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
This office action is responsive to the amendment filed 12 December 2025. As directed by the amendment: claims 1-15 remain pending in this application.
Response to Arguments
Applicant's arguments filed 12 December 2025 have been fully considered but they are not persuasive.
Applicant argues that the mechanism of Wendland does not teach “without displacement of the plurality of lock pins relative to the longitudinal axis” in independent claims 1, 10 and 14. As stated in the previous office action, the notches and the actual pins of the device are two different features in the same area that relate to the securement of the device of Wendland. The notches that move away from the longitudinal axis and the pins of the device are not the same objects, therefore, the displacement of the pins that applicant points out is not what is happening in the figures of Wendland, but rather the notches that couple with the pins of the device that are being displaced.
Applicant also argues that the plurality of locking pins are next to the housing. The use of terms like adjacent and next to do not change the structure of Wendland. The locking pins that are inside the notches are next to and/or adjacent to the housing. There is a space between the parts, but the space does not include anything else; therefore, the notches and locking pins are both next to the housing.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wendland et al. (US 2018/0339114).
Regarding claim 1, Wendland discloses a drug delivery device (Fig. 1A-4C, 10) comprising:
a housing (11) having a longitudinal axis (Fig. 1A, X);
a container (18) at least partially disposed within the housing (¶[0052]), the container configured to contain a medicament (¶[0043]);
an injection mechanism at least partially disposed within the housing, the injection mechanism configured to exert a force to urge the medicament from the container (¶[0048]);
a drug delivery component (17) at least partially disposed within the housing (¶[0043]);
a protective cap (12) selectively coupled with the housing adjacent to the drug delivery component (Fig. 1B, where the cap 12 can be placed on the device or removed); and
a plurality of lock pins (Fig. 2A, where the pins in notches near 124 connect the inner surface 126 to an outer layer 125) positioned next to the housing (where the housing 11 runs parallel to the locks and notches and is next to the release area of the device where the cap is located as shown in figure 2B) and the protective cap and preventing relative movement therebetween until the plurality of lock pins reach a desired temperature (¶[0054], [0060], [0063]-[0066], where a threshold temperature must be met to release the pins inside shield 123 that retains cap 12), the plurality of lock pins each having a first thickness at a temperature below the desired temperature for activation of the injection mechanism and a second thickness at the desired temperature, a change between the first thickness and the second thickness activation of the injection mechanism without displacement of the at least one lock pins relative to the longitudinal axis (¶[0056], [0060], [0063]-[0066], where the retention means includes expansion and retraction of the interior parts including the pins in order to remove the cap easily, this is a change in thickness when a threshold temperature is reached is a change from a first thickness to a second thickness, the thickness of the inner and outer layer does change to allow for space to release the locking pins and the locking pins do not move, but rather the locking mechanism releases relative to the longitudinal axis).
Regarding claim 2, Wendland discloses wherein the plurality of lock pins includes at least three lock pins annularly spaced about an inner surface of the protective cap (Fig. 2A, where the pins in notches near 124 connect the inner surface 126 to an outer layer 125, there are 3 pins on each side).
Regarding claim 3, Wendland discloses wherein the plurality of lock pins includes at least four lock pins annularly spaced about the inner surface of the protective cap (Fig. 2A, where the pins in notches near 124 connect the inner surface 126 to an outer layer 125, there are 3 pins on each side for a total of six pins).
Regarding claim 4, Wendland discloses wherein the housing includes a needle shield (123) at least selectively surrounding the drug delivery component (Fig. 2A, where the needles shield surrounds the delivery component 17), wherein the plurality of lock pins are each connected to an outer surface of the needle shield (Fig. 2A, where the interior surface 126 has pins connected to the outer layer surface 127) .
Regarding claim 5, Wendland discloses wherein the needle shield includes a plurality of locking notches each configured to selectively engage the plurality of lock pins until the plurality of lock pins reach the desired temperature (Fig. 2A, where the pins in notches near 124 connect the inner surface 126 to an outer layer 125, there are 3 pins on each side with their own notch, ¶[0072], where the pins and notches are deformable at a threshold temperature).
Regarding claim 6, Wendland discloses wherein the plurality of lock pins are shape memory alloys (¶[0072]).
