DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
2. Applicant’s correspondence of May 11, 2023 is acknowledged; claims 1-12 are pending.
Information Disclosure Statement
3. The listing of references in the specification 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.
Specification
4. The use of the terms “JadiCell” and “Leukine,” which are a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
5. Claims 1-10 and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention.”
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicants were in possession of the claimed genus.
a) Claims 1-8 are directed to methods of treating Chronic Obstructive Pulmonary Disease (COPD) comprising steps of: inducing an increase in endothelial progenitor cell numbers and/or activity in the blood; and obtaining/administering a mesenchymal stem cell population to the patient suffering from COPD. The methods further recite various sources for the mesenchymal stem cells and endothelial progenitor cells.
The specification only provides examples of treating a murine COPD model with (i) mesenchymal stem cells (“JadiCells” specifically) in combination with myeloid derived suppressor cells (e.g., FIG. 1); and (ii) mesenchymal stem cells in combination with GM-CSF (e.g., “Leukine”; FIG. 2). The specification provides no examples or support for treating a COPD model with endothelial progenitor cells and/or “inducing an increase in endothelial progenitor cell numbers and/or activity in the blood.” The specification also provides no examples or support for treating a COPD model with a mesenchymal stem cell other than a JadiCell. Consequently, the claims are far broader than the therapeutics/agents supported by the examples.
The claims recite inducing “an increase in endothelial progenitor cell numbers and/or activity in the blood,” thereby encompassing any theoretical means of achieving an increase in endothelial progenitor cells, including that administering mesenchymal stem cells may induce the increase in endothelial progenitor cell number and/or activity. The claims further recite that “inducing increase in said endothelial progenitor cell population is induced by administration of exogenous endothelial progenitor cells” (e.g., claim 4) and various potential sources for the exogenous endothelial progenitor cells (e.g., autologous/allogenic/xenogenic, adipose, bone marrow, umbilical cord tissue (see claims 5-8)). However, no endothelial progenitor cell—let alone an exogenous autologous/allogenic/xenogenic, adipose, bone marrow or endothelial progenitor cell—is further provided by the specification. Instead, the specification only provides guidance for how to induce “an increase” of myeloid derived suppressor cells (e.g., the specification teaches GM-CSF “would increase the amount of MDSC into circulation” at paragraph [0036]). The claimed invention encompasses the use of all mesenchymal stem cell populations when administered to a subject suffering from COPD which results in inducing “an increase in endothelial progenitor cell numbers and/or activity in the blood.” A brief assessment of the state the art regarding Applicant’s is made herein. Medeiros et al. (Challenges and limitations of mesenchymal stem cell therapy for lung disease in clinical trials, Expert Opinion on Emerging Drugs, Volume 30, 2025, Issue 2) teaches that mesenchymal stem cell (MSC) therapy has called significant attention as a potential treatment modality for various lung diseases, including acute respiratory distress syndrome (ARDS), chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), and COVID-19-related respiratory failure. Medeiros et al. teaches that the therapeutic appeal of MSCs lies in their unique properties: immunomodulation, anti-inflammatory effects, and the ability to promote tissue regeneration. Phase 1 and 2 clinical trials have explored these benefits, demonstrating adequate safety and evidence of promising efficacy. However, despite these latest developments, several challenges and limitations hinder the widespread adoption and consistent success of MSC therapy in clinical settings for lung diseases (see the Abstract). Medeiros et al. teaches that 1) one of the foremost challenges is the heterogeneity of MSC sources and their resultant biological variability. MSCs can be harvested from various tissues, including bone marrow, adipose tissue, umbilical cord, and placental tissue, each conferring distinct cellular properties and therapeutic potentials. MSCs derived from different sources exhibit significant differences in proliferative capacity, differentiation potential, and secretion profiles of bioactive molecules. This variability makes it challenging to compare outcomes across different clinical trials and to establish universally effective treatment protocols, as inter- and intra-donor heterogeneity can significantly impact results. Additionally, donor-to-donor and intra-donor variability introduces another layer of complexity, as MSCs from different individuals may respond differently to the same therapeutic intervention, further challenging reproducibility and consistency in their effects; and 2) Another critical limitation is the lack of standardization in cell processing and culture conditions, the insufficient details in methods sections of papers, which reduces reproducibility. The methods used to isolate, expand, and store MSCs can significantly affect their therapeutic efficacy. Factors such as the number of cell passages, the composition of the culture medium, and cryopreservation techniques can alter MSC phenotype and function. Consequently, differences in tissue culture protocols can lead to inconsistencies in therapeutic outcomes observed in both preclinical and clinical settings. Recent advancements have underscored the importance of optimizing these parameters to maintain MSC potency, yet a lack of standardized protocols across laboratories and clinical settings persists. This lack of uniformity not only affects the comparability of clinical trial results but also poses regulatory challenges in ensuring the quality and safety of MSC-based therapies. The teachings of Medeiros et al. support the position that all mesenchymal stem cells encompassed by the claimed invention would not possess the same function.
