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 .
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 32-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13 of U.S. Patent No. 12,102,808 in view of Soerensen et al (US 2016/0235924). Note that the instant application has been filed as a divisional of 17/036,556, now US 12,102,808 currently relied upon in this double patenting rejection. Claims 32-40 were not presented in the parent application and therefore were not subject to the restriction requirement in that application. As such, these claims are not precluded from a double patenting rejection.
Regarding claim 32 of the application, claim 1 of the patent recites a drug delivery device (claim 1, line 62) comprising: a housing having an opening (claim 1, line 63); a drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening in the housing (claim 1, lines 64-66); a plunger (claim 1, line 67); a drive mechanism activatable to drive the plunger in a distal direction to expel a drug from the drug storage container through the delivery member (claim 1, lines 1-3); a guard moveably disposed adjacent to the opening and operably coupled to the drive mechanism (claim 1, lines 4-5); a lock selectively engageable with the guard to limit movement of the guard in a proximal direction (claim 1, lines 9-13).
Claim 32 of the application differs from claim 1 of the patent in calling for an indicator operably coupled to the drive mechanism to generate a continuous or repeating audible signal during drug delivery. Soerensen teaches a drug delivery device including an indicator operatively coupled to the drive mechanism to generate a continuous or repeating audible signal during drug delivery to indicate to the user that the drug is being delivered to increase patient safety (page 10, para. 0098). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device of claim 32 of the patent to include an indicator as taught by Soerensen to provide an indication that the drug is being delivered to increase safety of use of the device.
Regarding claim 33, Soerensen further teaches that the indicator is rotatable relative to the housing (page 5, para. 0051).
Regarding claim 34, Soerensen further teaches that activating the drive mechanism causes the drive mechanism to rotate the indicator relative to the housing, and wherein the drive mechanism ceases rotating the indicator when drug delivery is complete (page 5, para. 0051; page 10, para. 0098).
Regarding claim 35, Soerensen further teaches a first plurality of projections 251 coupled to the indicator (fig. 4); and a second plurality of projections 241 concentrically arranged with the first plurality of projections (fig. 8; page 5, para. 0051), wherein the first plurality of projections slidably engages the second plurality of projections to generate the continuous or repeating audible signal during drug delivery (page 5, para. 0051; page 10, para. 0098).
Regarding claim 36, Soerensen further teaches that the second plurality of projections is disposed around the first plurality of projections (fig. 8).
Regarding claim 37, Soerensen further teaches that during drug delivery, the first plurality of projections rotates relative to the second plurality of projections such that each projection of the first plurality of projections slidably engages one or more projections of the second plurality of projections (page 10, para. 0098).
Regarding claim 38, Soerensen further teaches that each projection of the first plurality of projections 251 extends in a radially outward direction, and wherein each projection of the second plurality of projections 241 extends in a radially inward direction (figs. 4, 8).
Regarding claim 39, Soerensen further teaches that each projection of the first plurality of projections 251 includes a flexible arm moveable between a first radial position and a second radial position when the flexible arm engages a respective projection of the second plurality of projections (page 10, para. 0098: ratchet arms).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 1 of the patent to include the features as taught by Soerensen as described above to provide the mechanism for making an audible indication during drug delivery to alert the user that the injection indeed took place thereby increasing safety of the device.
Regarding claim 40, claim 13 of the patent recites wherein the drug storage container is filled or pre-filled with the drug, and wherein the drug comprises one of: a drug containing a human IgG1 kappa antibody, a drug containing a small interfering RNA (siRNA) that lowers lipoprotein(a), efavaleukin alfa, evolocumab, a drug containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist, romiplostim, etanercept, blinatumomab, and tezepelumab.
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.
Claim(s) 21-30, 32-39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Soerensen et al (US 2016/0235924).
Regarding claim 21, Soerensen discloses a drug delivery device 1 comprising: a housing 2 having an opening (fig. 2A); a drug storage container 380 including a delivery member (col. 3, para. 0039: needle not shown) having an insertion end configured to extend at least partially through the opening in the housing (fig. 12A); a plunger 280; a drive mechanism 270 activatable to drive the plunger to expel a drug from the drug storage container through the delivery member (page 10, para. 0098); and an indicator 250 operably coupled to the drive mechanism to generate a continuous or repeating audible signal during drug delivery, and to cease generating the continuous or repeating audible signal when drug delivery is complete (page 10, para. 0098: ratchet arms 251 provide clicks during dose delivery).
Regarding claim 22, Soerensen discloses that the indicator is rotatable relative to the housing (page 5, para. 0051).
Regarding claim 23, Soerensen discloses that activating the drive mechanism causes the drive mechanism to rotate the indicator relative to the housing, and wherein the drive mechanism ceases rotating the indicator when drug delivery is complete (page 5, para. 0051; page 10, para. 0098).
Regarding claim 24, Soerensen discloses that the drive mechanism includes a rotational biasing member 139 initially held in an energized state and a mechanical linkage 290 operably coupling the rotational biasing member and the plunger, and wherein the mechanical linkage is configured to rotate as the rotational biasing member de-energizes (page 5, para. 0048; page 11, para. 0101).
