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 4-7, 9-10, and 15 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.
Claims 4, 10, and 15 are indefinite because the scope of the claims is unclear. They all claim the broad statement, following a narrow statement including “in particular” and/or “preferably” which makes the scope of the claim confusing as to whereas applicant intends to claim the broad statement or the narrow statement. Applicant must correct the claims with a broad or narrow statement, not both.
Claim 5, there is no antecedent basis for “the supply cavity”. It is also not clear if “a wall” in line 1 is the same or in addition to the one set forth in claim 1. Appropriate correction is required. The examiner will interpret as being the same wall from claim 1.
Claim 6, there is no antecedent basis for “the elastic restoring force”.
Claim 9, there is no antecedent basis for “the nonpierceable element”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 14 preamble set forth “The method according to claim 1” while claim 1 is directed to “A device”. It appears the dependency is improper.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 5, 6, 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schulte (US 3310051 A).
Regarding claim 1, Schulte 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 20 for metering a defined volume of a liquid,
an inlet (through 32) in fluidic communication with the metering apparatus for supplying liquid to the metering apparatus and
an outlet (21,24) in fluidic communication with the metering apparatus for delivering the defined volume of the liquid,
wherein the metering apparatus comprises a wall 32 which encloses a metering cavity (between 31,32) for receiving the liquid, 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.
Regarding claim 2, Schulte discloses the wall 32 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 (col 2 lines 50-55, 61-69).
Regarding claim 5, Schulte discloses the supply cavity is formed by the wall 32 which is elastically deformable at least in some regions, so that the supply cavity decreases as the supply of the liquid decreases (fig 4).
Regarding claim 6, Schulte discloses the elastic restoring force of the metering cavity is greater than an elastic restoring force of the supply cavity (it bounces back; col 2 lines 50-55, 61-69).
Regarding claim 12, Schulte discloses the wall of the metering cavity is convex at least in some regions (Fig 1).
Regarding claim 13, Schulte discloses 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, wherein by manual pressure on the wall, the metering cavity is reduced so that a defined volume of the liquid is delivered from the metering cavity to the outlet (col 2 lines 50-60).
Regarding claim 14, the step where the device is implanted under the skin in a human body (fig 1; title).
Regarding claim 15, Schulte 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, wherein the device is implanted under the skin (fig 1; title).
Claims 1-3, 5-6, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alferness et al (US 20070299400 A1).
Regarding claim 1, Alferness discloses a device (figs 11-12) 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 170 for metering a defined volume of a liquid,
an inlet 180 in fluidic communication with the metering apparatus for supplying liquid to the metering apparatus and
an outlet 182 in fluidic communication with the metering apparatus for delivering the defined volume of the liquid,
wherein the metering apparatus comprises a wall 174 which encloses a metering cavity 184 for receiving the liquid, 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.
Regarding claim 2, Alferness discloses the wall 174 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 [0043-0044].
Regarding claim 3, Alferness discloses 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 [0044].
Regarding claim 5, Alferness discloses the supply cavity is formed by the wall 174 which is elastically deformable at least in some regions, so that the supply cavity decreases as the supply of the liquid decreases.
Regarding claim 6, Alferness discloses the elastic restoring force of the metering cavity is greater than an elastic restoring force of the supply cavity (it bounces back see fig 11; [0043-0044]).
Regarding claim 12, Alferness discloses the wall 174 of the metering cavity is convex at least in some regions.
Regarding claim 13, Alferness discloses 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, wherein by manual pressure on the wall, the metering cavity is reduced so that a defined volume of the liquid is delivered from the metering cavity to the outlet [0043-0044].
Claims 1-7, 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dalton (US 20140236078 A1).
Regarding claim 1, Dalton discloses a device (fig 7) 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 5 for metering a defined volume of a liquid,
an inlet [0049] in fluidic communication with the metering apparatus for supplying liquid to the metering apparatus and
an outlet 21 [0049-0050] in fluidic communication with the metering apparatus for delivering the defined volume of the liquid,
wherein the metering apparatus comprises a wall 17 which encloses a metering cavity 19 (fig 7) for receiving the liquid, 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.
Regarding claim 2, Dalton discloses the wall 17 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 [0049-0050].
Regarding claim 3, Dalton discloses 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 [0047,0050].
Regarding claim 4, Dalton discloses the device additionally comprises a supply cavity 3 for receiving a supply of the liquid to be metered, wherein the supply cavity is in fluidic communication with the inlet (fig 7), wherein a volume of the supply cavity is greater than a volume of the metering cavity [0058,0065-0067].
Regarding claim 5, Dalton discloses the supply cavity is formed by the wall 17 which is elastically deformable at least in some regions, so that the supply cavity decreases as the supply of the liquid decreases [0046].
Regarding claim 6, Dalton discloses 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]).
Regarding 7, Dalton discloses 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, in order 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.
Regarding claim 12, Dalton discloses the wall 17 of the metering cavity is convex at least in some regions.
Regarding claim 13, Dalton discloses 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, wherein by manual pressure on the wall, the metering cavity is reduced so that a defined volume of the liquid is delivered from the metering cavity to the outlet [0049].
Regarding claim 14, Dalton discloses the step where the device is implanted under the skin in a human body (abstract).
Regarding claim 15, Dalton 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, wherein the device is implanted under the skin (abstract).
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 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Schulte (US 3,310,051) in view of Vogt (US 2022/0105325).
Regarding claims 8-9, Schulte discloses the invention substantially as claimed. However, Schulte fails 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 (26) made of a biocompatible material, which is arranged at least partially in the supply cavity.
Vogt teaches a device (implant) including a nonpierceable element being a plate 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 Schulte’s implant by including a nonpierceable plate as taught by Vogt since such modification would prevent the rear region of the wall piercing by needles.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Schulte, Alferness et al, and Dalton.
Regarding claims 10-11, Schulte, Alferness et al, and Dalton discloses the invention substantially as claimed. However, they fail to disclose the device has a maximum height (H) less than 13 mm, 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 Schulte, Alferness et al, and Dalton 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.
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 Mon-Thur 8am- 2pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783