It would not have been apparent to one skilled in the art that administering any mesenchymal stem cells may result in an increase in the number and/or activity of endothelial progenitor cells, nor would the other means for “inducing an increase in endothelial progenitor cell numbers and/or activity” potentially encompassed by this limitation be recognized. Furthermore, no means for achieving an “increase the number and/or activity” of endothelial progenitor cells is demonstrated in the specification. Applicant also has not established any nexus that the beneficial COPD treatments demonstrated at FIGs. 1-2 (e.g., administration of mesenchymal stem cells with myeloid derived suppressor cells) has any relevance to a treatment comprising administration of mesenchymal stem cells with endothelial progenitor cells as encompassed by claims 1-8.
Therefore, neither the art nor the specification provides a sufficient representative number of “inducing an increase in endothelial progenitor cell numbers and/or activity” to meet the written description requirements.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow person of ordinary skill in the art to recognize that he or she invented what is claimed’”. The courts have decided: the purpose of the "written description" requirement is broader than to merely explain how to "make and use"; the Applicant must convey with reasonable clarity to those skilled in the art, that as of the filing date sought, he or she was in possession of the invention. The invention is for purposes of the “written description” inquiry, whatever is now claimed. See Vas-Cath, Inc v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).
Furthermore, the written description provision of 35 USC §112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993). And Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Moreover, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has the Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that Applicant had possession of the claimed invention at the time the instant application was filed.
b) Claims 9-10, and 12 are directed to methods of treating Chronic Obstructive Pulmonary Disease (COPD) comprising administration of: a) either myeloid derived suppressor cells or one or more compounds capable of inducing an increase in number and/or activity of myeloid derived suppressor cells (e.g., GM-CSF) and b) a mesenchymal stem cell population to a subject suffering from COPD. The claims therefore encompass administration of any species of the genus of mesenchymal stem cells to treat COPD. The claimed invention encompasses any myeloid derived suppressor cells or one or more compounds capable of inducing an increase in number and/or activity of myeloid derived suppressor cells. A brief assessment of the state the art regarding Applicant’s is made herein. Scrimini et al. (The role of myeloid-derived suppressor cells in the relationship between chronic obstructive pulmonary disease and lung cancer, Integr Cancer Sci Therap, 2016, Volume 3(4):495-499) teaches that chronic obstructive pulmonary disease (COPD) is characterized by chronic pulmonary and systemic inflammation. Scrimini et al. teaches that there is strong evidence showing that COPD is an independent risk factor for lung cancer (LC). Scrimini et al. teaches that chronic inflammatory response can affect all stages of tumor development, from tumor initiation to metastasis. Inflammation also alters tumor immune surveillance and myeloid-derived suppressor cells (MDSC) are a heterogeneous mixture of immature granulocytic and monocytic cells characterized by an ability to suppress the antitumor activity of T-cells by down-regulation of the T-cell receptor chain (TCR ζ) through the catabolism of l-arginine. COPD and lung cancer share a common pattern of expansion of MDSC associated with TCR ζ downregulation and T-cell dysfunction. MDSC may impair tumor immunosurveillance in COPD and can potentially facilitate tumor initiation and growth, contributing to explain the increased incidence of lung cancer reported in these patients. As to other compounds such as GM-CSF used in treating COPD, Day et al. (Elevated GM-CSF in COPD may drive defective macrophage phenotype, European Respiratory Journal 2014 44(Suppl 58): P1482) teaches that Healthy pulmonary macrophages (mΦ) respond to environmental change by altering their phenotype. In COPD, mΦ are phenotypically distinct with increased pro-inflammatory mediator release and defective phagocytosis. The reasons for this are unclear, but the growth factors GM-CSF and M-CSF can determine mΦ differentiation. (see the Abstract). Day et al. teaches that regardless of culture changes, COPD macrophages retain phagocytic defects indicating lack in plasticity. This may be further exacerbated by a pro-inflammatory, GM-CSF-rich lung environment (see the Abstract).
