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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. CN202011175769.9 , filed on 10/29/2020.
Status of Claims
Claims 1-20 are pending and currently under consideration for patentability.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/30/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Response to Arguments
Applicant's arguments filed 3/30/2026 have been fully considered but they are not persuasive.
Burkholz does teach a needle assembly (32) comprising: a body comprising: a distal end comprising a male port (36)(paragraph [0036]; figure 2), the distal end extending into the insert completely through the septum; a proximal end; a lumen extending through the distal end and the proximal end; and a needle extending from the proximal end (paragraph [0023]).
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 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.
Claim(s) 6, 9, and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) being anticipated by Burkholz (US 20120016266 A1).
Regarding Claim 6, Burkholz teaches a catheter system, comprising: a catheter assembly (24), comprising:
a catheter adapter(28);
a catheter (30) extending distally from the catheter adapter (figure 2);
an extension tube (36), comprising a distal end and a proximal end, wherein the distal end is coupled to the catheter adapter (figure 1);
an adapter (40) coupled to the proximal end of the extension tube (paragraphs [0024], [0031]); and
a needleless connector coupled to the adapter (36) (paragraphs [0024], [0031]); and
an insert (42), comprising:
a distal end, comprising a male port (figure 2);
a proximal end (see ex. fig. 1), comprising a female port (54) (fig. 2) opposite the male port (52) (figure 2);
a middle portion disposed between the distal end and the proximal end (figure 2), wherein the middle portion comprises an elongated tubular portion (see ex. fig. 1) and a tapered or stepped portion proximal (see ex. fig. 1) and proximate to the elongated tubular portion, wherein an outer diameter of the elongated tubular portion is uniform (figure 2), wherein an outer diameter of the tapered or stepped portion increases in a proximal direction (figure 2); and
a lumen (96, 94) extending through the male port, the middle portion, and the female port (paragraph [0036]; figure 2), wherein the insert is inserted through the needleless connector and the adapter such that the male port is disposed within the extension tube and the tapered or stepped portion is proximal to the needleless connector (paragraphs [0034], [0036]; figure 3).
A needle assembly (32) comprising: a body comprising: a distal end comprising a male port (36)(paragraph [0036]; figure 2), the distal end extending into the insert completely through the septum; a proximal end; a lumen extending through the distal end and the proximal end; and a needle extending from the proximal end (paragraph [0023]).
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Regarding Claim 9, Burkholz teaches the catheter system of claim 6. Burkholz further teaches wherein in response to inserting the insert through the needleless connector and adapter of the catheter system, blood is configured to flow through the insert and does not contact the needleless connector or the adapter (paragraph [0024, 0031]).
Regarding Claim 11, Burkholz teaches the catheter system of claim 6. Burkholz further teaches wherein the insert is monolithically formed as a single unit (figure 2).
Regarding Claim 12, Burkholz teaches the catheter system of claim 6. Burkholz further teaches wherein the elongated tubular portion has a greater length than the tapered or stepped portion (figure 2).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20120016266 A1) in view of Moorehead (US 20030032922 A1).
Regarding Claim 1, Burkholz teaches an insert for a catheter system (20) paragraphs ([0034] - [0037], [0041];figures 1, 2), the insert comprising:
a distal end (see ex. Fig. 1), comprising a male port (figure 2);
a proximal end (see ex. fig. 1), comprising a female port (fig. 2) opposite the male port (figure 2); a middle portion disposed between the distal end and the proximal end (figure 2), wherein the middle portion comprises an elongated tubular portion (see ex. fig. 1) and a tapered or stepped portion proximal (see ex. fig. 1) and proximate to the elongated tubular portion, wherein an outer diameter of the elongated tubular portion is uniform (figure 2), wherein an outer diameter of the tapered or stepped portion increases in a proximal direction (figure 2); and
a wall forming a lumen extending through the male port, the middle portion, and the female port (paragraph [0036]; figure 2).
