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 .
Response to Amendment
The Amendment filed 3/24/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/27/2026 was filed after the mailing date of the Non-Final Rejection on 1/5/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-3, 12 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sonderegger et al. (US 8,961,469 B2).
Regarding claim 1, Sonderegger teaches a drug delivery system (figure 5) for injecting a medicament, the drug delivery system comprising:
a housing (housing of the device shown in figure 5) having a top portion (see “TP” in figure 5 below) and a bottom portion (see “BP” in figure 5 below);
a needle 152 having a sharp (end that gets inserted into the patient), the needle 152 movable relative to the housing from a retracted position (position of element 152 shown in figure 5) to an extended position (position shown in figure 10), to move the sharp from within the housing to outside of the housing, with the sharp (see figure 10) extending out from the bottom portion (see “BP” in figure 5 below) of the housing when in the extended position; and
a barrier apparatus 114A, 114B, 114D (figures 19, 20A, 22A) removable from the housing (housing of the device shown in figure 5) and the needle 152, the barrier apparatus comprising:
a barrier (see “B” in figure 5 below) configured to protectively surround at least the sharp of the needle 152, and a pull tab 532, 580 comprising:
a connecting portion (see “CP” in figure 5 below) connected to the barrier 112, 112d,
a gripping portion (portion of element 532, 580 that can be gripped by the person, for instance surface inside the hole of elements 532, 580 that person holds could be construed as a gripping portion) disposed apart from the connecting portion and at least partially external with respect to the housing, and
a body portion 516, 536 (living hinge between elements 580 and 112d) extending between the connecting portion (see “CP” in figure 5 below) and the gripping portion,
wherein the body portion has a flexible portion (engagement between element 516 and 536 is flexible, “living hinge” is flexible) for reducing strain on the barrier.
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Regarding claim 2, Sonderegger teaches wherein the flexible portion (engagement between element 516 and 536 is flexible, “living hinge” is flexible, the engagement has to be more flexible in order to effectively remove element 112 from element 152) is more flexible than the connecting portion and the gripping portion.
Regarding claim 3, Sonderegger teaches wherein the flexible portion (engagement between element 516 and 536 is flexible, “living hinge” is flexible) extends from at or about the connecting portion (see “CP” in figure 5 above) to or about the gripping portion.
Regarding claim 12, Sonderegger teaches wherein the barrier (see “B” in figure 5 above) comprises a cylindrical-shaped surface (surface of element 112) and an internal ledge (see “IL” in figure 20C below) extending radially inwardly from the cylindrical-shaped surface; wherein the needle 152 extends through the internal ledge (see “IL” in figure 20C below); and wherein the internal ledge (see “IL” in figure 20C below) engages (at least indirectly engages) the needle 152.
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Regarding claim 13, Sonderegger teaches wherein the barrier (see “B” in figure 5 above) comprises an elongated portion (elongated portion of element “B” in figure 5 above) and a generally planar portion (portion extending planar in the area represented by “IL” in figure 20C above) extending from the elongated portion of the barrier (see “B” in figure 5 above) and being disposed generally perpendicular with respect to a longitudinal axis of the needle 152.
Claims 1-3, 5, 12, 13, 15, 16, 18 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schrul et al. (US 2019/0151564 A1).
Regarding claim 1, Schrul teaches a drug delivery system (figure 10a) for injecting a medicament, the drug delivery system (figure 10a) comprising:
a housing 1, 3 (paragraph 0068) having a top portion 1 and a bottom portion 3;
a needle 11 having a sharp (an end of element 11 that gets inserted into the patient’s skin), the needle 11 movable relative to the housing 1, 3 from a retracted position (position shown in figure 7b) to an extended position (position where element 11 extends out of element 3 to get inserted into the patient’s body), to move the sharp from within the housing to outside of the housing; and
a barrier apparatus 20 removable (see figure 7a) form the housing and the needle 11, the barrier apparatus 20 comprising:
a barrier 17 configured to protectively surround at least the sharp of the needle, and
a pull tab (figure 9) comprising:
a connecting portion 26 connected to the barrier 17,
a gripping portion 27 disposed apart from the connecting portion 26 and at least partially external (as shown in figure 13a, element 27 is external to element 3) with respect to the housing 3, and
a body portion (portion of element shown in figure 9 extending between elements 26 and 27) extending between the connecting portion and the gripping portion,
wherein the body portion (portion of element shown in figure 9 extending between elements 26 and 27) has a flexible portion 28 (paragraph 0084, lines 9-24) for reducing strain on the barrier.
Regarding claim 2, Schrul teaches wherein the flexible portion is more flexible than the connecting portion and the gripping portion (paragraph 0084, lines 9-24, due to the design and presence of elements 31, 32, 33, 34, the element 28 would change the length compared to the connecting portion and the gripping portion).
Regarding claim 3, Schrul teaches wherein the flexible portion 28 extends from at or about the connecting portion 26 to at or about the gripping portion 27.
Regarding claim 5, Schrul teaches wherein the flexible portion is a webbed portion (paragraph 0084, lines 30-35).
Regarding claim 12, Schrul teaches wherein the barrier 17 comprises a cylindrical-shaped surface (see “CS” in figure 10a below) and an internal ledge (see “IL” in figure 10a below) inwardly from the cylindrical-shaped surface; wherein the needle 11 extends through the internal ledge; and wherein the internal ledge engages the needle 11.
