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 (RCE) under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 12/9/25 has been entered.
Information Disclosure Statements
The RCE was filed with a 14-page IDS on 12/9/25. On 12/12/25, the examiner contacted applicant’s representative to identify an issue with citation 70 on page 7 of that IDS. On 1/6/26, applicant refiled the entire IDS, including a change to citation 70. With the exception of the new citation 70, the 1/26/26 IDS has been crossed out because it is duplicative of the 12/9/25 IDS.
On 1/22/26, applicant supplied a 1-page IDS and a 2-page “letter regarding copending applications.” The latter of these has been crossed out because it is not a properly formatted IDS. The former has been considered.
On 2/27/26, applicant again filed the 14-page IDS, this time correcting citation number 68 on page 6. With the exception of new citation 68, the 2/27/26 IDS has been crossed out because it is duplicative of the 12/9/25 IDS.
On 3/26/26, applicant filed a 2-page IDS. This document has been considered.
To avoid processing delays at the printer’s office, applicant is requested not to resubmit the entire 14-page IDS should any further corrections be deemed necessary.
Claim Rejections - 35 USC § 102 and 103
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.
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.
Claims 1, 2, 4-7, and 9 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Pivoraite et al. (Inflammation 38: 1933-1941; NPL reference 127 on 12/9/25 IDS).
Pivoraite teaches culturing SHED (stem cells from the dental pulp of human exfoliated deciduous teeth) in DMEM supplemented with 10% fetal bovine serum (FBS), then switching to serum-free medium. (Page 1934.) Pivoraite teaches exosomes (which are microparticles) derived from a culture supernatant of SHED. (Page 1935, column 1.) Pivoraite’s method includes centrifuging the supernatant at increasing speeds until reaching 100,000g and spinning for 70 minutes, then washing the pellet and spinning again at 100,000g for 70 minutes. (Page 1935, column 1.) Pivoraite teaches storing the exosomes at -70oC. (Page 1935, column 1.)
Claim 1 is a product-by-process claim because it defines the microparticles according to their method of production (i.e., “derived from a culture supernatant of dental-pulp stem cells . . . .”) “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” MPEP 2113(I).
Pivoraite is silent as to the presence or absence of MCP-1 and Siglec-9 in her exosome preparation. The method of preparing the exosomes from SHED supernatant, however, is substantially identical to that employed by applicants. (See paragraph 42 at page 22 of as-filed specification, which cultures dental-pulp stem cells in DMEM + serum, then in serum-free DMEM, before centrifuging twice at 100,000g for 60 minutes each time before storing at -80oC.) The person of ordinary skill in the art would therefore have concluded that the exosome preparations are the same or substantially identical. Once a product appearing to be substantially identical is found and a prior-art rejection is made, the burden shifts to the applicant to show a nonobvious difference. See MPEP 2113(II). Claim 1 does not specify any particular parameters for exosome collection that the skilled artisan would have expected to affect the structure of the exosomes.
“[W]hen the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable.” MPEP 2113(III). The person of ordinary skill in the art would have understood that Pivoraite’s exosome preparation either anticipates the claimed preparation because they are identical or renders it obvious because the preparation methods are so similar.
Claims 1, 2, and 4-9 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Kong et al. (2020, Stem Cell Reviews and Reports 17: 318-331; NPL reference 115 on 12/9/25 IDS; full reference provided on PTO-892 as reference W).
Kong teaches culturing dental-pulp tissue pieces in alpha-MEM supplemented with 15% fetal bovine serum (FBS), then switching to serum-free medium. (Page 320, column 1.) Kong teaches extracellular vesicles (which are microparticles) derived from the culture supernatant of dental-pulp stem cells (DPSCs). (Page 320, column 1.) Kong’s method includes centrifuging the supernatant at increasing speeds until reaching 110,000g and spinning for 70 minutes, then washing the pellet and spinning again at 110,000g for 70 minutes. (Page 320, column 1.) Kong teaches storing the exosomes at -80oC. (Page 320, column 1.) Regarding claim 8, Kong teaches a preparation containing 5-7x107 particles per mL (i.e., 0.5-0.7x108 particles per mL). (Page 320, column 1.)
Claim 1 is a product-by-process claim because it defines the microparticles according to their method of production (i.e., “derived from a culture supernatant of dental-pulp stem cells . . . .”) “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” MPEP 2113(I).
Kong is silent as to the presence or absence of MCP-1 and Siglec-9 in her exosome preparation. The method of preparing the exosomes from DPSC supernatant, however, is substantially identical to that employed by applicants. (See paragraph 42 at page 22 of as-filed specification, which cultures dental-pulp stem cells in DMEM + serum, then in serum-free DMEM, before centrifuging twice at 100,000g for 60 minutes each time before storing at -80oC.) The person of ordinary skill in the art would therefore have concluded that the exosome preparations are the same or substantially identical. Once a product appearing to be substantially identical is found and a prior-art rejection is made, the burden shifts to the applicant to show a nonobvious difference. See MPEP 2113(II). Claim 1 does not specify any particular parameters for exosome collection that the skilled artisan would have expected to affect the structure of the exosomes.
