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 .
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.
Claims 1-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Devgon et al (US 2020/0230358 A1).
Regarding claim 1, Devgon discloses a medical device (Fig 44; [0166-0167]), comprising:
an instrument 1060 having a proximal end and a distal end;
an instrument delivery device 1010 (introducer) configured to moveably receive the instrument 1060 and having:
an outer housing 1010 having a proximal end, a distal end, and a sidewall therebetween defining an inner volume; and
an inner housing 1086 having a proximal end, a distal end, and a sidewall therebetween defining an inner volume, the inner housing coupled to the instrument at 1075 [0166] and slidably received within the outer housing [0167];
the distal end of the instrument delivery device configured to couple the instrument delivery device to an intravenous line [0166]; and
wherein the inner housing 1086 is configured to move relative to the outer housing [0167] to move the instrument 1060 between a first position, in which the instrument is disposed within the outer housing, and a second position, in which the distal end of the instrument is disposed beyond the distal end of the outer housing such that at least a first portion of the instrument is disposed within the intravenous line when the instrument delivery device is coupled to the intravenous line.
Regarding claim 2, Devgon discloses the outer housing 1010 comprises a lock 1040 at the distal end thereof, the lock configured to couple the instrument delivery device to an intravenous line.
Regarding claim 3, Devgon discloses a joint 216 ([0089], can be seen in fig 4) is arranged at the distal end of the outer housing.
Regarding claim 4, the joint is a rotating joint (threads, [0089]).
Regarding claim 5, Devgon further comprising a septum (seal, [0089-0090]) arranged at the distal end of the outer housing.
Regarding claim 6, further comprising a seal (seal, [0089]) arranged at the proximal end of the instrument.
Regarding claim 7, further comprising lubricant [liquid, 0090] arranged at one or more locations within the inner housing.
Regarding claim 8, Devgon discloses the inner housing comprises a grip at 1075 arranged at the proximal end thereof.
Regarding claims 9-10, Devgon discloses the instrument is a catheter.
Regarding claims 11-13, the inner housing at 1086 includes a clamp at at the proximal end thereof, configured to selectively block fluid flow through the inner housing (see fig 24, [0105, 0128]).
Regarding claim 14, Devgon discloses the inner housing is in fluid communication with the catheter 1060, such that fluid flowing proximally from the catheter is received within the inner housing (fig 44).
Regarding claim 15, Devgon discloses the inner housing 1086 further comprises a fluid conduit 265 (figs 25-28) or 365 (figs 31-32) in fluid communication with the catheter 1060 (not labeled in fig 44).
Regarding claim 16, Devgon discloses the fluid conduit 265 (figs 27-28) extends proximally beyond the proximal end of the inner housing.
Regarding claim 17, further comprising a fluid conduit at 265 (figs 27-28) coupled to the proximal end of the inner housing.
Regarding claim 18, further comprising one support at 1086 [0167] arranged within the outer housing and configured to limit buckling of the instrument as it is advanced through the outer housing.
Regarding claim 19, Devgon discloses the inner housing 1086 is formed of a material with sufficient stiffness to limit and/or prevent buckling of the inner housing as it is advanced through the outer housing [0167].
Regarding claim 20, Devgon discloses an inner diameter of the outer housing (figs 5-7, and 44) is configured such that buckling of the inner housing and/or instrument is limited and/or prevented when the inner housing is advanced through the outer housing.
Regarding claim 21, Devgon further comprising a seal (friction fit at 276 [0202]) arranged about an outer circumference of the instrument, and slidable with the instrument through the outer housing.
Regarding claim 22, further comprising one or more indicia arranged on instrument delivery device (210, fig 3, [0119, 0131]).
Regarding claim 23, Devgon discloses the one or more indicia are visual and/or tactile indicia [0119, 0131].
Regarding claim 24, Devgon discloses the inner housing comprises a connector 1075 or 269 at the proximal end thereof.
Herein below is an alternative interpretation of Devgon et al:
Regarding claim 1, Devgon discloses a medical device (100, 200, Figs 1-29), comprising:
an instrument 160, 260 having a proximal end and a distal end;
an instrument deliver device (introducer 100, 200) configured to moveably receive the instrument and having:
an outer housing 110, 210,220,230 having a proximal end, a distal end, and a sidewall therebetween defining an inner volume; and
an inner housing 265 (optionally a secondary catheter at 163 not shown in
figs 1-2, [0068] connected to the actuator 170 that slides with the actuator) having a proximal end, a distal end, and a sidewall therebetween defining an inner volume, the inner housing coupled to the instrument at 270 and slidably received within the outer housing;
the distal end of the instrument deliver device configured to couple the instrument deliver device to an intravenous line [0008]; and
wherein the inner housing 265(or secondary catheter) is configured to move relative to the outer housing 100,220,230 to move the instrument 160,260 between a first position, in which the instrument is disposed within the outer housing, and a second position, in which the distal end of the instrument is disposed beyond the distal end of the outer housing such that at least a first portion of the instrument is disposed within the intravenous line when the instrument deliver device is coupled to the intravenous line.
