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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 Mar. 19, 2026 has been entered.
Claim Status
Claims 1, 6, 8-9, 33, and 36-42 are currently pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9 and 18, in the reply filed 8/5/24 is acknowledged as directed to a process of making product (“treatment composition”), e.g., “creating a treatment composition” or “generating a composition for treating.” Claim 36 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim.
Newly submitted claims 37-42 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: these claims comprise process features related to non-elected processes (e.g., Group III) of administering a product to a subject. Since applicant has received an action on the merits for the originally presented invention (e.g., claims 5-6 of 7/30/25 and claims 1, 5-6, 8-9, and 33 of 1/17/26), this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 37-42 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention. Note that once a claim to a product is found allowable, withdrawn claims are considered for rejoinder and unity of invention pursuant to MPEP 821.03. A single inventive concept for unity of invention may include both an unelected process of using the product (e.g., in treating a subject) and a process for the manufacture of the allowable product (e.g., treatment composition).
Claims 1, 6, 8-9, and 33 have been considered on the merits, and all arguments have been fully considered.
Priority
Acknowledgement is made of applicant’s claim for the benefit of the prior-filed applications US 62/785,155; US 62/785,126; US 62/785,072; and US 62/787,672 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c). The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosures of the prior-filed applications, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Entitlement to priority to Dec. 26, 2018 and Jan 2, 2019 does not apply to the subject matter of claims 1, 6, 8-9, 33, and 36-42 (e.g., due to a lack of support for culturing MSCs at about 0.1% to about 5% oxygen and an acidic pH of 6 to 6.9) and claims 36 (e.g., due to neuregulin1-B1 and urokinase type plasminogen activator receptor), therefore the earliest effective filing date of claims 1, 5-6, 8-9, and 20-35 is Dec. 26, 2019 based on the filing date of PCT/US2019/068615.
Claim Interpretation
Regarding claim 1, “the cell-free secretome composition” for treating male pattern baldness is interpreted as comprising extracellular vesicles secreted from the cultured bmMSCs regardless of the type of “separating” step; however, the extracellular vesicle need not comprise PDGFR-B, TIMP-1, TIMP-2, and/or TNFR1, each of which need only be present in the composition.
The elected invention (e.g., of claims 1, 6, 8-9, and 33) was previously directed to a method of making a product (e.g., cell-free secretome composition) but not a method of using this product. Thus, the “administering” step merely represents an intended use of the product generated by the claimed method (e.g., claim 1 as amended on 8/5/24, 12/4/2024, or 3/26/2025); however this intended language is interpreted as an implied functional limitation that the composition of claims 1, 8-9 and 33 must be capable of treating male pattern baldness in a subject. Similarly, claim 6 has an additional implied functional limitation that the composition must be capable of stimulating the activation of hair follicles of a subject thereby promoting hair growth for the subject in need of treating for male pattern baldness.
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.
The invention of claims 1, 6, 8-9, 33, and 37-42 are presently directed to a non-statutory subject matter. Although the claims all fall within a process, the claims do not fall within at least one of the four categories of patent eligible subject matter because as indicated in the preamble of claim 1, the invention as claimed is a process of “generating a cell-free secretome composition” (e.g., culturing and preparing a MSC preparation for treating a hair or skin disorder) while the active process steps recited also include a method of using the composition made (e.g., to treat male pattern baldness in a subject by administering an effective amount of the composition to a subject). For all of claims 1, 6, 8-9, and 33, this change in subject matter first occurred in the amendment to claim 1 of 10/30/2025, “administering an effective amount of the cell-free secretome composition to a subject.” Thus, claims 1, 6, 8-9, and 33 as amended are directed to an unelected hybrid process for both (1) the manufacture of a composition product (elected without traverse) combined with (2) the non-elected process of using the composition for treating male pattern baldness in a subject by a step of administering the composition to the subject in need thereof.
It would be remedial to restrict the claimed method steps only to those necessary for generating the cell-free secretome composition (i.e., cancel any method step solely to using a product produced by the elected method as claimed).
Claim Rejections - 35 USC § 112(a), Written Description
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1, 6, and 8-9 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 written description requirement and under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention as a whole is not adequately described if the claims require essential or critical elements that are not adequately described in the specification and that is not conventional in the art as of applicant’s effective filing date. Possession may be shown by actual reduction to practice, clear depiction of the invention in a detailed drawing, or by describing the invention with sufficient relevant identifying characteristics such that a person skilled in the art would recognize that the inventor had possession of the claimed invention. Pfaff v. Wells Electronics, Inc., 48 USPQ2d 1641,1646 (1998).
