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 01/27/2026.
Claims 2-18 are currently pending and have been examined on their merits.
Information Disclosure Statement
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.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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.
Claims 2-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating oral inflammation, does not reasonably provide enablement for preventing oral inflammation.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized in In re Wands, 858 F.2d 731, 737, 8 USPQd 1400, 1404 (Fed. Cir. 1988) (a) the breadth of the claims; (b) the nature of the invention; (c) the state of the prior art; (d) the level of one of ordinary skill; (e) the level of predictability in the art; (f) the amount of direction provided by the inventor; (g) the existence of working examples; and (h) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. While all of these factors are considered, a sufficient number are discussed below so as to create a prima facie case.
The instant claims are directed to methods of preventing and/or reducing, mitigating, ameliorating, reversing oral inflammation in a mammal in need comprising administering an effective amount of adipose-derived mesenchymal stem cells (AdMSCs) and further wherein the AdMSCs are obtained from the mammal being treated.
The instant claims are based on the efficacy of AdMSCs in treating oral inflammation in a subject including felines.
It has been known in the art that AdMSCs have therapeutic efficacy in treating inflammation in general (Lin et al (WO 2009/152084-page 1 para 1 and page 11 para 53) and oral inflammation in particular (Beckman DVM 360, October 1, 2008- page 2).
Lin teach methods of using adipose stem cells (ADSC) for veterinary care for various medical conditions (page 1 para 1), including inflammatory conditions (page 11 para 53).
Beckman teaches a method of utilizing adipose- derived mesenchymal stem cells to treat LPGS in felines (page 2 of 3, last paragraph). Beckman teaches that the inflammation is chronic (oral inflammation) (Title).
However, the treatment of oral inflammation has been shown to be complicated in many cases and often prone to unpredictable results especially with refractory cases that do not respond completely to treatment (Hale www.toothvet.ca., December 2010).
Hale teaches that LPGS (Lymphatic/Plasmacytic Gingivo-Stomatitis) represents feline gingivostomatitis (page 1 column 1). This is inflammation of the gingiva (oral tissue). Hale also teach that there are numerous types of oral inflammation including gingivitis, periodontitis, alveolar mucositis, sublingual mucositis, and many others (page 1, column 2-page 2 column 1). The etiology for oral inflammation varies from bacterial and viral infection to food antigens and indicated as unpredictable in many cases (pages 2-3).
Further, the burden of enabling "prophylaxis" (i.e. prevention), of a disease is greater than that of enabling a treatment method due to the need to screen the subjects susceptible to the respective condition and the difficulty of proof that the administration of the cells was the agent that acted to prevent the condition. The specification does not provide guidance as to how one skilled in the art would go about screening those patients susceptible to the recited diseases, nor is guidance provided as to a specific protocol to be utilized in order to prove the efficacy of the presently claimed methods in preventing these disease states. Accordingly, to the extent that the claimed methods are deemed to be enabled for treating certain specific conditions, it remains unpredictable whether any condition can be prevented by the claimed methods.
Given that the outcomes of practicing the claimed methods beyond the scope defined above are highly unpredictable, and that the disclosure does not provide sufficient direction, guidance or working examples, the experimentation left to those skilled in the art is extremely extensive. It would initially require experimentation in animal models of the oral inflammation of various causes and severity which are within the scope of the claims, using numerous potential sources of adipose-derived mesenchymal stem cells, with or without any of the numerous antigens, under various dosing regimens. The number of possible permutations of these parameters is so large that, even in cases where the requisite methods are routine, the amount of experimentation is beyond the capacity of even the largest research institutions. Since the skilled artisan understands that, for the reasons addressed above, the chances of identifying a set of conditions resulting in methods of sufficient prevention are extremely low, the skilled artisan would reasonably view such experimentation as unnecessarily, and improperly, extensive and undue.
