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 .
Information Disclosure Statement
The information disclosure statement (IDSs) submitted on 07/10/24 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Preliminary Amendment
The preliminary amendment filed 01/27/25 has been entered. Claim 1 has been amended. Claims 2-13 are cancelled. Claims 14-29 are newly presented. Thus, claims 1 and 14-29 remain pending in the application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “actuator dissolvable component is located on a central shaft” such as in at least claim 23 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 20 is objected to because of the following informalities:
Claim 20 lines 2-3 read “wherein the second dissolvable component is configured to prevent the second attachment part from transitioning…” and should likely read “wherein the second dissolvable component is configured to prevent [[the]] a second attachment part from transitioning…”” to provide antecedent basis for “second attachment part” which has not been recited in the claim language due to the preliminary amendment in claim 1
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 14-19, 24, and 26-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Skak (DK202070302 provided on 07/10/24 IDS).
Regarding claim 1, Skak discloses a drug delivery device (see FIG. 9 provided for ease of reference immediately below) comprising:
PNG
media_image1.png
500
970
media_image1.png
Greyscale
a first body part (4 comprising 4A&4B, see page 33 lines 30-33);
a second body part (10 comprising 10A/10B);
a first attachment part (36) connected to (see page 9 line 33- page 34 line 6: attachment part connected by rotation to body part 4) the first body part (4) and having a first distal end (40); and
an actuator mechanism (16) configured to rotate one of the first body part (4) and/or the second body part about a central axis (see page 34 lines 20-22: 16 rotates first body part 4);
wherein the drug delivery device is configured to transition from an initial configuration (see FIG. 9) to an attachment configuration (when delivery device is initially assembled together such as in FIG. 10 and described in page 34 line 23- page 35 line 28), and from the attachment configuration to a release configuration (see page 32 lines 6-19: FIG. 10 includes the degradable locking element 72 as described for FIG.3 and therefore once the element 72 shown in FIG. 10 dissolves as in page 32 lines 6-19 for FIG.3, the drug will be released from the device in a “release configuration”);
wherein the transition from the initial configuration (see FIG. 9) to the attachment configuration (see FIG. 10) comprises translating the first attachment part (36) in a first direction (along angular direction of needle as described on page 33 line 30- page 34 line 28:) about a first axis (axis through needle 38 comprising distal end 40) in relation to the first body part (4), and rotating the first body part (4) in relation to the second body part (10) in a first actuating direction about the central axis (see page 33 line 30- page 34 line 28: attachment part 36 is rotated along angular position and then the first body part rotates relative central/ longitudinal axis); and
wherein the transition from the attachment configuration (see FIG. 10) to the release configuration (see page 32 lines 6-19) comprises one or more of translating the first attachment part in the first direction, and rotating the first body part in relation to the second body part in a first detachment direction opposite the first actuating direction (see page 32 lines 6-19: first body part 4 is rotated relative the second body part upon dissolving of 72.).
Regarding claim 14, Skak discloses the drug delivery device according to claim 1, and Skak further discloses wherein translating the first attachment part (36, see FIG. 9) in the first direction about the first axis (along angular direction of needle as described on page 33 line 30- page 34 line 28) comprises rotating the first attachment part in the first direction about the first axis (see page 33 line 30- page 34 line 28).
Regarding claim 15, Skak discloses the drug delivery device according to claim 1, and Skak further discloses wherein the transition from the attachment configuration (see FIG. 10) to the release configuration (after 72 dissolves, see page 32 lines 6-19) comprises translating the first attachment part in the first direction about the first axis (see page 34 line 32- page 34 line 9 or as described for FIGS. 11A-d on page 35 line 29-page 36 line 11).
Regarding claim 16, Skak discloses the drug delivery device according to claim 1, and Skak further discloses wherein the transition from the attachment configuration (see FIG. 10) to the release configuration (after 72 dissolves) comprises rotating the first body part (4) in relation to the second body part in the first detachment direction opposite the first actuating direction (see page 32 lines 6-19: first body part 4 is rotated relative the second body part upon dissolving of 72. Rotation would be opposite that of the actuating direction that assembled device).
