DETAILED CORRESPONDENCE
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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 29, 2026 has been entered.
This action is in response to the papers filed April 29, 2026. Currently, claims 1-5, 7, 13, 76-83 are pending. Claims 76-82 have been withdrawn as drawn to non-elected subject matter.
All arguments have been thoroughly reviewed but are deemed non-persuasive for the reasons which follow.
Any objections and rejections not reiterated below are hereby withdrawn.
Election/Restrictions
Applicants’ election of a combination of proteins recited in Claim 83 in the paper filed April 29, 2026 has been acknowledged.
Applicant's election of Group I, baldness, male pattern baldness, Androgen receptor and RS6152 in the paper filed June 13, 2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 65-75 have been withdrawn as non-elected subject matter.
Priority
This application claims priority to
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It is noted that the provisional application does not provide support for the oxygen or pH levels for culturing the MSCs. Thus, the instant claims are entitled to the priority date of the 371, namely January 30, 2020.
Information Disclosure Statement
It is noted that the IDS filed January 27, 2025 and June 10, 2025 contains an extremely large number of references for consideration by the Examiner. The January 27, 2025 IDS is 42 pages and the June 10, 2025 IDS is 26 pages. If the Applicant and/or Applicant and/or Applicant's representative are aware of any particular reference or portion of a reference in the extensive list which the examiner should pay particular attention to, it is required that it be specifically pointed out in response to this Office action.
Applicant is reminded that "burying" relevant references in a lengthy IDS is discouraged. See, e.g., Molins PLC v. Textron Inc., 48 F.3d 1172, 33USPQ2d 1823, 1831 (Fed. Cir. 1995) The court concluded that, by “burying” Wagenseil in a multitude of other references, Hirsh and Smith intentionally withheld it from the PTO becausethis manner of disclosure was tantamount to a failure to disclose. Citing Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F.Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff'd, 479 F.2d 1328, 178 USPQ 577 (5th Cir.), cert. denied, 414 U.S. 874 (1973), the court stated that Hirsh's and Smith's failure to highlight Wagenseil in light of their knowledge of Whitson's actions in the foreign prosecutions violated their duty of candor to the PTO. Citing our precedent, Textron asserts that Smith's and Hirsh's conduct is “inexcusable,fraudulent, and cannot operate to cure Whitson's inequitable conduct.” See
Rohm & Haas Co. v. Crystal Chem. Co., 722 F.2d 1556, 220 USPQ 289 (Fed.Cir. 1983), cert. denied, 469 U.S. 851 (1984) (where intentional material misrepresentations have been made, a “cure” through voluntary efforts during prosecution must be demonstrated y clear, unequivocal, and convincing evidence).
Response to Arguments
The response provides 14 references identified in a search of the IDS for particular review.
Specification
The specification has been amended to remove the reference to Figures.
Claim Rejections - 35 USC § 112-Scope of Enablement
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-5, 7, 83 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404,
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
The nature of the invention and breadth of claims
Claims 1-5, 7, 83 are directed to a treating baldness using the MSC exosome composition. Claims 1-5 have been amended to recite the intended use of the composition for treatment.
The invention is in a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The unpredictability of the art and the state of the prior art
Yuan et al. (E. J. of Pharmacology, Vol. 881, August 15, 2020) published after the filing date of the application reviews current advances in stem cell-based therapies for hair regeneration. Figure 1 illustrates currently available treatments for hair loss which does not include exosomes. Yuan reviews exosomes and their use for hair treatment (para 4). Yuan clearly states “there are no clinical studies regarding the use of exosomes or EVs for the treatment of hair loss” (para 5). Table 4 further provides the limitations of exosome for hair regeneration.
Istanbul Med Assist further considers whether exosomes work for hair loss (IMA, 2024, https://www.istanbulmedassist.com/blog/do-exosomes-really-work-for-hair-loss/#:~:text=Do%20Exosomes%20Actually%20Work?,%2C%20age%2C%20and%20overall%20health.). IMA states that in 2024 research is currently being done to determine whether exosome treatment works for hair loss but experts warn that more extensive, long-term research is necessary to properly prove its usefulness, the majority of the evidence is anecdotal.
