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 .
Response to Applicants Arguments/Amendments
The amendments have altered the scope of the invention. As a result of the amendments, the former rejections are withdrawn and new rejections put forward. Because claim 24 is canceled, the indefiniteness rejection is withdrawn. The examiner has used all previous references cited in past rejections in the instant rejections with the exception of Pandey. The arguments for each reference are addressed below the rejection.
Claims 1-3,7,9-14,18-19,21,23,25-26 are under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 21 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 21 recites that the nanocapsules are water soluble; this limitation is already present in independent claim 1. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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.
Claims 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 Labhasetwar (WO2014124142) and Morein (WO2014163558)
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 and Page 12, last paragraph to Page 13, first paragraph 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 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 cannabinoids 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 cannabinoids 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 Labhasetwar teaches that adult stem cells can be used to treat spinal cord injuries (Paragraph 48 of Labhasetwar) as in instant Claim 1.
Yeshurun does not teach that water soluble nanocapsules(Page 1, line 16 of Morein) 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 water-soluble 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 cannabinoid 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 Claims 1- 2 and 22
Dependent Claims taught by Yeshurun
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.
Dependent Claims taught by Morein
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 that cannabinoids can be administered to protect the adult stem cells that are administered for therapeutic purposes. Yeshurun does not specifically teach that such cells can be administered into the bodies of individuals suffering from spine/spinal cord injuries. However, Labhasetwar teaches that adult stem cells can be introduced to treat spine/spinal cord injuries, and artisan would have been motivated to have further added cannabinoids since they would help preserve and protect the administered mesenchymal stem cells. Yeshurun does not teach that the capsule/tablet is water soluble. Yeshurun does not teach that the nanocapsule is composed of a terpene from quillaja. Morein teaches water-soluble 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 KSR 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.
Response to applicants’ arguments
Applicants argue that, “Yeshurun does not teach an encapsulated cannabinoid compound at all” and that its formulation is merely in an oil. The examiner does not find this argument to be persuasive because in pages 12-13 of Yeshurun, the reference states that oral administration can be accomplished by placing the formulation in granules, capsules, lozenges, gels, liposome, etc. The term “encapsulate” is rather broad. To encapsule something can mean enclosing or encasing; this includes enclosing a cannabinoid in an oil. There is nothing in the claim language that specifically rules out oil being present.
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Labhasetwar acknowledges that adult stem cells can be administered into the body of an individual to treat a spine/spinal cord injury. Once those donor adult stem cells are introduced into the recipient’s body, they are at risk of being rejected by the host immune system. This risk can be decreased by administering the cannabinoid composition to the recipients body because it protects the newly administered cells from graft rejection. The instant claims do not require that the cannabinoids heal the spine/spinal injuries themselves, it is enough that they are protecting the administered adult stem cells. Therefore, there is adequate motivation to include a cannabinoid therapy with the administration of adult stem cells.
Applicants argue that the examiner did not fully explain why a person of ordinary skill in the art would have modified Yeshurun’s cannabinoid administration oral composition with Morein’s nanoparticle, nor did examiner adequately explain why such a modification would have been reasonably expected to be successful in the claimed context.”
Yeshurun and Morein are both analogous art references because they teach oral administration compositions. An artisan would have been motivated to have used Morein’s nanocapsule in place of Yeshurun’s capsule because the nanocapsule can still be used for successfully deliver of an agent through oral administration. Because Morein’s delivery agent can successfully deliver agents orally, that is enough of a motivation to use it for the oral delivery taught in Yeshurun.
Conclusion
All claims stand rejected.
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 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
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