In making a determination of whether the application complies with the written description requirement under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant is claiming and what Applicant has possession of. The elected invention of claim 1 is a method of making a product (a composition), the method comprising (1) culturing bone marrow-derived mesenchymal stem cells (bmMSCs) at about 0.1% to about 5% oxygen and an acidic pH of 6.0 to 6.9 to generate a secretome composition comprising extracellular vesicles, and (2) separating the secretome composition from the bmMSCs to obtain a cell-free secretome composition; wherein the cell-free secretome composition comprises platelet derived growth factor receptor B (PDGFR-B), tissue inhibitor of metalloprotease 1 (TIMP-1), tissue inhibitor of metalloprotease 2 (TIMP-2), and tumor necrosis factor receptor (TNF R1).
Dependent claim 33 limits claim 1 to wherein the PDGFR-B in the composition is present at a higher concentration than all of TIMP-1, TIMP-2, and TNF R1. Thus, by the principle of claim differentiation, claim 1 necessarily encompasses wherein the composition has PDGFR-B at a concentration equal to or less than at least one of TIMP-1, TIMP-2, or TNF R1. As there is no additional method step recited for claim 33, then either the composition of the method of claim 1 inherently has the requisite property or claim 33 lacks sufficient claim limitation(s) to ensure this property is present. The instant specification does describe using a method according to claim 1 wherein the resulting composition has PDGFR-B concentrations that are always higher than TIMP-1, TIMP-2, and TNF R1 (Table 1). Therefore, the skilled artisan cannot envision the full scope of claim 1 wherein the method generates a cell-free secrteome composition with PDGFR-B at concentrations less than any of the recited proteins. Claims 6 and 8-9 are included in this rejection for having the same deficiencies as claim 1.
Also, claim 6 limits claim 1 to wherein the composition is capable of stimulating the activation of hair follicles to promote hair growth in a subject upon administration of a suitable amount of the composition to the subject having a need for treatment of male pattern baldness. Thus, by the principle of claim differentiation, claim 1 also encompasses wherein the composition lacks the capability recited in claim 6. As there is no additional method step or structural feature recited for claim 6, then either the composition of the method of claim 1 either inherently has the requisite capability or claim 6 lacks sufficient claim limitation(s) to ensure this ability is present. The instant specification describes using a method according to claim 1 wherein the composition stimulates hair growth in a subject with male pattern baldness; however, this is only when platelet rich plasma is included in the composition (FIG. 2). Therefore, the skilled artisan cannot envision possession of claim 6, wherein the method generates a cell-free secrteome composition predicted to have the ability to stimulate the activation of hair follicles upon injection of a certain amount in the absence of a platelet rich plasma cotreatment.
The claimed invention as a whole is not adequately described if the claims require essential or critical elements that are not adequately described in the specification and that is not conventional in the art as of applicants effective filing date, such as structures/functions to (1) provide for the ability to stimulate the activation of hair follicles to promote hair growth of a subject upon injection into the scalp or (2) ensure the concentration of PDGFR-B is greater than TIMP-1, TIMP-2, and TNF R1.
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 6 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 pre-AIA the applicant regards as the invention.
Claim 6 recites “the method of claim 5” but claim 5 was canceled rendering claim 6 indefinite. All the limitations of claim 5 needs to be recited in claim 6 and not merely by reference to a canceled claim. Because claim 6 depends from a canceled claim, the metes and bounds of claim 6 cannot be determined for the purposes of applying prior art. Regardless, claim 6 was considered on the merits as if it depended from claim 1 instead.
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.
Claims 6 and 33 are 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.
The claims are interpreted as provided in a previous section.
Claim 6 is interpreted as requiring the cell-free secretome composition of claim 1 has the implied functional limitation of being capable of stimulating the activation of hair follicles to promoting hair growth for a subject in need of treating for male pattern baldness upon an administering of at least some amount(s). However there is no additional process step or modification of a process of step of claim 1 from which claim 6 depends. Thus by the logic of claim 1 and 6 as written, the composition of claim 1 inherently has this property/characteristic implied by the language of claim 6 in the absence of evidence to the contrary. Thus without more, claim 6 prima facie fails to further limit the subject matter of claim 1. To the extent Applicant argues otherwise, see 112(a) WD rejection above.
Claim 33 attempts to further narrow claim 1 to wherein the PDGFR-B is present at a higher concentration than TIMP-1, TIMP-2 and TNF R1. However there is no additional process step or modification of a process of step of claim 1 from which claim 6 depends. Thus by the logic of claim 1 and 33 as written, the composition of claim 1 inherently has the property/characteristic of the limitation recited in claim 33 in the absence of evidence to the contrary. Thus without more, claim 33 prima facie fails to further limit the subject matter of claim 1. To the extent Applicant argues otherwise, see 112(a) WD rejection above.
