DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election without traverse of Group I, claims 1-12 in the reply filed on 10 December 2025 is acknowledged. Claims 13-20 have been withdrawn. Claims 1-12 are currently pending and under examination.
This application is a continuation-in-part of U.S. Application No. 17/165371, filed February 2, 2021, now U.S. Patent No. 12,268,796, which claims priority to U.S. Application No. 15/987732, filed May 23, 2018, now U.S. Patent No. 12,133,930, which claims priority to U.S. Provisional Application No. 62/510601, filed May 24, 2017.
It is noted that the limitations of a second syringe and a syringe connector were not present in U.S. Provisional Application No. 62/510601, and were first presented in U.S. Application No. 15/987732. Thus, benefit of priority for claims 1-12 is to May 23, 2018.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 11 and 12 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 11 and 12 indicate that the soft-tissue agent (claim 11) and the vehicle (claim 12) are contained in an ampoule instead of being contained in a respective syringe. However, claim 1, from which claims 11 and 12 depend, requires the soft-tissue agent to be in a first syringe and the vehicle to be in a second syringe. As such, claims 11 and 12 fail to include all the limitations of the claim upon which they depend.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Trollsas et al. (US 2014/0186446; Published 2014).
With regard to claims 1-6, Trollsas et al. teach formulations, delivery systems, and kits containing these components, wherein the formulations are usable for treating cartilage, wounds, tissue scaring due to surgery, and eye diseases in humans and animals (Para. 99-113, 139, Table 2), which is augmenting soft tissue. Trollsas et al. teach a first syringe containing a formulation in solution, which is a soft-tissue augmenting agent, and a second syringe containing an activation buffer, which is a vehicle (Para. 74, 139). The syringes are connected together with a female-to-female Luer fitting, and the contents of each syringe mixed by plunging the contents back and forth (Para. 74, 139). The female-to-female Luer fitting is a female-to-female luer lock connector, and is therefore configured for placing the first and second syringes in fluid communication, configured to facilitate mixing of the soft-tissue augmenting agent with the vehicle to form an injectable composition, and configured to facilitate retaining the injectable composition in either the first syringe or the second syringe.
Another syringe with a needle is provided for administration of the injectable composition, the syringe and needle further including a needle stop at a depth of 5 mm (Para. 139). As Applicant indicates that the targeting arm controls an injection depth (see Specification, Para. 24), the needle stop as taught is a targeting arm for the syringe.
As Trollsas et al. teach that the formulations and delivery systems may be provided in a kit (Para. 112-113), it would have been obvious to an ordinary artisan to provide a kit with the formulations and components as taught to perform the desired embodiments. Additionally, while Trollsas et al. teach that the needle is attached to a third syringe for administration, as the two syringes utilized for mixing are likewise 1 mL syringes (see Para. 139), it would have been obvious to one of ordinary skill in the art that the needle and needle stop as taught could instead be coupled to the first or second syringe if so desired by the end user of the kit. Thus, the needle is configured to facilitate delivering the injectable composition from either syringe into a target soft tissue.
With regard to claims 7-10, Trollsas et al. teach that the 1 mL syringe, which can include either the first or second syringe as discussed above, has a needle and a needle stop at a depth of 5 mm (Para. 139). As the syringe has a needle stop, which is a targeting arm, that is configured to control an injection depth for injection of the injectable composition (Para. 139), the needle stop is in contact with the syringe and includes a longitudinal member that controls the depth. Further, as the needle stop prevents the needle from exceeding the desired depth of 5 mm (Para. 139), the longitudinal member of the needle stop extends parallel to the needle when connected to the syringe and is shorter than the needle by 5 mm, allowing for the 5mm injection depth as taught. While it is not specifically taught that the targeting arm is configured to “snap onto” a barrel of the syringe, it would have been obvious to one of ordinary skill in the art that the targeting arm is attached to the syringe, which is necessary to provide the taught depth control, wherein this attachment is deemed to be “snapping onto” a barrel of the syringe.
With regard to claims 11 and 12, Trollsas et al. teach that as an alternative to the two syringes, the soft-tissue augmenting agent and the vehicle may be contained in a multichannel delivery vehicle (Para. 113), which is deemed to be a first and second ampoule, in lieu of the first and second syringes.
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, 2, 4, and 7-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,268,796. Although the claims at issue are not identical, they are not patentably distinct from each other because both encompass a soft-tissue augmenting kit, where the kit includes a soft-tissue augmenting agent and a vehicle for the soft-tissue augmenting agent that mixed together provide an injectable composition, and a targeting arm that snaps onto a barrel of a syringe, the targeting arm comprising a longitudinal member that is parallel to and extending in a same direction as the needle when the targeting arm and the needle are both coupled to the syringe, and wherein the longitudinal member comprises a fixed length in the targeting arm to control an injection depth for an injection of the injectable composition with the syringe (Instant claims 1, 2, 4, and 7-10; Cited patent claim: 1).
Claims 1, 2, 4, 11, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, and 19-21 of U.S. Patent No. 12,133,930. Although the claims at issue are not identical, they are not patentably distinct from each other because both encompass a soft-tissue augmenting kit for augmenting one or more soft tissues of a human or animal, the kit including a first syringe containing a soft-tissue augmenting agent and a second syringe containing a vehicle for the soft-tissue augmenting agent that mixed together provide an injectable composition, a syringe connector for coupling the first syringe and the second syringe, and a targeting arm for the syringe; the soft-tissue augmenting agent and the vehicle alternatively in separate containers, which are ampoules (Instant claims 1, 2, 4, 11, 12; Cited patent claims: 1, 11, 19-21).
Conclusion
No claims are allowable.
Art of Record:
Chapman, US 2013/0072903; Published 2013 (two syringes containing a vehicle and soft-tissue repair composition, the syringes connected via a female-to-female luer lock for mixing).
Chetan et al., US 2009/0131938; Published 2009 (two syringes containing a vehicle and soft-tissue repair composition, the syringes connected via a female-to-female luer lock for mixing).
Davis et al., US 5,217,438; Published 1993 (needle stop and guard tube).
Giambattista et al., US 2003/0014018; Published 2003 (safety shield system for a needle that allows the needle to be injected only at a specific depth).
Lerougle et al., US 2017/0360912; Published 2017 (two syringes containing a vehicle and soft-tissue repair composition, the syringes connected via a female-to-female luer lock for mixing).
Stroumpoulis et al., US 2010/0098764; Published 2010 (two syringes containing a vehicle and soft-tissue repair composition, the syringes connected via a female-to-female luer lock for mixing).
Wilson et al., US 2009/0024107; Published 2009 (two syringes containing a vehicle and soft-tissue repair composition, the syringes connected via a female-to-female luer lock for mixing).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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, Sharmila G. Landau can be reached at (571)272-0614. 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.
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653