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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 12, 2026 has been entered.
Claims 1-9 and 21 remain pending in the application. Claims 10-20 were previously cancelled.
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 1-4 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamen et al. (US 2070219597).
Regarding claim 1, Kamen discloses an apparatus (reservoir filling station 7000; Figure 107), comprising:
a baseplate (fill station base 7010); and
an arm (fill station cover 7020) extending from the baseplate (Figure 107), wherein:
the baseplate includes a nest (see annotated Figure 7 below) extending from a top portion of the baseplate into a bottom portion of the baseplate (see annotated Figure 7 below) and adapted for accepting a drug delivery device (reservoir 20) having a fill port (reservoir septum 6270), wherein the arm is adapted to retain a syringe (syringe 7040) having a needle tip (needle 7050; Figure 107; “A needle 7050 attached to the syringe 7040 may then be inserted through a filling aperture 7060 in the cover 7020, and through the reservoir septum 6270.” [0438]), wherein the nest is a keying feature (interior shape of nest, see annotated Figure 7) configured to mate with the drug delivery device (“the station 7000 may be opened and closed to accept and hold the reservoir 20… Since the fill station base 7010 and cover 7020 are rigid, the flexible reservoir 20 generally cannot be distended past a fixed volume and overfilling of the reservoir 20 is discouraged.” [0438]) and position a bottom surface of the drug delivery device above the top portion of the baseplate (see annotated Figure 7 below); and
the baseplate and arm are arranged such that when a drug delivery device is positioned in the nest and a syringe is positioned in the arm, the syringe is aligned directly over the fill port of the drug delivery device (Figure 107; “The fluid may be withdrawn from its original container with a syringe 7040 and introduced into the reservoir 20 by using the fill station 7000…the station 7000 may be opened and closed to accept and hold the reservoir 20. A needle 7050 attached to the syringe 7040 may then be inserted through a filling aperture 7060 in the cover 7020, and through the reservoir septum 6270.” [0438]).
Regarding claim 2, Kamen discloses the apparatus of claim 1, wherein the arm (cover 7020) is rotatable (“The fill station 7000 may include a substantially rigid fill station base 7010 hinged to a substantially rigid fill station cover 7020 via a hinge 7030.” [0438]).
Regarding claim 3, Kamen discloses the apparatus of claim 1, wherein the nest is adapted for accepting the drug delivery device in an upside-down position so as to expose the fill port to the needle tip (Figure 107; “A needle 7050 attached to the syringe 7040 may then be inserted through a filling aperture 7060 in the cover 7020, and through the reservoir septum 6270” [0438]).
Regarding claim 4, Kamen discloses the apparatus of claim 1, wherein the nest is shaped to stabilize the drug delivery device when the drug delivery device is positioned in the nest (Figure 107; “the station 7000 may be opened and closed to accept and hold the reservoir 20…Since the fill station base 7010 and cover 7020 are rigid, the flexible reservoir 20 generally cannot be distended past a fixed volume and overfilling of the reservoir 20 is discouraged.” [0438]).
Regarding claim 21, Kamen discloses the apparatus of claim 1, wherein the keying feature includes a perimeter of the drug delivery device (Figure 107; the station 7000 may be opened and closed to accept and hold the reservoir 20… Since the fill station base 7010 and cover 7020 are rigid, the flexible reservoir 20 generally cannot be distended past a fixed volume and overfilling of the reservoir 20 is discouraged.” [0438]).
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.
Claims 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kamen et al. (US 20070219597) in view of Romano et al. (USPN 5795336).
Regarding claim 5, Kamen discloses the apparatus of claim 1.
Kamen fails to explicitly disclose a safety device including: a skirt body having an inner shell and an outer shell; a skirt coupled to the skirt body, the skirt positioned below the skirt body, a first portion of the skirt positioned between the inner and outer shells of the skirt body, a second portion extending beyond the skirt body; and a spring, the spring positioned over the skirt and between the inner and outer shells of the skirt body.
Romano teaches a safety device (needle protector device 220; Figures 22-24) including a skirt body (mount 100; Figures 13-15) having an inner shell (forming interior channel 106; Figure 14) and an outer shell (forming exterior wall 142); a skirt (protective cover 180; Figures 17-20) coupled to the skirt body (Figure 23; “the upper end 182 of the cover 180 to be received within the lower end 104 of the mount 100.” [Col 11, line 66]), the skirt positioned below the skirt body (Figure 23), a first portion of the skirt positioned between the inner and outer shells of the skirt body (upper end 182 in retracted position; Figure 24), a second portion (lower end 184) extending beyond the skirt body (Figures 22-23); and a spring (spring 144), the spring positioned over the skirt and between the inner and outer shells of the skirt body (Figures 23-24).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the apparatus of Kamen to include a safety device having a skirt body, a skirt, and a spring based on the teachings of Romano so that when a syringe is used to fill the drug delivery device, the needle of the syringe automatically returns to a locked, needle covering position when removed from the fill port in order to prevent accidental needle sticks from the syringe during use of the apparatus (Romano [Col 1, lines 65]).
