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 .
Status of Claims
Claims 1-5 are pending and under examination.
Priority
This application filed on 05/29/2024 claims priority from Korean application KR10-2023-0070622 filed on 6/1/2023. Applicant cannot rely upon the certified copy of the foreign priority application to overcome the below rejections over KR20220079315A and over Minyoung Jung et al (both become 102(a)(1) with more than one year without this priority date of 6/1/2023) because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Information Disclosure Statement
The information disclosure statement filed on 05/29/2024 has been considered by the examiner.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 contains the trademark/trade name BxC, which appears to reference to the companies name of Brexogen via the Bx (a company trade name used for the cells rather than what the cells are). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a cell that is prepared by isolating SSEA-4 (-) cells from a culture of induced pluripotent stem cells and, accordingly, the identification/description is indefinite. It is suggested that applicant remove the “BxC” from the claims and replacing it with a generic term such as “selectively cultured cells” to reference back to the cells since the claim already provides how these cells are produced via the process step of selectively culturing.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim WO2022025559A1 (with Google English translation).
Kim teaches “A composition according to the present invention has excellent effects in terms of anti-inflammatory effects, fibrosis inhibition, vascular endothelial cell proliferation, blood vessel formation, survival rate improvement, and protective regeneration of cardiomyocytes, and thus can be used as an agent for preventing or treating heart disease, inflammatory disease, immune disease, fibrotic disease, or vascular disease.” (abstract, also claims of Kim). Kim teaches culturing induced pluripotent stem cell-derived mesenchymal cell culture and isolation of the SSEA-4(-) cells that are then cultured to form BxC stem cells and then further cultured to differentiate into mesenchymal stem cells (example 1). Kim teaches “As used herein, the term “pretreatment” refers to a process of culturing by adding a specific substance to the medium of mesenchymal stem cells” (in English translation of Kim). Kim teaches isolating the exosomes and their characterization (examples 2-1, 2-2). Kim teaches the use of hyaluronic acid pretreatment of BxC stem cells (section 3-1) and then carrying out the process to collect the exosomes. Kim teaches the stem cell are animals including human (English translation). Therefore, it is anticipated that human stem cells had intention of being used. Kim provides for different administrations including topical administration of the pharmaceutical composition.
Claims 2-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KR20220079315A (Published June 13, 2022, with Google English translation).
If and when applicant files a certified copy of the English translation of its foreign priority document and if it is found to support applicant’s claimed invention, then it is noted this rejection will remain a rejection under USC 102(a)(1), but will then fall into the one year grace period. This document comes from the same applicant (Brexogen) but has different inventors such as Seon Yeong Jeong. Once the prior art publication date is in the grace period, applicant will have the opportunity to utilize one of the 102(b)(1) prior art exceptions such as a declaration of ownership to possibly overcome the rejection.
KR ‘315 teaches a pharmaceutical composition for the prevention or treatment of periodontal disease comprising, as an active ingredient, exosomes isolated from induced pluripotent stem cells-derived mesenchymal stem cells, either pre-treated or not pre-treated with a pre-treatment material (abstract). KR ‘315 teaches “the induced pluripotent stem cell-derived mesenchymal stem cells are differentiated from progenitor cells of induced pluripotent stem cell-derived mesenchymal stem cells that do not express stage-specific embryonic antigen 4 (SSEA-4) protein. , pharmaceutical composition.” (claim 2 of KR ‘315). Examples 1 and 2 of KR ‘315 provide for culturing induced pluripotent stem cells, isolating SSEA-4 negative cells, culturing them to become BxC stem cells and then further culturing them into mesenchymal stem cells where exosomes are then isolated. Example 3 provides for pretreatment with different materials, Phobol 12-myristate 13-acetic acid, Resveratrol and substance P. Example 7 provides for periodontal cell wound healing by administering isolated exosomes from examples 2 and 3 (also claims of KR ‘315). KR ‘315 teaches induced pluripotent stem cells from humans as a mammal (English translation). Therefore, it is anticipated human cells would be used.
Claims 2 and 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jung et al (“Anti-senescence effects of extracellular vesicle from hyaluronic acid primed iMSC on human dermal fibroblast”, Brexogen, 1 page, May 10, 2023, in applicant IDS).
