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 .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
This Action is responsive to the Reply filed 29 July 2025 (“Reply”). As directed in the Reply:
Claims 1, 5, 12, and 21 have been amended;
Claims 3, 4, 7, 10, 11, 14-19, and 23, have been and/or remain cancelled; and
no claims have been added.
Thus, Claims 1, 2, 5, 6, 8, 9, 12, 13, 20-22, and 24 are presently pending in this application.
Response to Arguments
Applicant’s arguments with respect to Claims 1, 2, 5, 6, 8, 9, 12, 13, 20-22, and 24 have been considered but not persuasive.
After painstakingly reproducing the entirety of each of independent Claims 1, 12, and 21 (Reply, pp. 6-8), Applicant’s sole argument for all of the claims is that Chelak, in Applicant’s view, does not disclose the feature quoted at the bottom of pg. 6, the only feature new to each of these independent claims being that the connector comprises a luer lock fitting and a first end with a “spin lock collar.” Those features, however, were already present in prior Claims 10 and 11, and thus the prosecution of a claim of that scope has already been conducted in this record.
Entirely absent from Applicant’s reply is the identification of any evidence of record that Chelak’s element 122 is not read on by the term “spin lock collar,” particularly in light of the fact that “SPIN-LOCK” is a registered U.S. trademark for “Connector for Syringe Needles” - see U.S. Reg. No. 1260427 (1983). Applicant accurately quotes Chelak in its brief description of element 122; that description uses the word “locking,” has the shape of a collar, and can certainly be spun with the rest of the device to attach to a catheter hub, in the event that the ridges on the exterior of the element, plainly provided to improve the user’s grip on the element, do not inform a person of ordinary skill in the art that it is, in fact, one of connectors covered by B BRAUM MEDICAL INC.’s registered trademark.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter.
The use of the term “SPIN LOCK,” which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1, 12 and 21 are objected to because of the following informalities: the use of the trademark SPIN LOCK. Appropriate correction is required.
Claim Rejections - 35 USC § 103
Claims 1, 2, 5, 6, 8, 9, 12, 13, 20-22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2021/0236777, by Chelak et al. (“Chelak “), in view of U.S. Patent App. Pub. No. 2021/0060301, by Pennell, II et al. (“Pennell”), U.S. Patent App. Pub. No. 2022/0401266, by Adams et al. (“Adams”), and U.S. Patent No. 8,870,837, granted to Locke et al. (“Locke”), and U.S. Patent No. 4,711,636, granted to Bierman (“Bierman”).
Regarding claim 1, Chelak discloses a holder for securing a venous access device to a patient, the holder comprising:
a substrate (110) having an upper surface (surface of 110 visible in fig. 2), a lower surface (116; fig. 1), and an aperture (at end of lead line for 180B in Fig. 5);
a solvent delivery line (220B; fig. 3, [0041]-[0042]) coupled to the upper surface of the flexible substrate (Fig. 3, fluidly coupled via 190B) and having a first end (170A,B), a second end (at 180A,B), and a hollow interior (190A,B), the first end of the solvent delivery line comprising a syringe connection portion (Fig. 5, outer surface of 220A, 220B, at which syringes 160A, 160B connector; as of 01/27/2024, the Merriam-Webster dictionary defines “syringe” as “a device used to inject fluids into or withdraw them from something”. By definition, 160B, used to inject fluids into solvent delivery line 190B per [0041], is a syringe. Therefore, outer surface of 220A, 220B are syringe connection portions) the second end of the solvent delivery line coupled to the aperture to fluidly connect the hollow interior of the solvent delivery line and the aperture (Figs. 3, 5, coupled via 220A, B);
an adhesive layer overlaying the lower surface of the substrate (adhesive layer comprised of 230 and adhesive 166 from 160A; fig. 3, [0042]-[0043]) and having an adhesive for adhering to skin of the patient ([0043]), the adhesive layer comprising a solvent pathway (the portions of the solvent pathway below 180A, 180B in the adhesive layer), the solvent pathway (180B; [0043]) integrated into at least a portion of the adhesive layer and fluidically coupled to the aperture (180B extends into the adhesive layer, and the aperture noted above; Fig. 3); and
a connector (comprised of 120, 122, and 130) secured to the upper surface (figs. 1-2, [0034]), the connector comprising a luer lock fitting (122), a first end (120, 122) having a spin lock collar (122) for connection to a needle assembly (120 is a luer connector and is thus considered capable of connecting to a needle assembly to administer an IV therapy as disclosed in [0035] and [0041]) and a second end (130) for connection to an IV fluid line (130 is a luer connector and is thus considered capable of connecting to a needle assembly to administer an IV therapy as disclosed in [0035] and [0041]).