Burkholz fails to teach wherein a thickness of a portion of the wall extending from the male port to a proximal end of the tapered or stepped portion is at least substantially uniform. Moorehead teaches wherein a thickness of a portion of the wall extending from the male port to a proximal end of the tapered or stepped portion is at least substantially uniform (paragraph [0038]) (fig. 2). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the wall of Burkholz so the wall near the port is uniform, similar to Moorehead to maintain a blunt and solid edge (Moorehead, paragraph [0038]).
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Regarding Claim 4, Burkholz in view of Moorehead teaches an insert of claim 1. Burkholz further teaches wherein the insert is monolithically formed as a single unit (figure 2).
Regarding Claim 5, Burkholz in view of Moorehead teaches an insert of claim 1. Burkholz further teaches wherein the elongated tubular portion has a greater length than the tapered or stepped portion (figure 2).
Claim(s) 2, 3, is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20120016266 A1) Moorehead (US 20030032922 A1) in view of Stout (US 20140018621 A1).
Regarding Claim 2, Burkholz in view of Moorehead teaches an insert of claim 1. Burkholz fails to teach a septum disposed within the female port. Stout teaches the insert (400) has housing that includes distal sealing surface (410), lumen (412), and base (402). A septum (406) disposed within the female port (paragraph [0028])(Figure 4). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the insert of Burkholz to include a split septum, similar to Stout, to create a seal within the insert (as motivated by Stout, paragraph [0028]).
Regarding Claim 3, Burkholz in view of Moorehead teaches an insert of claim 2. Burkholz fails to teach wherein the septum comprises a split septum. Stout teaches the insert (400) has housing that includes distal sealing surface, lumen, and base, wherein the septum comprises a split septum (paragraph [0028])(Figure 4). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the insert of Burkholz to include a split septum, similar to Stout, to create a seal within the insert (as motivated by Stout, paragraph [0028]).
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20120016266 A1) in view of Stout (US 20140018621 A1).
Regarding Claim 7, Burkholz teaches the catheter system of claim 6. Burkholz fails to teach a septum disposed within the female port. Stout teaches the insert (400) has housing that includes distal sealing surface, lumen, and base. A septum (406) disposed within the female port (paragraph [0028])(Figure 4). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the insert of Burkholz to include a split septum, similar to Stout, to create a seal within the insert (as motivated by Stout, paragraph [0028]).
Regarding Claim 8, Burkholz teaches the catheter system of claim 7. Burkholz fails to teach wherein the septum comprises a split septum. Stout teaches the insert (400) has housing that includes distal sealing surface, lumen, and base, wherein the septum comprises a split septum (paragraph [0028])(Figure 4). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the insert of Burkholz to include a split septum, similar to Stout, to create a seal within the insert (as motivated by Stout, paragraph [0028]).
Claim(s) 10 and 13-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20120016266 A1) in view of Harding (US 20200129738 A1).
Regarding Claim 10, Burkholz teaches the catheter system of claim 6. Burkholz teaches wherein the needle assembly further comprises a needle extending from the proximal end of the body and configured to receive an evacuated blood collection tube.
Burkholz fails to teach further comprising a needle assembly and a blood collection tube holder coupled to the needle assembly. Harding teaches a catheter system may include a catheter adapter (12), a catheter (10) extending distally from the catheter adapter (12), an introducer needle (16) extending through the catheter (fig. 1), a flash chamber (46) in fluid communication with a needle lumen of the introducer needle, and a seal element comprising a needle assembly and a blood collection tube (collection tube) holder coupled to the needle assembly (paragraph [0092-0093]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter system of Burkholz so a blood collection tube holder is coupled to the needle assembly, similar to Harding, so the blood may be collected for analysis and efficiently.
