DETAILED ACTION
This is a non-final rejection in response to application filed 1/18/24. Claims 1-20 are currently pending.
Claim Objections
Claims 16 and 20 objected to because of the following informalities: “a said”. 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”) 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.
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 1-20 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 7,11,12,18,19 recites the limitation "preferably". The term renders the claim indefinite as it is unclear whether the limitation is required.
Claims 1,6,13 recites the limitation "substantially parallel" and "substantially completely". The term fails to provide a standard for measuring the scope of these terms.
Subsequent dependent claims are further rejected.
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.
Claim(s) 1-11 and 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanson et al. (US 20212/0172803) in view of Bzosteck et al. (US 2009/0227863).
Regarding independent claim 1, Hanson teaches a transport element for transporting a substance contained in a reservoir 40 [0096], said transport element being arranged to be part of an infusion set, said transport element comprising a transport means 50, and a connector 56 arranged at an inlet end 401 of the transport means for connecting to said reservoir such that in a connected condition in which the connector is connected to said reservoir a medium through flow connection is provided between said reservoir and the inlet end of the transport means for receiving said substance from said reservoir [0113]. While Hanson teaches aligning with rails [0208) and latches, magnets for holding and aligning [0217-226] the housing, Hanson is silent to wherein said connector comprises aligning and holding means for aligning and holding the reservoir in a predetermined orientation with respect to and/or position along a longitudinal axis of the connector.
Bzostek teaches it was known to have a similar apparatus, wherein a needle apparatus is aligned with a port of an implantable infusion device reservoir [0008,0045].
It would have been obvious to one of ordinary skill in the art at the time of filing to modify Hanson, in order to have the connector align with reservoir port, as Bzostek teaches it prevents leakage and ensures proper fluid communication [0004].
Regarding dependent claim 2, Hanson in view of Bzostek teaches the claim as discussed above. Hanson further teaches wherein the connector of the transport element comprises additional aligning means 559, said additional aligning means extending before and/or after the aligning and holding means as seen in the direction of the longitudinal axis [0208,0224].
Regarding dependent claim 3, Hanson in view of Bzostek teaches the claim as discussed above. Hanson further teaches wherein said additional aligning means 559 extending before the aligning and holding means are arranged for pre-aligning the reservoir with respect to the longitudinal axis of the connector in a first part of a connection path of connecting the reservoir to the connector, wherein in a second, subsequent part of said connection path said reservoir is aligned by said aligning and holding means and optionally said additional aligning means, and is subsequently held by the aligning and holding means at the end of the connection path in the connected condition [0209-0224].
Regarding dependent claim 4, Hanson in view of Bzostek teaches the claim as discussed above. Hanson further teaches wherein said additional aligning means 559 extending after the aligning and holding means are arranged for maintaining the alignment of said reservoir in said predetermined orientation in the connected condition [0217-0220].
Regarding dependent claim 5, Hanson in view of Bzostek teaches the claim as discussed above. Hanson further teaches wherein the aligning and holding means are more flexible than the additional aligning means. Latches are more flexible than rails [0208,0225].
Regarding dependent claim 6, Hanson in view of Bzostek teaches the claim as discussed above. Hanson further teaches wherein the additional aligning means comprise at least one elongated rib 559 that protrudes inwardly from the inner side of a circumferential wall of said connector and extends substantially parallel to said longitudinal axis.
Regarding dependent claim 7, Hanson in view of Bzostek teaches the claim as discussed above. Hanson further teaches wherein the additional aligning means comprise a plurality of said ribs distributed along the circumference of the circumferential wall, preferably in a uniform distribution [0208-0220].
Regarding dependent claim 8, Hanson in view of Bzostek teaches the claim as discussed above. Hanson further teaches wherein the aligning and holding means comprise at least one resilient member, said resilient member having a first state for holding said reservoir and being moveable to a second state when said reservoir is pushed against said resilient member when said reservoir is connected to or disconnected from said connector, and which resilient member is elastically urged to its first state [0224-0226].