If and when applicant files a certified copy of the English translation of its foreign priority document and if it is found to support applicant’s claimed invention, then it is noted this rejection will remain a rejection under USC 102(a)(1), but will then fall into the one year grace period. This document comes from the same applicant (Brexogen) but has different inventors such as Jimin Kim, Somi Park and others. Once the prior art publication date is in the grace period, applicant will have the opportunity to utilize one of the 102(b)(1) prior art exceptions such as a declaration of ownership to possibly overcome the rejection.
Jung describes a method of using exosomes isolated from a hyaluronic acid primed (pre-treated) iMSC cell culture to administer to subjects with skin lesions of burn wounds and have healing (abstract and results). The methods provide for using human cells (stem cells are derived from human dermal fibroblasts).
Claims 2 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al (J Transl Med, 2015, DOI 10.1186/s12967-015-0417-0, pages 1-14).
“Pre-treatment substance” is left as a broad genus in claim 2, and thus, if there are substances/agents that are cultured with or supplemented to the mesenchymal stem cells then they will be considered as pre-treatment substance.
Zhang teaches that mesenchymal stem cell exosomes can facilitate wound healing after transplanting the exosomes at wound sites (abstract). Zhang provides for hiPSC-MSCs which were used to collect the exosomes (pages 2-3). Zhang teaches a skin wound model on rats (page 3). Zhang teaches hiPSC-MSCs were incubated in adipogenic medium (Gibco) for 2 weeks (first column of page 3). This would serve as a pretreatment with the medium being the agent.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (J Transl Med, 2015, DOI 10.1186/s12967-015-0417-0, pages 1-14) and Kim WO2022025559A1.
Zhang teaches that mesenchymal stem cell exosomes can facilitate wound healing after transplanting the exosomes at wound sites (abstract). Zhang provides for hiPSC-MSCs which were used to collect the exosomes (pages 2-3). Zhang teaches a skin wound model on rats (page 3).
Zhang does not teach exosomes prepared from a process with SSEA-4 negative cells or pretreatment with hyaluronic acid before obtaining exosomes.
Kim teaches “A composition according to the present invention has excellent effects in terms of anti-inflammatory effects, fibrosis inhibition, vascular endothelial cell proliferation, blood vessel formation, survival rate improvement, and protective regeneration of cardiomyocytes, and thus can be used as an agent for preventing or treating heart disease, inflammatory disease, immune disease, fibrotic disease, or vascular disease.” (abstract). Kim teaches culturing induced pluripotent stem cell-derived mesenchymal cell culture and isolation of the SSEA-4(-) cells that are then cultured to form BxC stem cells and then further cultured to differentiate into mesenchymal stem cells (example 1). Kim teaches isolating the exosomes and their characterization (examples 2-1, 2-2). Kim teaches the use of hyaluronic acid pretreatment of BxC stem cells (section 3-1) and then carrying out the process to collect the exosomes. Kim teaches the stem cell are animals including human (English translation). Therefore, it is anticipated that human stem cells had intention of being used. Kim provides for different administrations including topical administration of the pharmaceutical composition. Kim provides that its pretreatment molecules including hyaluronic acid increase the proliferation and stemness of stem cells (English translation). Additionally, Kim notes that with hyaluronic acid pretreatment “Compared to the mesenchymal stem cells that were not pretreated with any substance, the BxC-R11 stem cells increased the cell proliferation rate by about 360%, the exosome production efficiency increased by about 5 times, and the amount of exosome-derived proteins was increased by 5 times or more. is increased” (English translation).
One of ordinary skill in the art before the time of filing would have utilized exosomes prepared in teachings of Kim for treating wounds in Zhang as they would be seen as having higher amounts of exosomes and higher amounts of exosomal proteins than those that are not prepared in this manner. Zhang recognizes the ability of human induced pluripotent stem cells-derived MSCs to produce exosomes that are effective at treating wounds by administering the exosomes to the subject in need thereof. Therefore, there was a reasonable expectation of success in practicing the methods of Zhang with the exosomes produced in Kim and getting better treatment due to more exosomes. Additionally, Kim recognizes anti-inflammatory effects, vascular endothelial cell proliferation effects, and blood vessel growth effects which would be seen as effects beneficial for healing by one of ordinary skill in the art. Zhang notes that there are proliferation and migration of vein endothelial cells with such mesenchymal stem cell exosomes (see abstract of Zhang).
Non-Statutory 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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5, 11, and 14 of copending Application No. 17/925450 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for a method of producing and isolating exosomes in the same manner as in applicant’s claims. ‘450 allows for hyaluronic acid pretreatment among its group of pretreatment substances.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613