Regarding claim 17, Skak discloses the drug delivery device according to claim 1, and Skak further discloses wherein the drug delivery device comprises at least one dissolvable component (72, see FIG.10) configured to prevent transitioning from the attachment configuration to the release configuration (page 32 lines 6-19).
Regarding claim 18, Skak discloses the drug delivery device according to claim 17, and Skak further discloses wherein the at least one dissolvable component (72, see FIG. 10) comprises a first dissolvable component (see page 32 lines 6-19: sugary substance dissolved by GI fluids), wherein the first dissolvable component is configured to prevent the first attachment part from transitioning from a first attachment position in the attachment configuration to a first release position in the release configuration (see page 32 lines 6-19: dissolvable component prevents transition to release configuration).
Regarding claim 19, Skak discloses the drug delivery device according to claim 18, and Skak further discloses wherein the first dissolvable component (see page 32 lines 6-19: sugary substance dissolved by GI fluids), in the attachment configuration of the drug delivery device, prevents rotation of the first attachment part in the first direction (see page 32 lines 6-19).
Regarding claim 24, Skak discloses the drug delivery device according to claim 1, and Skak further discloses wherein the actuator mechanism (16, see FIG. 9) comprises a dissolvable material (72, see FIG. 10 and page 32 lines 6-19: dissolving 72 initiates release of actuator 16 and thus forms part of the entire actuator mechanism), and wherein the actuator mechanism is configured to prevent the rotating the first body part (4) in relation to the second body part (10) in the first detachment direction in the attachment configuration (see page 32 lines 6-19:actuator mechanism prevents rotation until 72 is dissolved to release actuator 16 and thus configured to prevent rotating in the first detachment direction).
Regarding claim 26, Skak discloses the drug delivery device according to claim 1, and Skak further discloses wherein the first axis (axis X_1 through needle 36, see FIG. 11b) is angled from the central axis at a first angle larger than 30 degrees (see page 35 line 29-page 36 line 2: axis through needles come into contact with plane of central axis==perpendicular as shown in FIG. 11b, which is larger than 30degrees).
Regarding claim 27, Skak discloses the drug delivery device according to claim 26, and Skak further discloses wherein the first axis (axis X_1 through needle 36, see FIG. 11b) is perpendicular to the central axis (see page 35 line 29-page 36 line 2: axis through needles come into contact with plane of central axis==perpendicular as shown in FIG. 11b).
Regarding claim 28, Skak discloses the drug delivery device according to claim 1, and Skak further discloses wherein the first axis (axis X_1 through needle 36, see FIG. 11b) is spaced away (see ‘Modified FIG.11b’ below) from the central axis (see page 35 line 29-page 36 line 2).
PNG
media_image2.png
420
307
media_image2.png
Greyscale
Regarding claim 29, Skak discloses the drug delivery device according to claim 1, and Skak further discloses the drug delivery device comprising a second attachment part (44, see FIG.9) connected to (see page 34 lines 10-14: 44 rotationally attached to second body part 10 via second joint connection) the second body part (10) and having a second distal end (48, see page 31 lines 3-4).
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.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Skak as applied to claim 17 above, and further in view of Imran (U.S. PGPUB No. 2022/0257502, with disclosure supported by provisional application 62/912,581 filed 2019).
Regarding claim 20, Skak discloses the drug delivery device according to claim 17, and Skak further discloses wherein the at least one dissolvable component (72, see FIG.10) is configured to prevent the second attachment part (44) from transitioning from a second attachment position in the attachment configuration to a second release position in the release configuration (see page 32 lines 6-19 and page 37 lines 8-21: 72 prevents rotation of first and second body part and attachment part 44 and is therefore configured to prevent transition between any positions).
Skak is silent to “wherein the at least one dissolvable component comprises a second dissolvable component” and “wherein the second dissolvable component” is configured to prevent the second attachment part from transitioning from a second attachment position in the attachment configuration to a second release position in the release configuration.