Regarding Claim 13, Burkholz teaches a method of sampling blood, comprising:
inserting an insert through a needleless connector and adapter of a catheter system, wherein the catheter system comprises (paragraph [0024, 0031]).:
a catheter adapter(28);
a catheter (30) extending distally from the catheter adapter (figure 2);
an extension tube (36), comprising a distal end and a proximal end, wherein the distal end is coupled to the catheter adapter (figure 1);
an adapter (40) coupled to the proximal end of the extension tube (paragraphs [0024], [0031]); and
a needleless connector coupled to the adapter (paragraphs [0024], [0031]); and
an insert (42), comprising:
a distal end, comprising a male port (figure 2);
a proximal end (see ex. fig. 1), comprising a female port (fig. 2) opposite the male port (figure 2);
a middle portion disposed between the distal end and the proximal end (figure 2), wherein the middle portion comprises an elongated tubular portion (see ex. fig. 1) and a tapered or stepped portion proximal (see ex. fig. 1) and proximate to the elongated tubular portion, wherein an outer diameter of the elongated tubular portion is uniform (figure 2), wherein an outer diameter of the tapered or stepped portion increases in a proximal direction (figure 2); and
a lumen (96, 94) extending through the male port, the middle portion, and the female port (paragraph [0036]; figure 2), wherein the insert is inserted through the needleless connector and the adapter such that the male port is disposed within the extension tube and the tapered or stepped portion is proximal to the needleless connector (paragraphs [0034], [0036]; figure 3)
wherein the middle portion of the insert extends through the catheter adapter and at least partially within the proximal end of the extension tube (figure 3)
wherein the body comprises a distal end, a proximal end, and a lumen extending through the distal end of the body and the proximal end of the body, wherein the distal end of the body comprises a male port, wherein the needle assembly further comprises a needle extending from the proximal end of the body and configured to receive an evacuated blood collection tube (paragraphs [0034], [0036]; figure 3).
Burkolz fails to teach and inserting a needle assembly into the female port of the insert, wherein the needle assembly comprises a body, and after inserting the insert through the needleless connector and the adapter and after inserting the needle assembly into the female port of the insert
Harding teaches and inserting a catheter system may include a catheter adapter (12), a catheter (10) extending distally from the catheter adapter (12), an introducer needle (16) extending through the catheter (fig. 1), a flash chamber (46) in fluid communication with a needle lumen of the introducer needle, and a seal element comprising a needle assembly and a blood collection tube (collection tube) holder coupled to the needle assembly (paragraph [0074]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Burkolz to insert through the needleless connector and the adapter and after inserting the needle assembly into the female port of the insert into the female port of the insert for stability and precision of access to the blood steam.
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Regarding Claim 14, Burkholz in view of Harding teaches the method of claim 12. Burkholz further teaches wherein after inserting the catheter into the vein of the patient, inserting the needle into the evacuated blood collection tube and collecting blood in the evacuated blood collection tube (paragraph [0037]).
Regarding Claim 15, Burkholz in view of Harding teaches the method of claim 13. The combination further comprising, removing the needle assembly from the female port of the insert and coupling a syringe to the female port (Harding, paragraph [0094]).
Regarding Claim 16, Burkholz in view of Harding teaches the method of claim 14. Burkholz further teaches wherein the female port is threaded, wherein coupling the syringe to the female port comprises threading the syringe to the female port (paragraph [0030][0038]).
Regarding Claim 17, Burkholz in view of Harding teaches the method of claim 15. Burkholz further teaches wherein comprising, flushing the catheter by activating the syringe [0033].
Regarding Claim 18, Burkholz in view of Harding teaches the method of claim 17. The combination further removing the insert from the catheter system during an indwelling period of the catheter in the vein of the patient (Harding, paragraph [0074]) .
Regarding Claim 19, Burkholz in view of Harding teaches the method of claim 12. Burkholz further teaches wherein in response to inserting the insert through the needleless connector and adapter of the catheter system, blood is configured to flow through the insert and does not contact the needleless connector or the adapter (paragraphs [0034], [0036]);.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20120016266 A1) in view of Harding (US 20200129738 A1) in view of Stout (US 20140018621 A1).
Regarding Claim 20, Burkholz in view of Harding teaches the method of claim 12. Burkholz fails to teach a septum disposed within the female port. Stout teaches the insert (400) has housing that includes distal sealing surface, lumen, and base. A septum (406) disposed within the female port (paragraph [0028])(Figure 4). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the insert of Burkholz to include a split septum, similar to Stout, to create a seal within the insert (as motivated by Stout, paragraph [0028]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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