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 .
This action is responsive to papers filed 02/25/2026.
Claims 1, 6-8, 14-15, 24, 29, 31-33, and 36 have been amended.
Claims 3, 11, 26, and 37-45 have been newly canceled and claims 48-56 have been newly added.
Claims 1-2, 6-10, 14-15, 24-25, 29-33, 36, and 48-56 are currently pending and have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claims 6, 16, 29 and 53-54 are objected to because of the following informalities:
Regarding claim 6, the word “a” should be between the terms “as” and “single dose” in line two for proper grammar.
Regarding claim 16, the new limitation of “TNF-α” should be underscored along with the other new limitations.
Regarding claim 29, the limitation "the dose of the steroid" should be “a dose of a steroid” for proper form and antecedent basis.
Regarding claims 53-54, the term “nice” in line two of each claim appears to be a typo and is interpreted as “nine” with regard to the number of months.
Claim 54 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 53.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Appropriate correction is required.
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.
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 48 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 48 is dependent upon claim 6 and recites the limitation "the second dose" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim as there is no prior recitation of a second dose in claim 48 or the parent claim 6.
Appropriate correction is required.
For examination purposes the claim is interpreted as further including a second dose of the umbilical lining-derived stem cells.
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.
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.
Claim(s) 1-2, 6, 24-25, 31, 49, and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson, V. (CGTlive Accessed 2022-from IDS filed 11/10/2025) in view of Opinc et al (Rheumatology International 2019-newly cited).
Regarding claims 1-2, 6, 24-25, 31, 49, Johnson discloses a method of treating idiopathic inflammatory myopathy in an individual (methods for treating dermatomyositis and polymyositis in a subject; page 1, paragraph 1), comprising administering an effective amount of umbilical lining-derived stem cells to the individual in need thereof (methods of treatment comprise administration of umbilical cord lining stem cells to a subject, at least a first single dose; title; page1, paragraphs 1, page 2, paragraph 2).
Johnson discloses wherein the effective amount of the administered cells is at least about 50 million cells, at least about 100 million cells, at least about 200 million cells (title, page 1, paragraph 1, page 2, paragraph 2).
While Johnson also disclose that an independent review group will evaluate data from each dose group before moving to the next, evaluating the number of participants with dose-limiting toxicities within 24 hours of infusion and evaluating possible therapies for dermatomyositis and polymyositis (page 2), they are silent with regard to the specifics of how this evaluation will be carried out.
Opinc disclose methods for evaluating idiopathic inflammatory myopathies (IIM) to study the level of disability and estimate clinical symptoms associated with greater risk of disability and distinguish the most troublesome activities in these patients. Measuring disease related symptoms to assess the intensity of clinical symptoms using a Health Assessment Questionnaire disability index is disclosed (HAQ-DI) and symptoms measured include muscle weakness, pain and fatigue, with high scores designated to high severity (abstract, page 1214, page 1216, page 1219). Fatigue is indicated to have a multifactorial aetiology including inflammatory processes (page 1219). Subtypes of IIM are studied and include dermatomyositis (DM) and polymyositis (PM) (page 1213, page 1216 Fig.2, page 1217-1218). Noticing a patient’s perspective is deemed necessary to improve their quality of life which remains one of the most important goals in the therapeutic process (page 1219).
One of ordinary skill in the art would have been motivated to evaluate the method of Johnson by measuring disease-related symptom severity and using a health assessment questionnaire disability index to assess the success of the Johnson method with reduced scores indicating a lowering in severity because Opinc teach and suggest that these type of assessments are used to study and evaluate IIM of various subtypes and because Johnson also suggests the use of evaluation methods to evaluate therapies for dermatomyositis and polymyositis. Since a higher score is indicative of a higher severity of the disease it is clear that a reduced score after therapy would indicate improvement of a symptom and a successful treatment (an improved health assessment score). One of ordinary skill in the art would have had a reasonable expectation of success because Opinc and Johnson are both drawn to improving the quality of life for patients with IIM, DM and PM and Opinc states that noticing a patient’s perspective is deemed necessary to improve their quality of life which remains one of the most important goals in the therapeutic process (page 1219).