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Regarding claim 13, Schrul teaches wherein the barrier 17 comprises an elongated portion (see “EL” in figure 10a above) and a generally planar portion (see “PP” in figure 10a above) extending from the elongated portion of the barrier and being disposed generally perpendicular with respect to a longitudinal axis of the needle 11.
Regarding claim 15, Schrul teaches wherein the barrier 17 comprises an elastomeric sleeve (sleeve formed by element 17, paragraph 0095, lines 3-10) for maintaining the sterility of the needle.
Regarding claim 16, Schrul teaches a barrier apparatus 20 for a drug delivery system (figure 10a) comprising a housing 3 (paragraph 0068) and a needle 11 having a sharp (an end of element 11 that gets inserted into the patient’s skin), the sharp being configured to move into and out of the housing, the barrier apparatus 20 comprising:
a barrier 17 configured to protectively surround at least the sharp of the needle, and
a pull tab (figure 9) comprising:
a connecting portion (see “CP” in figure 9 below) connected to the barrier 17,
a gripping portion 27 disposed apart from the connecting portion (see “CP” in figure 9 below) and configured to be disposed at least partially external (as shown in figure 13a, element 27 is external to element 3) with respect to the housing 3, such that the gripping portion 27 is graspable by the user (user can grasp during manufacturing process) and
a body portion (portion of element shown in figure 9 extending between elements 26 and 27) extending between the connecting portion and the gripping portion,
wherein the body portion (portion of element shown in figure 9 extending between elements 26 and 27) has a flexible portion 28 (paragraph 0084, lines 9-24) for reducing strain on the barrier, the flexible portion 28 being more flexible than the connecting portion 226 and the gripping portion 27, so as to deflect a greater distance from its original position than the connecting and gripping portions when a force is applied to the pull tab that is perpendicular to a longitudinal axis of the pull tab, thereby preventing motion of the barrier when the gripping portion is moved laterally (paragraph 0078, “also transverse to the longitudinal axis L” would mean that if the force is applied in element 28 area perpendicular to a longitudinal axis, element 28 would move more from its original position due to the structure compared to the connecting portion and the gripping portion).
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Regarding claim 18, Schrul teaches wherein the connecting portion (see “CP” in figure 9 above) is connected to the barrier 17 by a press-fit mechanism (see figures 10a-11b).
Regarding claim 19, Schrul teaches wherein the barrier 17 is substantially enclosed by the connecting portion (see “CP” in figure 9 above, portion of element 17 enclosed by “CP” in figure 9 above is construed as substantial) of the pull tab.
Claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Talley (US 5,348,543).
Regarding claim 20, Talley teaches a pull tab 14 for a barrier apparatus (apparatus formed by elements 12 and 14) of a drug delivery system (figure 1), the barrier apparatus comprising a barrier 12; the pull tab 14 comprising:
a connecting portion 38 configured to be connected to the barrier 12, the connecting portion 38 comprising a cavity (hollow portion inside element 38) within which the barrier 12 is disposed and engaged;
a gripping portion 34 disposed apart from the connecting portion 38, the gripping portion 34 comprising a base and a protrusion, wherein the base (see “FP” in figure 3 below) has a larger diameter than the protrusion (see “P” in figure 3 below); and
an elongated body portion 42 extending between the connecting portion 38 and the gripping portion 34,
wherein the elongated body portion has a flexible portion (column 5, lines 64-66) for reducing strain on the barrier.
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Allowable Subject Matter
Claims 4, 6-11, 14 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Schrul et al. (US 2019/0151564 A1), is silent regarding wherein the flexible portion is a segmented tube because the specification discloses the definition of segmented tube as having varied diameter along a central axis (paragraph 0059). Furthermore, one will not be motivated to modify the flexible portion of Schrul to incorporate such change. Therefore, Schrul fails to disclose a segmented tube as required by claim 4 in combination with other claimed limitations of claim 4.
The closest prior art of record, Schrul et al. (US 2019/0151564 A1), fails to disclose a coiled portion in combination with other claimed limitations of claim 6. Furthermore, one will not be motivated to modify the flexible portion of Schrul to incorporate a coiled portion.
The closest prior art of record, Schrul et al. (US 2019/0151564 A1), fails to disclose a stretchable straight segment in combination with other claimed limitations of claim 7. Furthermore, one will not be motivated to modify the flexible portion of Schrul to incorporate a stretchable straight segment.
The closest prior art of record, Schrul et al. (US 2019/0151564 A1), fails to disclose
The closest prior art of record, Schrul et al. (US 2019/0151564 A1), fails to disclose, the gripping portion has a base having a first diameter; and wherein the connecting portion has a second diameter less than the first diameter in combination with other claimed limitations of claim 8.
Claims 9 and 10 being dependent on claim 8 are also allowable.
The closest prior art of record, Schrul et al. (US 2019/0151564 A1), fails to disclose further comprising a removal component, the gripping portion attached to the removal component in combination with other claimed limitations of claim 11.
The closest prior art of record, Schrul et al. (US 2019/0151564 A1), fails to disclose further comprising a removal component having a serrated portion, wherein the gripping portion is attached to the removal component by the serrated portion in combination with other claimed limitations of claim 14.
The closest prior art of record, Schrul et al. (US 2019/0151564 A1), fails to disclose wherein the barrier and the pull tab are a unitary component made from one single piece of material in combination with other claimed limitations of claim 17.
Response to Arguments
Applicant’s arguments with respect to claims 1, 16 and 20 have been considered but are moot because the arguments do not apply in view of the present rejection.
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 NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM 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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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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