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 statements (IDS) submitted before the mailing date of the instant action are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
On line 11 of claim 1, “coupled with the power source and the hub and comprising a slot” should read coupled with the power source and the hub, the motion conversion mechanism comprising a slot” for a clearer recitation of the limitation indicating that the slot is part of the motion conversion mechanism and not power source or hub.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regard to claim 12, “the connector” does not have antecedent basis. The connector is interpreted as the pin of claim 11. Appropriate correction is required.
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.
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(s) 1-3, 5, and 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over Cole et al. (US 2015/0306307; hereafter Cole) in view of Schabbach et al. (2016/0213837; hereafter Schabbach).
Regarding claim 1, Cole teaches a wearable drug delivery device (1, Fig. 1) comprising: a housing (2/9, Fig. 2); a container (4, Fig. 2) positioned at least partially within the housing (2/9, see Fig. 1); and an insertion mechanism (7, Fig. 2) positioned at least partially within the housing (2/9) and comprising: a delivery member (70, Fig. 6) connected or configured to be connected in fluid communication with the container (4, see [0055]), the delivery member (70) being moveable between a first position (position of 70/71 in Fig. 8, see [0052]) wherein an insertion portion (71, Fig. 11) of the delivery member (70) is positioned within the housing (2/9) and a second position (position of 70/71 in Fig. 11, see [0056]) wherein the insertion portion (71) of the delivery member (70) is positioned exterior to the housing (2/9/) for insertion into a patient (see [0056]), a hub (10, Fig. 8) operably coupled with the delivery member (70, see [0048]), a power source (30, Fig. 6) configured to generate rotational motion (see [0048]), and a motion conversion mechanism (54, Fig. 7) operably coupled with the power source (30) and the hub (10, see Figs. 6-7 and [0048]), the motion conversion mechanism (54) being configured to convert the rotational motion of the power source (30) into linear motion of the hub (10) to move the delivery member (70) between the first position (position of 70 in Fig. 8) and the second position (position of 70/71 in Fig. 11, see [0048]) but does not teach wherein operation of the power source causes at least a portion of the motion conversion mechanism comprising the slot to move with respect to the housing.
However, Schabbach et al. teaches an insertion mechanism (1, Fig. 1) including: a delivery member (2, Fig. 1) connected or configured to be connected in fluid communication with the drug storage container (see [0046[), the delivery member (2) being moveable between a first position (initial/retracted position, see Fig. 4, [0039] and [0052]) and a second position (extended position, see Fig. 5) wherein an insertion portion (tip of 2) of the delivery member (2) is positioned for insertion into a patient (see [0053]), a hub (6, Fig. 1) operably coupled with the delivery member (2, see Fig. 1 and [0046]), a power source (13/14, Fig. 3A) configured to generate rotational motion (see [0050]-[0053]), and a motion conversion mechanism (7/10/11/15) operably coupled with the power source (30) and the hub (6, see Figs. 4-5 and [0050]-[0053]), the motion conversion mechanism (7/10/11/15) being configured to convert the rotational motion of the power source (13/14) into linear motion of the hub (6) to move the delivery member (2) between the first position (initial/retracted position) and the second position (insertion position, see [0050]-[0053]), wherein the motion conversion mechanism includes a slot (11.2), and wherein operation of the power source causes at least a portion (11) of the motion conversion mechanism comprising the slot (11.2) to move with respect to the housing (see at least par. [0055]- the second roller rotates relative to the housing to retract needle upon spring 14 being triggered).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Cole by substituting the insertion mechanism taught by Cole for the insertion mechanism taught by Schabbach et al. for having a fault-tolerant system that achieves high speed needle movements and exact needle guidance thus reducing pain for the patients when inserting and retracting the needle and increasing consumer acceptance and satisfaction; and Schabbach teaches that the low part count of the insertion arrangement allows for an increased mechanical robustness and low manufacturing costs (see [0033]). Further, Cole teaches that modifications may be made to the device (see [0072]).
Regarding claim 2, Cole in view of Schabbach teaches comprising at least one fluid conduit (14/16, Fig. 10) configured to fluidly connect the delivery member (2) and the container (4, see [0055]), the at least one fluid conduit (14/16) being coupled to the hub (6, it is the Examiner's position that all of the components of the device are either directly or indirectly coupled) such that at least a portion of the fluid conduit (14/16) and the hub (6) translate jointly during insertion of the delivery member (2) into the patient (see [0055]-[0057]).