However, Imran teaches a drug delivery device (see [0002-0004] & [0045-0046]) comprising at least one dissolvable component (520, see FIG. 5B and [0092]: plug 520 wrapped around shell exterior, plug aligns with applicant disclosure in [0107] of the current Application) configured to prevent transitioning from a first configuration to a release configuration (see [0089] & [0097]), wherein the at least one dissolvable component comprises a second dissolvable component (see [0094-0096]: plug 520 can include one/more layers with one/more degradable materials).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one dissolvable component configured to prevent transitioning from the attachment configuration to the release configuration and configured to prevent the second attachment part from transitioning from a second attachment position in the attachment configuration to a second release position in the release configuration disclosed in Skak to include a first and second dissolvable component as taught by Imran for the purpose of designing the dissolvable component with a desired property such as rate of degradation, shear strength, material stability, etc. (see [0089] & [0094-0097]), thus achieving “wherein the at least one dissolvable component comprises a second dissolvable component” and “wherein the second dissolvable component” is configured to prevent the second attachment part from transitioning from a second attachment position in the attachment configuration to a second release position in the release configuration.
Claims 21-22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Skak as applied to claim 17 above, and further in view of Imran et al. (U.S. PGPUB No. 2022/0118056), hereinafter Imran2.
Regarding claim 21, Skak discloses the drug delivery device according to claim 17, and Skak further discloses wherein, in the release configuration, the actuator mechanism (16, see FIG. 9) is disengaged from one or both of the first body part and the second body part (see page 30 lines 3-27: 16 disengages internal engagement part 30 of first body part 4 during rotation).
Skak is silent to “wherein the at least one dissolvable component comprises an actuator dissolvable component, wherein the actuator mechanism, in the attachment configuration, is connected to one or both of the first body part and the second body part via the actuator dissolvable component”.
However, Imran2 teaches a drug delivery device (see FIG. 2 and [0220]) comprising a first body part (20), an actuator mechanism (60 comprising spring, see [0210]), and at least one dissolvable component (70) configured to prevent transitioning from an attachment configuration to a release configuration (see [0210-0214]: 70 attached to actuating mechanism 60 and retains needle 40 within device. Then 70 degrades to release medicament through 40, see [0220]), wherein the at least one dissolvable component (70) comprises an actuator dissolvable component (see [0210-0214] and [0214]: 70 can include portions connected to tubes 30 and actuator mechanism 60), wherein the actuator mechanism (60), in the attachment configuration (as shown in FIG. 2), is connected to the first body part (20) via the actuator dissolvable component (70), and wherein, in the release configuration, the actuator mechanism (60) is disengaged from the first body part (see [0214]: degradation results in actuator mechanism disengaging from portion of 20 that 70 retained actuator mechanism against).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one dissolvable component disclosed in Skak to comprise an actuator dissolvable component, wherein the actuator mechanism, in the attachment configuration, is connected to one or both of the first body part and the second body part via the actuator dissolvable component as taught by Imran2 for the purpose of connecting the dissolvable component directly to the actuator mechanism to initiate the release timing for the actuator mechanism (see [0210-0214]) such that the needles are deployed at a desired target site (see [0220]) or at a desired depth (see [0207]), thus achieving “wherein the at least one dissolvable component comprises an actuator dissolvable component, wherein the actuator mechanism, in the attachment configuration, is connected to one or both of the first body part and the second body part via the actuator dissolvable component”.
Regarding claim 22, the modified system of Skak teaches the drug delivery device according to claim 21, but Skak is silent to “wherein the actuator dissolvable component is located on a radially inward facing surface of the first body part and/or the second body part.”
