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
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.
Response to Amendments
Applicant’s amendments, corrected Specification and response filed Jul. 23, 2026 have been received and entered into the case.
Status of the Claims
Claims 1, 3, 8, 9, 12, 15-22, 27, and 29-33 are currently pending.
Claims 8 and 9 are amended.
Claims 15-22, 27, 29 and 30 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 1-7, 10, 11, 13, 14, 23-26 and 28 are cancelled.
Claims 31-32 are new.
Claims 8, 9, 12 and 31-32 have been considered on the merits.
Drawing Objections
Some of the drawing objections are due to amendment and one is maintained.
The disclosure is objected to because of the following informalities:
The drawings are objected to because of the following informalities: there is a statement in the specification that there are color drawings in 0029.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification Objections
Specification objections are withdrawn due to amendment.
Claim Rejections - 35 USC § 112 (a)
The claim rejections under 35 USC § 112, (a) or first paragraph (pre-AIA ), are withdrawn due to amendment.
Claim Rejections - 35 USC § 112 (b)
The claim rejections under 35 USC § 112, (b) or second paragraph (pre-AIA ), are withdrawn due to amendment.
Claim Rejections - 35 USC § 102
The claim rejections under 35 USC § 102 are withdrawn due to amendment. New claim rejections under 35 USC § 102 have been added to address the claim amendments.
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 8, 9, 31 and 33 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Wobma et al. (US 2019/0314417 A1) as evidenced by Luo et al. (Biochemistry, 2018) (ref. of record).
With respect to claims 8 and 33, Womba teaches method for treating a subject by administering to the subject a therapeutically effective amount of immunosuppressive mesenchymal stromal cells (mesenchymal stem cells, MSCs) which is a pharmaceutical composition (abstract, 0004, 0012-0013). Womba teaches the source of MSCs can be human umbilical cord mesenchymal stromal cells (0038, 0094 and 0096). Womba teaches the administration of the MSCs can be by IV injection (intravenously administration) (0094). Womba teaches the MSCs are in a pharmaceutically acceptable carrier (0017).
With respect to claim 33, the MSCs inherently contain processing bodies (p-bodies) as evidenced by Luo. Luo reports that p-bodies are conserved in eukaryotes (pg. 2424 para. 1).
Wobma does not teach the method where the suppressing the T cell response includes suppressing activation of helper T cells in the subject as recited in claim 9. Similarly, Wobma does not teach the method where following the administering step, the gene programs for antigen presentation and co-stimulation are down regulated in monocytes and macrophages as recited in claim 31. However, these wherein clauses of claims 9 and 31 recite the intended result of the method rather than requiring an additional step be performed. MPEP 2111.04 states “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” and that a such a clause ‘"in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Therefore since these claims only recite the results of the steps, then art reading on the method of claim 8 will also read on these results since performing the same steps will inherently lead to the same results in the absence of evidence to the contrary including unexpected results.
Therefore, the reference anticipates the claimed subject matter.
Claim Rejections - 35 USC § 103
The claim rejections under 35 USC § 103 are withdrawn due to amendment. New claim rejections under 35 USC § 103 have been added to address the claim amendments.
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 8, 9, 12, and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Wobma et al. (US 2019/0314417 A1) as evidenced by Luo et al. (Biochemistry, 2018) in view of Betancourt (US 2014/0017787 A1).
With respect to claims 8 and 33, Womba teaches method for treating a subject by administering to the subject a therapeutically effective amount of immunosuppressive mesenchymal stromal cells (mesenchymal stem cells, MSCs) which is a pharmaceutical composition (abstract, 0004, 0012-0013). Womba teaches the source of MSCs can be human umbilical cord mesenchymal stromal cells (0038, 0094 and 0096). Womba teaches the administration of the MSCs can be by IV injection (intravenously administration) (0094). Womba teaches the MSCs are in a pharmaceutically acceptable carrier (0017).