Regarding claim 2, the outer housing 210 comprises a lock 240 at the distal end thereof, the lock configured to couple the instrument deliver device to an intravenous line (see also [0063] for figs 1-2).
Regarding claim 3, a joint 216 [0089] is arranged at the distal end of the outer housing (see also [0063] for figs 1-2).
Regarding claim 4, the joint is a rotating joint (threads, [0089, 0063]).
Regarding claim 5, further comprising a septum (seal, [0064-0065, 0089-0090]) arranged at the distal end of the outer housing.
Regarding claim 6, further comprising a seal arranged at the proximal end of the instrument [0113, 0202].
Regarding claim 7, further comprising lubricant [liquid, 0068,0090] arranged at one or more locations within the inner housing.
Regarding claim 8, the inner housing comprises a grip 269 arranged at the proximal end thereof (not shown in figs 1-2, located with 163).
Regarding claims 9-10, the instrument is a catheter.
Regarding claims 11-13, (see figs 1-2, [0062]) the inner housing at 163,265 includes a clamp at 111 (fig 1) at the proximal end thereof, configured to selectively block fluid flow through the inner housing (see fig 24, [0105, 0128]]).
Regarding claim 14, the inner housing is in fluid communication with the catheter, such that fluid flowing proximally from the catheter is received within the inner housing (figs 1-2 and 28, secondary catheter not shown in figs 1-2).
Regarding claim 15, the inner housing 265 further comprises a fluid conduit 268 in fluid communication with the catheter 260 (fig 22).
Regarding claim 16, the fluid conduit 268 (fig 22) extends proximally beyond the proximal end of the inner housing.
Regarding claim 17, further comprising a fluid conduit at 269 [0106] coupled to the proximal end of the inner housing.
Regarding claim 18, further comprising one support 280 (([0076, 0067], ([0144] for
figures 1-2)) arranged within the outer housing and configured to limit buckling of the instrument as it is advanced through the outer housing.
Regarding claim 19, Devgon discloses the inner housing is formed of a material with sufficient stiffness to limit and/or prevent buckling of the inner housing as it is advanced through the outer housing [0078, 0086].
Regarding claim 20, an inner diameter of the outer housing (0078,0086] is configured such that buckling of the inner housing and/or instrument is limited and/or prevented when the inner housing is advanced through the outer housing.
Regarding claim 21, further comprising a seal (friction fit at 276 [0109]) arranged about an outer circumference of the instrument, and slidable with the instrument through the outer housing.
Regarding claim 22, further comprising one or more indicia arranged on the inner housing and/or the instrument and corresponding to instrument length and/or instrument position relative to the intravenous catheter ([0137] indicia on instrument or instrument deliver device 210).
Regarding claim 23, the one or more indicia are visual and/or tactile indicia [0137].
Regarding claim 24, the inner housing comprises a connector 269 at the proximal end 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.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Devgon et al (US 2020/0230358 A1) in view of Devgon et al (US 10,076,272 B2).
Devgon (‘358) discloses the invention substantially as claimed. Devgon discloses the apparatus/medical device 100 and 200 to be used with a peripheral intravenous catheter (PIV) system 105 (fig 2; not shown for figs 3-29; not shown for fig 44 [0166])). However, Devgon (‘358) does not teach the specifics of the system set forth in claim 25.
Devgon (‘272) teaches (in figures 9-14), a system 6000, comprising:
a catheter assembly 6400 comprising:
a catheter adapter 6300, comprising a distal end; a proximal end;
a lumen 6401 (fig 14) extending between the distal end and the proximal end; and
a side port 6420 arranged between the distal end and the proximal end, the side port in fluid communication with the lumen 6401;
a catheter secured to the distal end of the catheter adapter 6300 and extending distally from the catheter adapter 6300; and
a fluid conduit 6425 having a proximal end coupled to the side port and a distal end, the fluid conduit in fluid communication with the side port; and a medical device (introducer 6100). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Devgon (‘358) system (medical device/introducer and PIV system) with the catheter assembly (PIV system) of Devgon (‘272) since such modification is a mere substitution of functionally equivalents parts.
Response to Arguments
Applicant's arguments filed 01/20/2026 have been fully considered but they are not persuasive.
Applicant’s arguments that the disclosure of Devgon, the actuator (1070) is coupled to the instrument (catheter 1060), such that by sliding the actuator, the instrument is moved. There is no disclosure of the internal support member 1086 (asserted to be the inner housing) being coupled to the catheter 1060, nor of the internal support member 1086 moving the catheter 1060.
It is the examiner’s position that the elements of claim 1 do not establish any further connection between elements but how they interact with each other without what is connected to what (except the amended language that has been addressed in the rejection above). Devgon anticipates the claims. The examiner recommends to further amend the claim(s) to define applicant’s invention from Devgon.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
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 Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783