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 .
Acknowledgment
Claims 1, 14-15, 24-25 are amended and filed on 12/29/2025.
Claims 2, 5, 8, 11-13, 16-17, 22-23 are canceled.
Claim Objections
Claims 15, 24 is objected to because of the following informalities:
In lime 4 of claim 15 “ the second medical” should read as “the second medical device”.
In lines 5-6 of claim 24 should be deleted as it is a repetition of limitation of last two lines of claim 15.
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 3, 6, 14 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 3 recites the limitation "a first medical device" in line 2. It is unclear if it referring to the limitation in line 4 of claim 1 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to line 4 of claim 1.
Claim 6 recites the limitation "a second medical device" in line 2. It is unclear if it referring to the limitation in line 7 of claim 1 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to line 7 of claim 1.
Claim 14 recites the limitation " a first medical device and a second medical device" in line 2. It is unclear if it referring to the limitation in claim 1 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to limitations in claim 1.
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.
Claim(s) 1, 3, 4, 6-7, 9-10, 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andino et al. (US. 20120271240A1) (“Andino”).
Re claim 1, Andino discloses a medical device hub (342 to 344 including 334, Figs. 1-3, ¶0064, ¶0066) comprising: a monolithic housing (housing of 330 as a single unit and made form injection molding ¶0054, ¶0065, ¶0070) defining: a first fitting (male luer lock 342, ¶0068), wherein he first fitting is configured to removably coupled with a first medical device (220, ¶0068); a second fitting (a portion under 344 and /or 344) in fluid communication with the first fitting (¶0064, ¶0067), wherein the second fitting is configured to removably couple with a second medical device (210, Fig. 3, ¶0064); and a mounting feature (334, ¶0066) comprising a pair of flanges (at least two of 334), the flanges being parallel and non-coplanar (Fig. 3).
Re claim 3, Andino discloses wherein the first fitting comprises a threaded portion ( lower end of 342) configured to threadedly engage with a first medical device (220, ¶0064 and wherein 220 has nut 222 that connected to 342).
Re claim 4, Andino discloses wherein the first fitting is a male luer fitting (¶0068).
Re claim 6, Andino discloses wherein the second fitting comprises a threaded portion configured to threadedly engage with a second medical device (¶0067).
Re claim 7, Andino discloses wherein the second fitting is a female luer fitting (¶0068, Fig. 3).
Re claim 9, Andino discloses wherein the mounting feature defines at least one engagement feature (surfaces of 334).
Re claim 10, Andino discloses, wherein the housing is comprised of a polymeric material (¶0065, ¶0054).
Re claim 14, Andino discloses wherein, when the medical device hub is coupled with a first medical device (220) and a second medical device (210, ¶0022, ¶0068).
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(s) 15, 18-21, -24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andino in view of Tyagi et al. (US 2018/0050176 A1) (“Tyagi”).
Re claim 15, Andino discloses a system (Fig. 1-4) for securing a first medical device (220, Figs. 1-3) relative to a second medical device (210), the system comprising: the first medical device (220); a second medical device (210) and a medical device hub (342 to 344 including 334) positioned between the first medical device and the second medical device (Fig. 4), the medical device hub comprising: a monolithic housing (housing of 330 as a single unit ¶0064), defining: a first fitting coupled to the first medical device (lower end of 342 that connected to 220, ¶0068); a second fitting coupled to the second medical device (344, ¶0068) in fluid communication with the first fitting via a fluid channel in the housing (Fig. 4. ¶0022, ¶0068); and a mounting feature (334) wherein the first medical device is in fluid communication with the second medical device (Fig. 4, ¶0022, ¶0068); and a mounting bracket (322, 110, 310) removably coupled to the mounting feature of the medical device hub (¶0066), the mounting bracket configured to be mounted on a patient (Fig. 4), but it fails to disclose wherein the mounting bracket comprises a bracket engagement structure configured to nest with the mounting feature of the medical device hub.
However, Tyagi teaches discloses a medical device hub (16, Fig.1-5, ¶0048) coupled to medical device (12, Fig. 1) and wherein the medical device hub comprises a mounting feature (36, 38) and a mount bracket (22, 30) comprises a bracket engagement structure (40, 42, and or 46, Fig. 4-51; ¶0051) configured to nest with the mounting feature of the medical device hub ( Fig. 4).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the device of Andino so that the mounting bracket comprises a bracket engagement structure configured to nest with the mounting feature of the medical device hub as taught by Tyagi for the purpose of fastening the hub to patient which capable to be adjustable to accommodate the size differences of patient’s arms or to accommodate the sizes of securing location of the patient (Tyagi, ¶0050, the modification by changing the engagement between the hub and the mounting bracket of Andino to one of Tyagi ).
Re claim 18, Andino discloses wherein the first medical device is an indwelling IV catheter hub (220, catheter, ¶0026, 20067).
Re claim 19, Andino discloses further comprising an IV catheter lumen coupled to the first medical device ( lumen of 220 which can be connected to other set to carry fluid to or from the patient, ¶0067).