Regarding claim 56, while Johnson and Opinc do not specify the percentage of improvement in the symptoms of the subjects after treatment within about 3 months following administration, the method of Johnson as modified by Opinc includes all the same method steps as claimed including administering the same cell type at the same concentrations and is therefore deemed to inherently have the same effect.
Providing guidance on instances where the method steps of the prior art and instant claims are the same, Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) states “[T]hat since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims.” Regarding the issue of inherency, see Persion Pharms. LLC v. Alvogen Malta Operations LTD., 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019), where the court stated that a proper finding of inherency does not require that all limitations are taught in a single reference, and that inherency may meet a missing claim limitation when the limitation is "the natural result of the combination of prior art elements." (emphasis in original). The court found that pharmacokinetic limitations of the asserted claims were inherently met by combining prior art references because the limitations were necessarily present in the prior art combination. Id. See also Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1329-32, 2020 USPQ2d 6227 (Fed. Cir. 2020). (see MPEP 2112 (IV)).
Therefore, the combined teachings of Johnson et al and Opinc et al render obvious Applicant’s invention as claimed.
Claim(s) 7, 32 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson, V. (CGTlive Accessed 2022-from IDS filed 11/10/2025) in view of Opinc et al (Rheumatology International 2019-newly cited) as applied to claims 1-2, 6, 24-25, 31, 49, and 56 above and further in view of Silva et al (US 8,778,679).
Regarding claims 7, 32 and 48, Johnson as modified by Opinc renders obvious the claimed method as described above, but does not disclose wherein the administering comprises multiple doses of the cells over a defined period of time such as 1 to 4 months apart.
Silva discloses methods of using umbilical lining-derived stem cells to treat subjects having a variety of disorders (column 10 lines 10-20). In some embodiments the cells are delivered only once and, in some embodiments, multiple deliveries of the cells are made and for a defined period of time (column 10 lines 39-49).
One of ordinary skill in the art would have been motivated to include administration methods that include multiple administrations over a defined period of time in the method of Johnson because Silva teach and suggest that this is a suitable option when administering umbilical lining stem cells for the treatment of a variety of disorders. The optimization of the administration to include additional cell doses at specific times such as 1 to 4 months would have provided the benefit of tailoring the method to the subject based on the severity of their symptoms. One of ordinary skill in the art would have had a reasonable expectation of success because both Johnson and Silva are administering umbilical lining stem cells for therapeutic purposes and Silva teach that these cells can be used to treat a variety of disorders.
Therefore, the combined teachings of Johnson, Opinc et al and Silva et al render obvious Applicant’s invention as claimed.
Claim(s) 33 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson, V. (CGTlive Accessed 2022-from IDS filed 11/10/2025) in view of Opinc et al (Rheumatology International 2019-newly cited) as applied to claims 1-2, 6, 24-25, 31, 49, and 56 above and further in view of Alekar et al (WO 2024/062420-from IDS filed 11/10/2025).
Regarding claim 33, Johnson as modified by Opinc renders obvious the claimed method as described above, but does not disclose wherein the symptom improvement is measured over a 1-month to 1 year duration.
Alekar discloses methods of treating dermatomyositis and polymyositis (page 5 lines 15-30), in a subject wherein symptom improvement is measured over at least a one-month duration (page 13 lines 33-34, page 17 lines 19-20).
One of ordinary skill in the art would have been motivated to measure symptom improvement over a one-month duration in the method of Johnson as modified by Opinc because Alekar teach and suggest that treatment of idiopathic inflammatory myopathy is desirable when the treatment has a sustained effect for the patient for a time period of at least one month. One of ordinary skill in the art would have had a reasonable expectation of success because Johnson and Alekar are both drawn to the treatment and alleviation of symptoms of dermatomyositis and polymyositis.
Therefore, the combined teachings of Johnson, Opinc et al and Alekar et al render obvious Applicant’s invention as claimed.
Claim(s) 36 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson, V. (CGTlive Accessed 2022-from IDS filed 11/10/2025) in view of Opinc et al (Rheumatology International 2019-newly cited) as applied to claims 1-2, 6, 24-25, 31, 49, and 56 above and further in view of Clark et al (WO 2009/126688-from IDS filed 11/10/2025) and Riordan (US 2018/0214489).
Regarding claim 36, Johnson as modified by Opinc renders obvious the claimed method as described above, but does not disclose wherein the symptom improvement correlates with a decrease in cytokine level.
Clark disclose methods of treating immune related diseases (Title) and wherein the symptom improvement correlates with a decrease in a cytokine level in the treated individual (page 3 lines 30-34, page 120 lines 32-35, page 121 lines 1-7). Clark discloses wherein the reduced cytokines include IL-12 (page 124, lines 4-5), IL-12p40 (page 12 lines 1-3, page 14 lines 12-14) and IL-12p70 (page 17 lines 8-9).
Riordan disclose methods of treating autoimmune disorders with mesenchymal stem cells including cells from umbilical cord tissue (page 2 paragraph 11) and autoimmune myopathies (page 4, number 58). The amount of steroid usage in patients was found to be reduced when these stem cells were administered as well as a reduction in symptoms and a decrease in a cytokine level (page 7 paragraph 22).
One of ordinary skill in the art would have been motivated to include steps for measuring the cytokine levels of the treated individual in the method of Johnson because Clark and Riordan teach and suggest that there has been observed to be a correlation between symptom improvement and decrease in certain cytokines, such as IL-12, IL12p40 and IL-12p70, during successful treatment of autoimmune disorders. The correlation between cytokine reduction and symptom improvement produced by the administration of stem cells is suggested and thus rendered obvious by the teaching of Riordan. One of ordinary skill in the art would have had a reasonable expectation of success because Riordan suggest that stem cells, such as those from a tissue source of umbilical cord, can be expected to reduce levels of inflammatory cytokines in a treated subject.
Therefore, the combined teachings of Johnson, Opinc et al, Clark et al and Riordan render obvious Applicant’s invention as claimed.
Claim(s) 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson, V. (CGTlive Accessed 2022-from IDS filed 11/10/2025) in view of Opinc et al (Rheumatology International 2019-newly cited) as applied to claims 1-2, 6, 24-25, 31, 49, and 56 above and further in view of Iaccarino et al (Autoimmun Highlights, 2014-newly cited) and Riordan (US 2018/0214489).
Regarding claims 29-30, Johnson as modified by Opinc renders obvious the claimed method as described above, but does not disclose wherein steroid usage is reduced in an individual afflicted with idiopathic inflammatory myopathy.
Iaccarino disclose that corticosteroids are the mainstay of treatment of for idiopathic inflammatory myopathies (IIM) but that these drugs are burdened by several side effects. Iaccarino suggests using a combinate approach by including an additional treatment to improve disease response and allow reduction of the dosage of corticosteroids and decreasing the risk of steroid-related long-term complications (abstract, pages 95-97). Steroids used include dexamethasone, betamethasone, triamcinolone, prednisone, and prednisolone (pages 96-97). Dose tapering usually begins after 1 month and is about 10-20% of the daily dose every month until the lowest possible dosage that controls the disease is achieved (page 97, corticosteroids). Dermatomyositis and polymyositis are both disclosed as subtypes of IIM (page 99, Table 1).
Riordan disclose methods of treating autoimmune disorders with mesenchymal stem cells including cells from umbilical cord tissue (page 2 paragraph 11) and autoimmune myopathies (page 4, number 58). The amount of steroid usage in patients was found to be reduced when these stem cells were administered as well as a reduction in symptoms and a decrease in a cytokine level (page 7 paragraph 22).