Additionally, the applicants have provided no direction for the claimed method to prevent oral inflammation to the full scope of the claims. The experiments provided in the specification demonstrates the ability Ad MSC administration to treat and alleviate oral inflammation Examples 1 and 2 pages 20-25, no long-term results are provided showing the subjects never acquire another episode of oral inflammation, as would be required to support the “prevention” claim. While lack of a working embodiment cannot be a sole factor in determining enablement, the absence of substantial evidence, in light of the unpredictable nature of the art and the direction applicants present, provides additional weight to the lack of enablement in consideration of the Wands factors as a whole. Thus, one of ordinary skill in the art would not have a reasonable expectation of successfully preventing all causes and levels of oral inflammation by performing the claimed method.
Therefore, the claims are not enabled for the full scope of prevention of oral inflammation in a mammalian subject.
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 12 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.
Regarding claim 12, the phrase "i.e.” (for example) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
For examination purposes the claim is interpreted as requiring wherein the AdMSCs are viable and not frozen.
Appropriate correction is required.
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)(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.
Claim(s) 2, 4-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beckman DVM 360, October 1, 2008) as evidenced by Hale, Fraser A. (www.toothvet.ca., December 2010).
Regarding claims 2, 4-6, Beckman teaches a method of utilizing adipose- derived mesenchymal stem cells to treat LPGS in felines (page 2 of 3, last paragraph). Beckman teaches that the inflammation is chronic (oral inflammation) (Title).
Hale teaches that LPGS (Lymphatic/Plasmacytic Gingivo-Stomatitis) represents feline gingivostomatitis (page 1 column 1). This is inflammation of the gingiva (oral tissue).
The disclosure by Hale is a supporting reference and properly used in a rejection under of U.S.C. 102 since it describes that LPGS is inherently gingivostomatitis. MPEP 2131.01.
Therefore, the teaching of Beckman anticipates Applicant's invention as claimed.
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Beckman, Brett (DVM 360, October 1, 2008) as evidenced by Hale, Fraser A. (www.toothvet.ca., December 2010) as applied to claims 2 and 4-6 above and further in view of Dominici et al (Cytotherapy 2006) and Quimby et al (Journal of Feline Medicine and Surgery 2011).
Regarding claim 10, Beckman teaches the claimed method of administering AdMSC as described above, but is silent with regard to specific marker expression of the adipose mesenchymal stem cells.
Dominici disclose that the minimal criteria for defining multipotent mesenchymal stromal cells proposed by the Mesenchymal and Tissue Stem Cell Committee of the International Society for Cellular Therapy that MSCs must express CD105 and CD90 and lack expression of CD45 and CD34 (abstract and page 316 table 1).
Quimby disclose feline MSCs from both bone marrow and adipose tissue expressed high levels of CD44, CD90 and CD105 and were negative for expression of MHC class II (page 421, column 2). These MSCs are described as beneficial for therapeutic use (abstract, page 418).
One of ordinary skill in the art would have been motivated to use adipose derived mesenchymal stem cells that express CD44, CD90, CD105 and lack expression of CD34, CD45, MHC class II in the method of Beckman because Dominici and Quimby teach that these cells are defined by such expression. One of ordinary skill in the art would have had a reasonable expectation of success because Beckman, Dominici and Quimby are drawn to methods of cell therapy by administering mesenchymal stem cells.
Therefore, the combined teachings of Beckman, Dominici et al and Quimby et al render obvious Applicant's invention as claimed.
Claim(s) 3, 7-9, 11-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Beckman, Brett (DVM 360, October 1, 2008) as evidenced by Hale, Fraser A.(www.toothvet.c., December 2010) as applied to claims 2, 4-6 above and further in view of Lin et al (WO 2009/152084).
. Regarding claims 3, 7-9, Beckman teaches the claimed method as described above, but does not specifically teach wherein the MSCs are autologous (from the tissue of the mammalian subject), syngeneic or allogeneic.