Regarding claim 25, Soerensen disclose that the mechanical linkage 290 includes a plunger guide 270 having a proximal end and a distal end, the plunger being at least partially disposed within the distal end of the plunger guide (page 5, para. 0049), the proximal end of the plunger guide being coupled to the indicator such that the indicator rotates jointly with the plunger guide (page 8, para. 0073).
Regarding claim 26, Soerensen discloses a first plurality of projections 251 coupled to the indicator (fig. 4); and a second plurality of projections 241 concentrically arranged with the first plurality of projections (fig. 8; page 5, para. 0051), wherein the first plurality of projections slidably engages the second plurality of projections to generate the continuous or repeating audible signal during drug delivery (page 5, para. 0051; page 10, para. 0098).
Regarding claim 27, Soerensen discloses that the second plurality of projections is disposed around the first plurality of projections (fig. 8).
Regarding claim 28, Soerensen discloses that during drug delivery, the first plurality of projections rotates relative to the second plurality of projections such that each projection of the first plurality of projections slidably engages one or more projections of the second plurality of projections (page 10, para. 0098).
Regarding claim 29, Soerensen discloses that each projection of the first plurality of projections 251 extends in a radially outward direction, and wherein each projection of the second plurality of projections 241 extends in a radially inward direction (figs. 4, 8).
Regarding claim 30, Soerensen discloses that each projection of the first plurality of projections 251 includes a flexible arm moveable between a first radial position and a second radial position when the flexible arm engages a respective projection of the second plurality of projections (page 10, para. 0098: ratchet arms).
Regarding claim 32, Soerensen discloses a drug delivery device 1 comprising: a housing 2 having an opening (fig. 2A); a drug storage container 380 including a delivery member (col. 3, para. 0039: needle not shown) having an insertion end configured to extend at least partially through the opening in the housing (fig. 12A); a plunger 280; a drive mechanism 270 activatable to drive the plunger to expel a drug from the drug storage container through the delivery member (page 10, para. 0098); a guard 331 moveably disposed adjacent to the opening and operably coupled to the drive mechanism (page 6, para. 0057-0058), a lock 219 selectively engageable with the guard to limit movement of the guard in the proximal direction (page 6, para. 0056, 0058; fig. 4), and an indicator 250 operably coupled to the drive mechanism to generate a continuous or repeating audible signal during drug delivery, and to cease generating the continuous or repeating audible signal when drug delivery is complete (page 10, para. 0098: ratchet arms 251 provide clicks during dose delivery).
Regarding claim 33, Soerensen discloses that the indicator is rotatable relative to the housing (page 5, para. 0051).
Regarding claim 34, Soerensen discloses that activating the drive mechanism causes the drive mechanism to rotate the indicator relative to the housing, and wherein the drive mechanism ceases rotating the indicator when drug delivery is complete (page 5, para. 0051; page 10, para. 0098).
Regarding claim 35, Soerensen discloses a first plurality of projections 251 coupled to the indicator (fig. 4); and a second plurality of projections 241 concentrically arranged with the first plurality of projections (fig. 8; page 5, para. 0051), wherein the first plurality of projections slidably engages the second plurality of projections to generate the continuous or repeating audible signal during drug delivery (page 5, para. 0051; page 10, para. 0098).
Regarding claim 36, Soerensen discloses that the second plurality of projections is disposed around the first plurality of projections (fig. 8).
Regarding claim 37, Soerensen discloses that during drug delivery, the first plurality of projections rotates relative to the second plurality of projections such that each projection of the first plurality of projections slidably engages one or more projections of the second plurality of projections (page 10, para. 0098).
Regarding claim 38, Soerensen discloses that each projection of the first plurality of projections 251 extends in a radially outward direction, and wherein each projection of the second plurality of projections 241 extends in a radially inward direction (figs. 4, 8).
Regarding claim 39, Soerensen discloses that each projection of the first plurality of projections 251 includes a flexible arm moveable between a first radial position and a second radial position when the flexible arm engages a respective projection of the second plurality of projections (page 10, para. 0098: ratchet arms).
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) 31, 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soerensen in view of Sanchez (US 2018/0021521).
Regarding claim 31, Soerensen discloses that the drug storage container is filled or pre-filled with the drug (page 6, para. 0055), but fails to disclose the specific drug. Sanchez teaches a drug delivery device wherein the drug is etanercept or romiplostim (page 9, para. 0077). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug of Soerensen to be etanercept of romiplostim as taught by Sanchez because such drugs are suitable for delivery using a self delivery device.
Regarding claim 40, Soerensen discloses that the drug storage container is filled or pre-filled with the drug (page 6, para. 0055), but fails to disclose the specific drug. Sanchez teaches a drug delivery device wherein the drug is etanercept or romiplostim (page 9, para. 0077). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug of Soerensen to be etanercept of romiplostim as taught by Sanchez because such drugs are suitable for delivery using a self delivery device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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, Bhisma Mehta can be reached at 571-272-3383. 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.
LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
Prosecution Insights