Regarding claim 3, Cole teaches wherein the delivery member (70) includes a hollow needle (see [0046]).
Regarding claim 5, Cole discloses wherein, the hub (10), in moving from the first position to the second position, moves with respect to a rotational axis of the motion conversion mechanism see [0050]-[0055]- the hub moves up and down which is considered movement with respect to a rotational axis).
Regarding claim 8, Cole teaches wherein the motion conversion mechanism (54) includes a rotatable member (20, Figs. 5-6 and see [0048]) operably coupled to the hub (10) and rotatable about a rotational axis (rotational axis about 12, Fig. 6) by the power source (30, see [0048]).
Regarding claim 9, Cole discloses wherein the rotational axis is traverse to a longitudinal axis of the delivery member (see Figs. 5-7).
Regarding claim 10, Cole teaches wherein initial rotation of the rotatable member (20) causes the delivery member (70) to translate from the first position (position of 70 in Fig. 8) to the second position (position of 70 in Fig. 11) and subsequent rotation of the rotatable member (20) causes the delivery member (70) to translate from the second position (position of 70 in Fig. 11) to the first position (position of 70 in Fig. 8, see [0047], [0048] and [0057]- [0058]).
Regarding claim 11, Schabbach discloses wherein the motion conversion mechanism comprises a pin (10.2) slidably received in the slot (11.2), wherein rotation of the rotatable member causes the pin to slide along a surface defining the slot (see [0055]-[0057]).
Regarding claim 12, Cole wherein the connector member is a pin (10.2) fixed to the rotatable member (20) (at least indirectly).
Regarding claim 13, Cole wherein the power source comprises a torsion spring (30 is a torsion spring; 13/14 of Shabbach are also torsion springs).
Regarding claim 14, Cole wherein at least a portion of the torsion spring is exterior to the rotatable member (see Figs. 5-7).
Regarding claim 15, Shabbach teaches wherein the rotational axis is stationary or substantially with respect to the housing during operation of the power source (see rotational axis through rollers in Fig. 2).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Cole and Schabbach in view of O'Connor et al. (Pub. No. 2013/0060233).
Regarding claim 4, Cole does not teach wherein the delivery member includes a solid trocar. However, O'Connor et al. teaches a delivery member (214, Fig. 3A) includes a solid trocar (see [0055] and [0062]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Cole by forming the device such that the needle is solid and used for puncturing the skin and such that the cannula is in fluid communication with the reservoir once the needle is retracted for drug delivery as taught by O'Connor (see [0059] and [0062]-[0063]) for minimizing pain and discomfort associated with drug delivery while providing a sterile fluid pathway for the drug to be delivered to the patient ([0008]). In addition, it is known in the art that an insertion needle may be hollow or solid (see [0055]) and Cole teaches that modifications may be made to the device (see Cole et al. [0072]).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Cole and Schabbach in view of Cole et al. (Pub. No. 2014/0276563; hereafter Cole 2).
Regarding claim 6, Cole does not teach comprising an adhesive applied to an exterior wall of the housing for attaching the housing to skin of a patient. However, Cole 2 teaches an insertion device (1, Fig. 1) comprising an adhesive (10, Fig. 2) applied to an exterior wall of a housing (2/3, Fig. 1-3) for attaching the housing (2/3) to skin of a patient (see [0083]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Cole by adding the adhesive pad/patch taught by Cole 2 to the bottom surface of the base of the device taught by Cole for securing the device to the skin surface of the patient with a reduced risk of tenting of the skin surface and/or precisely target the intradermal depth (see [0012]). Further, Cole teaches that modifications may be made to the device (see [0072]).
Regarding claim 7, Cole in view of Cole 2 teaches comprising an opening (591, Fig. 9) formed in the exterior wall of the housing (2/9, see Fig. 9; 591 is formed in 9), wherein the insertion portion (71) of the delivery member (70) extends through the opening (591) in the second position (position of 70/71 in Fig. 11).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,464,900. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the patented claims.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,986,624. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the patented claims.
Conclusion
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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