However, Imran2 teaches a drug delivery device (see FIG. 2 and [0220]) comprising a first body part (20), an actuator mechanism (60 comprising spring, see [0210]), and at least one dissolvable component (70), wherein the at least one dissolvable component (70) comprises an actuator dissolvable component (see [0210-0214] and [0214]: 70 can include portions connected to tubes 30 and actuator mechanism 60), wherein the actuator dissolvable component (70) is located on a radially inward facing surface (81, see [0208]) of the first body part (20) and/or the second body part.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one dissolvable component disclosed in Skak to comprise an actuator dissolvable component located on a radially inward facing surface to connect with the actuator mechanism as taught by Imran2 for the purpose of connecting the dissolvable component directly to the actuator mechanism to initiate the release timing for the actuator mechanism (see [0210-0214]) such that the needles are deployed at a desired target site (see [0220]) or at a desired depth (see [0207]), thus achieving “wherein the actuator dissolvable component is located on a radially inward facing surface of the first body part and/or the second body part”.
Regarding claim 25, the modified system of Skak teaches the drug delivery device according to claim 21, and Skak further discloses wherein a dissolution (see page 32 lines 6-19: dissolving the sugary substance by GI fluids) of the at least one dissolvable component (72, see FIG. 10) reduces a force applied by the actuator mechanism (16, see page 32 lines6-19: after dissolving, force of actuator is released and thus the force is reduced due to dissolution) between the first body part (4) and the second body part (10).
Skak is silent to the dissolution of the “actuator mechanism or the actuator dissolvable component”.
However, Imran2 teaches a drug delivery device (see FIG. 2 and [0220]) comprising a first body part (20), an actuator mechanism (60 comprising spring, see [0210]), and at least one dissolvable component (70), wherein the at least one dissolvable component (70) comprises an actuator dissolvable component (see [0210-0214] and [0214]: 70 can include portions connected to tubes 30 and actuator mechanism 60).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one dissolvable component disclosed in Skak to comprise an actuator dissolvable component to connect with the actuator mechanism as taught by Imran2 for the purpose of connecting the dissolvable component directly to the actuator mechanism to initiate the release timing for the actuator mechanism (see [0210-0214]) such that the needles are deployed at a desired target site (see [0220]) or at a desired depth (see [0207]), thus achieving the dissolution of the “actuator mechanism or the actuator dissolvable component”.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Skak in view of Imran2 as applied to claim 21 above, and further in view of Jensen et al. (U.S. PGPUB No. 2022/0105330), hereinafter Jensen.
Regarding claim 23, the modified system of Skak teaches the drug delivery device according to claim 21, but Modified Skak is silent to “wherein the actuator dissolvable component is located on a central shaft extending through the drug delivery device along the central axis.”
However, Jensen teaches a drug delivery device (see FIG. 1a-1b for entire device. However, this rejection relies on the specific internal mechanism disclosed for embodiment of design IV shown in FIG. 3) with an actuator mechanism (firing and propulsion mechanism initiated by dissolving of plug 160/160’, see design IV in FIG. 3 for all subsequent reference numerals and see [0091] & [0099]), a central axis (vertical axis through center of 112’), and at least one dissolvable component (material forming plug 160/160’ dissolves, see [0099] & [0118]) comprising an actuator dissolvable component (160’), wherein the actuator dissolvable component (160’) is located on a central shaft (112’) extending through the drug delivery device along the central axis (see [0118]: 160’ formed of ring surrounding central shaft ).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the actuator dissolvable component affixed to the first body part taught by Modified Skak with the actuator dissolvable component located on a central shaft extending through the drug delivery device along a central axis as taught by Jensen. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (an actuator dissolvable component retaining the actuator mechanism in place by way of a radially extension to the first body part as taught by Modified Skak) for another known element (An actuator dissolvable component retaining the actuator mechanism by way of a circumferentially surrounding ring as taught by Jensen) in the art to obtain the predictable result of retaining an actuator mechanism in place by a dissolvable/time release component (see MPEP § 2143.I.B), thus achieving “wherein the actuator dissolvable component is located on a central shaft extending through the drug delivery device along the central axis.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM 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, Michael Tsai can be reached at (571) 270-5246. 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.
/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights