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 .
DETAILED ACTION
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 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.
Notice of Change of Examiner
The examiner assigned to the application has changed from Janet Joseph to Emily Cordas.
Election/Restrictions
Applicant’s election of Group I, claims 1-6 in the reply filed on Jun. 26, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
In addition, Applicant’s election of the species of stem cell for selected cell, an exosome for selected particle, a stem-cell exosome, and, particularly a mesenchymal stem cell (MSC)-derived exosome for a cell-derived particle, the 5” position for the CBD modification, a phospholipid moiety as a moiety attached to a position of the CBD, a phosphoglycerol as a phospholipid, and Compound 1.1 in Table 1 or PCL5 as the modified CBD is acknowledge. After further consideration of the claims, the species election requirement between the species in claims 2-6 has been withdrawn.
Claims 1-21 remain pending in the current application, claims 7-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Claims 1-6 have been considered on the merits.
Status of the Claims
Claims 1-6 are currently pending.
Claims 7-21 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 1-6 have been considered on the merits.
Specification
The disclosure is objected to because of the following informalities: the use of trademarks.
The use of the terms: TSKgel® G4000 SWXL on pg. 18 line 18; Tween® on pg. 53 line 30; Odyssey® Imager on pp. 53 line 34; Odyssey® 2.1 Software on pg. 54 line 3; Triton™ X on pg. 54 line 8; Alexa Fluor® 488 on pg. 54 line 11; RNeasy® Mini Kit on pg. 54 line 19; SYBR® Green Master mix on pg. 54 line 23, which are a trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
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.
Appropriate correction is required.
Claim Interpretation
In claim 1, the limitation of “a cell-derived particle and a cannabidiol associated with said particle” is being interpreted based on the definition provided in the specification for “associated with” in paragraph 0155 of the published application. The instant specification defines “associated with” as:
“by "associated with" and grammatical diversions thereof it is meant that the CBD and the particle are in association with one another, whereby the association can be a chemical interaction ( e.g., a chemical bond such as a covalent bond, an electrostatic bond, a hydrogen bond) or a physical interaction ( e.g., encapsulation, entrapment, deposition, absorption, etc.).”
Claim Objections
The disclosure is objected to because of the following informalities: minor grammatical error in claims.
Claim 5 is objected to because of the following informalities: the first time an acronym is utilized in a claim-set, said acronym should be spelled out in its entirety followed by said acronym in parenthesis (e.g. cannabidiol (CBD)). It is suggested that this amendment be included in claim 1, where cannabidiol is first mention in the claim set.
Appropriate corrections are appreciated.
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.
Claims 2 and 5 are 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.
In claim 2, line 1, the phrase "said cell" lacks sufficient antecedent basis and renders the claim and its dependents indefinite. In claim 1, from which the claim depends upon, there is no cell, but a cell-derived particle. For the sake of compact prosecution the claim will be interpreted to mean “wherein said cell-derived particle is derived from a stem or progenitor cell.”
The term "preferably" in claim 5 is a relative term which renders the claim indefinite. The term "preferably" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the sake of compact prosecution the phrase, “preferably to position 6 and/or 5” of the CBD” will be interpreted to mean to be optional and not required.
Appropriate correction is required.
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.
(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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Chadwick et al. (WO 2019/204630 A1)(ref. of record).
With respect to claim 1, Chadwick teaches a composition containing a cannabidiol and Aloe Vera in the form of nanoencapsulations (abstract and pg. 2 lines 15-21). Further with respect to claim 1, Chadwick teaches the Aloe Vera used is a plant extract derived from the leaves (a cell-derived particle and would contain membrane particles of the plant cells) (pg. 4 lines 27-29).
Therefore, the reference anticipates the claimed subject matter.
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Aricha et al. (WO 2019/198077 A1) (ref. of record) in view of Kharazmi (US 2020/0030253 A1).