Guidance in the Specification.
The specification provides no evidence that an MSC exosome composition cultured in media at 0.1% to 10% oxygen and a pH of 6-7.4 to generate a conditioned media may be administered in a therapeutically effective amount to treat baldness. The specification is filled with definitions and prophetic discussions. There is no evidence of any MSC exosome composition cultured at the particular oxygen or pH levels treats baldness.
The guidance provided by the specification amounts to an invitation for the skilled artisan to try and follow the disclosed instructions to make and use the claimed invention.
Working Examples
The specification has no working examples of treating baldness with the MSC exosomes.
Quantity of Experimentation
The quantity of experimentation in this area is extremely large since there is significant number of parameters which would have to be studied to enable the skilled artisan to treat baldness using an exosome conditioned media created from a MSC at a particular oxygen and pH. The specification fails to treat baldness using the MSC exosome composition. The art teaches exosomes to treat hair loss is being researched but extensive unpredictable experimentation is required before exosomes may be used to treat hair loss. This would require significant inventive effort, with each of the many intervening steps, upon effective reduction to practice, not providing any guarantee of success in the succeeding steps.
Level of Skill in the Art
The level of skill in the art is deemed to be high.
Conclusion
Thus given the broad claims in an art whose nature is identified as unpredictable, the unpredictability of that art, the large quantity of research required to define these unpredictable variables, the lack of guidance provided in the specification, the absence of a working example and the negative teachings in the prior art balanced only against the high skill level in the art, it is the position of the examiner that it would require undue experimentation for one of skill in the art to perform the method of the claim as broadly written.
Response to Arguments
The response traverses the rejection. The response asserts a patent need not teach and preferably omits what is well known in the art. This argument has been considered but is not deemed persuasive. The prior art does not teach a method for creating MSC exosome compositions for treatment of baldness. In fact, the art demonstrates exosomes to treat hair loss is being researched but extensive unpredictable experimentation is required before exosomes may be used to treat hair loss.
The response asserts the claim is fully enabled by the specification at paragraphs 72 and 99 and Park. Paragraph 72 is directed to dilution factors for the compositions. Paragraphs 97-99 do not provide any evidence or discussion of what was administered or the results, for example. The specification does not provide any guidance to how reducing oxygen levels treats baldness. There is no nexus between the passage in the specification and the claims. There is no evidence in the specification to overcome the evidence in the art. The art teaches exosomes to treat hair loss is being researched but extensive unpredictable experimentation is required before exosomes may be used to treat hair loss. Paragraphs 72 and 99 do not provide an enabling disclosure for creating MSCs that can treat baldness.
Formulating and treating MSCs into a treatment is unpredictable. The response previously stated that working examples for treating baldness are not required. The response also points to Sasaki et al. (Aesthetic surgery journal, Open Forum 4: ojac045, 1-15 (2022)). It is noted Sasaki is published nearly 2 years post-filing date and does not demonstrate the state of the art at the time the invention was made. Sasaki states that “no evidence-based data has been published” (page 3, para 1). Even more the Sasaki paper does not provide the method for bone marrow MSCs culturing or formulating, the oxygen levels or the pH in the exosomes such that the results have any bearing on the instant claims. XoFLo is a bone marrow mesenchymal stem cell-derived EV isolate, but there is no evidence these exosomes were cultured in media at 0.1% to 10% oxygen and a pH of 6-7.4.
The response filed January 20, 2026 includes a Declaration filed by Dr. Moseley. The response states the Declaration presents data in Exhibit B to demonstrate administration of bone marrow MSC derived conditioned media to treat baldness. The Declaration has been fully considered. The declaration does not teach how the MSCs were cultured or the particular conditions, including oxygen and pH and proteins. There is no evidence provided in the specification or the Declaration to describe the condition under which the bone marrow MSCs were cultured. The Declaration states “administration of an example MSC exosome composition of the claimed method (termed “XoFlow”)” was performed. There is no explanation of how the exosome composition XoFlow was cultured or created or which proteins were found in the conditioned media. As provided in 716.02(b), Applicants have the burden of explaining proffered data. Furthermore, it is not clear that the XoFlow composition is commensurate in scope with the claimed invention or these results are consistent over the ranges claimed. Applicant may wish to provide a Declaration outlining the protocol used for culturing the bone marrow MSCs in XoFlow including the particular oxygen percentage and the pH and the proteins comprised in the conditioned media.