Regarding dependent claim 9, Hanson in view of Bzostek teaches the claim as discussed above. Hanson further teaches wherein said at least one resilient member comprises at least one substantially crescent-shaped member, wherein the substantially crescent-shaped member is attached to the inner side of a or the circumferential wall of the connector with two opposing end zones thereof and wherein a convex side of said substantially crescent-shaped member that extends between the two opposing end zones protrudes inwardly from the inner side of said circumferential wall of the connector [0224]. It should be noted Hanson is silent to the shape being crescent shaped.
said at least one resilient member comprises at least one substantially crescent-shaped member
Regarding the claimed limitations “at least one resilient member comprises at least one substantially crescent-shaped member”. It is noted that applicant has not disclosed that crescent shaped member results in an unpredicted result not seen in the Prior Art and it appears that the invention would perform equally well with cooling holes, as taught by Simons (element 56). Accordingly, absent persuasive evidence that the cooling slot is functionally significant, the limitations above constitute a mere change in shape and fail to patentably distinguish over the prior art. See MPEP 2144.04(4)(b).
Regarding dependent claim 10, Hanson in view of Bzostek teaches the claim as discussed above. Hanson further teaches wherein a hole or opening is provided in said circumferential wall [0186,0213] in an area between said two opposing end zones of the at least one substantially crescent-shaped member (as modified above).
Regarding dependent claim 11, Hanson in view of Bzostek teaches the claim as discussed above. Hanson further teaches comprising a plurality of said resilient members and wherein the resilient members are distributed along the circumference of a or the circumferential wall [0217-0220].
Regarding dependent claim 13, Hanson in view of Bzostek teaches the claim as discussed above. Hanson further teaches wherein said connector comprises a penetrating means [0114], as modified Bzostek teaches that extends substantially parallel to the longitudinal axis with a free end thereof in the direction of the aligning and holding means for penetrating a membrane or the like of said reservoir in at least the connected condition, wherein said aligning and holding means and optionally said additional aligning means are configured for aligning the reservoir in a predetermined orientation with respect to said penetrating means such that the penetrating means are oriented substantially perpendicular to the membrane of said reservoir during penetrating the membrane during connecting of the connector to said reservoir, and for holding said reservoir in said predetermined orientation and in such a position that the penetrating means substantially completely penetrates the membrane in the connected condition [0050].
Regarding dependent claim 14, Hanson in view of Bzostek teaches the claim as discussed above. Hanson further teaches wherein the aligning and holding means are configured to protrude into an area of and/or grip a neck portion of said reservoir in the connected condition [0112,0224].
Regarding independent claim 15, Hanson in view of Bzostek teaches an infusion set, comprising:
a transport element according to claim 1 (see claim 1 above), further comprising an additional connector arranged at an outlet end of the transport means [0115,0130, 0150-0153], and
an infusion element comprising an infusion means 103 for infusing a substance into a body of a person [0147-0150], said infusion means comprising an inlet end for receiving said substance and an outlet end for infusing said substance into said body [0131,0183,0186], wherein said infusion element comprises a connector for connecting to said additional connector of said transport element of the infusion set [0153-0154], wherein said additional connector of said transport element is connectable to said connector of said infusion element such that in a connected condition in which the additional connector of the transport element is connected to the connector of the infusion element a medium through flow connection is provided between the outlet end of the transport means and the inlet end of the infusion means for feeding the substance to the infusion means [0113-0115,0152-0154,0191-0192].
