9a-b: valve formed by structure 78 around hole 88; para. [0093], sentence 1); a fluid flow connection coupled with the container and the needle insertion mechanism, the fluid flow connection adapted to allow the medicament to flow from the container to the needle insertion mechanism (Fig. 4b: 33+35, 33 connecting container 4 to the pump, and 35 connecting the pump to the needle insertion mechanism; para. [0057]); wherein the valve assembly is repeatedly movable between at least a valve open position (Fig. 9b: 88 is open allowing for flow indicated by the arrows) and a valve closed position (Fig. 9b: 88 is closed preventing flow, indicated by the short arrows and “X”) to selectively allow and restrict the medicament to flow through the needle and/or the cannula. However, Staub fails to explicitly disclose that the valve is open and closed repeatedly after the cannula is inserted, enabling time-controlled multi-dose drug delivery.
Yodfat teaches an analogous drug delivery device wherein the valve assembly (402) is repeatedly movable between at least a valve open position and a valve closed position after the cannula is inserted and the needle is retracted (para. [0209], cannula is replaced/repunctures 402 after initial insertion after Fig. 6c) to selectively allow and restrict the medicament to flow through the needle and/or the cannula thereby enabling time-controlled multi-does drug delivery (para. [0209]). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Staub device by incorporating the repeated opening and closing of the valve for multi-dose insulin delivery taught by Yodfat, such that the Staub valve is automatically repeatedly opened and closed via the cannula positioning, in order to be able to delivery many doses of medication throughout the day(s) and eliminate the waste and trouble of continually using and discarding the drug delivery devices (Yodfat: para. [0198]).
Regarding claim 2, Staub in view of Yodfat teaches the drug delivery device of claim 1, as described above, wherein the needle insertion mechanism further comprises: a needle yoke operably coupled with the actuation assembly (Staub: Fig. 8b: needle yoke 74 coupled to 10), the needle yoke including a needle coupling portion to receive a portion of the needle (Staub: Fig. 8d: 74 center portion couples needle 72); a cannula yoke operably coupled with the actuation assembly (Staub: Fig. 8b: cannula yoke 78 coupled to 10), the cannula yoke including a cannula coupling portion to receive a portion of the cannula (Staub: Fig. 8d: 78 center portion couples cannula 76).
Regarding claim 3, Staub in view of Yodfat teaches the drug delivery device of claim 2, as described above, wherein the actuation assembly comprises a scotch yoke assembly adapted to engage the needle yoke and/or the cannula yoke (Staub: Fig. 8b: scotch yoke 63 engages structure 70 containing and operating 74 and 78), the scotch yoke assembly including a first spindle operably coupled with the needle yoke and the cannula yoke (Staub: Figs. 10a-c: first spindle being the top half of cam 56 which interacts with 82a and 82b), the first spindle adapted to, in response to a needle insertion input, move at least one of the needle or the cannula to an extended position (Staub: Figs. 10a-c; para. [0085], the first spindle extending the needle and cannula together in response to the activation input).
Regarding claim 5, Staub in view of Yodfat teaches the drug delivery device of claim 3, as described above, wherein the valve assembly comprises a second spindle operably coupled with the needle yoke (Staub: Figs. 10a-c: second spindle being the bottom half of cam 56 which interacts with 84), the second spindle adapted to, in response to a valve input, move the needle yoke between the valve open position and the valve closed position (Staub: Figs. 10a-c; para. [0097], the second spindle retracting the needle in response to the activation input in combination with engagement of 84).
Regarding claim 47, Staub discloses a needle insertion mechanism for use with a drug delivery device (Figs. 2-3: needle insertion mechanism 10+12), the needle insertion mechanism comprising: a cannula yoke (Fig. 8b: cannula yoke 78) having a cannula coupling portion (Fig. 8d: 78 center portion couples cannula 76), the cannula yoke being movable between a storage state (cannula position in Fig. 9a) and an extended state (cannula position in Fig. 9b); a cannula (76) coupled with the cannula coupling portion of the cannula yoke (Fig. 8d: 78 center portion couples cannula 76); a needle yoke (Fig. 8b: needle yoke 74) having a needle coupling portion (Fig. 8d: 74 center portion couples needle 72), the needle yoke being movable between at least a storage state (needle position in Fig. 9a), an extended state (needle position in Fig. 9b), and a valve open (Fig. 9b: 88 is open allowing for flow indicated by the arrows) and a valve closed state (Fig. 9b: 88 is closed preventing flow, indicated by the short arrows and “X”); a needle (72) coupled with the needle coupling portion of the needle yoke (Fig. 8d: 74 center portion couples needle 72); an actuation assembly (10) operably coupled with the cannula yoke and/or the needle yoke (Fig. 8b: 10 coupled to 74 and 78), the actuation assembly adapted to insert the needle and/or the cannula to deliver the medicament (para. [0085]); and a valve assembly in fluid communication with the cannula (Fig. 9b: fluid communication indicated by the arrow), the valve being movable between at least a first position (valve position in Fig. 9a) and a second position (valve position in Fig. 9b); wherein upon the cannula yoke and the needle yoke moving respectively from the storage state to the extended state, the valve assembly is configured to repeatedly move between the first position and the second position (Figs. 9a-b: valve moves from first position to second position when cannula and needle yokes move from storage to extended states) to selectively restrict and allow the medicament to flow through the cannula (as indicated by the “X” in Fig. 9a and the arrow of flow in Fig. 9b). However, Staub fails to explicitly disclose that the valve is open and closed repeatedly after the cannula is inserted, enabling time-controlled multi-dose drug delivery.