Lin teach methods of using adipose stem cells (ADSC) for veterinary care for various medical conditions (page 1 para 1), including inflammatory conditions (page 11 para 53). Lin teach that the adipose-derived stem cells may be autologous, syngeneic or allogeneic to the mammal and may be feline as well (page 14 para 62-63).
One of ordinary skill in the art would have been motivated to use cells that were autologous, syngeneic or allogeneic to the mammalian subject because Lin teaches that these are suitable sources for adipose-derived stem cells for therapeutic use.
Regarding claims 11-13, Beckman is silent with regard to if the MSCs have been frozen and how many of the cells are viable.
Lin teach that methods for preserving the viability of the ADSC are necessary and include a method for storing the ADSC at temperatures of 4°C as suitable (not frozen) (page 15 para 65-66).
One of ordinary skill in the art would have been motivated to preserve the viability of the adipose derived MSCs in the method of Beckman at non-freezing temperatures because Lin suggest that this provides the benefit of preserving the viability of these stem cells. One of ordinary skill in the art would have been motivated to administer a cell population that is at least about 50% viable as Lin teach and suggest that preserving the viability is necessary for adipose-derived cells administered for therapeutic purposes and this suggests that having as many viable cells as possible, and as close to 100% is desirable.
Regarding claim 15, Beckman teaches the claimed method as described above, but does not specifically teach wherein the MSCs are cultured in serum-free cell culture medium.
Lin disclose that the integration of animal protein into the stem cells has been reported during the use of animal serum and that this is a major concern in cell therapy. Lin suggest that a serum-free medium containing platelet lysate is a suitable and beneficial alternative to culture medium containing serum (pages 35-36 para 141-143).
One of ordinary skill in the art would have been motivated to use serum-free cell culture medium to expand the MSCs in the method of Beckman because this would have provided the benefit of increased cell numbers without the major concern of integration of animal protein into the stem cells. One of ordinary skill in the art would have had a reasonable expectation of success because Lin disclose that the proliferative effect of platelet lysate on ADSC was evaluated and shown to have the same effect in supporting cell growth and proliferation as FBS (fetal bovine serum) (page 36 para 143).
Therefore, the combined teachings of Beckman and Lin et al render obvious Applicant's invention as claimed.
Claim(s) 13-14, 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Beckman, Brett (DVM 360, October 1, 2008) as evidenced by Hale, Fraser A.(www.toothvet.c., December 2010) and in view of Lin et al (WO 2009/152084) as applied to claims 2, 3, 4-6, 7-9, 11-13 above and further in view of Honmou et al (Brain 2011).
Regarding claim 13, Beckman is silent with regard to how many of the MSCs are viable.
Honmou are drawn to a method of treating stroke by intravenous administration of auto serum-derived autologous MSCs and teach that a higher cell viability of greater than 95.2% is desired for their cell preparation (page 1792, column 1).
One of ordinary skill in the art would have been motivated to use a MSC population that is as high a percent viability as possible (at least 50% viable) in the method of Beckman because viable MSCs are suggested by Honmou to be preferable when administering MSCs for therapeutic purposes.
Regarding claim 14, Beckman is silent with regard if their MSCs are cultured in vitro and for how long.
Honmou each that while expanding MSCs in vitro that cell passages were limited to three or less with a target cell number of 1.0 X 10⁸ (page 1792, column 1).
One of ordinary skill in the art would have been motivated to expand the MSCs in the method of Beckman for at least one passage because this would allow Beckman to increase the MSC number to an effective amount for therapeutic purposes.
Regarding claims 16-18, Beckman is silent with regard to what type of serum is used to culture and expand the MSCs.
Honmou suggest that serum that is substantially free of xenogeneic proteins is preferred to minimize potential risk of transmitting viruses and prions (page 1791, column 2) and specifically suggest autoserum which is also allogeneic (same species as subject).
