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 .
Applicant’s amendment and response filed on 11/26/2025 has been received and entered into the case.
Claims 7-9 have been canceled, claim 13 is newly added, claims 1-3 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 4-6 and 10-13 have been considered on the merits. All arguments have been considered.
Response to Amendment
The claim rejections under 35 USC 112 have been withdrawn due to the instant amendment.
The claim rejection under 35 USC 103 based on McCully has been withdrawn due to the instant amendment, and replaced with a new rejection necessitated due to the instant amendment (see below).
Claim Rejections - 35 USC § 112 (New Rejection)
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 13 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 13 discloses the wherein clause directed to the sources of the mitochondria. It is not clear if the isolated mitochondria are from all of the listed cells or the listed cells are alternative. This is because there is no conjunction in the clause. For search purpose, the listed cells are considered as alternative.
Claim Rejections - 35 USC § 103 (New Rejection)
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 4-6 and 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCully et al. (US20180057610) in view of Ding et al. (2017, Ann. Plast. Surg.) as evidenced by Samson et al. (1960, Am. J. Physiol.).
McCully et al. teach methods of treating a wound in a subject, the method comprising administering a composition comprising isolated mitochondria and/or a
combined mitochondrial agent to the wound area in an amount sufficient to treat the wound. McCully et al. teach that the wound can be any kind of wound, e.g., an open wound, or a bum wound (para. 35). McCully et al. also teach a method of treating skin wrinkles or scars on a subject, and the method includes the steps of administering a composition comprising isolated mitochondria (para. 40). McCully et al. teach that isolated mitochondria or combined mitochondrial agents can be used to improve mitochondrial function in these damaged or aged tissue, thereby removing skin wrinkles, scars, or treating loose skin, burns, wounds, lipoma, etc. (para. 212). Thus, the teachings of McCully et al. meet the limitation of claim 4 directed to step of administering a composition comprising an isolated mitochondria to a wound of a subject.
Regarding the blood product being a growth factor or PRF, McCully et al. teach that mitochondria can be included in compositions that include blood and/or products derived from blood (para. 132). However, McCully et al. do not teach growth factors or PRF.
Ding et al. teach that platelet-rich fibrin accelerates skin wound healing in diabetic mice (see entire document).
It would have been obvious to a person skilled in the art to use the PRF taught by Ding et al. along with the mitochondria taught by McCully et al. with a reasonable expectation of success. As McCully et al. teach the use of blood product in combination with mitochondria, and PRF is a blood product useful in treating wounds, one skilled in the art would have been motivated to combine two teachings for the same purpose of treating wounds. M.P.E.P. §2144.06 states “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
Regarding claims 6 and 10 directed to the dose of the mitochondria being from 1 to 40 mg or 15 to 40 mg, McCully et al. do not teach the limitation. However, McCully et al. teach the quantity of mitochondria to be administered is at least about 1x103 to 1x1014 (para. 151). Considering the weight of a mitochondrion being about 0.3 pg according to Samson et al., 1x103 to 1x1014 of mitochondria would be 0.3 ng to 30 mg. Therefore, the amount of mitochondria taught by McCully et al. would meet the limitation of claims 6 and 10.
Regarding claim 11 directed to the growth factors and their concentration, McCully et al. in view of Ding et al. do not particularly teach the limitation. However, the use of PRF taught by McCully et al. in view of Ding et al. would inherently meet the types of growth factors because the instant specification discloses that platelet-rich fibrin (hereafter as PRF) contains a variety of growth factors, such as PDGF-AA, PDGF-AB, PDGF-BB, TGF-β1, VEGF, EGF, IGF, etc. (para. 23). Thus, the PRF of McCully et al. in view of Ding et al. would inherently contain the claimed growth factors.
Regarding claim 12 directed to the PRF being greater than 5% by volume, McCully et al. in view of Ding et al. do not particularly teach the amount or ratio of the PRF in the composition.
However, it would have been obvious to a person skilled in the art to mix the mitochondria of McCully et al. and the PRF taught by Ding et al. at any desired ratio by volume with a reasonable expectation of success. As McCully et al. teach that the mitochondria being included in compositions comprising products derived from blood (para. 132), one skilled in the art would recognize that the ratio of mitochondria and the blood product would be readily modified for the desired outcome of repairing, healing, and/or regenerating wound/tissue by routine experimentations. For example, one skilled in the art would try an 1:1 mixing ratio by volume as it is within the purview of the skilled artisan. By doing so, the volume of PRF would be 50% of the total mixture and it would meet the claimed greater than 5% by volume.
The selection of mixing ratio between the components in a composition would have been a routine matter of optimization on the part of the artisan of ordinary skill. A holding of obviousness over the cited claims is therefore clearly required. The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages. See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382.; See also M.P.E.P. § 2144.05.
Regarding claim 13 directed to the source cells of the isolated mitochondria, McCully et al. teach that the mitochondria can be isolated from any source, e.g. isolated from cultured cells or tissue, and the tissue can be liver tissue, skeletal muscle, heart, brain and adipose tissue (para. 135). Thus, it would have been obvious to a person skilled in the art to choose any cells from the liver tissue (i.e. liver cells), or skeletal muscle (i.e. skeletal muscle cell), etc.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Response to Arguments
Applicant’s arguments with respect to claim(s) 4-6 and 10-12 have been considered but are moot because the instant amendment has changed the scope of the claimed method to repairing skin wound, promoting skin wound healing or promoting skin tissue regeneration. The primary reference, McCully et al., was cited again in the new rejection because the reference teaches the amended subject matter.
Applicant argued that McCully does not explicitly teach using a composition with a mitochondria to treat skin wounds. The Examiner respectfully disagrees with this argument. As discussed in the new claim rejection above, McCully et al. clearly teach the use of the isolated mitochondria for treating skin wounds.
Regarding the teaching of Ding et al., applicant alleged that Ding does not explicitly teach whether a composition with mitochondria is applied. It is submitted that there is no requirement that a reference cited in the 103 rejection teaches all the limitation as the obviousness rejection is based on the combined teachings of the cited reference. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Samson et al. was cited as an evidentiary reference to calculate the concentration of the mitochondria, and this reference does not need to teach any of the claimed subject matter.
Conclusion
No claims are allowed.
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 TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
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, JAMES SCHULTZ can be reached at 571-272-0763. 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.
/TAEYOON KIM/Primary Examiner, Art Unit 1631