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 § 112
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 1-4, 6-17 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.
Claim 1 recites the limitation "the housing". There is insufficient antecedent basis for this limitation in the claim.
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 1-2, 4, 7, and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Hanson (US 20200397981 A1) in view of Dalton (US 20070088336 A1).
Regarding claim 1, Hanson discloses a device (figs 1a-1c, [0030]) 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 106 for metering a defined volume of a liquid,
an inlet (at 104) in fluidic communication with the metering apparatus for supplying liquid to the metering apparatus and
an outlet (108) in fluidic communication with the metering apparatus for delivering the defined volume of the liquid,
wherein the metering apparatus 106 comprises a wall [0041] which encloses a metering cavity for receiving the liquid [0035], and wherein the metering cavity can be reduced by manual pressure on the wall [0032-0034], such that the defined volume of the liquid is conveyed from the metering cavity to the outlet; and
a supply cavity 100 for receiving a supply of the liquid to be metered,
wherein the supply cavity is in fluidic communication with the inlet (at 104),
wherein the supply cavity 100 is formed by a wall ([0041], pressure receiver, [0030,0032-0035,0041]) which is elastically deformable at least in some regions
so that the supply cavity decreases as the supply of the liquid decreases [0038-0041],
wherein the wall of the supply cavity comprises a base and an elastic cover element mechanically connected to the base (in order to form a leak proof reservoir [0030], pressure receiver),
and wherein the wall of at least one side of the supply cavity 100 consists of the elastically deformable material of the cover element [0033] so that the supply cavity becomes smaller as the supply of liquid decreases, which is fastened to the housing [0032],
wherein the cover element is configured to elastically deform toward the base as the supply of the liquid decreases, thereby reducing the volume of the supply cavity and substantially preventing collection of air or unwanted liquid within the supply cavity [0030-0041].
Hanson fails to specifically disclose the wall of the supply cavity comprises a substantially rigid base plate and the elastic cover element mechanically connected to the substantially rigid base plate
Dalton teaches, in figure 7, a device 700 to be implanted with the wall of the supply cavity 720,725 comprises a substantially rigid base plate 745 and the elastic cover element 720,725 mechanically connected to the substantially rigid base plate [0049-0050]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Hanson with the teachings of Dalton since such structure is well known in the art as shown by Dalton.
Regarding claims 2 and 13, Hanson discloses the wall wherein the wall on the metering cavity 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 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, comprising 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.[0030,0032-0034]
Regarding claim 4, Hanson discloses a volume of the supply cavity 100 that is greater than a volume of the metering cavity 100 by a factor of 2 than a volume of the metering cavity.
Regarding claim 7, Hanson discloses the wall [0041] of the supply cavity being made of an elastomeric material (diaphragm [0032, 0037]. Dalton also discloses a wall of the supply cavity 730 that can be pierced by a needle [0050].
Regarding claim 10, Hanson discloses in an alternative embodiment in figure 4 the device has a maximum height (H) less than 10mm (1 cm, [0108]).
Regarding claim 11, Hanson discloses the device is small enough to be implanted in a patient [010]. Hanson also discloses in figure 4 an alternative device where the width (B) of the device is greater (3 cm) by at least a factor of 3 than a height (H) of the device (1 cm).
Regarding claim 12, Hanson discloses that the wall of the metering cavity is elastic and collapsible [0032,0033]. But it fails to disclose the wall of the metering cavity is a convex in at least in some regions.
Dalton teaches a device in figure 7 having a wall that is convex 720,725 at least in some regions. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Hanson’s wall of the metering cavity with the convex configuration taught by Dalton since the convex wall would be capable of holding or retaining fluid in a fluid delivery device which is taught old and well known.
Regarding claim 14, Hanson discloses the step where the device is implanted under the skin in a human body [0095]].
Regarding claim 15, Hanson 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 or animal body (patient) [0095], wherein the device is implanted under the skin in a human or an animal (patient) [0095].
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hanson (US 20200397981 A1) in view of Dalton (US 20070088336 A1), further in view of Alferness et al. (US 20070299400 A1)
Regarding claim 3, Hanson discloses the device comprises a first check valve 104 that prevents flow of the liquid from the metering cavity 106 to the inlet at 104, but fails to disclose the metering apparatus 106 comprises the 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.
Alferness teaches a bolus pump in figures 11-12 having a first valve 180 that prevents flow of the liquid from an inlet to the pump, and a second check valve 182 that prevents flow of the liquid from the outlet to the pump [0044]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Hanson’s device by rearranging the first valve and incorporating a second valve in the metering device since such modification is taught old and well known in the art by Alferness for fluid control.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hanson (US 20200397981 A1) in view of Dalton (US 20070088336 A1), further in view of Dalton (US 20140236078).
Regarding claim 6, Hanson discloses in [0083] that a second compression force can be applied to the metering apparatus 106 via elastic compression force. 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 Hanson/Dalton (‘336) with the teachings of Dalton (‘078) since such modification would enhance the performance of the device by preventing fluid backflow into the metering cavity.
Claims 8-9, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Hanson (US 20200397981 A1) in view of Dalton (US 20070088336 A1), further in view of Vogt (US 2022/0105325).
Regarding claims 8-9, Hanson/Dalton 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 Hanson/Dalton implant device by including a nonpierceable plate as taught by Vogt since such modification would further prevent the rear region of the wall piercing by needles.
Regarding claim 16, Vogt further discloses the nonpierceable element is made of metal [0033].
Regarding claim 17, Vogt further discloses the nonpierceable element comprises stainless steel [0034].
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.
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
Prosecution Insights