DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claim 19 is objected to because of the following informalities: a an
a
Appropriate correction is required.
Claim 20 is objected to because of the following informalities: please spell out acronyms when first time use in this independent claim set. 5 pounds per square inch (PSI) to 40 PSI. Appropriate correction is required.
Claim 29 is objected to because of the following informalities: a
a
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) (claim 30) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Inlet port is interpreted as corresponding to the structure of the first means and outlet port, needle set, or tubing set are interpreted as corresponding to the structure of the second means.
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 5, 24, 30 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 5 and 24 recite the limitation "the flow rate device" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 recites the limitations "the first portion" in line 6 and “the second portion” in line 6. There is insufficient antecedent basis for this limitation in the claim. Should either read as first and second means or remove the “means” with “portion”.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-5, 8-10, 12-13, 15, 17-19, 21-26, 28 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Wonder et al. (US 5,234,413) (“Wonder”).
(claims 1, 19) Wonder discloses: (Figs. 1,4, abstract): A system or apparatus, comprising: a first portion 36 comprising an inlet port 44 configured to receive fluid originating from an infusion device; a second portion 6 comprising an outlet port 12 configured to deliver fluid to a patient, the second portion forming a rotatable snap-fit coupling (C4L55-63;at 52,26) with the first portion (claim 17); and a fluid path (82,84) disposed between the first portion and the second portion, the fluid path having at least one manually adjustable dimension (metering plate 16, groove 30) which, when adjusted due to relative rotation between the first portion and the second portion during infusion, changes a flow rate of fluid exiting the outlet port, see abstract, C6L47-68.
In addition to above, for claim 19, the fluid path having a manually adjustable fluid path length, see fluid metering groove 30, Fig. 1, C7L1-9
Claims 2-5, 22-25: The infusion device is fluidically coupled to the inlet port C6L25-37; infusion device is a non-electric infusion pump 82; dispenses fluid at a constant force (conventional IV tubing C3L17-19); infusion device coupled to a flow rate device 4 by way of tubing sets (Fig.4); one or more tubing sets 82,84 are coupled to the outlet port 12 to cause the fluid to be delivered to the patient
Claims 8-10: The at least one manually adjustable dimension comprises a width or/and length of the fluid path, see fluid metering groove 30, Fig. 1, C7L1-9
Claims 12, 15, 21, 28: A seal 68 between and rotatable relative to one of the first portion or the second portion and fixed relative to the other of the first or second portion, Figs. 1,4; the seal consists of a single orifice 72, Fig. 1
Claim 13, 26: The second portion 6 comprises a channel 30 of varying diameter, wherein a position of the second portion relative to the first portion changes a position at which the fluid enters the channel thereby affecting the flow rate of fluid exiting the outlet port, Fig. 1, abstract, C7L1-9
Claim 18: the first and second portions when coupled form a barrel like structure, Fig. 2
Claim Rejections - 35 USC § 103
14. 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.
15. 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.
16. Claims 6-7, 11, 16, 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wonder in view of Pike et al. (US 5,009,251) (“Pike”) further in view of Hessel (US 4,769,008).
Wonder discloses the invention as substantially claimed but does not directly disclose a needle set is fluidically coupled to the outlet port or the fluid originating from the infusion device is at a pressure within a range of 5 PSI to 40 PSI. Pike, in the analogous art, teaches a similar fluid flow controller for regulating the rate of flow from a source of fluid under pressure (see abstract). Pike teaches both a needle set fluidically coupled to the outlet port C2L66-C3L5 and the infusion device in Pike is described as a relatively constant pressure delivery system such as the Intermate.RTM. elastomeric bladder infusion pump disclosed in U.S. Pat. No. 4,769,008, “Hessel” (Pike, C2L50-60). The infusion pump taught by Hessel in Pike dispenses pressurized fluid to between 5PSI and 40PSI (Hessel, C7L44-45) (claim 16). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the originating (infusion device) and delivery outlets (needle set) to meet the mobility needs of a patient.