The specification only provides examples of treating a murine COPD model with (i) “JadiCell” mesenchymal stem cells in combination with myeloid derived suppressor cells (e.g., FIG. 1); and (ii) JadiCells in combination with GM-CSF (e.g., “Leukine”; FIG. 2). The specification provides no examples or support for treating a COPD model with any species of mesenchymal stem cell other than a JadiCell mesenchymal stem cell. Consequently, the claims are far broader than the therapeutics/agents supported by the examples.
The specification provides no guidance regarding which mesenchymal stem cells—other than a JadiCell mesenchymal stem cells—may be operable to treat COPD. Accordingly, the specification provides insufficient written description to support the broad genus of “mesenchymal stem cells” encompassed by the claims.
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that Applicant had possession of the claimed invention at the time the instant application was filed.
6. 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.
a) Claim 10, which depends from claim 9, recites the limitation "wherein said compound capable of increasing number and/or activity of said mesenchymal stem cell is GM-CSF.” There is insufficient antecedent basis for this limitation in the claims since claim 9 only recites a compound “capable of inducing an increase in number and/or activity of myeloid derived suppressor cells.” Applicant may overcome the rejection by amending claim 10 to recite “myeloid derived suppressor cells” in place of “mesenchymal stem cell.”
b) Claim 11 contains the trademark/trade name “JadiCell.” Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the mesenchymal stem cell and, accordingly, the identification/description is indefinite.
c) Claim 1 is rejected for a lack of clarity as to the phrase “inducing an increase in endothelial progenitor cell numbers and/or activity in the blood of said patient”;
Claim 2 is rejected for a lack of clarity as to the phrase “inducing an increase in endothelial progenitor cell numbers and/or activity in the blood of said patient”; and
Claim 9 is rejected for is rejected for a lack of clarity as to the phrase “one or more compounds capable of inducing an increase in number and/or activity of myeloid derived suppressor cells”.
It is unclear in view of the specification what meaning should be ascribed to the term “activity,” especially considering this term is associated with three distinct cell types throughout the claims. Does increasing “activity” include increasing the “number” of the cells? Furthermore, the specification only discloses activity as it relates to “immunosuppressive activity” or “suppressive activity” associated with MDSCs at paragraphs [0028] and [0037]. Applicant therefore is advised to amend the claim-recited term “activity” into a more discrete term having support in the specification as filed.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
7. Claims 1-8 are rejected under 35 U.S.C. 102(a)(2) as being unpatentable over Akabutu et al. (WO2007124594-A1; Nov 2007).
The claims are drawn to a method of treating Chronic Obstructive Pulmonary Disease (COPD) comprising the steps of: a) identifying a subject suffering from COPD; b) obtaining a mesenchymal stem cell population; c) inducing an increase in endothelial progenitor cell numbers and/or activity in the blood of said patient; and d) administering said mesenchymal stem cell population to the patient suffering from COPD.
Akabutu et al. discloses a method for using mesenchymal stems cells from various origins, including umbilical cord (p. 6 para 0028), to treat lung diseases or injury like COPD, emphysema, and acute respiratory distress syndrome (ARDS) (p. 6, para 0025). This reference teaches that mesenchymal cells are characterized by the presence of CD73 markers (p.7, para 0031) and that the stem cells used in the described invention can express one or more other markers, including PECAM (CD31) (p. 9 para 0040). Akabutu et al. discloses that the stem cells may be obtained or isolated from any of a variety of sources including but not limited to bone marrow, umbilical cord blood, and/or donor cells from peripheral, circulating blood of any mammal, preferably a human. The stem cells may be endothelial stem cells, muscle stem cells, or neural stem cells. An endothelial stem cell is a stem cell that is capable of maturing into more mature endothelial cells (page 6, p. 0028). Akabutu et al. discloses the stem cells in the present invention can be of various origin. According to a preferred embodiment of the present invention, stem and/or progenitor cells (page 6, p.0029). Akabutu et al. anticipates the claimed invention.