Yodfat teaches an analogous drug delivery device wherein the valve assembly (402) is repeatedly movable between at least a valve open position and a valve closed position after the cannula is inserted and the needle is retracted (para. [0209], cannula is replaced/repunctures 402 after initial insertion after Fig. 6c) to selectively allow and restrict the medicament to flow through the needle and/or the cannula thereby enabling time-controlled multi-does drug delivery (para. [0209]). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Staub device by incorporating the repeated opening and closing of the valve for multi-dose insulin delivery taught by Yodfat, such that the Staub valve is automatically repeatedly opened and closed via the cannula positioning, in order to be able to delivery many doses of medication throughout the day(s) and eliminate the waste and trouble of continually using and discarding the drug delivery devices (Yodfat: para. [0198]).
Regarding claim 48, Staub in view of Yodfat teaches the needle insertion mechanism of claim 47, as described above, wherein the actuation assembly comprises a scotch yoke assembly adapted to engage the needle yoke and/or the cannula yoke (Staub: Fig. 8b: scotch yoke 63 engages structure 70 containing and operating 74 and 78), the scotch yoke assembly including a first spindle operably coupled with the needle yoke and the cannula yoke (Staub: Figs. 10a-c: first spindle being the top half of cam 56 which interacts with 82a and 82b), the first spindle adapted to, in response to a needle insertion input, move at least one of the needle or the cannula to an extended position (Staub: Figs. 10a-c; para. [0085], the first spindle extending the needle and cannula together in response to the activation input).
Regarding claim 49, Staub in view of Yodfat teaches the needle insertion mechanism of claim 48, as described above, wherein the first spindle comprises a needle insertion mechanism engagement portion (Staub: Figs. 8a-c: surface/housing 58) comprising an arcuate track (Staub: Figs. 8a-c: curved track 63), the needle insertion mechanism engagement portion adapted to receive a portion of the needle yoke and/or the cannula yoke (Staub: Fig. 8b: 58 engages both 74 and 78 via 82a, 82b, and 84), wherein upon rotating the first spindle, the needle insertion mechanism engagement portion urges the needle and/or the cannula to the extended position (Staub: as seen in Figs. 10a-c, the projection engaged with 82a and 82b being 63 of 58).
Regarding claim 50, Staub in view of Yodfat teaches the needle insertion mechanism of claim 48, as described above, wherein the valve assembly comprises a second spindle operably coupled with the needle yoke and the cannula yoke (Staub: Figs. 10a-c: second spindle being the bottom half of cam 56 which interacts with 84), the second spindle adapted to, in response to a valve input, move the needle yoke between the valve open position and the valve closed position (Staub: Figs. 10a-c; para. [0097], the second spindle retracting the needle in response to the activation input).
Regarding claim 59, Staub in view of Yodfat teaches the needle insertion mechanism of claim 48, as described above, wherein the first spindle is further adapted to, in response to a valve input, move the needle yoke between the valve open position and the valve closed position (Staub: Figs. 10a-c: the valve being in the open or closed position depending on the extension or retraction of the needle relative to the valve).
Response to Arguments
Applicant’s arguments filed 02/13/2026, with respect to the prior art rejections, have been considered but are moot in light of the amendments which changed the scope of independent claims 1 and 47. Independent claims 1 and 47 no longer solely rely on Staub to teach all limitations of the amended claims, but now rely on Staub in view of Yodfat to motivate and teach the amended limitations that the valve is open and closed repeatedly after the cannula is inserted, enabling time-controlled multi-dose drug delivery.
For these reasons, independent claims 1 and 47 and their depending claims stand rejected as recited above.
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.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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