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 .
DETAILED ACTION
Claims 1-21 are pending and examined.
Election/Restrictions
Applicant’s election without traverse of the species fibrin sealant, fiber continuity, type I fibrillar collagen, maximum load in the reply filed on 5/18/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/5/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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) 1- 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shi et al. (from IDS, 2020, J Ortho Res, 2020:1-13).
Shi et al. teaches a method of repairing Flexor Tendons failure in dogs with purified exosome product (PEP) (Abstract). Flexor Tendons are located on the palm side of the hand. They are thick cord-like connective tissues that attach the finger bones to muscles in the forearm and allow the fingers to bend. Therefore, there is bone-tendon interface. The exosome diameter ranges from 93.70 to 124.65 nm (Abstract); therefore, the limitations of Claims 2-5 are met. PEP increased the expression of collagen III, matrix metallopeptidase 2, 3, 14 (Abstract). Fibrin sealant is used as an adhesive for tissue repair during surgical treatment for bone growth and vascularization and it is a scaffold for tendon and bone healing (page 2, left column, paragraph 3); therefore, the limitation of Claim 12 is met. The carrier is commercially available (page 2, right column, 2.1 Study rationale and design). The PEP is 5x1012 vesicles per mL for final concentration of 1x1012 vesicles per mL (page 2, right column, 2.2 PEP-Tissue patch preparation); therefore, the limitations of Claims 8-9 are met. Type I collagen is mostly present in collagen fiber (page 5, right column, paragraph last sentence of first paragraph), which is a collagen scaffold; therefore, the limitation of Claims 10-11 and 17 are met. The same purified exosome would inherently contain from 1-20% CD63- exosomes and from 80-99% CD63+ exosomes of Claim 6 because the same composition would have the same characteristics. The properties of tendon repair would inherently occur for Claims 13-19 because the method of tendon repair would require the same mechanisms.
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 1-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-18 of copending Application No. 18/709915. Although the claims at issue are not identical, they are not patentably distinct from each other because a method of repairing tendon injury with purified exosome product are claimed.
18/709915 teaches:
12. A method of treating injured tendon tissue, the method comprising applying the composition of claim 1 to injured tendon tissue.
13. The method of claim 12, wherein the composition is applied in an amount effective to decrease adhesion production compared to injured tendon tissue treated without the composition.
14. The method of claim 12, wherein the composition is applied in an amount effective to increase the ratio of type I to type III collagen compared to injured tendon tissue treated without the composition.
15. The method of claim 12, wherein the composition is applied in an amount effective to produce more organized collagen architecture compared to injured tendon tissue treated without the composition.
16. The method of claim 12, wherein the injured tendon tissue comprises disruption of a tendon.
17. The method of claim 16, wherein the disruption of the tendon comprises rupture of the tendon.
18. The method of claim 17, wherein the rupture of the tendon comprises an Achilles tendon rupture.
However, 18/709915 does not teach characteristics of the exosomes and its amounts, supportive matrix comprising collagen or fibrin sealant.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use supportive matrix comprising collagen or fibrin sealant because tendon repair requires support such as collagen and fibrin. One would have been motivated to make supportive matrix comprising collagen or fibrin sealant for the expected benefit of repairing tendons. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
The reference does not specifically teach adding the ingredients in the amounts claimed by applicant for treatment tendons. However, the reference does teach the composition for repairing tendons with exosomes. The amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
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, Anand U Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
Prosecution Insights