DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-16) in the reply filed on 06/15/2026 is acknowledged. The traversal is on the grounds that the claims have been amended such that they are no longer taught by Kim et al. and therefore the claims have a special technical feature.
For the reasons discussed below in the rejection under 35 U.S.C. § 103, Yamamoto in view of Taghavi-Farahabadi, the prior art renders obvious the composition of claim 1 (i.e., the linking feature). Namely, Yamamoto teaches the use of supernatants derived from dental pulp stem cells and Taghavi-Farahabadi provides sufficient motivation to modify Yamamoto in order to arrive at a composition comprising microparticles derived from a culture supernatant of dental pulp-derived stem cells or immortalized stem cells thereof.
Therefore, although the requirement for Unity of Invention has been reconsidered in light of applicant’s new amendments to claim 1, the requirement is still deemed proper a posteriori and is therefore made FINAL.
17-18 and 21-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant’s request for rejoinder of Group II upon allowance of the elected subject matter is noted and rejoinder will be considered at the appropriate time.
Claims 1-10 and 12-16 are directed to the elected invention and have been examined on their merits.
Priority
The present application is a § 371 National Stage Entry of PCT/JP2021/030978 (filed on 08/24/2021) and claims priority to Japanese applications JP2021-124104 (filed on 07/29/2021) and JP2020-150775 (filed on 09/08/2020).
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 04/22/2026, 06/05/2026, and 06/24/2026 are in compliance with the provisions of 37 C.F.R. 1.97. All references cited in these IDSs have been fully considered.
The listing of references in the specification (pars. [0006]-[0007]) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
Claim 13 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 13 is rejected as indefinite because it recites subjective terminology and terms of degree. Specifically, the claim requires the dental pulp-derived stem cells to be genetically modified cells in which the microparticles highly express the SOD3 (emphasis added). The term “highly” is subjective and is descriptive of a term of degree.
MPEP § 2173.05(b)(I)
…when a term of degree is used in the claim, the examiner should determine whether the specification provides some standard for measuring that degree.
MPEP § 2173.05(b)(IV)
When a subjective term is used in the claim, the examiner should determine whether the specification supplies some objective standard for measuring the scope of the term. Some objective standard must be provided in order to allow the public to determine the scope of the claim. A claim term that requires the exercise of subjective judgment without restriction may render the claim indefinite.
Thus, the appropriate analysis is whether the specification provides sufficient support for the term “highly” such that a person having ordinary skill in the art would be apprised of what constitutes “high expression” of SOD3. Applicant’s specification has been fully considered but it is unclear what is meant by the term “highly” and the specification does not provide an objective standard for this claim. For example, is any amount of elevation in SOD3 expression considered to be “high expression” or is there a certain amount of increase (e.g., 2x, 3x, etc.) which causes a microparticle to be considered “highly expressing” of SOD3.
Because the term is unclear, the metes and bounds of the claim are indefinite.
For the purpose of examination, this term has been interpreted to refer to any elevation of SOD3 expression.
Claim Rejections - 35 USC § 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 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.
Claims 1-10, 12, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al. (US 2015/0366917 A1) in view of Taghavi-Farahabadi et al. (Medical Hypotheses, 2020, Vol. 144, Article 109865, pages 1-5).
Yamamoto et al. (US 2015/0366917 A1) teaches that the inflammatory reaction is a series of processes associated with the elimination of foreign matter and pathogens and the protection and repair of tissue ([0002]). Yamamoto provides a composition for preventing or treating inflammatory disease containing a culture supernatant obtained by culturing dental pulp stem cells and not containing the dental pulp stem cells ([0016]-[0018]). Yamamoto teaches that the culture supernatant contains various cytokines and because the culture supernatant contains such cytokines, it can cause proliferation at injury sites, resulting in recovery of the tissue at the injury cite ([0064]).
Regarding claim 1, Yamamoto teaches compositions comprising the culture supernatant of dental pulp stem cells which may include low-molecular weight organic compounds in addition to proteins and other high-molecular-weight compounds secreted in the culture ([0088]). Additionally, Yamamoto teaches compositions not containing the dental pulp stem cells ([0018]) and teaches that the dental pulp stem cells can also be provided as immortalized cells of dental pulp stem cells ([0072]).