The pump of Hessel operates in the area of about 8-10psi C7L44-45. Thus, although not directly disclosed, since the device of Pike utilizes a pump generating pressures of about 8-10psi, then it follows that the parts (inlet and outlet handles) would be composed of materials that can withstand these pressures (of from 5 to 40psi). It would have been obvious to one having ordinary skill in the art at the time the invention was made to compose the inlet and outlet handles of a polycarbonate and another material having a similar hardness coefficient to polycarbonate to withstand pressures of from 5 to 40psi since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 f.2d 197, 125 USPQ 416 (CCPA 1960).
17. Claims 14, 27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wonder in view of Kriesel (US 6,095,491).
Wonder discloses the invention as substantially claimed, including a seal between first and second portions with a selectively alignable orifice, see above. Wonder does not directly disclose the seal having a plurality of orifices alignable with the inlet port and the channel. Kriesel, in the analogous art, teaches a flow rate control device that has a selectively alignable seal with a plurality of orifices to control the flow rate, Fig. 6, C3L30-42. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the seal of Wonder with the seal as taught by Kriesel as a substitution of the same part for another way to adjust the flow rate.
18. Claim 29 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wonder in view of Pike.
(Claim 29) Wonder discloses: an apparatus for fluid control along a flow path between an infusion device and a patient comprising (Figs. 1,4, abstract): a first portion 36 comprising an inlet port 44 configured to receive fluid originating from the infusion device; a second portion 6 comprising an outlet port 12 configured to deliver the fluid originating from the infusion device to the patient, the second portion forming a rotatable snap-fit coupling (C4L55-63;at 52,26) with the first portion; and a fluid path 82,84 disposed between the first portion and the second portion, the fluid path having a manually adjustable width (C7L1-9; metering plate 16,groove 30) which, when adjusted due to rotation of the first portion relative to the second portion during infusion, changes a flow rate of fluid exiting the outlet port. See abstract, C6L47-68
Wonder does not directly disclose the inlet and outlet ports having a luer lock although it would be obvious that some sort of connection would be necessary to attach the regulator device 4 to the system. Pike, in the analogous art, teaches attaching the flow regulator 22 to the system (Figs. 1,2) via luer locks at the inlet and outlet ports C2L66-C3L5. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the inlet and outlet ports of Wonder with the luer connections as taught by Pike as a well-known way to attach the flow regulator to the system.
19. Claim 30 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wonder in view of Pike further in view of Hessel.
(Claim 30) Wonder discloses a system comprising (Figs. 1,4, abstract): first means 36 for receiving fluid originating from an infusion device; second means 6 for delivery for delivering the fluid originating from the infusion device to a patient; and a fluid path 82,84 disposed between the first portion and the second portion, the fluid path having a manually adjustable width (C7L1-9; metering plate 16,groove 30) which, when adjusted due to rotation of the first means relative to the second means, changes a flow rate of fluid exiting the second means. See abstract, C6L47-68
Wonder discloses the invention as substantially claimed but does not directly disclose receiving fluid from an infusion device at a pressure within a range of 5 PSI to 40 PSI. Pike, in the analogous art, teaches a similar fluid flow controller for regulating the rate of flow from a source of fluid under pressure (see abstract). The infusion device in Pike is described as a relatively constant pressure delivery system such as the Intermate.RTM. elastomeric bladder infusion pump disclosed in U.S. Pat. No. 4,769,008, “Hessel” (Pike, C2L50-60). The infusion pump taught by Hessel in Pike dispenses pressurized fluid to between 5PSI and 40PSI (Hessel, C7L44-45) (claim 16). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the pressure with which the infusion device delivers fluid to the system to be a high pressure fluid delivery as taught by Pike and Hessel to meet the infusion needs of a patient. E.g., if highly viscous medication or contrast solution is to be delivered, a high pressure infusion device would need to be used to adequately move the solution to the regulator such that the solution then could be safely delivered to the patient.
Conclusion
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/DEANNA K HALL/Primary Examiner, Art Unit 3783