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 § 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brodie (of record) as evidenced by Vesiclepedia (Vesiclepedia database, http://microvesicles.org/; last accessed 1/7/2026; PDGFRB, TIMP1, TIMP2, and TNFRSF1A).
The claims are interpreted as provided in a previous section. For purposes of applying prior art, intended language is not given patentable weight unless the intended language imparts an implied limitation to the method step(s). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The phrases “treating male pattern baldness” and the administering step are intended use limitations, which does not contain any further structural limitations with respect to claimed “cell free secretome composition” made by the active steps of the claimed method (see MPEP §2114).
In claim 1, the intended use of the composition made by the claimed process “for treating male pattern baldness” is considered but does not imply anything more to the active steps positively recited for the claimed method. Additionally, a process of administering is unelected subject matter and, thus, the phrases “administering an effective amount of the cell-free secretome composition via injection to the scalp of a subject in need thereof to treat the male pattern baldness” and “wherein the effective amount is effective to treat the male pattern baldness” is merely intended use.
Regarding claim 1, Brodie discloses methods of making an acellular composition comprising a bmMSC secretome, wherein said MSC secretome is produced by obtaining and culturing bmMSCs (BM-MSCs) ([076]; [034], [036], [060]; [042]) under hypoxic and acidic pH conditions to increase exosome production ([0120]), including oxygen levels below 5% to 0.1% ([0141]) and at a pH of about 6.0 ([0120]; [0147]), wherein the composition comprises all secreted proteins and vesicles (including exosomes) and the exosomes/vesicles are purified by ultracentrifugation, beads, columns, filters and/or antibodies to form the composition ([067]; [0203]; [0120]; [0195]). Note, where claimed ranges overlap ranges or values disclosed in the prior art, the claim may be anticipated (see MPEP 2131.03).
Although Brodie does not disclose the composition expressly comprises PDGFR-B, TIMP-1, TIMP-2, and TNF RI, these proteins are inherently present as evidenced by Vesiclepedia (at PDGFRB, TIMP1, TIMP2, and TNFRSF1A). Thus, Brodie teaches a cell-free bmMSC-derived secretome composition inherently comprising PDGFR-B, TIMP-1, TIMP-2, and TNF RI.
Regarding claims 6 and 33, none of the claim language implies any additional limitation to the elected method of claim 1 (see 112(d) rejections, above), instead merely noting inherent characteristics of the composition made by the claimed method. To the extent Applicant argues otherwise, see 112(a) WD rejection above.
Therefore, claim 6 and 33 is each anticipated by Brodie as evidenced by Vesiclepedia for the same reasons set forth fully above for claim 1. To the extent any such characteristic is argued to be absent from the method taught by the prior art as laid out above, then the active methods steps as recited in the claims may lack sufficient written description to ensure the implied characteristic(s) would predictably be present. Thus, Brodie anticipates the claimed invention.
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.
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.
Claims 1, 6, 8-9, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Brodie (of record) as evidenced by Vesiclepedia as applied above, and further in view of Cheng (of record).
Claims 1, 6, and 33 are anticipated as set forth above, and, thus, Brodie as evidenced by Vesiclepedia (at PDGFRB, TIMP1, TIMP2, and TNFRSF1A). render obvious the subject matter of claims 1, 6, and 33.
The claims are interpreted as set forth in a previous section. For purposes of applying prior art, intended language is not given patentable weight unless the intended language imparts an implied limitation to the method step(s). In claim 1, the intended use of the composition made by the claimed process “for treating male pattern baldness” is considered but does not imply anything more to the active steps positively recited for the claimed method. Additionally, a process of administering is unelected subject matter and, thus, the phrases “administering an effective amount of the cell-free secretome composition via injection to the scalp of a subject in need thereof to treat the male pattern baldness” and “wherein the effective amount is effective to treat the male pattern baldness” is merely intended use.
Brodie teaches a methods of making a cell-free composition comprising a bmMSC secretome produced by obtaining and culturing bmMSCs ([076]; [034], [036], [060]; [042]) under hypoxic and acidic pH conditions to increase exosome production ([0120]) using oxygen levels below 5% to 0.1% ([0141]) and at a pH of about 6.0 and a cell removal step ([0120]; [0147]; [067]; [0203]; [0120]; [0195). Vesiclepedia teaches exosomes from bmMSCs comprise the proteins PDGFRB, TIMP1, TIMP2, and TNFRSF1A (at PDGFRB, TIMP1, TIMP2, and TNFRSF1A).