Thus, although Yamamoto may not call its composition a “cytokine storm suppressor”, it nonetheless teaches a composition containing microparticles derived from a culture supernatant of dental pulp-derived stem cells or immortalized stem cells thereof, wherein the cytokine storm suppressor does not contain the dental pulp-derived stem cells or the immortalized stem cells thereof.
With respect to the requirement that the composition is used for administration to a human or a nonhuman animal with a cytokine storm before damage of a tissue is caused by the cytokine storm to suppress the tissue damage by the cytokine storm through suppression of the cytokine storm or is used administration to a human or nonhuman animal with damage of a tissue caused by a cytokine storm to repair the tissue damaged by the cytokine storm through suppression of the cytokine storm, these are the intended uses of the composition. The claim is to the composition and the intended uses recited in these clauses of the claim do not impart meaningful structure on the composition itself. Accordingly, there is no requirement that Yamamoto teach what the composition is used for (i.e., for prophylactic or therapeutic administration to a specific patient population) or how the composition functions (i.e., by suppressing of the cytokine storm). Nonetheless, it is noted that Yamamoto contemplates administration to humans and nonhumans ([0094]) and is useful for treating a variety of inflammatory diseases including inflammatory lung diseases like respiratory distress syndromes ([0091]).
However, Yamamoto differs from the instant claims because it does not teach that:
The cytokine storm suppressor is not the culture supernatant; and
The cytokine storm suppressor does not contain MCP-1 and does not contain Siglec-9.
Taghavi-Farahabadi et al. teaches that the cytokine storm is the main cause of acute respiratory distress syndrome (ARDS) in COVID-19 infection and since ARDS is recognized as one of the leading causes of mortality in patients and appears to be caused by cytokine storm, suppression of this inflammation may decrease the inflammatory cytokine production and consequently reduce the inflammation and lung injury (p. 2, left col., par. 2). One therapeutic approach for the treatment of ARDS is mesenchymal stem cell (MSC) therapy because MSCs alter the function of immune cells, modulate the immune response, promote tissue repair, and may have antiviral activity (p. 2, left col., par. 3 through right col., par. 3). Rather than using MSCs per se, Taghavi-Farahabadi suggests using MSC-derived exosomes because “it has been shown that MSC-derived exosomes apply the same effects of MSCs” (p. 2, right col., par. 5). Taghavi-Farahabadi teaches that MSC-derived exosomes advantageously include ease of access, lack of problems associated to cell maintenance and injections, proper size, and phospholipid membranes which enable them to fuse with the target cell membranes (Id.). Taghavi-Farahabadi concludes that the use of MSCs has previously shown satisfactory effects on cytokine storms and MSC exosomes should be studied because it has been previously shown that these exosomes can reduce inflammatory cytokines, increase regulatory cytokines and suppress inflammation (p. 4, left col., par. 2 through right col., par. 1).
Accordingly, because Yamamoto teaches compositions comprising supernatants derived from dental pulp stem cells (a type of MSC; see specification, [0046] for support) for treating inflammatory conditions such as respiratory distress syndromes and because Taghavi-Farahabadi teaches MSC-derived exosomes “apply the same effects of MSCs” (p. 2, right col., par. 5) and therefore are previously known to suppress cytokine storms and are known to be useful for treating inflammatory conditions, it would have been obvious to have purified Yamamoto’s supernatant such that the composition is a dental-pulp derived exosome rather than a supernatant. There would have been a reasonable expectation of success because the function of the exosome was previously known and because the exosome isolation methods were previously known (Taghavi-Farahabadi, p. 3, left col., par. 2). And it would have been particularly advantageous to use exosomes rather than the supernatant because, as discussed above, exosomes were previously known to “apply the same effects” and also advantageously improve ease of access, lack of problems associated to cell maintenance and injections, proper size, and phospholipid membranes which enable them to fuse with the target cell membranes (p. 2, right col., par. 5). This obviousness is based upon the “Some Teaching, Suggestion, or Motivation in the Prior Art That Would Have Led One of Ordinary Skill To Modify the Prior Art Reference or To Combine Prior Art Reference Teachings To Arrive at the Claimed Invention” rationale set forth in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See MPEP 2143(I)(G).