8. Claims 1-9 and 11 are rejected under 35 U.S.C. 102(a)(2) as being unpatentable over Patel (US 9,803,176 B2 published October 31, 2017).
Claims 1-8 are drawn to a method of treating Chronic Obstructive Pulmonary Disease (COPD) comprising the steps of: a) identifying a subject suffering from COPD; b) obtaining a mesenchymal stem cell population; c) inducing an increase in endothelial progenitor cell numbers and/or activity in the blood of said patient; and d) administering said mesenchymal stem cell population to the patient suffering from COPD.
Claims 9 and 11 are drawn to a method of treating COPD comprising administration of: a) either myeloid derived suppressor cells or one or more compounds capable of inducing an increase in number and/or activity of myeloid derived suppressor cells and b) a mesenchymal stem cell population to a subject suffering from COPD, wherein said mesenchymal stem cell is JadiCell.
Patel teaches a method of treating COPD comprising administering a COPD agent to patient (column 12). Patel teaches that the method of the invention comprises administering an effective active agent including stem cells, wherein the stem cells are JadiCells (column 12). Patel teaches the use of biologic agent in the method of treating COPD (column 12). Patel anticipates the claimed invention.
Claim Rejections - 35 USC § 103
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.
9. Claims 1-12 are rejected under 35 U.S.C.103(a) as being unpatentable over Akabutu et al. (WO2007124594-A1; Nov 2007) in view of Patel (US 9,803,176 B2 published October 31, 2017) and further view of Ichim et al. (US 2012/0269774 published October 25, 2012).
Claims 1-8 are drawn to a method of treating Chronic Obstructive Pulmonary Disease (COPD) comprising the steps of: a) identifying a subject suffering from COPD; b) obtaining a mesenchymal stem cell population; c) inducing an increase in endothelial progenitor cell numbers and/or activity in the blood of said patient; and d) administering said mesenchymal stem cell population to the patient suffering from COPD.
Claims 9-12 are drawn to method of treating COPD comprising administration of: a) either myeloid derived suppressor cells or one or more compounds capable of inducing an increase in number and/or activity of myeloid derived suppress
or cells and b) a mesenchymal stem cell population to a subject suffering from COPD wherein the mesenchymal stem cell is a Jadicell.
Akabutu et al. discloses a method for using mesenchymal stems cells from various origins, including umbilical cord (p. 6 para 0028), to treat lung diseases or injury like COPD, emphysema, and acute respiratory distress syndrome (ARDS) (p. 6, para 0025). This reference teaches that mesenchymal cells are characterized by the presence of CD73 markers (p.7, para 0031) and that the stem cells used in the described invention can express one or more other markers, including PECAM (CD31) (p. 9 para 0040). Akabutu et al. discloses that the stem cells may be obtained or isolated from any of a variety of sources including but not limited to bone marrow, umbilical cord blood, ad/or donor cells from peripheral, circulating blood of any mammal, preferably a human. The stem cells may be endothelial stem cells, muscle stem cells, or neural stem cells. An endothelial stem cell is a stem cell that is capable of maturing into more mature endothelial cells (page 6, p. 0028). Akabutu et al. discloses the stem cells in the present invention can be of various origin. According to a preferred embodiment of the present invention, stem and/or progenitor cells (page 6, p.0029). Figs 1 and 2 of Akabutu et al. show that administering both human UCB derived stem cells and bone marrow derived stem cells prevent oxygen-induced lung injury.
Akabutu et al. do not specifically teach mesenchymal stem cells that are JadiCells.
Patel teaches a method of COPD comprising administering a COPD agent to patient (column 12). Patel teaches that the method of the invention comprises administering an effective active agent including stem cells, wherein the stem cells are JadiCells (column 12). Patel teaches the use of biologic agent in the method of treating COPD (column 12).
