DETAILED ACTION
Status of Application, Amendments, And/Or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The preliminary amendment of 02 December 2022 has been entered in full. Claims 7 and 15 are canceled. Claims 1-6 and 8-14 are under examination.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6 and 8-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (specifically, a product of nature) without significantly more. Claim 1 recites an exosome isolated from dermal papilla progenitor cells or from a culture product of dermal papilla progenitor cells. Dependent claims recite cellular sources for the progenitor cells, size and protein expression products of the exosomes, a method of obtaining the exosomes, methods of culturing the progenitor cells, and pharmaceutical compositions comprising the exosomes as an active ingredient for use in treating different types of hair loss.
This judicial exception is not integrated into a practical application because the recited exosomes are no different from naturally occurring exosomes released by naturally occurring dermal papilla progenitor cells, absent evidence to the contrary. For example, the progenitor cells are not transformed with a DNA construct expressing a protein that is not normally produced by untransformed dermal papilla progenitor cells.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the following reasons. The recited feature of the exosomes being “isolated” and the recited processes of isolating the exosomes do not confer a property to the exosomes that makes them materially different from the naturally occurring exosomes. The very nature of exosomes being a structure that is naturally released from a cell through the cell membrane renders the exosomes “isolated” from the cell. The intended use of the exosomes to treat hair loss also does not change the nature of the exosomes themselves. The claims directed to pharmaceutical compositions do not recite additional elements that are not associated with the exosomes in nature, such as non-naturally occurring carriers or matrices.
For all of these reasons, the claimed subject matter is directed to the judicial exception of a product of nature.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 13 further limits the intended use of the claimed pharmaceutical composition to treat hair loss by reciting specific forms of hair loss. However, this does not affect the scope of the claimed subject matter, which is the pharmaceutical composition itself. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(b)
Claims 4 and 6 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 4 recites that the exosomes have a “size” of 50-150 nm. It is unclear what aspect of the size must be in this range. Is this intended to reflect the radius, diameter, or circumference? The metes and bounds of the claim cannot be determined.
Claim 6 recites that the expression rate of CD63 is at least 80%. Is this 80% (w/w) of the total protein being expressed by the exosome? Is this 80% of the highest rate of expression of CD63? Without context, the recitation of a percentage is meaningless.
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(s) 1-6 and 8-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (01 January 2020; Theranostics 10(3): 1454-1478) with evidence from Lin et al. (2016, ACS Appl Mater Interfaces 8:5906-5916), Magerl et al. (2002, Experimental Dermatol 11:381-385), and Morgan (2014, Cold Spring Harbor Perspectives in Medicine 4:a015180; pp. 1-14).
Chen et al. teach a pharmaceutical composition comprising, as an active ingredient, exosomes isolated from dermal papilla (DP) cells (which inherently comprise DP progenitor cells) or a culture product of the same. Chen et al. further teach a method of treating hair loss comprising administering the pharmaceutical composition to a subject in need thereof. Note that Chen et al. refer to exosomes as extracellular vesicles, or EVs. See abstract; Scheme 1 at p. 1456; Figure 9B. Note that the procedure used by Chen et al. to isolate the DP cells for culture was previously disclosed by Lin et al. (2016, ACS Appl Mater Interfaces 8:5906-5916) and Magerl et al. (2002, Experimental Dermatol 11:381-385). See pp. 1472-1473 of Chen et al. who cite Lin et al. In turn, Lin et al. cite Magerl et al. as the procedure for isolating DP cells at p. 5907. Magerl et al. describe a surgical method of isolating the “bulb” containing the DP cells, which Magerl et al. refer to as hair follicle papilla (HFP) cells. It was known from the prior art that the “bulbs” described by Magerl et al. included DP cells and their progenitors. See illustration in Morgan, p. 2, Figure 1. It is noted that the exosome derived from this procedure are “isolated” to a substantial degree from other structures such as the skin cells of the scalp sample and the hair shaft, as well as the cells which released the exosomes including the dermal papilla progenitor cells. Thus, the disclosure of Chen et al. anticipates claims 1, 11, and 14.
Regarding claim 2, naturally occurring dermal papilla progenitor cells are derived from mesenchymal stem cells through the normal development process. As evidence thereof, see Morgan, p. 1, right column.
Regarding claim 3, Chen et al. obtain their exosomes from human explants that comprising human stem cells. See p. 1472 “Cell culture.”
Regarding claim 4, the exosomes of Chen et al. had an average diameter of 91.3 nm, which falls within the 50-150 nm size range recited in the claim. See p. 1456, left column.
Regarding claim 5, Chen et al. teach that the exosomes expressed CD9. See Figure 1E.
Regarding claim 6, while Chen et al. do not expressly teach that the exosomes expressed CD63 at 80% or more, the reference is interpreted as meeting this limitation for two reasons. First, the recitation of “80%” expression rate in the claim is determined to be indefinite as discussed above in the rejection under 35 U.S.C. 112(b). Second, absent evidence to the contrary, it can reasonably be assumed that the exosomes of Chen et al. match the expression rate of the exosomes described in the instant application since they are both derived from human dermal papilla progenitor cells. Chemical compounds and their properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA1963)), as are their processes and yields (In re Von Schickh, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)).
Regarding claims 8-10, while the culturing and isolation procedures of Chen et al. were slightly different than the conditions recited in the claims, the resulting exosomes would have been the same, absent evidence to the contrary. The exosomes are still exosomes from dermal papilla progenitor cells. Note that what is being claimed is the exosome, not a composition comprising the exosomes.
Regarding claim 11, Chen et al. teach pharmaceutical compositions comprising exosomes as the active ingredient, which they term OSA-EV hydrogels. See pp. 1474-1475.
Regarding claim 12, Chen et al. report that the exosomes were present in the pharmaceutical compositions at 2.5 mg/ml (p. 1474), which includes a number of particles between 1 x 106 and 1 x 1012 absent evidence to the contrary.
Regarding the limitations of “for prevention, improvement, or treatment of hair loss” in claim 11 and the specific types of hair loss recited in claim 13, it is noted that these limitations appear in the claim preambles. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). Furthermore, Chen et al. demonstrate a positive effect on hair growth at Figures 7-9. Therefore, Chen et al.’s teachings fully anticipate claims 11-13.
Regarding claim 14, Chen et al. teach a method for the improvement of air loss comprising administering a pharmaceutical composition comprising exosomes as the active ingredient to a subject in need thereof. See Figure 9B.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zhou et al. (2018, Biochem Biophys Res Coomun 500:325-332).
Poddar et al. (2025, World J Stem Cells 17(7):108519; pp. 1-26).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH C. KEMMERER whose telephone number is (571)272-0874. The examiner can normally be reached M-F 6:30-3.
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/ELIZABETH C. KEMMERER/Primary Examiner, Art Unit 1674
/ECK/
28 August 2025