One of ordinary skill in the art would have been motivated to reduce steroid dosage or taper the steroid dosage in the method of Johnson because Iaccarino teach that the use of steroids for the treatment of IIM produces adverse effects and that a secondary treatment can reduce the reliance on steroids and thus allow for the reduction of steroid usage and because Riordan also suggest the same (page 1 paragraph 6) and indicate that umbilical cord stem cells can provide relief. The use of dexamethasone, betamethasone, triamcinolone, prednisone, and prednisolone are well known and commonly used in the art of treating IIM as suggested by Iaccarino and thus obvious choices for the selection of the steroid used, reduced and tapered. The correlation between cytokine reduction and symptom improvement produced by the administration of stem cells is suggested and thus rendered obvious by the teaching of Riordan. One of ordinary skill in the art would have had a reasonable expectation of success because Johnson, Iaccarino and Riordan are all drawn to the combination treatment of autoimmune disorders such as autoimmune myopathy.
Therefore, the combined teachings of Johnson, Opinc et al, Iaccarino et al and Riordan render obvious Applicant’s invention as claimed.
Claim(s) 8-10, 14-15, and 50-55 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson, V. (CGTlive Accessed 2022-from IDS filed 11/10/2025) in view of Iaccarino et al (Autoimmun Highlights, 2014-newly cited) and Riordan (US 2018/0214489).
Regarding claims 8-10, 14, 51, Johnson discloses a method of treating idiopathic inflammatory myopathy in an individual (methods for treating dermatomyositis and polymyositis in a subject; page 1, paragraph 1), comprising administering an effective amount of umbilical lining-derived stem cells to the individual in need thereof (methods of treatment comprise administration of umbilical cord lining stem cells to a subject with a single first dose; title; page 1, paragraphs 1, page 2, paragraph 2). Johnson discloses wherein the effective amount of the administered cells is at least about 50 million cells, at least about 100 million cells, at least about 200 million cells (title, page 1, paragraph 1, page 2, paragraph 2).
However, Johnson does not disclose a method of reducing steroid usage in an individual afflicted with idiopathic inflammatory myopathy.
Iaccarino disclose that corticosteroids are the mainstay of treatment of for idiopathic inflammatory myopathies (IIM) but that these drugs are burdened by several side effects. Iaccarino suggests using a combinate approach by including an additional treatment to improve disease response and allow reduction of the dosage of corticosteroids and decreasing the risk of steroid-related long-term complications (abstract, pages 95-97). Steroids used include dexamethasone, betamethasone, triamcinolone, prednisone, and prednisolone (pages 96-97). Dose tapering usually begins after 1 month and is about 10-20% of the daily dose every month until the lowest possible dosage that controls the disease is achieved (which provides a reduction of about 30% of the steroid dosage by the third month of steroid usage) (page 97, corticosteroids). Dermatomyositis and polymyositis are both disclosed as subtypes of IIM (page 99, Table 1).
Riordan disclose methods of treating autoimmune disorders with mesenchymal stem cells including cells from umbilical cord tissue (page 2 paragraph 11) and autoimmune myopathies (page 4, number 58). The amount of steroid usage in patients was found to be reduced when these stem cells were administered as well as a reduction in symptoms and a decrease in a cytokine level (page 7 paragraph 22).
One of ordinary skill in the art would have been motivated to reduce steroid dosage or taper the steroid dosage in the method of Johnson because Iaccarino teach that the use of steroids for the treatment of IIM produces adverse effects and that a secondary treatment can reduce the reliance on steroids and thus allow for the reduction of steroid usage and because Riordan also suggest the same (page 1 paragraph 6) and indicate that the administration of umbilical cord stem cells for autoimmune diseases such as myopathies can provide relief. The use of dexamethasone, betamethasone, triamcinolone, prednisone, and prednisolone are well known and commonly used in the art of treating IIM as suggested by Iaccarino and thus obvious choices for the selection of the steroid used, reduced and tapered. The correlation between cytokine reduction and symptom improvement produced by the administration of stem cells is suggested and thus rendered obvious by the teaching of Riordan. The optimization of the steroid dosage over time to taper and use the lowest possible effective dose would have provided the benefit of reducing the side effects of the steroid treatment. One of ordinary skill in the art would have had a reasonable expectation of success because Johnson, Iaccarino and Riordan all include the use of umbilical cord-derived stem cells for the treatment of autoimmune disorders such as autoimmune myopathy.