Chelak does not describe that:
its substrate is flexible;
its solvent delivery line is flexible;
its solvent delivery line second end is connected to the upper outer surface of the substrate;
the adhesive layer comprises a solvent pathway having legs extending therefrom.
Pennell relates to medical infusion devices which are mountable on a patient’s skin and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Pennell teaches that such a device can include a holder (100; figs. 1, 5, [0048]) having a substrate (102) for holding a catheter ([0049]) which includes a flexible substrate (silicone; [0065]), in order to improve patient comfort.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have made the substrate disclosed in Chelak of flexible silicone, because Pennell teaches doing so in a closely related device, to improve patient comfort.
Chelak also describes, in the embodiments of Figs. 6-17B, orienting the solvent delivery line such that it is coupled to the upper outer surface of the substrate (Figs. 9A, 11B, 13B, 14C, 15C, 16C, at 290), which a person of ordinary skill in the art understands makes manipulating the solvent delivery easier because the upper outer part of the device is facing away from the patient’s skin, rather than next to it in the embodiment of Figs. 1-5, which therefore gives the practitioner more room to manipulate the pistons 160A,B.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have made oriented the solvent delivery line second end so that it is connected to the upper outer surface of the substrate in Chelak’s device, because Chelak teaches doing so in a closely related device, which therefore gives the practitioner more room to manipulate the solvent delivery pistons.
Locke relates to medical infusion devices which are mountable on a patient’s skin and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Locke teaches that such device can use a flexible line 28, 54 to deliver a solvent to a medical patch which is adhered to a patient’s skin, which a person of ordinary skill in the art understands will permit the use of larger and reusable solvent reservoirs, rather than Chelak’s one-use, dedicated, smaller reservoirs, which would reduce manufacturing complexity and cost, as well as more easily permitting the use of more solvent in the event the adhesive does not adequately dissolve.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the invention, to make Chelak’s solvent delivery line flexible, because Locke teaches doing so in a closely related device, which would reduce manufacturing complexity and cost by better enabling the use of reusable solvent delivery lines, and more easily permitting the use of more solvent in the event the adhesive does not adequately dissolve.
Adams relates to medical wound closure devices which are mountable on a patient’s skin over a wound and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Adams teaches that the solvent pathway of the adhesive layer of such a device advantageously includes legs (“channels” 314 as stated in Adams) extending therefrom, “. . . to facilitate contact of the adhesive layer 104 with a solvent to reduce the tackiness of the adhesive layer 104” ([0032]; see also [0093]).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the invention, to make Chelak’s solvent pathway of its adhesive layer to legs, because Adams teaches doing so in a closely related device, in order to facilitate contact of the adhesive with its solvent.
Bierman relates to medical tube holding devices which are mountable on a patient’s skin adjacent to an infusion point and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Bierman teaches (Fig. 1) that the substrate (34) of such a device can further include pair of tube holders (40, 42), through which the medical fluid tube (26) passes, to form a portion of the medical tube between the tube holders which acts a strain relief (“safety loop” in Bierman’s words, col. 4, line 65), thus inhibiting pullout of the tube.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the invention, to make Chelak/Locke’s device such that the first end of the flexible solvent delivery line is coupled to the upper outer surface of the flexible substrate, because Bierman teaches doing so in a closely related medical device, in order to form a safety loop / strain relief in the fluid line. The “first end” portion of this feature is met because, as applied to Locke’s flexible solvent delivery line, the “first end” can be any length of its tube 28 between connectors 22 and 58 which is not the portion immediately at connector 22.
