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 .
Response to Amendment
The amendment filed 03/25/2022 has been entered. Claim 1-8 are pending in the application.
Claim Objections
Claims 1 and 4 are is objected to because of the following informalities:
Claim 1: On line 7, “the needle” should recite “the cannula-needle” to coincide with previous recitations of the element.
Claim 4: On line 3, “a sliding actuation means (32)” should recite “a sliding actuation means (42)” since numeral 32 appears to designate the opening and the sliding actuation means is designated as 42 in the specification.
Appropriate correction is required.
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 1-8 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 “a Seldinger assembly” in line 2. It is unclear what elements necessarily make up a Seldinger assembly. The Seldinger technique is known in the art as a technique for obtaining access to a blood vessel with the use of a guidewire, however, there is no concrete definition of the elements of a catheter insertion assembly that do or do not make up a Seldinger assembly. For the sake of examination, the limitation will be interpreted as reciting “a Seldinger assembly comprising a guidewire and a sliding actuation means” (in light of Page 6 , lines 15-17 of the specifications and dependent claim 4).
Claim 1 recites the limitation “obtained in said cylindrical seat” in line 11. There is insufficient antecedent basis for a “cylindrical seat” in the claim. For the sake of examination, the limitation will be interpreted as reciting “obtained in said end”.
Claim 4 recites the limitation “the opening” in line 3. There is insufficient antecedent basis for this limitation in the claim. While claim 3 recites “a longitudinally developed upper opening”, claim 4 does not depend from claim 3. For the sake of examination, the limitation will be interpreted as reciting “an opening”.
Claim 7 recites the limitation “said clamping means” in line 2. There is insufficient antecedent basis for this limitation in the claim. Further, based on the numeral, it is unclear if this is refereeing to the “safety means” recited in claim 1 or a new element. For the sake of examination, the limitation will be interpreted as reciting “the safety means”.
Claims 2-3, 5-6 are rejected as depending from a rejected claim.
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.
Specifically, the limitation “safety means” in claim 1 is being interpreted in view of page 6, lines 18-28 of the specification or equivalence thereof. Further, the limitation “sliding actuation means” in claim 4 is being interpreted in view of page 6, lines 10-17 of the specification or equivalence thereof
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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Korkuch (US 2019/0143082) in view of McKinnon (US 2008/0097344).
Regarding claim 1, Korkuch discloses a biomedical device (Device of Fig 1) for carrying out an arterial catheterization comprising a catheter assembly (102, Fig 1), a Seldinger assembly (132 and 138, Fig 3A), an outer sheath assembly (110, Fig 1) configured to contain thereinside both said catheter assembly and said Seldinger assembly when the device is assembled before its use (See Fig 1), at least a cannula-needle (130, Fig 3A) integral to the Seldinger assembly (Para 0045), valve means (122, Fig 2A) to avoid blood backflow and safety means (134, Fig 9A) for needle clamping (Para 0068), protection means (136, Fig 3A) for the needle (Para 0046), said catheter assembly comprising a thin tube (106, Fig 2B), a nearly cylindrically shaped end (120, Fig 2A) provided with a couple of side wings (118, Fig 2A), an inner cavity obtained in said end (208, Fig 11B), said device wherein said valve means and said safety means are located inside said outer sheath assembly (See Fig 8D) and wherein the valve means is located inside the inner cavity obtained in said end of the catheter assembly (Para 0071).
Korkuch is silent regarding the safety means is located inside the inner cavity obtained in said end of the catheter assembly
McKinnon teaches a biomedical device for carrying out catheterization comprising a catheter assembly (14, 16, 18, Fig 1), a cannula-needle (12, Fig 2), safety means (32 and 34, Fig 2) for needle clamping (Para 0023), said catheter assembly a thin tube (14, Fig 1), a nearly cylindrically shaped end (16, Fig 1) provided with a couple of side wings (18, Fig 1), an inner cavity (36, Fig 2) obtained in said end, said device wherein said safety means is located inside the inner cavity obtained in said end of the catheter assembly (See Fig 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the safety means to be the tip shield and septum disclosed by McKinnon in order to provide blood containment during withdrawal of the needle (Para 0006).
Regarding claim 2, the modified invention of Korkuch and McKinnon discloses said outer sheath assembly (110, Fig 1 -Korkuch) is provided with a couple of longitudinally developed side openings (side openings between arms 127 and 129, Fig 3A -Korkuch) configured to allow said couple of wings (118, Fig 2A -Korkuch) to come out of the catheter assembly (See Fig 1 -Korkuch).
Regarding claim 3, the modified invention of Korkuch and McKinnon discloses said outer sheath assembly (110, Fig 1 -Korkuch) is provided with a longitudinally developed upper opening (156, Fig 5 -Korkuch) through which it is possible to insert said Seldinger assembly (Para 0053 -Korkuch).
Regarding claim 4, the modified invention of Korkuch and McKinnon discloses said Seldinger assembly (132 and 138, Fig 3A -Korkuch) is made up of a sliding actuation means (138, Fig 3A -Korkuch), to be introduced in an opening (156, Fig 5 -Korkuch) of the outer sheath assembly (110, Fig 1 -Korkuch), and of a guidewire (132, Fig 3A -Korkuch) to be injected in the artery of the patient through the cannula-needle (Para 0003; Para 0053).
Regarding claim 5, the modified invention of Korkuch and McKinnon discloses said outer sheath assembly (110, Fig 1 -Korkuch) is also configured to be divided in two parts (Part 126 and part 128, Fig 3A -Korkuch), subjected to the actions of both the catheter assembly and the Seldinger assembly (Para 0059 -Korkuch).
Regarding claim 6, the modified invention of Korkuch and McKinnon discloses said thin tube (106, Fig 2B -Korkuch) of the catheter assembly (102, Fig 1 -Korkuch) comes out from an open end of the outer sheath assembly (110, Fig 1 -Korkuch) (See Fig 1 -Korkuch).
Regarding claim 7, the modified invention of Korkuch and McKinnon discloses said catheter assembly (102, Fig 1 -Korkuch) is also provided with a shunt tube (108, Fig 1 -Korkuch) with a universal end (116, Fig 2A -Korkuch), preferably of "luer lock" type (Para 0042 -Korkuch) and of at least one clamp (114, Fig 2A -Korkuch).
Regarding claim 8, the modified invention of Korkuch and McKinnon discloses said safety means (32 and 34, Fig 2 -McKinnon) comprise a spring bulkhead (34, Fig 2 -McKinnon) located inside a convex seat (34, Fig 2 -McKinnon), said bulkhead being configured to be closed when it is crossed by the tip of the needle (Para 0023 -McKinnon).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783