Thus, it would have been obvious to have arrived at a cytokine storm suppressor containing microparticles (i.e., exosomes) derived from a culture supernatant of dental pulp-derived stem cells or immortalized stem cells thereof, wherein the cytokine storm suppressor is not the culture supernatant.
With respect to the requirement that the microparticles contain SOD3 in an effective amount capable of repairing a tissue or a cell damaged by a cytokine storm or a higher amount, wherein the SOD3 is extracellular superoxide dismutase, as discussed above, Yamamoto in view of Taghavi-Farahabadi renders obvious a composition comprising microparticles derived from dental pulp-derived stem cells or immortalized stem cells thereof. Because Yamamoto’s supernatant inherently comprises the microparticles, it also necessarily contains SOD3 in an effective amount capable of repairing a tissue or a cell damaged by a cytokine storm or a higher amount, wherein the SOD3 is extracellular superoxide dismutase. Applicant’s disclosure provides support for this inherency argument by showing that dental pulp-derived stem cell EVs have natural SOD3 activity ([0077]). See the preparation for Example 1 which involves obtaining a culture supernatant and purifying the EVs from this supernatant ([0069]).
With respect to the requirement that the cytokine storm suppressor does not contain MCP-1 and does not contain Siglec-9, Yamamoto teaches that MCP-1 and Siglec-9 are contained in the culture supernatant ([0101]). As the proposed modification simply excludes all components except the exosomes (e.g., by purifying out the exosomes), the modified composition would necessarily not contain MCP-1 and Siglec-9. Applicant’s disclosure supports this assessment of inherency by stating that when the obtained cytokine storm suppressor was obtained the Examples “did not contain MCP-1 and did not contain Siglec-9” ([0073]). These exemplary compositions were obtained by “receiving a composition containing a culture supernatant” and “purifying microparticles from the composition” ([0057]).
For at least these reasons, the cytokine storm suppressor of claim 1 is obvious over Yamamoto in view of Taghavi-Farahabadi.
Regarding claim 2, as discussed above, Yamamoto in view of Taghavi-Farahabadi renders obvious the cytokine storm suppressor wherein the microparticles are exosomes.
Regarding claim 3, as discussed above, Yamamoto in view of Taghavi-Farahabadi renders obvious the cytokine storm suppressor wherein the microparticles are microparticles purified from the culture supernatant (see, for example, Fig. 2 of Taghavi-Farahabadi).
Regarding claim 4, as discussed above, Yamamoto in view of Taghavi-Farahabadi renders obvious the cytokine storm suppressor. The instant claim merely recites what the cytokine storm suppressor does. Because the claim is to the composition, not what the composition does, and because Yamamoto in view of Taghavi-Farahabadi renders obvious the same composition, it necessarily must have the ability to suppress all of IL-2, IL-4, IL-6, IL-10, IL-17, IFNγ and TNFα in a cell or in blood.
Regarding claim 5, as discussed above, because Yamamoto in view of Taghavi-Farahabadi renders obvious the same composition, it must necessarily be able to increase the survival rate when the cytokine storm suppressor is administered to a human or a nonhuman animal in a cytokine storm state compared to when the cytokine storm suppressor is not administered.
Regarding claims 6-7, as discussed above, because Yamamoto in view of Taghavi-Farahabadi renders obvious the same composition, it must necessarily also contain 1.0 ng/mg or more of the SOD3 per 1 mg of the microparticles (claim 6) and must have a SOD3 activity of 0.3 unit/µg or more. In support of this assertion, it is noted that Table 1 of applicant’s disclosure shows that dental pulp-derived stem cell EVs have a SOD3 activity of 3.05 unit/µg, which is an order of magnitude larger than the instantly recited range.
Alternatively, even if the obvious composition does not comprise SOD3 in this amount or a SOD3 activity in the recited range, a person could have arrived at these values by merely concentrating the obvious cytokine storm suppressor. There would have been particular motivation to perform such concentration because Yamamoto teaches that its composition “can be concentrated as necessary” ([0086]). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical (MPEP § 2144.05(II)(A)). There is no evidence of record that the concentration or activity of SOD3 is critical to the claimed composition.