Claim 2: (The holder of claim 1), wherein the flexible substrate comprises at least one of foam, silicone, soft plastic, rubber or elastomers (silicone; Pennell [0065]).
Claim 5: (The holder of claim 1), wherein the syringe connection portion comprises a housing (Chelak, portion of housing 110 receiving 160B) adapted to receive a syringe (160B) containing a solvent ([0041]) configured to dissolve and break down at least a portion of the adhesive layer ([0041]).
Claim 6: (The holder of claim 1), wherein the solvent pathway is interposed between the skin of a patient and the adhesive layer when the holder is adhered to the skin of the patient (180B is interposed between the patient’s skin and the adhesive layer in the direction noted in annotated Chelak Fig. 3 below).
PNG
media_image1.png
267
827
media_image1.png
Greyscale
Annotated Figure 3 (from Figure 3 of Chelak)
Claim 8: (The holder of claim 1), wherein the connector comprises a luer lock connector (120 is a luer lock connector; Chelak, fig. 1, [0034]).
Claim 9: (The holder of claim 1), further comprising a hydrophilic matrix (matrix formed by wicking/hydrophilic material 230; Chelak, [0043]) integrated into at least a portion of the adhesive layer (Chelak, [0043]).
Claim 12: A method for providing a venous access device for a patient, the method comprising:
providing a substrate (Chelak, 110) having an upper surface (surface of 110 visible in fig. 2), a lower surface (116; Chelak, fig. 1) and an aperture (at 170A, 170B in Fig. 5);
providing an adhesive layer on the lower surface of the substrate (adhesive layer comprised of 230 and adhesive 166 from 160A; Chelak, fig. 3, [0042]-[0043]) and having an adhesive for adhering to skin of the patient ([0043]), the adhesive layer comprising a solvent pathway (180B; [0043]) integrated into at least a portion of the adhesive layer and fluidically coupled to the aperture (180B extends into the adhesive layer; aperture as noted above; fig. 3);
providing a solvent delivery line (190A,B; fig. 3) coupled to the upper surface of the flexible substrate (Fig. 3, fluidly coupled via 190B) and having first end (180A,B; fig. 3), a second end (170A,B), and a hollow interior (190A, 190B, fig. 3), the first end of the flexible solvent delivery line comprising a syringe connection portion (see discussion above, in Claim 1), the second end of the solvent delivery line coupled to the aperture (Fig. 5, at 180A, 180B) to fluidly couple the hollow interior of the solvent delivery line, the aperture, and the solvent pathway (id.); and
providing a connector (comprised of 120 and 130) coupled to the upper surface of the substrate (figs. 1-2), the connector comprising a luer lock fitting (122), a first end having a spin lock collar (122) for connection to a needle assembly (120 is a luer connector and is thus considered capable of connecting to a needle assembly to administer an IV therapy as disclosed in [0035] and [0041]) and a second end (130) for connection to an IV fluid line (130 is a luer connector and is thus considered capable of connecting to a needle assembly to administer an IV therapy as disclosed in [0035] and [0041]).
Chelak does not describe that:
its substrate is flexible;
its solvent delivery line second end is connected to the upper outer surface of the substrate;
its solvent delivery line is flexible; and
the adhesive layer comprises a solvent pathway having legs extending therefrom.
Pennell teaches a holder (100; figs. 1, 5, [0048]) having a substrate (102) for holding a catheter ([0049]) with a flexible substrate (silicone; [0065]).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have made the substrate disclosed in Chelak of flexible silicone, because Pennell teaches doing so in a closely related device, to improve patient comfort.
