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 .
Response to Arguments
Applicant’s arguments, filed 13 April 2026, with respect to the rejection(s) of claim(s) 1-2, 4-6, 9-13, 16-20, 28-37 under 35 USC 102 and 103 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 Therefore, the rejection has been withdrawn.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 in view of Colangelo (US 10086984) in view of Kempf (US 4585446).
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.
Claims 1-2, 9-10, 16-20, 37-43 are rejected under 35 U.S.C. 103 as being unpatentable over Colangelo
(US 10086984) in view of Kempf (US 4585446).
Regarding claim 1, Colangelo discloses a medical delivery assembly (figure 6) comprising:
a blow-fill-seal (BFS) vial (200, col 1, lines 5-10, ) having first and second longitudinal ends (top and bottom of vial), the BFS vial comprising:
at least one reservoir (interior of vial) having a fluid therein (col 2, lines 45-47); and
a longitudinally-extending neck portion (generally depicted at 299, best shown in figure 5) having a fluid seal (100, col 4, lines 14-16) at the first longitudinal end of the BFS vial (figure 5); and
a connector (500, figure 6 and 10a-10d) comprising:
a body (body of the connector) defining an inlet port (port at bottom end 523) connecting to a first interior volume (area interior 524, figure 9, see annotated figure 6 below);
a nozzle (opposite end from 523) defining an outlet port (opposite opening from inlet port, see annotated figure 6 below) connecting to a second interior volume (end would be connected to another device that has an interior volume to move fluid) in fluid communication with the first interior volume (figure 6-9); and
a piercing element (523) having a least a piercing tip disposed within the first interior volume of the body (figure 9),
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wherein the neck portion of the BFS vial extends through the inlet port into the first interior volume such that at least part of the piercing element breaches and extends through the fluid seal (figure 9, inlet port is in the first interior volume such that the spike is past the stopper).
Colangelo does not disclose wherein the piercing element comprises at least a first and second cross members arranged to form a cross-shape adjacent the piercing tip.
Kempf discloses a needles relatively pertinent to problem posed by Applicant of establishing fluid communication and teaches wherein the piercing element comprises at least a first (34, figures 2-6) and second cross members (40, figures 2-6) arranged to form a cross-shape adjacent the piercing tip (figures 2-6, col 4, lines 8-25).
Kempf provides an improvement for needles that minimizes tearing and stretching of the entry area and generally improves the entry of the conventional needles (col 4, lines 28-47). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify/substitute Colangelo needle tip with the Kempf tip to minimize tearing and stretching which would prevent leaks.
Regarding claim 2, Colangelo discloses wherein the inlet port and the outlet port are substantially coaxial and disposed at opposite longitudinal ends of the connector (figure 6).
Regarding claim 9, Colangelo discloses wherein the piercing element defines at least a portion of a flow path from an interior of the neck portion to the second interior volume (figure 9).
Regarding claim 10, Colangelo discloses wherein an interior sidewall of the connector that forms the first interior volume comprises a mating feature (524, figure 8), and the neck portion of the BFS vial comprises a laterally-protruding portion (229) that is received in the mating feature so as to couple the BFS vial to the connector (edge of 229 that attaches and latches onto 524, (col 8, lines 65-68-col 9, lines 1-4).
Regarding claim 16, Colangelo does not disclose the first and second cross members are arranged orthogonally.
Kempf further teaches wherein the first (34, figures 2-6) and second cross members (40, figures 2-6) arranged to form a cross-shape adjacent the piercing tip are orthogonal (figures 2-6, col 4, lines 8-25).
Kempf provides an improvement for needles that minimizes tearing and stretching of the entry area and generally improves the entry of the conventional needles (col 4, lines 28-47). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Colangelo needle tip with the Kempf tip to minimize tearing and stretching which would prevent leaks.
Regarding claim 17, Colangelo discloses wherein the first interior volume is defined at least in part by a chamber end wall of the connector (area interior to 524), the piercing element longitudinally extends from the chamber end wall toward the inlet port (523 extends toward the chamber), and the chamber end wall comprises one or more openings fluidically connecting the first interior volume to the second interior volume (523 has opening for fluid communication, figure 8-9).