Akabutu et al. and Patel do not specially teach the use of GM-CSF.
Ichim et al., directed to methods of treating inflammatory diseases including COPD (paragraph [0033]), teaches that in a certain embodiment where committed progenitor cells are administered, the committed progenitor cells can be selected from a group consisting of endothelial progenitor cells, neuronal progenitor cells, and hematopoietic progenitor cells (paragraph [0053]). The committed endothelial progenitor cells can be purified from the bone marrow or peripheral blood, for example. In certain aspects, the committed endothelial progenitor cells are purified from peripheral blood of a patient whose committed endothelial progenitor cells are mobilized by administration of a mobilizing agent or therapy. In certain aspects, the mobilizing agent can be selected from a group consisting of: G-CSF, M-CSF, GM-CSF, 5-FU, IL-1, IL-3, kit-L, VEGF, Flt-3 ligand, PDGF, EGF, FGF-1, FGF-2, TPO, IL-11, IGF-1, MGDF, NGF, HMG CoA) reductase inhibitors and small molecule antagonists of SDF-1. In certain aspects, the mobilization therapy can be selected from a group consisting of exercise, hyperbaric oxygen, autohemotherapy by ex vivo ozonation of peripheral blood, and induction of SDF-1 secretion in an anatomical area outside of the bone marrow (paragraph [0052]).
It would have been prima facie obvious at the time of filing to modify the method of using a method for using mesenchymal stems cells from various origins, including umbilical cord to treat lung diseases or injury like COPD as taught by Akabutu et al. to include the JadiCell of Patel and the GM-CSF of Ichim et al. because Patel demonstrates that the Jadicells of their invention significantly improved COPD and Ichim et al. teaches that GM-CSF is a mobilizer for stem cells. One of ordinary skill in the art could reasonably conclude that the combined teachings of the prior art would be beneficial in using mesenchymal stem cell/endothelial progenitor cells to treat COPD.
As instructed by the MPEP at § 2143, the Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness, including combining prior art elements according to known methods to yield predictable results. In the instant case, the prior art includes each element claimed: as discussed above, Akabutu et al. teaches the beneficial treatment of COPD with mesenchymal stem cells/endothelial progenitor cells; Patel teaches that specifically JadiCell mesenchymal stem cells may be used to treat COPD; and Ichim et al. teaches the beneficial treatment of COPD with GM-CSF. One of ordinary skill in the art could have combined the elements as claimed by known methods, and in combination each element merely performs the same function as it does separately. Furthermore, one of ordinary skill in the art would have recognized the predictability of the results of the combination. For example, the MPEP at § 2144.06 states that the motivation to combine compositions taught by the art to be useful for the same purpose (e.g., the treatment of COPD) flows logically from their having been individually taught in the art; the result of the combination is therefore predictable:
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)
That is the case here. The instantly claimed combination of known COPD treatments follows from ordinary logic and predictably had a beneficial effect. Therefore, there was a reasonable expectation of success that combining one known beneficial COPD treatment with another would result in the third beneficial COPD treatment.
Pertinent Art
10. The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure:
Shi et al. (Shi, Zhihui, et al. "Intratracheal transplantation of endothelial progenitor cells attenuates smoking-induced COPD in mice." International journal of chronic obstructive pulmonary disease (2017): 947-960); discloses treatment of a murine COPD model with endothelial progenitor cells.
Song et al. (Song, C., et al. "Passive Transfer of Tumour‐Derived MDSCs Inhibits Asthma‐Related Airway Inflammation." Scandinavian Journal of Immunology 79.2 (2014): 98-104); discloses treatment of a murine asthma model with myeloid derived suppressor cells.
Martins et al. (Martins, Núbia Sabrina, et al. "Artepillin C reduces allergic airway inflammation by induction of monocytic myeloid-derived suppressor cells." Pharmaceutics 13.11 (2021): 1763); discloses treatment of a murine asthma model with a compound capable of inducing an increase in the number and/or activity of myeloid derived suppressor cells.
Conclusion
11. No claims are allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON R SCHWECHTER whose telephone number is (571)272-1270. The examiner can normally be reached M-T 7-5 EST.
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/BRANDON R SCHWECHTER/
Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674