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 Species I (Figures 2A-2E, 3A-3D, 9H-9I) in the reply filed on July 21, 2026, is acknowledged.
Claims 9-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Species II-III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 21, 2026.
Specification
The abstract of the disclosure is objected to because:
In line 8, “the other needle shield element” should be changed to “the another needle shield element”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 2 and 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.
In regards to claim 2, lines 2-3 recite: “an insertion slot” transverse to a longitudinal axis of the housing and “providing access to the insertion slot”. Interpreting said limitation as “an insertion slot… providing access to the insertion slot”, it is unclear how the insertion slot would provide access to itself.
In regards to claim 8, line 4 recites “the medical device”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kulli (US 2007/0270753).
In regards to claim 1, Kulli teaches a catheter system (Figures 5-8), comprising:
a catheter hub (56), comprising a distal end, a proximal end, and a lumen extending through the distal end and the proximal end (Figures 7-8)
a catheter (57) extending from the distal end of the catheter hub
a needle hub (15)
an introducer needle (12) extending distally from the needle hub, wherein the introducer needle extends through the catheter when the introducer needle is in an advanced position (Figure 7)
a compressible element (10’) comprising a first hole (32’) and a second hole (34’), wherein the introducer needle extends through the first hole and the second hole when the introducer needle is in the advanced position (Figures 5, 7), wherein in response to movement of the introducer needle proximally to a retracted position, the introducer needle is removed from the first hole and the second hole and the compressible element expands, wherein in response to the compressible element expanding, the first hole and the second hole misalign, shielding the introducer needle from distal movement beyond the compressible element (Figures 6, 8)
In regards to claim 2, Kulli teaches a housing (labeled in Figure 7 below), wherein the housing comprises a pocket (labeled in Figure 7 below) and an insertion slot (labeled in Figure 7 below) transverse to a longitudinal axis of the housing and providing access to the insertion slot, wherein a distal end of the housing is coupled to the proximal end of the catheter hub (labeled in Figure 7 below), wherein the compressible element is disposed within the pocket, wherein the compressible element is configured to compress in order to fit through the insertion slot and into the pocket (Figure 7).
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In regards to claim 3, Kulli teaches a housing (labeled in Figure 7 below) comprising an elongated slot (labeled in Figure 7 below) aligned with a longitudinal axis of the housing, wherein a distal end of the housing is coupled to the proximal end of the catheter hub, wherein the needle hub extends through the elongated slot and is configured to move along the elongated slot to move the introducer needle from the advanced position to the retracted position (Figures 7-8).
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In regards to claim 4, Kulli teaches wherein the elongated slot is a first elongated slot (labeled in Figure 7 below), wherein the housing comprises a second elongated slot (labeled in Figure 7 below) aligned with the longitudinal axis of the housing, wherein the needle hub extends through the first elongated slot and is configured to move along the first elongated slot and the second elongated slot to move the introducer needle from the advanced position to the retracted position (Figure 7-8).
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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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kulli, as applied to claim 3 above, and further in view of Rossetti (EP 0459954).
In regards to claim 5, Kulli does not teach wherein a proximal end of the elongated slot comprises a retainer snap. Rossetti teaches a catheter system (Figures 1-4) wherein a proximal end of an elongated slot (11) comprises a retainer snap (12). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify a proximal end of the elongated slot, of the system of Kulli, to comprise a retainer snap, as taught by Rossetti, as such will irreversibly lock the needle completely retracted within the housing (column 2, lines 49-54)(column 4, lines 11-19).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kulli, as applied to claim 1 above, and further in view of Shevgoor et al (US 2017/0035995).
In regards to claim 8, Kulli does not teach wherein a lumen of the catheter hub comprises a blood-control septum, a septum actuator, and a spring coupled to the septum actuator, wherein the spring is configured to return the septum actuator to an initial position proximal to the septum in response to removal of the medical device from the proximal end of the catheter hub. Shevgoor et al teaches a catheter system (Figures 1-20) wherein a lumen of a catheter hub (14) comprises a blood-control septum (26), a septum actuator (28), and a spring (30) coupled to the septum actuator, wherein the spring is configured to return the septum actuator to an initial position proximal to the septum in response to removal of a medical device from a proximal end of the catheter hub (Figure 20). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify a lumen of the catheter hub, of the system of Kulli, to comprise a blood-control septum, a septum actuator, and a spring, as taught by Shevgoor et al, as such will allow for permitting fluid flow through the catheter hub and preventing unwanted fluid flow through the catheter hub (paragraphs [0118][0119]).
Allowable Subject Matter
Claims 6-7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regards to claim 6, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a catheter system, as claimed, specifically including wherein the compressible element comprises a coil shape, wherein the first hole is disposed in a first end of the coil shape and the second hole is disposed in a second end of the coil shape.
Kulli does not teach wherein the compressible element comprises a coil shape, wherein the first hole is disposed in a first end of the coil shape and the second hole is disposed in a second end of the coil shape, as Kulli instead teaches wherein the compressible element comprises a disks shape 28’/30’, wherein the first hole (32’) is disposed in a first end (28’) of the disks shape and the second hole (34’) is disposed in a second end (30’) of the disks shape.
Thus, claim 6 is objected to as being dependent upon a rejected base claim 1, but would be allowable if rewritten in independent form including all of the limitations of the base claim 1. Claim 7 is objected to by virtue of being dependent upon claim 6.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm EST.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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