Regarding claims 15 and 50, Johnson does not disclose wherein the administering comprises multiple doses of the cells over a defined period of time of 1-4 months at the same concentration of the first dose.
Riordan teach and suggest that their stem cell compositions can be administered in a single dose or in multiple doses for a defined period of time (page 17 paragraphs 111-page 18 paragraph 118).
One of ordinary skill in the art would have been motivated to include administration methods that include multiple administrations over a defined period of time in the method of Johnson at the same concentration as the first dose because Riordan teach and suggest that it is a suitable option when administering umbilical cord stem cells for the treatment of a variety of autoimmune disorders, including autoimmune myopathies. The optimization of the administration to include additional cell doses at specific times would have provided the benefit of tailoring the method to the subject based on the severity of their symptoms. One of ordinary skill in the art would have had a reasonable expectation of success because both Johnson and Riordan are administering umbilical cord stem cells for therapeutic purposes and Riordan teach that these cells can be used to treat a variety of disorders, including autoimmune myopathies.
Regarding claims 52-54, while the combined teachings of Johnson, Iaccarino and Riordan do not specifically disclose reducing the dose of the steroid by about 40-45% at six months or nine months after the first dose of the steroids relative to the dose of the steroid used before the administration of the stem cells, given the typical tapering schedule provided by Iaccarino, this is deemed to be a matter of routine optimization and experimentation.
With regard to the concentrations of steroid used in the treatment method, 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. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05).
The selection of specific concentrations clearly would have been a routine matter of optimization and experimentation on the part of the artisan of ordinary skill, said artisan recognizing that the therapeutic effect and the severity of side effects would have been affected by these concentrations.
Regarding claim 55, Iaccarino disclose that high doses of steroids are recommended as starting doses (typically 0.75-1 mg/kg/day) and steroid dose tapering usually begins after 1 month and is about 10-20% of the daily dose every month until the lowest possible dosage that controls the disease is achieved (which is usually 5-15 mg/day) (page 97, corticosteroids). Arriving at a reduction of a steroid dose of more than 5.5 mg/daily would have been a matter of routine optimization and experimentation.
With regard to the concentrations of steroid used in the treatment method, 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. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05).
The selection of specific concentrations clearly would have been a routine matter of optimization and experimentation on the part of the artisan of ordinary skill, said artisan recognizing that the therapeutic effect and the severity of side effects would have been affected by these concentrations.
Therefore, the combined teachings of Johnson, Iaccarino et al and Riordan render obvious Applicant’s invention as claimed.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2, 6-10, 14-15, 24-25, 29-33, 36, and 48-56 have been considered but are moot because the new grounds of rejections does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments have been addressed in so far as they relate to the new rejections above.
Applicant argues that Silva does not cure the deficiencies of Johnson because the Silva reference does not touch on the treatment of idiopathic inflammatory myopathy.
This is not found persuasive. The teaching of Silva is relevant because they disclose that when treating disorders with umbilical lining derived stem cells that it is suitable and beneficial to deliver the cells multiple times over a defined period of time. Using multiple doses in cell therapy is a commonly known strategy to achieve an optimal therapeutic result.
Applicant argues that Riordan is limited to the treatment of rheumatoid arthritis with mesenchymal stem cells and does not teach the treatment of IIM or suggest that the stem cell therapy in IIM can reduce steroid dosage specifically at the claimed level.