Regarding claim 18, Colangelo does not disclose wherein the chamber end wall has a plurality of the openings, each opening corresponding to and connecting with a respective quadrant defined by the cross shape of the piercing element.
Kempf discloses a needles relatively pertinent to problem posed by Applicant of establishing fluid communication and teaches wherein the chamber end wall has a plurality of the openings (42), each opening corresponding to and connecting with a respective quadrant defined by the cross shape of the piercing element (figure 4).
Kempf provides an improvement for needles that minimizes tearing and stretching of the entry area and generally improves the entry of the conventional needles (col 4, lines 28-47). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Colangelo needle tip with the Kempf tip to minimize tearing and stretching which would prevent leaks.
Regarding claim 19, Colangelo discloses wherein the piercing element is integrally formed with the connector (integral as shown in figure 6), but does not disclose the connector and the piercing element are formed of a plastic having a hardness greater than that of the BFS vial.
Kempf further teaches the needle and device be made from stainless steel and/or nylon which is harder than polyprolyene (col 4, lines 1-6).
Kempf provides an improvement for needles that minimizes tearing and stretching of the entry area and generally improves the entry of the conventional needles (col 4, lines 28-47). The selection of material would aid in the achieving the end result, thus it would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Colangelo needle tip with the Kempf tip to minimize tearing and stretching which would prevent leaks.
Regarding claim 20, Colangelo does not disclose wherein the first and second crossmembers of the piercing element are substantially solid, such that the fluid from the at least one reservoir flows around the crossmembers en route to the second interior volume.
Kempf discloses a needles relatively pertinent to problem posed by Applicant of establishing fluid communication and teaches wherein the first and second crossmembers of the piercing element are substantially solid (col 4, lines 1-6), such that the fluid from the at least one reservoir flows around the crossmembers en route to the second interior volume (col 3, lines 60-67, fluid flows from opening 42 to the opposite end of the needle which would be the connector).
Kempf provides an improvement for needles that minimizes tearing and stretching of the entry area and generally improves the entry of the conventional needles (col 4, lines 28-47). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Colangelo needle tip with the Kempf tip to minimize tearing and stretching which would prevent leaks.
Regarding claim 37, Colangelo discloses wherein the fluid seal comprises a foil, wax, paper, a section of the BFS vial (figure 9), or any combination of the foregoing.
Regarding claim 38-41, Colangelo does not disclose the first crossmember has a first pair of first tapered surfaces extending to the piercing tip and the second crossmember has a second pair of second tapered surfaces and terminating proximal of the piercing tip such that the piercing tip extends beyond the second crossmember (claim 38), wherein the first pair of first tapered surfaces are dimensioned to continuously extend to the piercing tip (claim 39), wherein the first and second crossmembers are each planar in configuration (claim 40), wherein the first and second crossmembers are arranged in orthogonal relation (claim 41).
Kempf further teaches the first crossmember has a first pair of first tapered surfaces (34, figure 5, tapered surface ends at the tip) extending to the piercing tip and the second crossmember has a second pair of second tapered surfaces (surface on 40) and terminating proximal of the piercing tip such that the piercing tip extends beyond the second crossmember (tapered surface ends before the tip, does not extend all the way since the surface 40 tapers drastically and then drops off before the tip), wherein the first pair of first tapered surfaces are dimensioned to continuously extend to the piercing tip (figure 5), wherein the first and second crossmembers are each planar and orthogonal (figure 5).
Kempf provides an improvement for needles that minimizes tearing and stretching of the entry area and generally improves the entry of the conventional needles (col 4, lines 28-47). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify/substitute Colangelo needle tip with the Kempf tip to minimize tearing and stretching which would prevent leaks.
Regarding claim 42, Colangelo discloses wherein the first interior volume is defined at least in part by a chamber end wall of the connector (see annotated figure above, the interior volume is connected to the connector), the piercing element longitudinally extends from the chamber end wall toward the inlet port (see annotated figure above),
Regarding claim 43, Colangelo does not disclose including one or more openings adjacent an intersection of the first and second crossmembers and extending through the chamber end wall to fluidly couple the first interior and the second interior.