Chelak also describes, in the embodiments of Figs. 6-17B, orienting the solvent delivery line such that it is coupled to the upper outer surface of the substrate (Figs. 9A, 11B, 13B, 14C, 15C, 16C, at 290), which a person of ordinary skill in the art understands makes manipulating the solvent delivery easier because the upper outer part of the device is facing away from the patient’s skin, rather than next to it in the embodiment of Figs. 1-5, which therefore gives the practitioner more room to manipulate the pistons 160A,B.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have made oriented the solvent delivery line second end so that it is connected to the upper outer surface of the substrate in Chelak’s device, because Chelak teaches doing so in a closely related device, which therefore gives the practitioner more room to manipulate the solvent delivery pistons.
Locke relates to medical infusion devices which are mountable on a patient’s skin and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Locke teaches that such device can use a flexible line 28, 54 to deliver a solvent to a medical patch which is adhered to a patient’s skin, which a person of ordinary skill in the art understands will permit the use of reusable solvent reservoirs, rather than Chelak’s one-use, dedicated reservoirs, which would reduce manufacturing complexity and cost.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the invention, to make Chelak’s solvent delivery line flexible, because Locke teaches doing so in a closely related device, which would reduce manufacturing complexity and cost.
Adams relates to medical wound closure devices which are mountable on a patient’s skin over a wound and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Adams teaches that the solvent pathway of the adhesive layer of such a device advantageously includes legs (“channels” 314 as stated in Adams) extending therefrom, “. . . to facilitate contact of the adhesive layer 104 with a solvent to reduce the tackiness of the adhesive layer 104” ([0032]; see also [0093]).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the invention, to make Chelak’s solvent pathway of its adhesive layer to legs, because Adams teaches doing so in a closely related device, in order to facilitate contact of the adhesive with its solvent.
Bierman relates to medical tube holding devices which are mountable on a patient’s skin adjacent to an infusion point and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Bierman teaches (Fig. 1) that the substrate (34) of such a device can further include pair of tube holders (40, 42), through which the medical fluid tube (26) passes, to form a portion of the medical tube between the tube holders which acts a strain relief (“safety loop” in Bierman’s words, col. 4, line 65), thus inhibiting pullout of the tube.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the invention, to make Chelak/Locke’s device such that the first end of the flexible solvent delivery line is coupled to the upper outer surface of the flexible substrate, because Bierman teaches doing so in a closely related medical device, in order to form a safety loop / strain relief in the fluid line. The “first end” portion of this feature is met because, as applied to Locke’s flexible solvent delivery line, the “first end” can be any length of its tube 28 between connectors 22 and 58 which is not the portion immediately at connector 22.
Claim 13: (The holder of claim 12), comprising integrating a hydrophilic matrix into at least a portion of the adhesive layer (matrix formed by wicking/hydrophilic material 230; Chelak [0043]).
Claim 20: (The method of claim 12), wherein the flexible substrate is configured to expand when a solvent is directed into the solvent pathway (Chelak as modified above discloses a flexible substrate as structurally claimed; therefore, the device taught by Chelak is considered capable of performing the disclosed function of expanding when a solvent is directed into the solvent pathway).
Claim 21: A holder for securing a venous access device to a patient (Fig. 3), the holder comprising:
a substrate (110) having an upper surface (surface of 110 visible in fig. 2), a lower surface (116; fig. 1), and an aperture (at 180A, 180B);
an adhesive layer overlaying the lower surface of the substrate (adhesive layer comprised of 230 and adhesive 166 from 160A; fig. 3, [0042]-[0043]) and comprising a solvent pathway (180B; [0043]) integrated into at least a portion of the adhesive layer (180B extends into the adhesive layer; fig. 3) and fluidically coupled to the aperture (at 180A,B);
a solvent delivery line (220B; fig. 3, [0041]-[0042]) coupled to the upper surface of the substrate (Fig. 3, coupled via 220A, B) and comprising a first end (170A,B), a second end (180A,B), and a hollow interior (190A,B), the first end of the solvent delivery line comprising a syringe connection portion (see discussion concerning Claim 1), the second end of the solvent delivery line coupled to the aperture (at 180A, 180B) and fluidly coupling the hollow interior of the solvent delivery line, the aperture, and the solvent pathway (id.); and
a connector (120, 130) secured to the upper surface (figs. 1-2, [0034]), the connector comprising a luer lock fitting (122), a first end (120) having a spin lock collar (122) for connection to a needle assembly (120 is a luer connector and is thus considered capable of connecting to a needle assembly to administer an IV therapy as disclosed in [0035] and [0041]), and a second end (130) for connection to an IV fluid line (130 is a luer connector and is thus considered capable of connecting to a needle assembly to administer an IV therapy as disclosed in [0035] and [0041]).