This is not found persuasive. Riordan disclose methods of treating autoimmune disorders with mesenchymal stem cells including cells from umbilical cord tissue (page 2 paragraph 11) and autoimmune myopathies (page 4, number 58). The amount of steroid usage in patients was found to be reduced when these stem cells were administered as well as a reduction in symptoms and a decrease in a cytokine level (page 7 paragraph 22).
Applicant argues that none of the references provides any insight that would have promoted a skilled person to measure the level of IL-12 in assessing symptom improvement of IIM patients receiving stem cells.
This is not found persuasive. Clark disclose methods of treating immune related diseases (Title) and wherein the symptom improvement correlates with a decrease in a cytokine level in the treated individual (page 3 lines 30-34, page 120 lines 32-35, page 121 lines 1-7). Clark discloses wherein the reduced cytokines include IL-12 (page 124, lines 4-5), IL-12p40 (page 12 lines 1-3, page 14 lines 12-14) and IL-12p70 (page 17 lines 8-9).
Riordan disclose methods of treating autoimmune disorders with mesenchymal stem cells including cells from umbilical cord tissue (page 2 paragraph 11) and autoimmune myopathies (page 4, number 58). The amount of steroid usage in patients was found to be reduced when these stem cells were administered as well as a reduction in symptoms and a decrease in a cytokine level (page 7 paragraph 22).
One of ordinary skill in the art would have been motivated to include steps for measuring the cytokine levels of the treated individual in the method of Johnson because Clark and Riordan teach and suggest that there has been observed to be a correlation between symptom improvement and decrease in certain cytokines, such as IL-12, IL12p40 and IL-12p70, during successful treatment of autoimmune disorders. The correlation between cytokine reduction and symptom improvement produced by the administration of stem cells is suggested and thus rendered obvious by the teaching of Riordan. One of ordinary skill in the art would have had a reasonable expectation of success because Riordan suggest that stem cells, such as those from a tissue source of umbilical cord, can be expected to reduce levels of inflammatory cytokines in a treated subject.
Applicant argues that the treatment of Alekar is limited to the use of IFN-beta antibodies which is a very different therapeutic agent as stem cells and thus cannot cure the deficiencies in Johnson.
This is not found persuasive. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
The teaching of Alekar is relied upon to demonstrate that it was known in the prior art of treating dermatomyositis and polymyositis (page 5 lines 15-30), that symptom improvement is measured over at least a one-month duration (page 13 lines 33-34, page 17 lines 19-20).
Applicant argues that the Clark reference discloses treating immune related diseases via modulating the expression and/or activity of TIGIT using agonists and antagonists and cannot be applied to methods of treating of IIM with stem cells. Applicant asserts that it was known in the art that agonists and antagonists would exert opposite effects and does not provide any insight as to which cytokines would be associated with IIM treatment effects and whether the increase or decrease of such a specific cytokine would be indicative of symptom improvement.
This is not found persuasive. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Clark disclose methods of treating immune related diseases (Title) and wherein the symptom improvement correlates with a decrease in a cytokine level in the treated individual (page 3 lines 30-34, page 120 lines 32-35, page 121 lines 1-7). Clark discloses wherein the reduced cytokines include IL-12 (page 124, lines 4-5), IL-12p40 (page 12 lines 1-3, page 14 lines 12-14) and IL-12p70 (page 17 lines 8-9).
Riordan disclose methods of treating autoimmune disorders with mesenchymal stem cells including cells from umbilical cord tissue (page 2 paragraph 11) and autoimmune myopathies (page 4, number 58). Riordan disclose that when these stem cells were administered that a reduction in symptoms was achieved as well as a decrease in cytokine level (page 7 paragraph 22).
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Min et al., “Assessment of disability in idiopathic inflammatory myopathy: a call for linearity”, Rheumatology, 2022, Vol. 61, pp. 3420–3426.
Saygin et al., “Utility of patient-reported outcomes measurement information system (PROMIS) physical function form in inflammatory myopathy”, Seminars in Arthritis and Rheumatism, 2021, Vol. 51, pp. 539 546.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/ Primary Examiner, Art Unit 1631
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