Regarding claim 7, Wendland discloses wherein the plurality of lock pins are constructed from a bi-metallic material (¶[0072]).
Regarding claim 8, Wendland discloses wherein the plurality of lock pins are constructed from a nitinol material (¶[0072]).
Regarding claim 9, Wendland discloses further comprising a release component coupled with the housing and configured to selectively permit release of the injection mechanism (¶[0054]); and at least one release pin positioned adjacent to the housing (pins on shield 123) and the release component and preventing relative movement therebetween until the at least one release pin reaches the desired temperature (¶[0054], [0060], [0063]-[0066]).
Regarding claim 10, Wendland discloses a drug delivery device (Fig. 1A-4C, 10) comprising:
a housing (11) having a longitudinal axis (Fig. 1A, X);
a container (18) at least partially disposed within the housing (¶[0052]), the container configured to contain a medicament (¶[0043]);
an injection mechanism at least partially disposed within the housing, the injection mechanism configured to exert a force to urge the medicament from the container (¶[0048]);
a drug delivery component (Fig. 4C, 17) at least partially disposed within the housing (¶[0043]);
a release component (Fig. 2A, notches near 124) coupled with the housing and configured to selectively permit release of the injection mechanism (¶[0056]); and
at least one release pin positioned next to the housing (where the housing 11 runs parallel to the locks and notches and is next to the release area of the device where the cap is located as shown in figure 2B) and the release component, and preventing relative movement therebetween until the at least one release pin reaches a desired temperature(¶[0054], [0060], [0063]-[0066], where a threshold temperature must be met to release the pins inside shield 123 that retains cap 12) the at least one release pin having a first thickness at a temperature below the desired temperature for activation of the injection mechanism and a second thickness at the desired temperature, a change between the first thickness and the second thickness enabling activation of the injection mechanism without displacement of the at least one release pin relative to the longitudinal axis (¶[0056], [0060], [0063]-[0066], where the retention means includes expansion and retraction of the interior parts including the pins in order to remove the cap easily, this is a change in thickness when a threshold temperature is reached is a change from a first thickness to a second thickness, the thickness of the inner and outer layer does change to allow for space to release the locking pins and the locking pins do not move, but rather the locking mechanism releases relative to the longitudinal axis).
Regarding claim 11, Wendland discloses wherein the at least one release pin contains shape memory alloys (¶[0072].
Regarding claim 12, Wendland discloses wherein the at least one release pin is constructed from a bi-metallic material (¶[0072]).
Regarding claim 13, Wendland discloses wherein the at least one release pin is constructed from a nitinol material (¶[0072]).
Regarding claim 14, Wendland discloses A drug delivery device (Fig. 1A-4C, 10) comprising:
a housing (11) having a longitudinal axis (Fig. 1A, X);
a container (18) at least partially disposed within the housing (¶[0052]), the container configured to contain a medicament (¶[0043]);
an injection mechanism at least partially disposed within the housing, the injection mechanism configured to exert a force to urge the medicament from the container (¶[0048]);
a drug delivery component (17) at least partially disposed within the housing (¶[0043]); and
at least one lock out mechanism positioned next to the housing (where the housing 11 runs parallel to the locks and notches and is next to the release area of the device where the cap is located as shown in figure 2B) and preventing activation of the injection mechanism until the at least one lock out mechanism reaches a desired temperature (¶[0054], [0060], [0063]-[0066], where a threshold temperature must be met to release the pins inside shield 123 that retains cap 12), the at least one lock out mechanism having a first thickness at a temperature below the desired temperature for activation of the injection mechanism and a second thickness at the desired temperature, a change between the first thickness and the second thickness enabling activation of the injection mechanism without displacement of the at least one lock out mechanism relative to the longitudinal axis (¶[0056], [0060], [0063]-[0066], where the retention means includes expansion and retraction of the interior parts including the pins in order to remove the cap easily, this is a change in thickness when a threshold temperature is reached is a change from a first thickness to a second thickness, the thickness of the inner and outer layer does change to allow for space to release the locking pins and the locking pins do not move, but rather the locking mechanism releases relative to the longitudinal axis).
Regarding claim 15, Wendland discloses wherein the at least one lock out mechanism contains a shape memory alloy (¶[0072]).
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 HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783