The Examiner conducted a search for XoFlow in the art and information was limited. A single review article from May 2023, Olumesi et al. (Journal of Cosmetic Dermatology, Vol. 22, pages 2628-2634, May 2023) reviews exosomes and their application in cutaneous medical aesthetics. Table A1 provides a list of commercially available EV formulation including XoFlow and founds that the therapeutic effects – information difficult to ascertain. Thus, it is not clear what culture conditions are used and what effects are found. The examiner is unable to compare the composition used in Exhibit B with the limitations of the claims to determine whether the claims are commensurate in scope with the proffered results in the Declaration. Further data and evidence are required.
Thus, for the reasons above and those already of record, the rejection is maintained.
Claim Rejections - 35 USC § 112
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.
Claims 1-5, 7, 83 are 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 has been amended to require an administering step and “thereby treating the baldness”. The preamble of the claim states the method is for treating MSC exosome compositions with an intended use of treating baldness. It is unclear whether the claim is for creating MSC exosome compositions or for administering the MSC exosome compositions and thereby treating baldness. The claims depending on Claim 1 are similarly indefinite. Clarification is required.
Claim Rejections - 35 USC § 112- 4th paragraph
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.
Claim 83 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 83 requires the conditioned media comprises particular proteins. The specification and Claim 1 state that the culturing of the bone marrow MSCs in media under particular conditions generate a conditioned media with these characteristics and proteins. The claim does not require any additional steps. This limitation in Claim 83 does not appear to limit Claim 1 in any way since this is a mere recitation of inherent proteins in the conditioned media. The claims are identical in scope. 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 § 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 1-5, 7, 83 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mathen (WO 2018/150440, August 23, 20218) in view of Brodie et al. (US 2019/0269739, September 5, 2019).
Mathen teaches a method of treating a subject having baldness, including Male Pattern Baldness (MPB) comprising administering a composition comprising a mesenchymal stem cells (MSC) conditioned medium separated from the MSC and resulting in improvements in control of hair loss and hair growth (effective treatment) (Example 5, pg. 21-22; pg. 17, last para., to pg. 18, 1st para.), such as using bone-marrow derived MSCs (pg. 7, 3rd para.). Mathen teaches such MSC-conditioned media comprise beneficial stem cell exosomes, extracellular microvesicles, and other stem cell factors for therapeutic uses on hair regeneration and dermatological conditions (pg. 1, 1st para.; pg. 6, last para., to pg. 7, 2nd para.; pg. 13, 2nd para.). Mathen teaches conditions of the culturing may be optimized by altering oxygen concentrations (page 12, para 2). Mathen teaches the pH may be between 5.5 to 9.0 pH (page 19, lines 5). Mathen teaches the MSC composition comprises protein including cytokines (limitations of Claim 2-3).
Mathen does not teach culturing the MSCs in hypoxic or pH of 6-7.4 to prepare an exosome preparation.
However, Brodie teaches mesenchymal stem cell populations may be cultured to obtain exosomes (para 219). Brodie teaches growing MSCs in hypoxic conditions (i.e. low oxygen) or incubated in medium with low pH increases the yield of exosomes (para 219). Brodie teaches hypoxic conditions is below 5% oxygen (see para 243). Brodie also teaches low pH is at or below 6.0 (i.e. about 6.0)(see par 249).
With respect to Claims 4-5, Brodie teaches analyzing RNAs following culturing.
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention to have modified the MSC treatment method of Mathen to have prepared an MSC exosome preparation for baldness using 0.1%-10% oxygen and pH of 6.0, as taught by Brodie to generate mesenchymal stem cell exosome compositions for treatment of diseases. Brodie teaches conditions to improve exosome yield. The ordinary artisan would have been motivated to have improved exosome yield to produce more exosomes for therapy.