Regarding claims 6-7, modified Kamen discloses the apparatus of claim 5.
Modified Kamen fails to explicitly disclose the skirt comprises at least one latch configured to couple and retain the skirt to the skirt body, as required by claim 6; and the skirt body comprises an opening corresponding to the at least one latch, as required by claim 7.
Romano teaches a safety device (needle protector device 220; Figures 22-24) including a skirt body (mount 100; Figures 13-15) and a skirt (protective cover 180; Figures 17-20), wherein the skirt (protective cover 180) comprises at least one latch (cantilevered tabs 186 and 196 having lugs 190, 200) configured to couple and retain the skirt to the skirt body (“The first and second lugs 190, 200 are adapted for engaging the first and second apertures 152, 154 of the mount 100 in assembly, respectively.” [Col 12, line 16]; Figure 23); and wherein the skirt body (mount 100) comprises an opening (mount apertures 152, 154) corresponding to the at least one latch (The needle protection position of the cover 180 corresponds to the lugs of 190, 200 the cover 180 being located in the entrance position 160 of the respective aperture 152, 154. The armed position corresponds to the lugs 190, 200 being in the armed position 162 of the respective aperture 152, 154. When the cover 180 is in a retracted position, the lugs 190, 200 are located in the respective aperture portion 170, above the entrance and armed positions 160, 162 and toward the upper end 102 of the mount 100 between the entrance wall 164 and the exit wall 166 of the respective aperture 152, 154.” [Col 13, line 7-17]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the apparatus of Kamen to include that the skirt comprises at least one latch configured to couple and retain the skirt to the skirt body and that the skirt body comprises an opening corresponding to the at least one latch based on the teachings of Romano to provide a safety device that automatically returns to locked, needle covering position in order to prevent accidental needle sticks from the syringe during use of the apparatus (Romano [Col 1, lines 65]).
Regarding claims 8 and 9, modified Kamen discloses the apparatus of claim 7.
Modified Kamen fails to explicitly disclose the safety device is adapted to be coupled to a syringe having a needle, and in a first latched position in which the at least one latch is positioned in the corresponding opening, the skirt surrounds the needle to prevent exposure of the needle, and the skirt extends beyond the end of the needle by a first distance, as required by claim 8; and wherein in a second unlatched position in which the at least one latch is deflected inward, the skirt body can move downward relative to the skirt, allowing the needle to extend beyond an end of the skirt by a second distance, as required by claim 9.
Romano teaches a safety device (needle protector device 220; Figures 22-24) adapted to be coupled to a syringe having a needle (needle subassembly 120; “when use of the device 220 is desired, the luer fitting 124 of the hub 122 is coupled to a conventional syringe barrel and plunger assembly” [Col 14, line 39-41]), wherein in a first latched position (Figures 22-23) in which the at least one latch is positioned in the corresponding opening (“The needle protection position of the cover 180 corresponds to the lugs of 190, 200 the cover 180 being located in the entrance position 160 of the respective aperture 152, 154.” [Col 13, line 7-10]), the skirt surrounds the needle to prevent exposure of the needle (Figure 22), and the skirt extends beyond the end of the needle by a first distance (Figures 22-23); and wherein in a second unlatched position (Figure 24) in which the at least one latch is deflected inward, the skirt body can move downward relative to the skirt, allowing the needle to extend beyond an end of the skirt by a second distance (Figure 24; “The device 220 is then armed by rotating the cover 180 clockwise causing the lugs 190, 200 to ride along the angled portions 168 of the respective aperture 152, 154. As the lugs 190, 200 clear the respective angled portion 168, an audible click occurs, indicating to the user that the device 220 is armed and ready for use. Actuation of the device 220 by pushing the cover 180 against a needle receiving surface forces the cover 180 further inside the mount 100, as shown in FIG. 24. In this retracted cover position, the lugs 190, 200 are positioned in portion 170 of the respective aperture 152, 154” [Col 14, line 42-53]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the apparatus of Kamen to include a safety device adapted to be coupled to a syringe having a needle, wherein in a first latched position, the skirt surrounds the needle to prevent exposure of the needle and that in a second unlatched position the skirt body can move downward relative to the skirt based on the teachings of Romano to provide a safety device that automatically returns to locked, needle covering position in order to prevent accidental needle sticks from the syringe during use of the apparatus (Romano [Col 1, lines 65]).
Response to Arguments
Applicant’s arguments with respect to claims 1-9 and 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783