Regarding claims 8-9, although Brodie teaches obtaining cells from a single donor person, such as for allogenic or autologous transplantation ([0117]) and using MSC or MSC exosomes to treat skin aging via injection (Example 11, 2, [0113]), the combination of Brodie and Vesiclepedia does not teach the bmMSC are obtained from a donor having any specific SNP profile.
However Cheng teaches an IL-18 SNP (−37G/C (rs187238)) correlated with a reduced likelihood of a skin disorder (allergic dermatitis) (Abstract; pg. 2, left col., 2nd para.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective time of filing to modify a method of Brodie to form the composition using cells from a donor having an SNP profile comprising the IL-18 SNP rs187238 correlated with a reduced likelihood of a skin disorder as taught by Cheng. One of ordinary skill in the art would be motivated to avoid using diseased/abnormal donor cells to risk promoting an undesirable condition in a recipient subject, i.e., allergic dermatitis, especially for a treatment to treat skin aging conditions. Therefore the claimed invention as a whole is prima facie obvious before the earliest effective filing date in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments filed 3/19/26 have been fully considered but not found persuasive. Applicant traverses the previous 103 rejections in part by arguing that the prior art does not provide either a motivation or reasonable expectation of success to arrive at a method for treating male pattern baldness involving delivery via scalp injection from the previous prior art of record (pg. 7-8). However as noted herein, the rejection need not address any implied use of the product made by the claimed invention as the instantly elected invention beyond the presence of the implied capability of treating male pattern baldness in a subject, which as detailed above is an inherent characteristic to any composition made by the same active steps absent evidence to the contrary.
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, 6, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7, 76, and 78-82 of copending Application No. 17/427,192 (reference application) as evidenced by as Vesiclepedia.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the reference application teaches a method for generating and administering a therapeutically effective amount of a bmMSC (bone marrow MSC) derived secretome composition for treating baldness (including male pattern baldness – reference claim 7), the method comprising: preparing an MSC exosome preparation from bmMSCs, wherein the MSC exosome preparation is created by culturing in conditions comprising about 0.1% to about 10% oxygen and a pH of about 6.0 to about 7.4.
Instant claim 1 differs in that the pH is 6.0 to 6.9 instead of about 6.0 to about 7.4 and the oxygen is no greater than about 5%. However a prima facie case of obviousness exists where claimed ranges overlap disclosed ranges, e.g., in the prior art (MPEP 2144.05). Instant claim 1 also differs in the composition must expressly comprise PDGFR-B, TIMP-1, TIMP-2, and TNF R1.
However as evidenced by Vesiclepedia, bmMSC-conditioned medium comprises PDGFR-B, TIMP-1, TIMP-2, and TNFR1 as explained in the 103 section above. Therefore, performing the method of reference claim 1 to make the cell-free exosome composition inherently creates a MSC exosome composition comprising PDGFR-B, TIMP-1, TIMP-2, and TNF R1. Furthermore, reference claims 76 and 78-82 teach wherein the composition comprises PDGFR-B, TIMP-1, TIMP-2, and/or TNF R1.
Regarding instant claim 6, as the method steps taught of making the composition are the same, the result of the method would inherently occur regardless of intent, and thus the composition would inherently have the ability to stimulate the activation of hair follicles to promote hair growth. Furthermore regarding both claim 6 and 33, none of the claim language implies any additional limitation to the elected method of claim 1 (see 112(d) rejections, above), instead merely noting inherent characteristics of the composition made by the claimed method. To the extent Applicant argues otherwise, see 112(a) WD rejection above. This is a provisional nonstatutory double patenting rejection because the reference application claims have not in fact been patented.
Claims 1, 6, 8-9, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7, 76, and 78-82 of copending Application No. 17/427,192 (reference application) as evidenced by Vesiclepedia as applied above, and further in view of Cheng (Cheng et al., Biomed Res Int 2014: 290687 (2014).
Regarding instant claims 8-9, the combination of the reference claims and Vesiclepedia does not teach wherein the composition is derived from a donor having a specific SNP profile. However Cheng teaches an IL-18 SNP (−37G/C (rs187238)) correlated with a reduced likelihood of a skin disorder (allergic dermatitis) (Abstract; pg. 2, left col., 2nd para.). Thus it would have been prima facie obvious to one of ordinary skill in the art to modify a method of the reference claims to form the composition using bmMSC cells from a donor having an SNP profile comprising the IL-18 SNP rs187238 correlated with a reduced likelihood of a skin disorder as taught by Cheng. One of ordinary skill in the art would be motivated to avoid using diseased/abnormal donor cells to risk promoting an undesirable disorder in a recipient subject when administering to treat baldness as taught by the reference claims. This is a provisional nonstatutory double patenting rejection because the reference application claims have not in fact been patented.