One of ordinary skill in the art would have been motivated to use serum that is free of xenogeneic proteins, such as autoserum, to expand the MSCs in the method of Beckman because Honmou suggest that this is preferred to minimize potential risk of transmitting viruses and prions. This teaching of Honmou would have rendered obvious using cells free of bovine serum proteins in the method of Becker because Becker is administering the cells to felines and not cattle
Therefore, the combined teachings of Beckman, Lin et al and Honmou et al render obvious Applicant's invention as claimed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-4 and 6-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,171,786.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent are drawn to a method of treating gingivostomatitis (oral inflammation) in a feline by isolating and administering autologous adipose-derived MSCs and anticipate the method of the current claims.
Therefore, the claims of the patent anticipate Applicant’s invention as claimed.
Claims 2-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,171,786 in view of Beckman and Hale.
The patent claims are drawn to a method of treating gingivostomatitis (oral inflammation) in a feline by isolating and administering autologous adipose-derived MSCs.
The patent claims do not specifically teach wherein the oral inflammation is chronic.
Beckman teaches a method of utilizing adipose- derived mesenchymal stem cells to treat LPGS in felines (page 2 of 3, last paragraph). Beckman teaches that the inflammation is chronic (oral inflammation) (Title).
Hale teaches that LPGS (Lymphatic/Plasmacytic Gingivo-Stomatitis) represents feline gingivostomatitis (page 1 column 1). This is inflammation of the gingiva (oral tissue).
One of ordinary skill in the art would have been motivated to include the treatment of chronic oral inflammation in the method of the patent claims because Beckman teach and suggest administering adipose-derived MSCs to treat LPGS and that this includes chronic inflammation. One of ordinary skill in the art would have had a reasonable expectation of success because Hale teaches that LPGS (Lymphatic/Plasmacytic Gingivo-Stomatitis) represents feline gingivostomatitis (page 1 column 1). This is inflammation of the gingiva (oral tissue).
Therefore, the combined teachings of the patent, Beckman and Hale render obvious the current claimed method.
Claims 8-9, 11-13 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,171,786 in view of Lin et al (WO 2009/152084).
The patent claims are drawn to a method of treating gingivostomatitis (oral inflammation) in a feline by isolating and administering autologous adipose-derived MSCs.
The patent claims do not specifically teach wherein the cells are syngeneic or allogeneic to the mammal
Lin teach methods of using adipose stem cells (ADSC) for veterinary care for various medical conditions (page 1 para 1), including inflammatory conditions (page 11 para 53). Lin teach that the adipose-derived stem cells may be autologous, syngeneic or allogeneic to the mammal and may be feline as well (page 14 para 62-63).
One of ordinary skill in the art would have been motivated to use cells that were autologous, syngeneic or allogeneic to the mammalian subject because Lin teaches that these are suitable sources for adipose-derived stem cells for therapeutic use.
The patent is silent with regard to if the MSCs have been frozen and how many of the cells are viable.
Lin teach that methods for preserving the viability of the ADSC are necessary and include a method for storing the ADSC at temperatures of 4°C as suitable (not frozen) (page 15 para 65-66).
One of ordinary skill in the art would have been motivated to preserve the viability of the adipose derived MSCs in the method of the patent at non-freezing temperatures because Lin suggest that this provides the benefit of preserving the viability of these stem cells. One of ordinary skill in the art would have been motivated to administer a cell population that is at least about 50% viable as Lin teach and suggest that preserving the viability is necessary for adipose-derived cells administered for therapeutic purposes and this suggests that having as many viable cells as possible, and as close to 100% is desirable.
The patent does not specifically teach wherein the MSCs are cultured in serum-free cell culture medium.
Lin disclose that the integration of animal protein into the stem cells has been reported during the use of animal serum and that this is a major concern in cell therapy. Lin suggest that a serum-free medium containing platelet lysate is a suitable and beneficial alternative to culture medium containing serum (pages 35-36 para 141-143).