Regarding claims 8-9, although Yamamoto in view of Taghavi-Farahabadi renders obvious the composition of claim 1, it does not teach that the cytokine storm suppressor is in the range of 0.01x108 particles/ml or more (claim 8) or 2.0x109 particles/ml or more (claim 9). Nonetheless, a person having ordinary skill in the art could have arrived at these concentration ranges as a result of routine experimentation such as by routinely concentrating the obvious composition. There would have been particular motivation to perform such concentration because Yamamoto teaches that its composition “can be concentrated as necessary” ([0086]). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical (MPEP § 2144.05(II)(A)). There is no evidence of record that the concentration of cytokine storm suppressor is critical to the claimed composition.
Regarding claim 10, Yamamoto teaches that considering the individual in which the composition is to be used, dental pulp stem cells from the same species (human in the case of a human subject) are preferred in order to suppress or avoid rejection reactions and more preferably autologous dental pulp stem cells are used ([0070]). Yamamoto provides working examples using human dental pulp stem cells ([0104]). Accordingly, Yamamoto in view of Taghavi-Farahabadi renders obvious the cytokine storm suppressor according to claim 1, wherein the dental pulp-derived stem cells are human dental pulp-derived stem cells.
Regarding claim 12, as discussed above, Yamamoto in view of Taghavi-Farahabadi renders obvious the cytokine storm suppressor. The instant claim merely limits the tissue involved in the intended use. Because Yamamoto in view of Taghavi-Farahabadi renders obvious the composition of claim 1, it similarly renders obvious the composition of the instant claim.
Nonetheless, in the interest of compact prosecution it is noted that both Yamamoto and Taghavi-Farahabadi are directed to treating inflammation in the lung.
Regarding claim 15, as discussed above, Yamamoto in view of Taghavi-Farahabadi renders obvious the cytokine storm suppressor and the instant claim only limits the intended use of the composition. Accordingly, for the reasons discussed above, this claim is obvious over Yamamoto in view of Taghavi-Farahabadi.
Regarding claim 16, as discussed above, Yamamoto in view of Taghavi-Farahabadi renders obvious the cytokine storm suppressor and the instant claim only describes what the composition does. Accordingly, for the reasons discussed above, this claim is obvious over Yamamoto in view of Taghavi-Farahabadi because the same composition must have the same function.
In the interest of compact prosecution, it is noted that both Yamamoto and Taghavi-Farahabadi teach the tissue-repair element.
Claims 1-10, 12-13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al. (US 2015/0366917 A1) in view of Taghavi-Farahabadi et al. (Medical Hypotheses, 2020, Vol. 144, Article 109865, pages 1-5) and Sah et al. (Cell & Bioscience, 2020, Vol. 10(22), pages 1-12).
The teachings of Yamamoto and Taghavi-Farahabadi are set forth above and applied herein. Yamamoto and Taghavi-Farahabadi are found to render obvious claims 1-10, 12, and 15-16.
Regarding claim 13, as discussed above, Yamamoto in view of Taghavi-Farahabadi renders obvious the cytokine storm suppressor of claim 1.
The instant claim differs from these prior art references because neither reference teaches nor suggests that the dental pulp-derived stem cells are genetically modified cells in which the microparticles highly express the SOD3.
Sah teaches that SODs are a group of antioxidant enzymes that detoxify the superoxide radicals into hydrogen peroxide and oxygen (p. 1, left col., par. 1). SOD3 has been identified as the major SOD in the extracellular matrix and SOD3-transduced MSCs have been shown to exhibit reduced ROS levels, suppressed expression of pro-inflammatory cytokines and diminished inflammatory cell infiltration (p. 7, left col., par. 3). Sah teaches that overexpression of SOD3 has been found to suppress the release of inflammatory mediators and adhesion molecules, thereby restricting inflammation during tissue damage (p. 3, right col., par. 2). Sah concludes that “several reports suggest that SOD3 overexpression in MSCs can be a better option than MSC’s only during a cell-based therapy through increased immunosuppressive, anti-inflammatory, and anti-oxidative properties” (p. 8, right col., par. 1 through p. 9, left col., par. 1; Fig. 4).
