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 .
This Office Action is in response to the paper filed 10 April 2026. Claim 1 has been amended. Claims 11 and 12 have been cancelled. Claims 13-20 remain withdrawn. Claims 1-10 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 1-10 is to May 23, 2018.
Withdrawal of Rejections:
The rejection of claims 11 and 12 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form, is withdrawn.
The rejection of claims 1, 2, 4, and 7-10 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,268,796, is withdrawn.
Maintained/Modified/New Rejections Necessitated by Amendment:
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.
Claim 2 is 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.
Claim 2 indicates that the syringe connector places the first and second syringes into fluid communication. However, claim 1 as amended, from which claim 2 depends, now requires the syringe connector to place the first and second syringes into fluid communication. As such, claim 2 fail to further limit the claim upon which is depends.
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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Trollsas et al. (US 2014/0186446; Published 2014 - Previously Presented).
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 prior to injection, which is delivery, 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.
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, and 4 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, wherein the syringe connector places the first and second syringes into fluid communication, and the connector allows the soft-tissue augmenting agent to be mixed with the vehicle prior to deliver; 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; Cited patent claims: 1, 11, 19-21).
Response to Arguments
With regard to the obviousness rejection over Trollsas et al., Applicant urges that Trollsas et al. do not teach the claims as amended.
This argument has been fully considered, but has not been found persuasive for the reasons set forth in the modified rejection above.
With regard to the double patenting rejection, Applicant requests that this rejection be held in abeyance until allowable subject matter is determined.
This rejection is maintained over U.S. Patent No. 12,133,930.
Conclusion
No claims are allowable.
Previously Presented 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).
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 JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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