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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 7, 2025 has been entered.
Claims 1-3,5,7,9-14,18-19,21-26 are under examination.
Response to Applicants’ Argument and Amendment
Applicant has amended the claim so that it involves an adult stem cell and not an embryonic stem cell. This has altered the scope of the invention. The former rejection is withdrawn and new rejections are now put forth.
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 24 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 24 recites, “said cannabinoid compound comprises 0.3% tetrahydrocannabinol (THC) or less.” It is unclear what the percent is referring to. For example it is unclear if the amount of THC is a percentage of the body weight of the person receiving the stem cells, a percentage or the amount of the encapsulated pharmaceutical, or a percentage of the amount of active agent. For purposes of examination, the examiner will interpret the claim to mean any amount of THC until further clarification occurs.
Claim Rejections - 35 USC § 102
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.
Claims 1,3,7,9-14,18,23,25-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yeshurun (WO 2014178048).
Yeshurun discloses (a) administering to said subject said stem cell (Page 5 of Yeshurun, last paragraph), wherein said stem cell is an adult stem cel (the stem cells were taken from an adult (Pages 6 and 10 of Yeshurun), and (b) administering to said subject a pharmaceutical composition comprising an encapsulated cannabinoid compound(Page 8 of Yeshurun), wherein (b) takes place before and/or after (a) (Pages 6 and 10 of Yeshurun). The method of Yeshurun potentiates the function of the stem cells administered because it prevents the recipient’s immune cells from harming and/or destroying the administered stem cells (graft versus host disease) by administering encapsulated cannabinoids as in instant Claim 1. Yeshurun discloses wherein treatment with step (b) reduces the side effects usually associated with step (a) (adding cannabidiol reduces graft versus host rejection) as in instant Claim 3. On page 11 of Yeshurun, the reference states that mesenchymal stem cells can be administered. Mesenchymal stem cells are SOX2 positive cells as in instant Claim 7. The stem cells taught in Yeshurun are from stem cells that yield/can differentiate into cold-sensitive primary sensory neurons (Page 6, 1st and 2nd paragraphs and Page 11) as in instant Claim 9. Yeshurun discloses wherein said stem cell is from stem cells that are delivered via intravenous infusion (Page 14, 1st paragraph) as in instant Claim 10. Yeshurun discloses wherein steps (a) and (b) exhibit a synergetic effect on a process in said subject (Pages 13-14) as in instant Claim 11. Yeshurun discloses wherein said pharmaceutical composition comprises nanocapsules, wherein said nanocapsules comprise an individual nanocapsule comprising said encapsulated cannabinoid compound (Page 13, 1st paragraph) as in instant Claim 12. Yeshurun discloses wherein said nanocapsules increase stem cell growth (the nanocapsule on Page 13, 1st paragraph helps increase the cells grow because it protects the stem cells from the recipient’s immune system; thus, allowing the stem cells to continue to grow and potentiate as in instant Claim 13. Yeshurun discloses wherein said nanocapsules are administered following said stem cell therapy (Pages 6 and 10 of Yeshurun) as in instant Claim 14. Yeshurun discloses wherein said nanocapsules are administered orally (Page 13 of Yeshurun) as in instant Claim 18. Yeshurun discloses wherein said cannabinoid compound comprises cannabidiol (CBD) (Page 8 of Yeshurun) as in instant Claim 23. Yeshurun discloses wherein said subject suffers or is suspected of suffering from a disease or injury, and wherein, subsequent to (b), said subject is monitored for a progress of said disease or injury in response to said subject being administered said pharmaceutical composition (Results and Conclusion of Yeshurun) as in instant Claim 25. Yeshurun discloses wherein said subject suffers or is suspected of suffering from said disease, and wherein, subsequent to (b), said subject is monitored for a progression or regression of said disease in response to said subject being administered said pharmaceutical composition (Results and Conclusion of Yeshurun) as in instant Claim 26.
The reference anticipated the claim limitations.