Regarding independent claim 16, Hanson in view of Bzostek teaches the claim as discussed above. Hanson as modified teaches a system for regulating the concentration of glucose in the blood of a person, comprising at least one said infusion set according to claim 15 (see above) and a device for selectively supplying at least one substance contained in at least one reservoir [0096,0118], said device comprising:
- at least one receiving space 20, for accommodating a said reservoir 40;
- at least one port 41, for connecting to a said connector 56 of a said transport element 50 of the infusion set, and
- a controller 16 for controlling said device such that a certain amount of a said substance is supplied and thereby infused into the body of the person [0101-0102,0118,0271-0272].
Regarding independent claim 17, Hanson in view of Bzostek teaches the claim as discussed above. Hanson as modified teaches a combination of a reservoir 40, and:
a transport element according to claim 1 (see claim 1 above).
Regarding independent claim 18, Hanson in view of Bzostek teaches the claim as discussed above. Hanson as modified teaches a method of at least fluidly connecting a transport element to a reservoir, comprising the steps of: a) providing a transport element according to claim 1 (see claim 1 above); b) providing a reservoir comprising an outlet end [0111-0113]; c) connecting the outlet end of the reservoir to the connector of the transport element, thereby aligning and holding said reservoir with the aligning and holding means of the connector in a connected condition [0191-0195,0207-0226].
Regarding dependent claim 19, Hanson in view of Bzostek teaches the claim as discussed above. Hanson further teaches, wherein in step c) said reservoir is connected to the connector along a connection path [0191-0194], wherein in a first part of said path the reservoir is pre-aligned by said additional aligning means [0207-0211], wherein in a second, subsequent part of said path the reservoir is aligned by said aligning and holding means and optionally the additional aligning means [0217-0222], and wherein said reservoir is subsequently held by said aligning and holding means in said connected condition and optionally aligned by said additional aligning means [0193,0214-0226].
Regarding dependent claim 20, Hanson in view of Bzostek teaches the claim as discussed above. Hanson further teaches wherein in step a) a system according to claim 16 is provided, wherein the transport element is part of an infusion set, said infusion set further comprising an additional connector arranged at an outlet end of the transport means, and an infusion element comprising an infusion means for infusing a substance into a body of a person, said infusion means comprising an inlet end for receiving said substance and an outlet end for infusing said substance into said body, wherein said infusion element comprises a connector for connecting to said additional connector of said transport element of the infusion set, wherein said additional connector of said transport element is connectable to said connector of said infusion element such that in a connected condition in which the additional connector of the transport element is connected to the connector of the infusion element a medium through flow connection is provided between the outlet end of the transport means and the inlet end of the infusion means for feeding the substance to the infusion means, wherein said infusion set is part of a system for regulating the concentration of glucose in the blood of a person, said system further comprising a device for selectively supplying at least one substance contained in at least one reservoir, said device comprising at least one receiving space, for accommodating a said reservoir, at least one port, for connecting to a said connector of a said transport element of the infusion set, and a controller for controlling said device such that a certain amount of a said substance is supplied and thereby infused into the body of the person, and wherein the method further comprises step d) of inserting the reservoir in said receiving space of the device [0111-0112,0127-0128,0138-0139,0190-0192].
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanson in view of Bzosteck and further in view of in view of Hansen et al. (WO 2009/027540).
Regarding dependent claim 12, Hanson in view of Bzostek teaches the claim as discussed above. Hanson further teaches wherein the additional aligning means comprise at least one elongated rib 559 that protrudes inwardly from the inner side of a circumferential wall of said connector and extends substantially parallel to said longitudinal axis. Hanson in view of Bzostek is silent to wherein the ribs and resilient members are arranged alternatingly along the circumference of the circumferential wall, preferably in an uniform distribution and/or spaced apart from each other.
Hansen teaches a medical connector with circumferentially distributed axially elongated lugs (see fig. 2).
It would have been obvious to one of ordinary skill at the time of filing to modify Hanson in view Bzostek, with the spaced ribs of Hansen, as Hansen teaches balanced load distribution (pg. 3, l. 1-17).
Conclusion
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/CRAIG KIM/
Primary Examiner
Art Unit 3741
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