Kempf discloses a needles relatively pertinent to problem posed by Applicant of establishing fluid communication and teaches one or more openings (42, figure 4) adjacent an intersection of the first and second crossmembers and extending through the chamber end wall to fluidly couple the first interior and the second interior (the opening connects and establishes communication through the needle to the opposite side.
Kempf provides an improvement for needles that minimizes tearing and stretching of the entry area and generally improves the entry of the conventional needles (col 4, lines 28-47). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Colangelo needle tip with the Kempf tip to minimize tearing and stretching which would prevent leaks.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Colangelo in view of Kempf further in view of Finke (US 2012/0078215).
Regarding claim 4-6, Colangelo and Kempf do not disclose wherein the connector comprises wherein the connector further comprises a longitudinally-extending annular flange that at least partially surrounds the nozzle to define an annular space between the annular flange and nozzle for connection to a cap or a housing of an administrator(claim 4), wherein a radially-inner surface of the annular flange comprises threads (claim 5), wherein the annular flange, the nozzle, or both form a luer lock connection member (claim 6).
Finke discloses a transfer connector wherein the connector comprises wherein the connector further comprises a longitudinally-extending annular flange (26, figure 2) that at least partially surrounds the nozzle to define an annular space between the annular flange and nozzle for connection to a cap or a housing of an administrator (space near the threads 56 between the flange and nozzle, figure 2), wherein a radially-inner surface of the annular flange comprises threads (56, [0033]), wherein the annular flange, the nozzle, or both form a luer lock connection member ([0033]).
Finke provides connecting structure to enable releasable engagement ([0026]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Colangelo by adding a luer connection as taught by Finke in order to enable releasable engagement with a further container.
Claims 11-13, 28-36 are rejected under 35 U.S.C. 103 as being unpatentable over Colangelo in view of Kempf further in view of Koska (PCT/US/2019/038302, for convenience, references will refer to US 2021/0128835 effectively filed 06/20/2018).
Regarding claim 11, Colangelo and Kempf do not disclose wherein the mating feature comprises a scalloped portion of the interior sidewall, and each laterally-protruding portion has a toroidal shape in a side view.
Koska discloses a BFS vial teaching mating features that comprise a scalloped portion (338 is scalloped of material to accommodate the vial) of the interior sidewall and each laterally-protruding portion has a toroidal shape (316, [0036]) in a side view (figure 3B).
Koska provides structure to allow selectively coupling ([0037]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify the coupling of Colangelo by substituting it with the coupling of Koska in order to provide selective coupling. It appears that both would achieve the same end result which is to engage and disengage containers when needed.
Regarding claim 12-13, Colangelo and Kempf do not disclose wherein: the BFS vial further comprises flange portions disposed on opposite lateral sides of a body portion of the BFS vial and proximal to a junction of the body portion with the neck portion; and the connector comprises a body portion that defines the inlet port, the body portion having one or more anti-rotation coupling features that interact with the flange portions of the BFS vial to inhibit rotation of the BFS vial with respect to the connector (claim 12) and wherein the anti-rotation coupling features comprises one or more longitudinally-extending slots through a sidewall of the body portion, one or more laterally-indented portions disposed around a circumference of the inlet port, or any combination of the foregoing (claim 13).
Koska discloses wherein: the BFS vial further comprises flange portions (330) disposed on opposite lateral sides of a body portion (332) of the BFS vial and proximal to a junction of the body portion with the neck portion (figures 3C-3D); and the connector comprises a body portion (340) that defines the inlet port, the body portion having one or more anti-rotation coupling features (332 and 332-1) that interact with the flange portions of the BFS vial to inhibit rotation of the BFS vial with respect to the connector (]0037]) and wherein the anti-rotation coupling features comprises one or more longitudinally-extending slots (332, figures 3A-3B) through a sidewall of the body portion, one or more laterally-indented portions disposed around a circumference of the inlet port, or any combination of the foregoing.