With respect to claim 33, the MSCs inherently contain processing bodies (p-bodies) as evidenced by Luo. Luo reports that p-bodies are conserved in eukaryotes (pg. 2424 para. 1).
Wobma does not teach the method where the suppressing the T cell response includes suppressing activation of helper T cells in the subject as recited in claim 9. Similarly, Wobma does not teach the method where following the administering step, the gene programs for antigen presentation and co-stimulation are down regulated in monocytes and macrophages as recited in claim 31. However, these wherein clauses of claims 9 and 31 recite the intended result of the method rather than requiring an additional step be performed. MPEP 2111.04 states “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” and that a such a clause ‘"in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Therefore since these claims only recite the results of the steps, then art reading on the method of claim 8 will also read on these results since performing the same steps will inherently lead to the same results in the absence of evidence to the contrary including unexpected results.
Wobma does not teach the method where the subject suffers from a lung inflammation, neuroinflammation, rheumatoid arthritis and/or a primary immunodeficiency as recited in claim 12. Wobma does not teach the method where the subject has received gene therapy as recited in claim 32.
However, Betancourt teaches a similar method of suppressing inflammation or a T cell response by administering to the subject a therapeutic effective amount of mesenchymal stem cells (abstract, 0002, 0008, 00018 and 0046). Betancourt further teaches a method of suppressing an immune response by inhibiting T cells in a subject where the subject suffers from rheumatoid arthritis, immunodeficiency, and acute lung injury (0046, 0049-0050, and 0062).
In further support, Wobma teaches the method where the subject suffers from cytokine storm, sepsis, autoimmune disease, transplant rejection, graft-vs-host disease, acute tissue injury, diabetic ulcer, and inflammatory disease.
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Wobma to include subjects with additional diseases or conditions that would benefit from suppressing a T cell response including lung inflammation, rheumatoid arthritis and a primary immunodeficiency as taught by Betancourt for the benefit of treating addition known inflammatory and immune conditions. Similarly, one of ordinary skill in the art would have been motivated to modify the method of Wobma to include subjects that have undergone gene therapy, which similar to graft-vs-host disease as taught by Womba, is known to elicit an unwanted immune responses. It would have been obvious to one of ordinary skill in the art to modify the treatment method Wobma to include subjects suffering from neuroinflammation, rheumatoid arthritis and a primary immunodeficiency and subjects that have received gene therapy, since these conditions are known to benefit from T cell suppression as taught and suggested by Betancourt and Wobma. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to Wobma, since Betancourt teaches administering MSCs to treat inflammatory and immune conditions and Wobma teaches a reducing an inflammatory response in a subject.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed Jul. 23, 2026 have been fully considered but they are not persuasive.
With respect to the rejections under 35 U.S.C. § 102 and 103, Applicant argues that neither Mohapatra nor Luo teach the method of administering to a mammalian subject a composition containing human umbilical cord tissue-derived mesenchymal stromal cells (Remarks pg. 7 para. 2 and pg. 8 para. 1). The Applicant’s amendments limiting claim 8 to include human umbilical cord tissue-derived mesenchymal stromal cells necessitated the withdrawal of the previous rejections. Applicant’s arguments are drawn to Mohapatra and Luo failing to teach this new limitation. However, this new limitation is addressed in the new rejection. Applicant is reminded that Luo is an evidentiary reference supporting the mesenchymal stromal cells taught by Mohapatra and now Wobma inherently contain processing bodies (p-bodies) (pg. 2424 para. 1). Luo is not a reference supporting a rejection under U.S.C. §102 or §103, and thus is not being used to establish obviousness of a particular limitation.
Applicant argues that Betancourt fails to remedy the deficiencies of Mohapatra and Luo (Remarks pg. 8 para. 2). However, this argument was not found to be persuasive, since the arguments with respect to the rejections over Mohapatra and Luo were not found to be persuasive as explained above.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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