Thus, because Yamamoto in view of Taghavi-Farahabadi renders obvious a cytokine storm suppressor derived from dental pulp stem cells or immortalized cells thereof and because Sah teaches that MSCs produce SOD3 and overexpression of SOD3 can enhance immunosuppression and anti-inflammatory effects in tissue damage, it would have been obvious to have used dental pulp-derived stem cells (or immortalized stem cells thereof) which are genetically modified cells in which the microparticles have elevated expression of SOD3. And although Sah suggests using elevated SOD3 MSCs (not exosomes), there would have been a reasonable expectation of success in this modification because, as discussed above, Taghavi-Farahabadi teaches that “it has been shown that MSC-derived exosomes apply the same effects of MSCs” (p. 2, right col., par. 5). Accordingly, the SOD3-enhanced microparticles would have been expected to function equally to SOD3 enhanced MSCs and would further possess the benefits described by Taghavi-Farahabadi above. This obviousness is based upon the “Some Teachings, Suggestion, or Motivation in the Prior Art That Would Have Led One of Ordinary Skill To Modify the Prior Art Reference or To Combine Prior Art Reference Teachings To Arrive at the Claimed Invention” rationale set forth in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See MPEP 2143(I)(G).
Thus, claim 13 is obvious over Yamamoto in view of Taghavi-Farahabadi and Sah.
Claims 1-10, 12, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al. (US 2015/0366917 A1) in view of Taghavi-Farahabadi et al. (Medical Hypotheses, 2020, Vol. 144, Article 109865, pages 1-5) and Wobma et al. (WO 2018/081514 A1).
The teachings of Yamamoto and Taghavi-Farahabadi are set forth above and applied herein. Yamamoto and Taghavi-Farahabadi are found to render obvious claims 1-10, 12, and 15-16.
Regarding claim 14, as discussed above, Yamamoto in view of Taghavi-Farahabadi renders obvious the cytokine storm suppressor of claim 1.
The instant claim differs from these prior art references because neither reference teaches nor suggests that the cytokine storm suppressor contains at least one of an anti-IL-6 antibody and a steroid.
Wobma teaches methods for treating a subject experiencing a condition selected from the group consisting of cytokine storm including a step of administering a primed exosome to the subject ([0012]-[0014]). Wobma teaches that the exosomes are exosomes secreted from mesenchymal stromal cells ([0037]). Wobma’s methods further comprise administering an immunosuppressive agent to the subject concurrently with the exosome ([0049]). Wobma teaches that the immunosuppressive agent is selected from steroids and other monoclonal antibodies used for immunosuppression ([0042]). Wobma teaches IL-6 as being among the pro-inflammatory cytokines ([0028]).
Accordingly, because Yamamoto and Taghavi-Farahabadi render obvious a cytokine storm suppressor including an exosome derived from a dental-pulp stem cell and because Wobma teaches that exosomes derived from mesenchymal cells can be used in conjunction with steroids or antibodies for immunosuppression including for the treatment of individuals suffering from cytokine storm, it would have been obvious to have further modified the composition such that the composition further comprises a steroid and a monoclonal antibody used for immunosuppression (i.e., an anti-IL-6 antibody; IL-6 being identified by Wobma as one of the pro-inflammatory cytokines). There would have been a particular motivation to make this modification because it would have been expected to result in a composition which is more effective in suppressing a cytokine storm. This obviousness is based upon the “Some Teachings, Suggestion, or Motivation in the Prior Art That Would Have Led One of Ordinary Skill To Modify the Prior Art Reference or To Combine Prior Art Reference Teachings To Arrive at the Claimed Invention” rationale set forth in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See MPEP 2143(I)(G).
Thus, claim 14 is obvious over Yamamoto, Taghavi-Farahabadi, and Wobma.
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 1-10 and 12-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 19/446,400.
Although the claims at issue are not identical, they are not patentably distinct from each other because they encompass the same subject matter.
Claim 1 of ‘400 is directed to a tissue repairing agent comprising exosomes derived from dental pulp-derived stem cells or immortalized stem cells thereof, wherein the exosomes comprise extracellular superoxide dismutase in an amount effective for repairing tissues or cells damaged by a cytokine storm, wherein the tissue repairing agent does not comprise the culture supernatant, the dental pulp-derived stem cells, the immortalized stem cells, MCP-1, and Siglec-9. Therefore, although claim 1 recites another intended use (“tissue repairing agent”), it nonetheless recites the same composition.
Similarly, the dependent claims of ‘400 recite overlapping subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/GRANT C CURRENS/Examiner, Art Unit 1651
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