Chelak does not describe that:
the substrate is flexible;
the solvent delivery line second end is connected to the upper outer surface of the substrate;
its solvent delivery line is flexible; and
the adhesive layer comprises a solvent pathway having legs extending therefrom.
Pennell teaches that such a device can include a holder (100; figs. 1, 5, [0048]) having a substrate (102) for holding a catheter ([0049]) which includes a flexible substrate (silicone; [0065]), in order to improve patient comfort.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have made the substrate disclosed in Chelak of flexible silicone, because Pennell teaches doing so in a closely related device, to improve patient comfort.
Chelak also describes, in the embodiments of Figs. 6-17B, orienting the solvent delivery line such that it is coupled to the upper outer surface of the substrate (Figs. 9A, 11B, 13B, 14C, 15C, 16C, at 290), which a person of ordinary skill in the art understands makes manipulating the solvent delivery easier because the upper outer part of the device is facing away from the patient’s skin, rather than next to it in the embodiment of Figs. 1-5, which therefore gives the practitioner more room to manipulate the pistons 160A,B.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have made oriented the solvent delivery line second end so that it is connected to the upper outer surface of the substrate in Chelak’s device, because Chelak teaches doing so in a closely related device, which therefore gives the practitioner more room to manipulate the solvent delivery pistons.
Locke relates to medical infusion devices which are mountable on a patient’s skin and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Locke teaches that such device can use a flexible line 28, 54 to deliver a solvent to a medical patch which is adhered to a patient’s skin, which a person of ordinary skill in the art understands will permit the use of reusable solvent reservoirs, rather than Chelak’s one-use, dedicated reservoirs, which would reduce manufacturing complexity and cost.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the invention, to make Chelak’s solvent delivery line flexible, because Locke teaches doing so in a closely related device, which would reduce manufacturing complexity and cost.
Adams relates to medical wound closure devices which are mountable on a patient’s skin over a wound and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Adams teaches that the solvent pathway of the adhesive layer of such a device advantageously includes legs (“channels” 314 as stated in Adams) extending therefrom, “. . . to facilitate contact of the adhesive layer 104 with a solvent to reduce the tackiness of the adhesive layer 104” ([0032]; see also [0093]).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the invention, to make Chelak’s solvent pathway of its adhesive layer to legs, because Adams teaches doing so in a closely related device, in order to facilitate contact of the adhesive with its solvent.
Bierman relates to medical tube holding devices which are mountable on a patient’s skin adjacent to an infusion point and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Bierman teaches (Fig. 1) that the substrate (34) of such a device can further include pair of tube holders (40, 42), through which the medical fluid tube (26) passes, to form a portion of the medical tube between the tube holders which acts a strain relief (“safety loop” in Bierman’s words, col. 4, line 65), thus inhibiting pullout of the tube.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the invention, to make Chelak/Locke’s device such that the first end of the flexible solvent delivery line is coupled to the upper outer surface of the flexible substrate, because Bierman teaches doing so in a closely related medical device, in order to form a safety loop / strain relief in the fluid line. The “first end” portion of this feature is met because, as applied to Locke’s flexible solvent delivery line, the “first end” can be any length of its tube 28 between connectors 22 and 58 which is not the portion immediately at connector 22.
Claim 22: (The holder of Claim 21,) wherein the first end of the flexible solvent delivery line comprises a housing configured to receive a syringe (Chelak, Fig. 3, near 118).
Claim 24: (The holder of Claim 21,) wherein the adhesive layer comprises a hydrophilic matrix (matrix formed by wicking/hydrophilic material 230; Chelak, [0043]).
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 Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
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, Bhisma Mehta, can be reached on 571.272.3383. 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.
/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783