Koska provides anti-rotation features in order to prevent the device from inadvertant rotation ([0037]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Colangelo with the anti-rotating features of Koska in order to prevent unwanted rotation of the container.
Regarding claim 28-30, Colangelo and Kempf do not disclose
an administration assembly comprising: a hub coupled to the outlet port of the connector; and at least one administration conduit having an outlet at an end thereof longitudinally spaced from the hub and being in fluid communication with the second interior volume (claim 28), wherein the hub is coupled to the outlet port via a luer lock connection (claim 29), wherein at least part of the administration assembly is formed separate from and constructed to be coupled to the connector, or at least part of the administration assembly is integrally formed with the connector (claim 30).
Koska further teaches an administration assembly (300) comprising: a hub (350) coupled to the outlet port of the connector; and at least one administration conduit (380) having an outlet at an end thereof longitudinally spaced from the hub and being in fluid communication with the second interior volume (350-2), wherein the hub is coupled to the outlet port via a luer lock connection (350 uses threads to secure to the outlet port connector, figure 3L-M), wherein at least part of the administration assembly is formed separate from and constructed to be coupled to the connector (350 is connected via luer and formed separately).
Koska provides an administration assembly in order to deliver medication ([0042]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Colangelo with the administration assembly of Koska to apply the medication as desired.
Regarding claim 31, Colangelo and Kempf do not disclose wherein the at least one administration conduit comprises a needle or cannula.
Koska further teaches an administration conduit (380) having a needle or cannula ([0042])
Koska provides an administration assembly in order to deliver medication ([0042]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Colangelo with the administration assembly of Koska to apply the medication as desired.
Regarding claim 32, Colangelo and Koska do not disclose wherein the needle has a length in a range of 0.5 mm to 4 mm, inclusive, or in a range of 4 mm to 15 mm, inclusive, or in a range of 15 mm to 30 mm, inclusive.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Colangelo and Koska to have a length in a range of 0.5 mm to 4 mm, inclusive, or in a range of 4 mm to 15 mm, inclusive, or in a range of 15 mm to 30 mm, inclusive, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of the cited prior art would not operate differently with the claimed length and needle is intended to puncture elements and deliver material. Further, applicant places no criticality on the range claimed, indicating simply that the length “can” be within the claimed ranges (specification pp. [0023]).
Regarding claim 33, Colangelo and Kempf do not disclose wherein the outlet of the at least one administration conduit is formed as a nozzle configured to facilitate dispersion of the fluid from the BFS vial into a spray, or the outlet of the at least one administration conduit is formed as a nozzle configured to facilitate dispersion of the fluid from the BFS vial into one or more droplets.
Koska further teaches wherein the outlet of the at least one administration conduit is formed as a nozzle configured to facilitate dispersion of the fluid from the BFS vial into a spray ([0020]).
Koska provides a nozzle to allow the material to exit the assembly ([0020]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Colangelo with the administration assembly of Koska to apply the medication as desired.
Regarding claim 34-35, Colangelo and Kempf do not disclose further comprising (iii) an intravenous (IV) therapy device coupled to the outlet port of the connector, wherein the IV therapy device is coupled to the outlet port via a luer lock connection
Koska further teaches (iii) an intravenous (IV) therapy device coupled to the outlet port of the connector ([0020]), wherein the IV therapy device is coupled to the outlet port via a luer lock connection (figure 3L, the connector is provided with thread connectors to enable coupling)
Koska provides a nozzle to allow the material to exit the assembly ([0020]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Colangelo with the administration assembly of Koska to apply the medication as desired.
Regarding claim 36, Colangelo does not disclose wherein the fluid in the BFS vial comprises a vaccine, a drug, a medicament, or a component of any of the foregoing.
Koska further teaches the contents of the BFS vial can be a drug ([0021]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify the Colangelo device to contain drug in order to allow the device to apply drugs since Colangelo discloses the fluid container but not the contents.
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 KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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 at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAI H WENG/ Primary Examiner, Art Unit 3781
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