DETAILED ACTION
Note: The present application is being examined under the pre-AIA first to invent provisions.
This Office action is in response to communications filed January 22, 2024.
Status of Claims
1. Claims 122-138 are pending and currently under consideration for patentability.
Claims 1-121 were canceled, and claims 122-138 are newly presented as of the January 22, 2024 preliminary claim amendment.
Priority
2. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on January 25, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Double Patenting
4. 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.
5. Claims 122-138 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,813,196. Although the claims at issue are not identical, they are not patentably distinct from each other because patented claims 1-18 contain additional limitations requiring the container to be arranged to collect the displaced sample of fluid for use in one or more analyses, the container comprising a window for viewing a level of the displaced sample of fluid in the container, and is thus more specific, in effect making the invention of patented claims 1-18 a "species" of the "generic" invention of instant claims 122-138. It has been held that the generic invention is "anticipated" by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Allowable Subject Matter
6. Claim 122-138 are allowable over prior art.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a). Namely, claims 122-138 remain rejected under non-statutory double patenting (see rejection above) pending a properly filed terminal disclaimer over U.S. Patent No. 11,813,196.
7. The closest prior art of record is de Juan, JR et al. (US PGPUB 2010/0255061), Breegi et al. (US PGPUB 2004/0230183) and Beyerlein (US PGPUB 2004/0260240).
de Juan, while disclosing a similar apparatus for collecting a sample of fluid from a reservoir chamber (140) of a therapeutic device (100) having a porous structure (150) and configured to be implanted in an eye of a patient (abstract; Figs. 1A-1-1, 1A-1-2, and 7), the apparatus comprising: a cartridge (injector, 701) comprising: a means for coupling to a syringe (plunger, lacking reference numeral, within first container 702C), the cartridge (701) being arranged to contain therapeutic agent (110, 702; Fig. 7), the cartridge (701) comprising: at least one needle (189) being operable to penetrate the implanted therapeutic device (100), wherein the at least one needle (189) comprises a first lumen and a second lumen, the first lumen arranged to allow an amount of the therapeutic agent (702) to be injected from the syringe through the first lumen into the reservoir chamber (140) of the implanted therapeutic device (100; “a double lumen needle with a first lumen coupled to the first container and a second lumen coupled to the second container, such that spent media 703 passes from the container reservoir of device 100 to the injector”; [0541]); a depth stop (stop, 189S; best shown in Figs. 7A-1, 7A-2) to guide depth of penetration of the at least one needle (189) within the reservoir chamber (140; [0544]); and a container (second container, 703C) coupled to the cartridge (701) and in fluid communication with the second lumen extending through the at least one needle (189; Fig. 7), the container (703C) configured to be at atmospheric pressure during use ([0742]), wherein the second lumen is arranged to allow a sample of fluid (spent media, 703) to be displaced from the reservoir chamber (140) through the second lumen into the container (703C) at the same time as the amount of therapeutic agent (702) is injected from the syringe through the first lumen into the reservoir chamber (140; “a double lumen needle with a first lumen coupled to the first container and a second lumen coupled to the second container, such that spent media 703 passes from the container reservoir of device 100 to the injector”; [0541]), fails to disclose or reasonably suggest alone or in combination, the unique combination of claimed structure, wherein the claimed apparatus includes a deformable visual indicator coupled to a depth stop to guide depth of penetration of the at least one needle, having a first and second lumen, within the reservoir chamber, wherein the visual indicator is coaxial with the longitudinal axis of the at least one needle.
Breegi, while disclosing a similar a drug delivery device and syringe for filling the same (abstract), including a method of collecting a sample of fluid from a reservoir chamber (therapeutic agent chamber, 30) of a therapeutic device implanted in an eye, the method comprising: penetrating the therapeutic device with at least one needle, displace fluid from the reservoir chamber through a second needle into a container while injecting an amount of therapeutic agent from a syringe (31) through a first needle into the reservoir chamber of the implanted therapeutic device; and collecting the displaced fluid in the container for use in one or more analyses (Figs. 3A, 4A; [0043]; [0046]), fails to disclose or reasonably suggest alone or in combination, the unique combination of claimed structure, wherein the claimed apparatus includes a deformable visual indicator coupled to a depth stop to guide depth of penetration of the at least one needle, having a first and second lumen, within the reservoir chamber, wherein the visual indicator is coaxial with the longitudinal axis of the at least one needle.
Beyerlein, while disclosing similar systems and methods for detecting tissue contact and needle penetration depth using static fluid pressure measurements (abstract; Figs. 12A-C), wherein a needle (830) has a stepped design with a distal portion (834) and a proximal portion (836; forming a stop; Fig. 12A; [0066]); and wherein a soft deformable silicone indicator (strain gauge, 840 embedded within a soft silicone encapsulant, 842; Figs. 12B-C; [0065]; [0051]; Fig. 9) is secured to the transition of the step between the distal and proximal portions (834, 836) to guide the depth of penetration of the needle (830; [0067]), fails to disclose or reasonably suggest alone or in combination, the unique combination of claimed structure, wherein the claimed apparatus includes a deformable visual indicator coupled to a depth stop to guide depth of penetration of the at least one needle, having a first and second lumen, within the reservoir chamber, wherein the visual indicator is coaxial with the longitudinal axis of the at least one needle.
This unique combination of claimed structure not disclosed or rendered obvious by de Juan, imparts a novel and non-obvious function of the claimed device, namely such a design allows for the claimed davice to include a depth stop that provides visual indication of coupling, which can be helpful to ensure that the correct amount of pressure is applied by the health care provider and also ensuring that the needle tip is located at an intended distance below the surface of the tissue, as described in paragraph [00312] of Applicant’s Specification, as originally filed.
Conclusion
8. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
McIntyre (US 4,014,333) discloses instrument for aspirating/irrigating during ophthalmic surgery.
Abergel (US PGPUB 2003/0120217) discloses methods and devices for sclerotherapy.
Siekas et al. (US 7,094,222) discloses a single device for simultaneous infusion and withdrawal.
Luloh et al. (US PGPUB 2007/0078359) discloses a tool extracting vitreous samples from an eye.
Cowan (US PGPUB 2009/0240208) discloses a microparticle delivery syringe and needle for placing particle suspensions and removing vehicle fluid.
Lobl et al. (US PGPUB 2008/0152694) discloses device, systems and methods for ophthalmic drug delivery.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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, Sarah Al-Hashimi can be reached at (571)272-7159. 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.
/ANDREW J MENSH/ Primary Examiner, Art Unit 3781