“[W]hen the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable.” MPEP 2113(III). The person of ordinary skill in the art would have understood that Kong’s exosome preparation either anticipates the claimed preparation because they are identical or renders it obvious because the preparation methods are so similar.
Claims 1, 2, 4-7, and 9 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Li et al. (2018, ACS Applied Materials and Interfaces 10: 5240-5254; reference U).
Li teaches culturing human adipose stem cells in DMEM supplemented with 10% fetal bovine serum (FBS), then switching to serum-free medium. (Page 5241, columns 1-2.) Li teaches exosomes (which are microparticles) derived from a culture supernatant of adipose stem cells. (Page 5241, column 2.) Li’s method includes centrifuging the supernatant at increasing speeds until reaching 100,000g and spinning for 70 minutes, then washing the pellet and spinning again at 100,000g for 70 minutes. (Page 1935, column 1.) Li teaches storing the exosomes at -70oC. (Page 5241, column 2.)
Claim 1 is a product-by-process claim because it defines the microparticles according to their method of production (i.e., “derived from a culture supernatant of dental-pulp stem cells . . . .”) “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” MPEP 2113(I).
Li is silent as to the presence or absence of MCP-1 and Siglec-9 in her exosome preparation. The method of preparing the exosomes from adipose-stem-cell supernatant, however, is substantially identical to that employed by applicants. (See paragraph 42 at page 22 of as-filed specification, which cultures dental-pulp stem cells in DMEM + serum, then in serum-free DMEM, before centrifuging twice at 100,000g for 60 minutes each time before storing at -80oC; page 23, indicating that adipose stem cells and exosomes were prepared the same way.) The person of ordinary skill in the art would therefore have concluded that the exosome preparations are the same or substantially identical. Once a product appearing to be substantially identical is found and a prior-art rejection is made, the burden shifts to the applicant to show a nonobvious difference. See MPEP 2113(II). Claim 1 does not specify any particular parameters for exosome collection that the skilled artisan would have expected to affect the structure of the exosomes.
“[W]hen the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable.” MPEP 2113(III). The person of ordinary skill in the art would have understood that Li’s exosome preparation either anticipates the claimed preparation because they are identical or renders it obvious because the preparation methods are so similar.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over either Pivoraite or Kong taken in view of Dissanayaka (2011, Journal of Endodontics 37: 1074-1080, abstract only; reference V).
The teachings of Pivoraite and Kong are set forth above. As discussed, the skilled artisan would have expected that an exosome preparation made by any of these references would have had the same properties as applicants’ preparation, which was made in the same way.
Neither Pivoraite nor Kong teach exosomes derived from non-human mammals.
Dissanayaka teaches dental-pulp stem cells isolated from canine teeth. Dissanayaka teaches that the canine-derived stem cells have the same stem-cell properties as human dental-pulp stem cells.
It would have been obvious to obtain exosomes from Dissanayaka’s canine dental-pulp stem cells using the methods of Pivoraite and Kong because Dissanayaka teaches that canine dental-pulp stem cells have the same properties as human dental-pulp stem cells. The skilled artisan would have likewise expected the exosomes to have the same properties as those claimed because the manner of making is the same and the starting materials are substantially identical.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, and 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 8-10 of copending Application No. 19/446,400 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ’400 application anticipate the examined claims.
The ’400 application claims a “tissue repairing agent” comprising exosomes (which are microparticles) derived from a culture supernatant of dental-pulp-derived stem cells. The agent does not comprise the cells themselves and does not comprise MCP-1 or Siglec-9. Claim 1 of the ’400 application requires that the agent is “for repairing tissues damaged by a [particular] cytokine storm,” but this statement of intended use does not clearly affect the structure of the agent itself. The agent also contains SOD3, so its scope is narrower than the examined agent, which is silent as to SOD3’s presence. The ’400 application’s claim 1 therefore anticipates examined claims 1 and 2.
Regarding examined claim 7, the ’400 application’s agent does not contain culture supernatant. (Claim 1.)
Regarding examined claim 8, the ’400 application’s agent contains 2x109 exosomes or more per mL. (Claim 8.)
Regarding examined claim 9, the ’400 application’s stem cells are human. (Claim 9.)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 11-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1-10 are rejected. Claims 11-14 are objected to as being dependent upon a rejected base claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORA E BARNHART DRISCOLL, whose telephone number is (571)272-1928. The examiner can normally be reached M-F 7:00-4:00 p.m. ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patricia Engle, can be reached at 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Lora E Barnhart Driscoll/Primary Examiner, Art Unit 3991
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