With respect to Claim 83, that requires particular proteins. The claims require culturing the bone marrows MSCs in a media at 0.1% to 10% oxygen and a pH or 6-7.4 to generate a conditioned media. The claims and the specification teach that the mere culturing of bone marrow MSCs in the conditions generate media with these properties. The specification teaches proteomic assessment of exosome suspensions was performed and the proteins claimed where present at physiologically relevant concentrations at duplicate test samples (Page 28, para 99). Furthermore, the Vesiclepdia database, cited in the IDS filed January 20, 2026, teaches exosomes from bmMSCs comprise the proteins PDGFRB, TIMP1, TIMP2, TNFRSF1A, follistatin. No additional steps are required. Thus, the conditioned media inherently and necessarily comprises these proteins.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5, 7, 83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of copending Application No. 17/418,342 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Although the conflicting claims are not identical, they are not patentable distinct from each other because Claims 1-5, 7, 83 of the instant application is generic to all that is recited in Claim 1 of U.S. Patent Application No. 17/418,342. That is, Claim 1 of 17/418,342 falls entirely within the scope of Claim 1-5, 7, 83, or in other words, Claim 1-5, 7, 83 are anticipated by Claim 1 of U.S. Patent Application No. 17/418,342. Here, Claim 1 of U.S. Patent Application No. 17/418,342 recites
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The claims each require generating or creating bone marrow MSCs by culturing using overlapping ranges of oxygen and pH and administering the MSC to treat baldness. Claim 1 of ‘342 teaches the composition comprises four of the proteins required in Claim 83.
With respect to Claim 83, that requires particular proteins. The claims require culturing the bone marrows MSCs in a media at 0.1% to 10% oxygen and a pH or 6-7.4 to generate a conditioned media. The claims and the specification teach that the mere culturing of bone marrow MSCs in the conditions generate media with these properties. The specification teaches proteomic assessment of exosome suspensions was performed and the proteins claimed where present at physiologically relevant concentrations at duplicate test samples (Page 28, para 99). Furthermore, the Vesiclepdia database, cited in the IDS filed January 20, 2026, teaches exosomes from bmMSCs comprise the proteins PDGFRB, TIMP1, TIMP2, TNFRSF1A, follistatin. No additional steps are required. Thus, the conditioned media inherently and necessarily comprises these proteins.
Claims 1-5, 7, 83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26, 39 of copending Application No. 19/300,197 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Although the conflicting claims are not identical, they are not patentable distinct from each other because Claims 1-5, 7, 83 of the instant application is generic to all that is recited in Claims 26, 39 of U.S. Patent Application No. 19/300,197. That is, Claims 26, 39 of U.S. Patent Application No. 19/300,197 falls entirely within the scope of Claim 1-5, 7, 83, or in other words, Claim 1-5, 7, 83 are anticipated by Claims 26, 39 of U.S. Patent Application No. 19/300,197. Here, Claim 39 of U.S. Patent Application No. 19/300,197recites
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Claim 1 is directed to treating a subject with a composition comprising a bone marrow MSC. It would have been obvious to have prepared the acellular composition for use in the method of treating of Claim 26 using the method of Claim 39.
The claims each require generating or creating bone marrow MSCs by culturing using overlapping ranges of oxygen and pH and administering the MSC to treat baldness.
With respect to Claim 83, that requires particular proteins. The claims require culturing the bone marrows MSCs in a media at 0.1% to 10% oxygen and a pH or 6-7.4 to generate a conditioned media. The claims and the specification teach that the mere culturing of bone marrow MSCs in the conditions generate media with these properties. The specification teaches proteomic assessment of exosome suspensions was performed and the proteins claimed where present at physiologically relevant concentrations at duplicate test samples (Page 28, para 99). Furthermore, the Vesiclepdia database, cited in the IDS filed January 20, 2026, teaches exosomes from bmMSCs comprise the proteins PDGFRB, TIMP1, TIMP2, TNFRSF1A, follistatin. No additional steps are required. Thus, the conditioned media inherently and necessarily comprises these proteins.
Conclusion
No claims allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng (Winston) Shen can be reached on (571) 272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
July 8, 2026
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