Re claim 20, Andino discloses wherein the second medical device is a needleless connector (Fig. 3).
Re claim 21, Andino discloses further comprising an IV extension line coupled to the second medical device (220, Fig.3;catheter extension set 220, ¶0064).
Re claim 24, Andino fails to disclose wherein: the mounting feature defines at least one engagement feature; the mounting bracket engagement structure comprises at least one mounting bracket engagement feature; and wherein the engagement feature is configured to nest with the mounting bracket engagement feature.
However, Tyagi teaches discloses a medical device hub (16, Fig. ¶0048) coupled to medical device (12, Fig. 1) and wherein the medical device hub comprises a mounting feature (36 and 38, Fig. 1; ¶0051] that can be removably coupled with a mounting bracket (22, Fig. 1; closure device 20, Fig. 5) and the mounting bracket comprises a bracket engagement structure ( slots 40, 42) configured to nest with the mounting feature of the medical device hub (Fig. 1).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the device of Andino to include a mounting bracket so that the mounting feature defines at least one engagement feature; the mounting bracket engagement structure comprises at least one mounting bracket engagement feature; and wherein the engagement feature is configured to nest with the mounting bracket engagement feature as taught by Tyagi for the purpose of fastening the hub to patient which capable to be adjustable to accommodate the size differences of patient’s arms or to accommodate the sizes of securing location of the patient (Tyagi, ¶0050).
Claim(s) 25-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andino in view of Tyagi and further in view of Albany (US 20190388652A1).
Re claim 25, the modified Andino fails to disclose a retention device removably coupled to the mounting bracket.
However, Albany teaches discloses a medical device hub (40, Fig. 1a-b) coupled to medical device (41 and 42, Fig. 1) and wherein the medical device hub comprises a mounting feature (surface of 40) that can be removably coupled with a mounting bracket (20, Fig. 1b) and a retention device (80) removably coupled to the mounting bracket (¶0125, hook and loop or buckles) .
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the device of Andino to include a retention device so that the retention device removably coupled to the mounting bracket as taught by Albany for the purpose of fastening the hub to patient which capable to be adjustable to accommodate the size differences of patient’s arms or to accommodate the sizes of securing location of the patient (Albany, ¶0006, ¶0125).
Re claim 26, the modified Andino fails to disclose wherein the retention device is removably affixed to a user.
However, Albany teaches discloses a medical device hub (40, Fig. 1a-b) coupled to medical device (41 and 42, Fig. 1) and wherein the medical device hub comprises a mounting feature (surface of 40) that can be removably coupled with a mounting bracket (20, Fig. 1b) and a retention device (80) is removably affixed to a user (¶0024, ¶0125, hook and loop or buckles).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the device of Andino to include a retention device so that the retention device is removably affixed to a user as taught by Albany for the purpose of fastening the hub to patient which capable to be adjustable to accommodate the size differences of patient’s arms or to accommodate the sizes of securing location of the patient (Albany, ¶0006, ¶0125).
Re claim 27, the modified Andino fails to disclose wherein the retention device is one or more of an arm band and a strap.
However, Albany teaches discloses a medical device hub (40, Fig. 1a-b) coupled to medical device (41 and 42, Fig. 1) and wherein the medical device hub comprises a mounting feature (surface of 40) that can be removably coupled with a mounting bracket (20, Fig. 1b) and a retention device (80) is one or more of an arm band and a strap (¶0024, ¶0125, hook and loop or buckles).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the device of Andino to include a retention device so that the retention device is one or more of an arm band and a strap as taught by Albany for the purpose of fastening the hub to patient which capable to be adjustable to accommodate the size differences of patient’s arms or to accommodate the sizes of securing location of the patient (Albany, ¶0006, ¶0125).
Re claim 28, the modified Andino fails to disclose the mounting bracket comprises at least one retention device engagement feature and wherein the retention device is removably engageable with the retention device engagement feature.
However, Albany teaches discloses a medical device hub (40, Fig. 1a-b) coupled to medical device (41 and 42, Fig. 1) and wherein the medical device hub comprises a mounting feature (surface of 40) that can be removably coupled with a mounting bracket (20, Fig. 1b) and a retention device (80) and at least one retention device engagement feature ( 22, Fig. 2a) and wherein the retention device is removably engageable with the retention device engagement feature (¶0024, ¶0125, hook and loop or buckles).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the device of Andino to include at least one retention device engagement feature so that at least one retention device engagement feature and wherein the retention device is removably engageable with the retention device engagement feature taught by Albany for the purpose of fastening the hub to patient which capable to be adjustable to accommodate the size differences of patient’s arms or to accommodate the sizes of securing location of the patient (Albany, ¶0006, ¶0125).
Response to Arguments
Applicant's arguments filed 12/29/2025 with respect to newly added limitation have been fully considered but they are not persuasive.
The applicant argues with regards to claim 1 that monolithic housing should not include 344. This is found not persuasive as Andino discloses that 342 is integral and 344 a threaded portion.
Applicant’s arguments with respect to the rejection(s) of claim(s) 15 under 102 rejection have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Andino in view of Tyagi.
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 HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783