One of ordinary skill in the art would have been motivated to use serum-free cell culture medium to expand the MSCs in the patent method because this would have provided the benefit of increased cell numbers without the major concern of integration of animal protein into the stem cells. One of ordinary skill in the art would have had a reasonable expectation of success because Lin disclose that the proliferative effect of platelet lysate on ADSC was evaluated and shown to have the same effect in supporting cell growth and proliferation as FBS (fetal bovine serum) (page 36 para 143).
Therefore, the combined teachings of the patent and Lin render obvious the current claimed method.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,171,786 in view of Dominici et al (Cytotherapy 2006) and Quimby et al (Journal of Feline Medicine and Surgery 2011).
Regarding claim 10, The patent teaches the claimed method of administering AdMSC as described above, but is silent with regard to specific marker expression of the adipose mesenchymal stem cells.
Dominici disclose that the minimal criteria for defining multipotent mesenchymal stromal cells proposed by the Mesenchymal and Tissue Stem Cell Committee of the International Society for Cellular Therapy that MSCs must express CD105 and CD90 and lack expression of CD45 and CD34 (abstract and page 316 table 1).
Quimby disclose feline MSCs from both bone marrow and adipose tissue expressed high levels of CD44, CD90 and CD105 and were negative for expression of MHC class II (page 421, column 2). These MSCs are described as beneficial for therapeutic use (abstract, page 418).
One of ordinary skill in the art would have been motivated to use adipose derived mesenchymal stem cells that express CD44, CD90, CD105 and lack expression of CD34, CD45, MHC class II in the method of the patent because Dominici and Quimby teach that these cells are defined by such expression. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Dominici and Quimby are drawn to methods of cell therapy by administering mesenchymal stem cells.
Therefore, the combined teachings of the patent, Dominici et al and Quimby et al render obvious Applicant's invention as claimed.
Claim 13-14, 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,171,786 in view of Honmou et al (Brain 2011).
Regarding claim 13, the patent is silent with regard to how many of the MSCs are viable.
Honmou are drawn to a method of treating stroke by intravenous administration of auto serum-derived autologous MSCs and teach that a higher cell viability of greater than 95.2% is desired for their cell preparation (page 1792, column 1).
One of ordinary skill in the art would have been motivated to use a MSC population that is as high a percent viability as possible (at least 50% viable) in the method of the patent because viable MSCs are suggested by Honmou to be preferable when administering MSCs for therapeutic purposes.
Regarding claim 14, the patent is silent with regard if their MSCs are cultured in vitro and for how long.
Honmou each that while expanding MSCs in vitro that cell passages were limited to three or less with a target cell number of 1.0 X 10⁸ (page 1792, column 1).
One of ordinary skill in the art would have been motivated to expand the MSCs in the method of the patent for at least one passage because this would allow the patent method to increase the MSC number to an effective amount for therapeutic purposes.
Regarding claims 16-18, the patent is silent with regard to what type of serum is used to culture and expand the MSCs.
Honmou suggest that serum that is substantially free of xenogeneic proteins is preferred to minimize potential risk of transmitting viruses and prions (page 1791, column 2) and specifically suggest autoserum which is also allogeneic (same species as subject).
One of ordinary skill in the art would have been motivated to use serum that is free of xenogeneic proteins, such as autoserum, to expand the MSCs in the method of the patent because Honmou suggest that this is preferred to minimize potential risk of transmitting viruses and prions. This teaching of Honmou would have rendered obvious using cells free of bovine serum proteins in the method of the patent because the patent is administering the cells to felines and not cattle
Therefore, the combined teachings of the patent and Honmou et al render obvious Applicant's invention as claimed.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zhou et al., “Administering human adipose-derived mesenchymal stem cells to prevent and treat experimental arthritis”, Clinical Immunology, 2011, Vol. 141, pp. 328-337.
(Disclose the anti-inflammatory effects of administering adipose-derived MSCs and how they prevent inflammation in a subject.)
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz can be reached at 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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