Claims 1,3,9,11, and 24-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pandey “Targeting Cannabinoid Receptors as a Novel Approach in the Treatment of Graft-versus-Host Disease: Evidence from an Experimental Murine Model” The Journal of Pharmacology and Experimental Therapeutics, Vol. 338, No. 3
Pandey teaches a method for (a) administering to said subject said stem cell, wherein said stem cell is an adult stem cell (allogenic hematopoietic cells are administered in the abstract), administering to said subject a pharmaceutical composition comprising an encapsulated cannabinoid compound (THC is encapsulated in PBS), wherein (b) takes place subsequent to step (a) (Page 820 of Pandey, Induction of Acute GVHD and Treatment with THC). The method of Pandey potentiates the function of the stem cells administered because it prevents the recipient’s immune cells from harming and/or destroying the stem cells (graft versus host disease) as in instant Claims 1. Pandey teaches wherein treatment with step (b) reduces the side effects usually associated with step (a) (Abstract of Pandey and Results on Pages 821-825) as in instant Claim 3. The stem cells taught in Pandey are from stem cells that yield cold-sensitive primary sensory neurons (Abstract of Pandey) as in instant Claim 9. The process taught in Pandey would exhibit the same effect as applicants’ recited invention because like applicant, Pandey is also administering stem cells and cannabinoids (Abstract of Pandey) as in instant Claim 11. Pandey teaches that the cannabinoid compound comprises THC as in instant Claim 24. Pandey teaches wherein said subject suffers or is suspected of suffering from said disease, and wherein, subsequent to (b), said subject is monitored for a progression or regression of said disease in response to said subject being administered said pharmaceutical composition (Abstract and Pages 819-821 and Pandey) as in instant Claim 25-26.
The reference anticipated the claim limitations.
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.
Claim(s) 1-3,7,9-14,18-19,21-23,25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Yeshurun (WO 2014178048) in view of Morein (WO2014163558)
Yeshurun applies as above to teach 1,3,7,9-14,18,23,25-26. Yeshurun does teach that nanocapsules can be used to deliver the cannabinoid compounds. Yeshurun does not teach that the nanocapsules are composed of terpenes and/or components of Quillaja Saponaria. Morein teaches nanocapsules composed of at least one sterol (e.g. cholesterol) and a component from Quillajua Saponaria Molina (Abstract of Morein) can be administered to individuals. Morein further teaches that nanocapsules used to deliver oral medicaments can be composed of nanocapsules that “have a strong hydrophobic interaction between terpene (Quillaja) and sterol groups as illustrated above (Figure 18:3 and its brief description listed on bottom of Page 9).” It would have been obvious to an artisan of ordinary skill at the time of effective fling to have used the nanocapsules of Morein to carry the cannabionoid taught by Yeshurun. An artisan would have been motivated to have used Morein’s nanocapsule as the delivery component because Morein’s nanocapsules are safe and effective for oral delivery into the body (Page 30, line 27 of Morein). Because Morein’s nanocapsules can be used for effective oral drug delivery, there would have been a high expectation for success using the Morein’s nanocapsule to encapsulate the cannabinoid agent (Page 30, line 27 of Morein) as in instant Claim 2 and 22. Morein further teaches that its nanocapsules can easily be incorporated into food and/or beverages for oral consumption (Page 15, line 8; Page 16, line 21; Page 66, lines 12-22 of Morein) as in instant Claim 19. These nanocapsules are water soluble (Page 1, line 16 of Morein) as in instant Claim 21.
Yeshurun teaches a cannabinoid nanocapsule that can be administered to promote the potentiating function of a stem cell because its cannabinoid nanocapsule protects the stem cells from an unwanted host immune response. Yeshurun teaches that its nanocapsule can be administered orally. Yeshurun does not teach that the nanocapsule is composed of a terpene from quillaja. Morein teaches nanocapsules composed of at least one sterol (e.g. cholesterol) and a component from Quillajua Saponaria Molina (Abstract of Morein) can be used to deliver oral medicaments; these nanocapsules “have a strong hydrophobic interaction between terpene (Quillaja) and sterol groups as illustrated in Figure 18:3 of Morein.” An artisan would have been motivated to have used Morein’s nanocapsules to carry cannabinoids since they can be effectively administered orally. Given the teachings of the cited references and the level of skill of an ordinarily skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinarily skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature. These people will have the practical knowledge in molecular biology, cell biology, pharmaceuticals and nanotechnology. Therefore, the level of ordinary skill in this art is high.
