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 .
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 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.
Claims 1-4, 6-8, and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Dalton et al (US 20150190620 A1) in view of Dalton (US 20140236078 A1).
Regarding claim 1, Dalton (‘620) discloses a device (figs 1-4) for the metered delivery of a liquid for the purpose of releasing an active substance in a human or animal body, comprising
a metering apparatus 14 for metering a defined volume of a liquid (fig 1;[0016]),
an inlet (at 16) in fluidic communication with the metering apparatus for supplying liquid to the metering apparatus and
an outlet (toward body site 18) in fluidic communication with the metering apparatus for delivering the defined volume of the liquid,
wherein the metering apparatus comprises a wall 48 which encloses a metering cavity (fig 4) for receiving the liquid, and wherein the metering cavity can be reduced by manual pressure on the wall, such that the defined volume of the liquid is conveyed from the metering cavity to the outlet; and
a supply cavity 12,22,44,47 (figs 1-4) for receiving a supply of the liquid to be metered, wherein the supply cavity is in fluidic communication with the inlet (at 16),
wherein the supply cavity 44,47 is formed by a wall (fig 4) which is elastically deformable at least in some regions, wherein the wall of the supply cavity comprises a substantially rigid base plate 54 and an elastic cover element 44 mechanically connected to the substantially rigid base plate 54 (at posts 57; [0020-0022]), and wherein the wall of at least one side of the supply cavity consists of the elastically deformable material of the cover element [silicone rubber;0024], so that the supply cavity becomes smaller as the supply of liquid decreases.
However, Dalton (‘620) discloses that the wall of the is elastically deformable, but fails to disclose that the supply cavity decreases as the supply of the liquid decreases.
Dalton (‘078) teaches a device to be implanted (figs 1-4) with a supply cavity 7 (containment chamber) made out of an elastomeric material [0018,0046] where the supply cavity decreases as the supply of the liquid decreases. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dalton (‘620) with the teachings of Dalton (‘078) since such modification would enhance the performance of the device, in addition this teaching is old and well known by Dalton (‘078) as an indicator that the supply cavity is empty.
Regarding claims 2 and 13, Dalton (‘620) discloses the wall on the metering cavity is elastomeric, and a method for metered delivery of a liquid for the purpose of releasing an active substance in a human or animal body using a device according to claim 1. However, it fails to disclose the wall is designed such that at least one region of the wall is elastically deformed by the manual pressure and the wall returns at least substantially to its original shape by an elastic restoring force after the manual pressure ceases, and the step of applying manual pressure to at least one region on the wall of the metering cavity such that a defined volume of the liquid is delivered from the metering cavity to the outlet.
Dalton (‘078) teaches a metering apparatus 5 [0049-0050] a method for metered delivery of a liquid where is elastically deformed by the manual pressure and the wall returns at least substantially to its original shape by an elastic restoring force after the manual pressure ceases due to its elastic capability. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dalton (620) with the teachings of Dalton (078) since such modification would enhance the performance of the device, in addition it is an indicator that the metering cavity is empty.
Regarding claim 3, Dalton (‘620) discloses the invention substantially as claimed. However, it fails to disclose the metering apparatus comprises a first check valve that prevents flow of the liquid from the metering cavity to the inlet, and a second check valve that prevents flow of the liquid from the outlet to the metering cavity.
Dalton (‘078) teaches, in [0047,0050], the metering apparatus comprises a first check valve that prevents flow of the liquid from the metering cavity to the inlet, and a second check valve that prevents flow of the liquid from the outlet to the metering cavity. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dalton (‘620) with the teachings of Dalton (‘078) since such modification would enhance the performance of the device by preventing fluid backflow into the cavity.
Regarding claim 4, Dalton (‘620) discloses a volume of the supply cavity 75 (alternative embodiment figs 5-6) is greater than a volume of the metering cavity 78 by a factor of 2 than a volume of the metering cavity. Dalton (‘078) also teaches a volume of the supply cavity 7
(figure 1) by a factor of 2 than a volume of the metering cavity 5.
