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 .
Election/Restrictions
Applicant’s election without traverse of Invention II, corresponding to claims 7-12 in the reply filed on 02/17/2026 is acknowledged.
Claims 1-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/17/2026.
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 8-9 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.
Regarding claim 8, the statement “further comprising a syringe cap” in line 1, renders the claim indefinite because it is unclear whether the syringe cap is an additional separate component of the vascular access system or if it is a structural feature in addition to the monolithic body. For purposes of examination, the examiner interprets “further comprising a syringe cap” as a structural feature in addition to the monolithic body. Claim 9 is rejected due to being dependent on claim 8.
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 7-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Fontana (US Pub No. 20220184369 A1).
Regarding claim 7, Fontana discloses a system comprising a monolithic, molded-polymer body (“formed in one piece from a medically acceptable thermoplastic, for example by injection molding” – Para [0051]) forming a female Luer connector defining an axial centerline (30 – Fig.1), the connector having inner (39 – Fig.1) and outer wall (Shown at 37 – Fig.1) circumferential surfaces, concentric with the axial centerline, which define a connector wall thickness therebetween relative to the axial centerline (See annotated Fig.1 below); four-lead, male, external helical threads on the outer wall circumferential surface (36 – Fig.1, “four-start threads” – Para [0052]), each helical thread having a respective, local, axial cross-section about the outer wall (Fig.1), the helical threads circumscribing a nested, concentrically aligned, frusto-conical, Luer-tapered, female mating surface that is formed in the inner wall circumferential surface (34 – Fig.1);
Fontana does not disclose wherein aggregate local, cross-sectional area of all threads aligned along any axial cross-section along the axial centerline of the connector is less than twelve percent (12%) of that of corresponding local, axial cross-sectional area of the connector wall.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify wherein aggregate local, cross-sectional area of all threads aligned along any axial cross-section along the axial centerline of the connector of Fontana to be less than twelve percent (12%) of that of corresponding local, axial cross-sectional area of the connector wall since it has been held that mere changes in size/proportion are obvious, MPEP 2144.04 IV A. the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In the instant case, the device of Fontana would not operate differently with the claimed size/proportion of the cross-sectional area of all threads aligned along any axial cross-section along the axial centerline of the connector. Further, applicant places no criticality on the size/proportion claimed, indicating simply, “in some embodiments, aggregate local, cross-sectional area of all threads aligned along any axial cross-section along the axial centerline of the connector is less than twelve percent (12%) of that of corresponding local, axial cross-sectional area of the connector wall” (Para [0014]).
Regarding claim 8, Fontana discloses the system as disclosed above, further comprising a syringe cap (Shown at 37 – Fig.1).
Regarding claim 10, Fontana discloses the system as disclosed above, further comprising a patient vascular port (Shown at 34 – Fig.1).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Fontana in view of the recited prior art in applicants’ specification (POSIFLUSH®).
Regarding claim 9, Fontana discloses the system as disclosed above, further comprising each of the four-lead, male external helical threads having dimensions, but Fontana does not explicitly disclose wherein each of the four-lead, male external helical threads having the following local dimensions relative to the axial centerline (in millimeters and degrees):
an 11.98-degree helix angle;
a 46-degree thread angle;
a 0.43 thread depth;
a 0.53 root axial width;
a 0.37 crest axial width;
a 5.08 thread lead; and
a 1.27 thread pitch.
(POSIFLUSH®) teaches a two-lead, male external helical threads having the following local dimensions relative to the axial centerline (in millimeters and degrees):
an 11.98-degree helix angle;
a 46-degree thread angle;
a 0.43 thread depth;
a 0.53 root axial width;
a 5.08 thread lead;
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the four-lead, male external helical threads of Fontana to comprise the same dimensions of the helix angle, thread angle, thread depth, root axial width, and thread lead taught by POSIFLUSH® since POSIFLUSH® teaches that these dimensions are well known, typical axial, cross-sectional dimensions of a Luer connector portion of a syringe cap.
It would also be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the crest axial width to be 0.37mm and the thread pitch to be 1.27mm since it has been held that mere changes in size/proportion are obvious, MPEP 2144.04 IV A. the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In the instant case, the device of Fontana would not operate differently with the claimed size/proportion of the local dimensions relative to the axial centerline. Further, applicant places no criticality on the size/proportion claimed, indicating simply, “ Therefore, the four-start thread, syringe cap of the present disclosure reduces axial, cross-sectional area of each helical rib by approximately 66 percent, compared to that of the helical rib of the known two-start syringe cap” (Para [0039]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Fontana in view of Davis et al. (US Pub No. 20130046287 A1, herein, Davis).