Claims 1,3,5,7,9-14,18,23,25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Yeshurun (WO 2014178048) in view of Labhasetwar (WO2014124142)
Yeshurun applies as above to teach 1,3,7,9-14,18,23,25-26. Yeshurun does not teach the adult stem cells are administered to a person with a spinal cord injury. However, Labhasetwar teaches that adult stem cells can be administered to treat spinal cord injury (Paragraphs 47-48, Claim 64). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have administered the encapsulated cannabidiol with the stem cells in an individual suffering from a spinal cord injury. An artisan would have been motivated to have administered both the adult stem cells and the encapsulated cannabinoids to an individual because stem cells can be used to treat spinal cords injury (discussed in Labhasetwar Paragraphs 47-48), and the cannibinoids can be administered to protect the adult stem cells as taught by Yeshurun (Pages 6 and 10 of Yeshurun). There would be a high expectation for success because Labhesetwar teaches that adult stem cells can be used to treat spinal cord injuries (Paragraph 48 of Labhesetwar). Given the teachings of the cited references and the level of skill of an ordinarily skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinarily skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature. These people will have the practical knowledge in molecular biology, cell biology, pharmaceuticals and nanotechnology. Therefore, the level of ordinary skill in this art is high.
Claims 1,3,7,9-14,18,23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Pandey “Targeting Cannabinoid Receptors as a Novel Approach in the Treatment of Graft-versus-Host Disease: Evidence from an Experimental Murine Model” The Journal of Pharmacology and Experimental Therapeutics, Vol. 338, No. 3 in view of Yeshurun et al. (WO2014178048)
Pandey applies as above to teach claims 1,3,9, 11, and 24-26. Pandey encapsulates the cannabinoids in PBS, not nanocapsules. Yeshurun teaches that cannabinoids can be administered using nanocapsules (Page 13, 1st paragraph). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used the nanocapsules taught in Yeshurun to deliver the cannabinoids taught in Pandey. An artisan would have been motivated to have used the Yeshurun’s nanocapsules in order to effectively deliver the cannabinoid compounds (Page 13, 1st paragraph) since these nanocapsules can be used to successfully deliver cannabinoid agents into the body (Pages 6, 8, and 10 of Yeshurun). Because Yeshurun’s nanocapsules can successfully deliver the cannabinoid compounds into the body, there would have been a high expectation for success (Pages 6,8, 10, Page 13, 1st paragraph of Yeshurun) as in instant Claims 1 and 12.
Dependent Claims taught by Yeshurun
On page 11 of Yeshurun, the reference states that mesenchymal stem cells can be administered. Mesenchymal stem cells are SOX2 positive cells as in instant Claim 7.
Yeshurun discloses wherein said stem cell is from stem cells that are delivered via intravenous infusion (Page 14, 1st paragraph) as in instant Claim 10. Yeshurun discloses wherein steps (a) and (b) exhibit a synergetic effect on a process in said subject (Pages 13-14) as in instant Claim 11. Yeshurun discloses wherein said pharmaceutical composition comprises nanocapsules, wherein said nanocapsules comprise an individual nanocapsule comprising said encapsulated cannabinoid compound (Page 13, 1st paragraph) as in instant Claim 12. Yeshurun discloses wherein said nanocapsules increase stem cell growth (the nanocapsule on Page 13 (1st paragraph) helps increase the cells grow because it protects the stem cells from the recipient’s immune system; thus, allowing the stem cells to continue to grow and potentiate) as in instant Claim 13. Yeshurun discloses wherein said nanocapsules are administered following said stem cell therapy (Pages 6 and 10 of Yeshurun) as in instant Claim 14. Yeshurun discloses wherein said nanocapsules are administered orally (Page 13 of Yeshurun) as in instant Claim 18. Yeshurun discloses wherein said cannabinoid compound comprises cannabidiol (CBD) (Page 8 of Yeshurun) as in instant Claim 23. Yeshurun discloses wherein said subject suffers or is suspected of suffering from a disease or injury, and wherein, subsequent to (b), said subject is monitored for a progress of said disease or injury in response to said subject being administered said pharmaceutical composition (Results and Conclusion of Yeshurun) as in instant Claim 25. Yeshurun discloses wherein said subject suffers or is suspected of suffering from said disease, and wherein, subsequent to (b), said subject is monitored for a progression or regression of said disease in response to said subject being administered said pharmaceutical composition (Results and Conclusion of Yeshurun) as in instant Claim 26.
Pandey teaches administering stem cells and cannabinoids (THC). Pandey does not teach encapsulating the THC in nanocapsules. However, an artisan would have been motivate to have used nanocapsules as taught by Yeshurun since nanocapsules can effectively deliver a therapeutic to the body as taught by Yeshurun (Page 13, 1st paragraph). Because nanocapsules are an effective delivery composition, there would have been a high expectation for success. Given the teachings of the cited references and the level of skill of an ordinarily skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinarily skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be high educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature. These people will have the practical knowledge in molecular biology, cell biology, pharmaceuticals and nanotechnology. Therefore, the level of ordinary skill in this art is high.
Conclusion
All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638