Regarding claim 6, Dalton (‘620) discloses the invention substantially as claimed. However, it fails to disclose the elastic restoring force of the metering cavity is greater than an elastic restoring force of the supply cavity.
Dalton (‘078) teaches the elastic restoring force of the metering cavity is greater than an elastic restoring force of the supply cavity (it bounces back see fig 7; [0046,0049]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dalton (‘620) with the teachings of Dalton (‘078) since such modification would enhance the performance of the device by preventing fluid backflow into the metering cavity.
Regarding claim 7, Dalton (‘620) discloses the wall 44 of the supply cavity being made of an elastomeric material [0024]. However, it fails to disclose at least one region of the wall of the supply cavity is designed such that a cannula can pierce through the wall of the supply cavity to introduce liquid into the supply cavity with the cannula.
Dalton (‘078) teaches at least one region of the wall of the supply cavity is designed such that a cannula can pierce through the wall of the supply cavity to introduce liquid into the supply cavity with the cannula [0015,0018]. The wall is made out of silicone rubber which is known to be a pierceable material. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dalton (‘620) with the teachings of Dalton (‘078) since such modification would provide an additional characteristic to the wall when using the device.
Regarding claim 8, Dalton (‘620) discloses wherein the device has a nonpierceable element 57 in chamber 42 (figure 4), so that undesired piercing of a rear region of the wall of the supply cavity is prevented ([0021,0022]; posts 57 are made of silicone, metal or a mesh or screen).
Regarding claims 10-11, Dalton (‘620) and Dalton (‘078) discloses the invention substantially as claimed. However, they fail to disclose the device has a maximum height (H) less than 10mm, and a width (B) of the device is greater by at least a factor of 3 than a height (H) of the device. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dalton (‘620) and Dalton (‘078) with these parameters since such modifications would have been obvious design choice, well within of one of ordinary skill in the art, obtained through routine experimentation in determining optimum results.
Regarding claim 12, Dalton (‘620) discloses the wall 48 of the metering cavity is convex in at least in some regions.
Regarding claim 14, Dalton (‘620) discloses the step where the device is implanted under the skin in a human body [mammal]; a rat in [0035]. Dalton (‘078) discloses the device is implanted under the skin in an animal or human body [0073].
Regarding claim 15, Dalton (‘620) discloses use of a device according to claim 1 for the metered delivery of a liquid for the purpose of releasing an active substance in a human body mammal], wherein the device is implanted under the skin (abstract) in a human or an animal. Dalton (‘078) discloses the device is implanted under the skin in an animal or human body [0073].
In an alternative interpretation for claim 8:
Claims 8-9, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Dalton et al (US 20150190620 A1) in view of Dalton (US 20140236078 A1), further in view of Vogt (US 2022/0105325).
Regarding claims 8-9, Dalton (‘620)/Dalton (‘078) discloses the invention substantially as claimed. However, they fail to disclose the device having a nonpierceable element, so that undesired piercing of a rear region of the wall of the supply cavity is prevented; and wherein the nonpierceable element is a nonpierceable plate made of a biocompatible material, which is arranged at least partially in the supply cavity.
Vogt teaches a device (implant) including a nonpierceable element 6 located within the supply cavity and made out of a biocompatible material. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dalton (‘620)/Dalton (‘078) implant by including a nonpierceable plate as taught by Vogt since such modification would prevent the rear region of the wall piercing by needles.
Regarding claim 16, Dalton (‘620) discloses wherein the nonpierceable element is made of metal [0022]. Dalton (‘078) discloses wherein the nonpierceable element is made of metal [0018].
Regarding claim 17, Dalton (‘620) discloses the nonpierceable element comprises stainless steel [0022]. Dalton (‘078) discloses the nonpierceable element comprises titanium, , or stainless steel, [0018], claims 16 and 34.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
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