Regarding claim 11, Fontana discloses a connector comprising:
a monolithic, molded-polymer, tubular body (“formed in one piece from a medically acceptable thermoplastic, for example by injection molding” – Para [0051]), defining an axial centerline, and a female Luer connector on a proximal end of the tubular body (30 – Fig.1);
respective inner (39 – Fig.1) and outer walls (Shown at 37 – Fig.1), and respective inner and outer wall circumferential surfaces of the female Luer connector defining a connector wall thickness therebetween relative to the axial centerline (See annotated Fig.1 above);
four-lead, male, external helical threads on the outer wall circumferential surface (36 – Fig.1, “four-start threads” – Para [0052]) of the female Luer connector each helical thread having a respective, local, axial cross-section about the outer wall (Fig.1); and
a frusto-conical, Luer-tapered, female mating surface, formed in the inner wall circumferential surface of the female Luer connector, in nested, coaxial alignment with the helical threads (34 – Fig.1);
Fontana does not disclose the tubular body incorporating an annular grip surface on a distal axial end thereof and the respective inner and outer wall circumferential surfaces of the annular grip surface defining a grip wall thickness therebetween relative to the axial centerline and wherein aggregate local, cross-sectional area of all threads aligned along any axial cross-section along the axial centerline of the connector is less than twelve percent (12%) of that of corresponding local, axial cross-sectional area of the connector wall.
Davis teaches a tubular body (106 – Fig.1) incorporating an annular grip surface on a distal axial end thereof (“griping surface” – Para [0031]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the tubular body of Fontana to incorporate an annular grip surface as taught by Davis since Davis teaches that ridges provide a gripping surface that enables a user to hold or grasp on to while positioning the tubular body about male tubing fitting (Davis, Para [0031]).
it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify wherein aggregate local, cross-sectional area of all threads aligned along any axial cross-section along the axial centerline of the connector of Fontana to be less than twelve percent (12%) of that of corresponding local, axial cross-sectional area of the connector wall since it has been held that mere changes in size/proportion are obvious, MPEP 2144.04 IV A. the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In the instant case, the device of Fontana would not operate differently with the claimed size/proportion of the cross-sectional area of all threads aligned along any axial cross-section along the axial centerline of the connector. Further, applicant places no criticality on the size/proportion claimed, indicating simply, “in some embodiments, aggregate local, cross-sectional area of all threads aligned along any axial cross-section along the axial centerline of the connector is less than twelve percent (12%) of that of corresponding local, axial cross-sectional area of the connector wall” (Para [0014]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Fontana in view of Davis and further in view of the recited prior art in applicants’ specification (POSIFLUSH®).
Regarding claim 12, Fontana discloses the system as disclosed above, further comprising each of the four-lead, male external helical threads having dimensions, but Fontana does not explicitly disclose wherein each of the four-lead, male external helical threads having the following local dimensions relative to the axial centerline (in millimeters and degrees):
an 11.98-degree helix angle;
a 46-degree thread angle;
a 0.43 thread depth;
a 0.53 root axial width;
a 0.37 crest axial width;
a 5.08 thread lead; and
a 1.27 thread pitch.
(POSIFLUSH®) teaches a four-lead, male external helical threads having the following local dimensions relative to the axial centerline (in millimeters and degrees):
an 11.98-degree helix angle;
a 46-degree thread angle;
a 0.43 thread depth;
a 0.53 root axial width;
a 5.08 thread lead;
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the four-lead, male external helical threads of Fontana to comprise the same dimensions of the helix angle, thread angle, thread depth, root axial width, and thread lead as taught by POSIFLUSH® since POSIFLUSH® teaches that these dimensions are well known, typical axial, cross-sectional dimensions of a Luer connector portion of a syringe cap.
It would also be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the crest axial width to be 0.37mm and the thread pitch to be 1.27mm since it has been held that mere changes in size/proportion are obvious, MPEP 2144.04 IV A. the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In the instant case, the device of Fontana would not operate differently with the claimed size/proportion of the local dimensions relative to the axial centerline. Further, applicant places no criticality on the size/proportion claimed, indicating simply, “ Therefore, the four-start thread, syringe cap of the present disclosure reduces axial, cross-sectional area of each helical rib by approximately 66 percent, compared to that of the helical rib of the known two-start syringe cap” (Para [0039]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm EST.
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/MARISSA TAYLOR/ Examiner, Art Unit 3783 /BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783