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 .
Claim Status
Claims 1, 3-10, and 31-37, are pending and under examination.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract recites “the present disclosure is concerned with,” a phrase which can be implied. Further, the abstract is less than 50 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The use of the terms Epogen (¶ 62) and CellTracker Far Red (¶ 91), which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 5 is objected to because of the following informalities: “an immunostimulating agents” should read “immunostimulating agents” or “an immunostimulating agent”, where “an” is singular and “agents” is plural. Appropriate correction is required.
Claim 37 is objected to because of the following informalities: “dissevans” should read “dissecans” to correct a typographical error. Appropriate correction is required.
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 36 and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,138,366, hereinafter ‘366, in view of Grunlan et al (US 20180236128 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘366 disclose a method of producing a continuous hydrogel material comprising a paramagnetic or superparamagnetic salt, magnetic objects comprising a magnetic material and an active agent, cells which are (i) not labeled with any magnetic label, (ii) do not have any magnetic particles tethered to or within the cells, and (iii) are diamagnetic; wherein the cells are arranged in a gradient; and wherein the magnetic objects are arranged in a gradient that is opposite the gradient of the cells.
The claims of ‘366 are different insofar as they do not disclose a method of improving the repair, formation or regeneration of tissue at a defective site, comprising implanting the at the defective site of claims 37 and 37.
Grunlan et al teaches it was known to implant hydrogels that are associated with cells for osteochondral defect tissue repair (abs, ¶ 11).
It would have been obvious to use the continuous hydrogel of ‘366 for the method of implanting the hydrogel at a defective site within a subject for repair of the tissue, including a site of osteochondral defect, where both are directed to hydrogels comprising cells, and hydrogels associated with cells were known to be used for implant based repair of osteochondral defects, as taught by Grunlan et al.
The examiner notes that the instant application is a divisional of parent application no. 17/229,829, however, there were no claims in the parent application directed to a method of improving the repair, formation, or regeneration of tissue at a defective site within a subject, and therefore were not a part of the restriction/election requirement in the parent case. The 35 U.S.C. 121 prohibition applies only where the Office has made a requirement for restriction. The prohibition does not apply where the divisional application was voluntarily filed by the applicant and not in response to an Office requirement for restriction. For claims that were not in the original application and are first formally entered in a later divisional application, 35 U.S.C. 121 "does not suggest that the original application merely needs to provide some support for claims that are first entered formally in the later divisional application. See MPEP 804.01.
Status of the Art
The closest prior art appears to be Li et al (Biomaterials, 2018, 176, 24-33), and while appearing to teach cell loaded hydrogel comprising superparamagnetic nanoparticle gradients comprising an active agent for osteochondral tissue engineering, the cells appear to be dispersed evenly throughout the hydrogel, and does not appear to provide any teachings, suggestions, or motivation, for forming a cellular gradient opposite of that of the superparamagnetic nanoparticle gradient specifically, as the bone promoting agents act on the cells to promote osteogenic differentiation. Moving the bone promoting agents and cells away from each other via opposing gradients may reduce the intended interaction. Further, label-free diamagnetic cells in a medium with paramagnetic or superparamagnetic salts were known, and can be manipulated via negative magnetophoresis, as taught by Zhao et al (Adv Funct Mater, 2016, 26, 3916-3932). However, the prior art appears to direct label-free diamagnetic cell manipulation towards cell separation, e.g., separating cytotoxic cells from blood, focusing, trapping, and levitation for forming cellular assemblies, not cellular gradients in a continuous hydrogel material, let alone in a gradient that is opposite of magnetic objects comprising an active agent. Accordingly, the combination as instantly claimed appears to be non-obvious over the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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, Sahana Kaup can be reached at 571-272-6897. 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.
/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Prosecution Insights