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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 4, 2025 has been entered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is in response to the papers filed on November 4, 2025. Claims 1-7, 10, and 12-16 have been canceled. Claims 8, 9, and 11 are presently amended.
Therefore, claims 8-9 and 11 are currently under examination.
Priority
The present application is a 35 U.S.C. 371 national stage filing of the International Application No. PCT/KR2019/014960, filed November 06, 2019, which claims priority to Republic of Korea Application No. KR 10-2018-0137578 filed on November 09, 2018, is acknowledged. Applicants previously perfected priority by providing translation of Korean Patent Application No. 10-2018-0137578 into English.
Thus, the earliest possible priority for the instant application is November 9, 2018.
Claim Interpretation
The methodological steps of the claims, recite the method for preventing or treating an autoimmune disease, comprising administering a pharmaceutical composition comprising stem cells treated with a protein kinase C activator or a culture thereof to a subject other than humans. As such, the methodology is not only limited by recited steps. Rather, the phrase "comprises" is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.
Regarding intended results of a recited process step, the method obtained has no positive or negative limitation as to other steps which would have similarly resulted in the effect being exhibited by the product. For instance, to increase the apoptosis of B cells, claims 8, 9 and 11 recite protein kinase C activator increases the expression of programmed death-ligand 1 (PD-L1) in the stem cells. However, the increase expression is in the said mesenchymal stem cells for which the only operative step is the treatment or exposure of the stem cells to protein kinase C activator. Thus, the ordinary artisan would reasonably interpret the essential methodological limitation here is the said stem cells being treated with the protein kinase C activator and being administered to the autoimmune patient.
As claimed, any downstream effects which would result, such as B cell apoptosis, are a result of the stem cell protein kinase C activator treatment which modulates the stem cell genetic and phenotypic profile prior to administration to the subject with autoimmune disease. These outcomes must necessarily result following administration and are considered an inherent property of the composition and treatment step.
Maintained Claim Rejections - 35 USC§ 102
Claims 8, 9, and 11 remain rejected under 35 U.S.C. 102(a)(2) as being anticipated by Faustman et al. (US 9,522,181 B2), as evidenced by Goel et al. (Int J Toxicol. 2007 Jul-Aug;26(4):279-88.).
Regarding claims 8, 9, and 11, Faustman discloses methods and compositions for treating autoimmune diseases comprising pretreated mesenchymal precursor cells, where mesenchymal cells are isolated and derived from the blood or bone marrow for administration. The administered cells are taught to have the potential to differentiate (column 9, line 16-35; column 10, lines 20-39; column 52, last para. through column 53, first para.). Faustman additionally discloses the administered stem cells are pretreated with phorbol myristate acetate (PMA), phorbol-12, 13-dibutyrate, necessarily species of protein kinase c activators (column 21, lines 21-22; column 54, lines 63-65).
Fig. 6, sheet 14, row 17-18:
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Moreover, Faustman discloses exemplary autoimmune diseases in humans treated or prevented by the pharmaceutical include lupus, rheumatoid arthritis, scleroderma, and myasthenia gravis, as well as applying the teachings to a subject other than humans (column 4, lines 20-22; column 10, last para through column 11; column 15, lines 48-57; column 16, lines 26-36).
As evidenced by Goel, PMA and phorbol-12,13-dibutyrate are PKC activators, see pg. 280, column 1, line 7; pg. 282, column 1, line 1. Thus, Faustman necessarily teaches treating the cells with PKC activators.
Hence, Faustman discloses the methodological preparation of the same product as claimed (i.e., stem cells treated with a protein kinase C activator or a culture thereof). Since all the limitations are anticipated, the ordinary artisan would expect the same mesenchymal stem cell phenotypic or expression profile to naturally flow from the mesenchymal stem cells as they were disclosed to be treated in the same way. Here, the natural results of pretreating the mesenchymal stem cells with the PKC activator, such as increased expression of CXCL10 and increasing the expression of programmed death-ligand 1 (PD-L1) would necessarily flow from treating the cells with PKC activators. Furthermore, the treatment of the autoimmune disease with the product of claim 1 is merely an intended used of the pharmaceutical product. The only active step claimed is the treatment of the stem cells with the protein kinase C activator. Regarding the increased PD-L1 expression and downstream effects which would result after the treatment and subsequent administration, such as B cell apoptosis, this necessarily flows from step of treating the cells with PKC activators. The specification does not teach more than this. Thus, Faustman discloses all claim limitations and anticipates the claimed invention.
Response to Applicants’ arguments as they apply to the rejection of Claims 8, 9, and 11 35 under USC§ 102
Applicant's arguments filed November 4, 2025, have been fully considered but they are not persuasive.
At pages 5-11 of the remarks filed on November 4, 2025, Applicants essentially argue the following:
The crux of the applicant’s argument is that Faustman fails to anticipate the claims because it does not “disclose each and every element as set forth in the claim.” This is repeated 4 times at pages 6 and 8, and applicant specifically point to treating mesenchymal stem cells with a protein kinase C activator for treating autoimmune disease, and the stem cell expression profiles recited in the wherein clauses, such as increased CXCL10 and PD-L1. Applicant further contends that inherency requires an “absolute standard” not met by the reference, arguing that the Office has not shown that the claimed CXCL10 and PD-L1 expression “necessarily” flow from the treatment disclosed in Faustman. Applicant therefore concludes that Faustman cannot anticipate the instant claims.
Applicant’s argument is not persuasive because the claims recite only a single operative methodological step, the step of treating stem cells with a protein kinase C activator, prior to administration. Faustman expressly discloses pretreating mesenchymal precursor or stem cells with phorbol esters, including PMA and phorbol-12,13-dibutyrate, which are protein kinase C activators. When the prior art discloses the same process applied to the same cell type, any functional or biological properties of the resulting treated cell population are inherent to that process, See MPEP § 2112 and § 2112.01. Faustman discloses the identical treatment step, and the resulting cellular characteristics are a natural consequence of that step.
Thus, applicant has failed to differentiate the methodological steps claimed from the prior art. Additionally, once a reference teaching the product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant. Here, the examiner has already presented the reasoning that since the method claims one operative step, being the treatment of the stem cells with the protein kinase C activator for an autoimmune indication and administration, and the prior art discloses the same, the expression profiles resulting from such treatment are a natural consequence of that step. Additionally, here the arguments are all directed to the properties of the mesenchymal stem cell treated with the protein kinase C activator, as a result of the process of treating the said mesenchymal stem cell with the PKC activator. The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255), see MPEP 2112 V.
The same methodological disclosure anticipates the claimed methodology, and Applicant’s remarks do not provide evidence that PKC-activated stem cells in Faustman would fail to exhibit the claimed expression profiles. Additionally, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978). Thus, under MPEP § 2112.02, a newly discovered property of a known product or an unrecognized result of a known process does not render the claim patentable. Even if the Applicant is the first to recognize that PKC activation in mesenchymal stem cells results in increased CXCL10 or PD-L1, such recognition does not confer novelty where the underlying treatment is the same as that disclosed in Faustman and all method steps are the same. Thus, because Faustman teaches the same treatment of the same stem cell populations for the same autoimmune indications, and because the remaining claim features merely recite inherent biological consequences of that treatment, Faustman fully anticipates the claimed subject matter under 35 USC§ 102.
Conclusion
Claims 8, 9 and 11 remain rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL D LEVIN whose telephone number is (571)270-0616. The examiner can normally be reached Fulltime Teleworker.
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/J.D.L./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633