Claims 1, 6, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-28, 39, and 42-43 of copending Application No. 19/300,197 (reference application) as evidenced by Vesiclepedia.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 39 of the reference application teaches a method of preparing an acellular composition comprising a bmMSC secretome from conditioned medium made by culturing bmMSCs at 0.1-10% oxygen and a pH of 6.0-6.9. Further reference claims 26-28 teaching use this composition for treating any condition in a subject, including a skin disorder, by administering via injection (subcutaneously) to the subject such an acellular composition comprising MSC vesicles and/or exosomes from bone marrow-derived mesenchymal stem cells (bm-MSCs). While the reference claim does not expressly teach the MSC secretome composition comprises PDGFR-B, TIMP-1, TIMP-2, and TNF R1, bmMSC-conditioned medium inherently comprises PDGFR-B, TIMP-1, TIMP-2, and TNFR1 as evidenced by Vesiclepedia as explained in the 103 section above. Therefore, performing the method of reference claim 39 involves a bmMSC secretome composition inherently comprising PDGFR-B, TIMP-1, TIMP-2, and TNF R1. Note, a prima facie case of obviousness exists where claimed ranges overlap disclosed ranges, e.g., in the prior art (MPEP 2144.05).
Regarding instant claim 6, as the method steps of making the composition taught are the same, the result of the method would inherently occur regardless of intent, and thus the composition would inherently be capable of stimulating the activation of hair follicles to promote hair growth. Furthermore regarding both claim 6 and 33, none of the claim language implies any additional limitation to the elected method of claim 1 (see 112(d) rejections, above), instead merely noting inherent characteristics of the composition made by the claimed method. To the extent Applicant argues otherwise, see 112(a) WD rejection above. This is a provisional nonstatutory double patenting rejection because the reference application claims have not in fact been patented.
Claims 1, 6, 8-9, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-28, 39, and 42-43 of copending Application No. 19/300,197 (reference application) as evidenced by Vesiclepedia as applied above, and further in view of Cheng (Cheng et al., Biomed Res Int 2014: 290687 (2014).
Regarding instant claims 8-9, the combination of the reference claims and Vesiclepedia does not teach wherein the composition is derived from a donor having a specific SNP profile. However Cheng teaches an IL-18 SNP (−37G/C (rs187238)) correlated with a reduced likelihood of a skin disorder (allergic dermatitis) (Abstract; pg. 2, left col., 2nd para.). Thus it would have been prima facie obvious to one of ordinary skill in the art to modify a method of the reference claims to form the composition using bmMSC cells from a donor having an SNP profile comprising the IL-18 SNP rs187238 correlated with a reduced likelihood of a skin disorder as taught by Cheng. One of ordinary skill in the art would be motivated to avoid using diseased/abnormal donor cells to risk promoting an undesirable disorder in a recipient subject when administering to treat a skin disorder as taught by the reference claim 28. This is a provisional nonstatutory double patenting rejection because the reference application claims have not in fact been patented.
Response to Arguments
Applicant’s arguments filed 3/19/26 on pg. 10-11 have been considered but not found persuasive as the double patenting rejection is not the only rejection remaining herein. Applicant’s double patenting response is considered to be non-responsive. 37 C.F.R. 1.111(b) requires applicants to respond to each rejection with “arguments pointing out the specific distinctions believed to render the claims, including any newly presented claims, patentable over any applied references.”
The double-patenting rejections will not be held in abeyance. See 37 C.F.R. 1.111(b), which allows that some objections or “requirements as to form” may be held in abeyance but includes no provision for holding rejections in abeyance. Section 1.111(b) also requires applicants to respond to each rejection with “arguments pointing out the specific distinctions believed to render the claims, including any newly presented claims, patentable over any applied references.” For each rejection, for example, applicants might provide a proper terminal disclaimer (or at least indicate a willingness to submit one when double patenting is the only remaining issue); explain why the rejection is overcome by amendments; provide convincing arguments that the rejection was made in error; and/or explain why amendments or claim cancellations in the copending applications have rendered the rejection moot. If any of the conflicting pending application matures to a patent, modifying the rejection to account for claim-number changes will not constitute a new ground of rejection.
Arguments regarding the filing dates of any reference application or patent in relation to the instant claims are not responsive to a double patenting rejection.
Conclusion
No claim is allowed.
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/ERIC J ROGERS/Examiner, Art Unit 1638
/KEVIN K HILL/Primary Examiner, Art Unit 1638
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