With respect to claims 1 and 3, Aricha teaches a composition containing an exosome and beneficial molecules including therapeutic factors which are encapsulated by the exosome (abstract and 0040, 0151). With respect to claims 2 and 4, Aricha teaches composition where the exosome is from a mesenchymal stem cells (MSCs) and neural progenitor cells (0011, 0036 and 0436). Aricha further teaches exosomes derived from MSCs have the benefit of being able to cross the blood brain barrier (BBB), can be loaded with further beneficial factors and have low immunogenicity (00131).
Zhang does not teach the composition where the beneficial molecule is a cannabidiol as recited in claim 1.
However, Kharazmi teaches a composition containing a cannabidiol and stem cell products (abstract and 0013). Kharazmi teaches the composition including conditioned medium recovered from stem cells (0015, 0021 and 0028). Conditioned medium from stem cells inherently contains exosomes as evidenced by Takeuchi. Takeuchi reports that conditioned media of mesenchymal stem cells contain exosomes (abstract). Kharazmi teaches compositions including growth factors for treating damaged tissue and improve healing (0009) and that they found cannabidiol has beneficial effects when applied with conditioned media from stem cell cultures (0028). Kharazmi teaches cannabidiol has neuroprotective, anti-inflammatory effects and supports bone regeneration (0022 and 0027). Kharazmi further teaches that it has high lipophilicity and low water solubility and teaches the composition where cannabidiol is encapsulated in liposomes (0024).
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the composition of Aricha so that the beneficial molecule is cannabidiol for the benefit of including a known therapeutic agent within the exosome as taught by Kharazmi. It would have been obvious to one of ordinary skill in the art to include additional therapeutic molecules within the exosome taught by Aricha, especially ones known to benefit from being encapsulated in liposomes as taught by Kharazmi. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in encapsulating cannabidiol in the exosomes of Aricha, since Kharazmi teaches cannabidiol can be encapsulated in liposomes and exosome have lipid membranes.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claim 5 and 6 are rejected under 35 U.S.C. 103(a) as being unpatentable over Aricha in view of Kharazmi (as applied to claim 1-4 above), and in further view of Chen et al. (WO 2020/191477 A1).
The teachings of Aricha and Kharazmi can be found in the previous rejection above.
Neither Aricha and Kharazmi teach the composition where the cannabidiol (CBD) is modified with at least one substituent or moiety attached to a position of the CBD as claim 5 is being interpreted as explained in the rejections under 35 U.S.C. §112 (b). Likewise, neither Aricha and Kharazmi teach the modified CBD contains a phospholipid moiety conjugated directly or by a linking moiety as recited in claim 6.
However, Chen teaches a drug moiety that can be cannabidiol with a lipid conjugate (abstract pg. 10 para. 5 and pg. 101 Example 7). Specifically, Chen teaches the lipid conjugate (L) is linked to a molecule of interest (M) by an linker (X1) to form M-X1-L and where X1 is a phosphate (pg. 5 para. 4) Therefore, Chen teaches the lipid can be a phospholipid lipid. Chen teaches the L scaffold (L) forms a carbon backbone of the lipid moiety and has 5 to 40 carbon atoms and a molecule of interest (M) can be attached (pg. 2-3 bridging para.). In addition, Chen teaches that many drugs fail to reach the intended disease site and that drug delivery systems, including lipid nanoparticles, have the potential to overcome this problem (pg. 1 para. 2-3). Chen further teaches by conjugating a drug with a lipid moiety, the drug is more amenable to incorporation in a drug delivery vehicle (pg. 1 last para.). Chen teaches the lipid conjugate can be incorporated in a lipid nanoparticle (LNP) which can be a liposome (pg. 3 last para.).
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the composition taught by the combined teachings of Aricha and Kharazmi so that the is cannabidiol is conjugated with phospholipid moiety for the benefit improving its incorporation in liposomes such as the exosome as taught by Chen. It would have been obvious to one of ordinary skill in the art to include a modified CBD with a conjugated phospholipid moiety in the composition taught by the combined teachings of Aricha and Kharazmi, since cannabidiol conjugated with a phospholipid was known and the conjugation was known to improve the association with liposomes as taught by Chen. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in including a modified cannabidiol in the exosomes of Aricha and Kharazmi, since Chen teaches cannabidiol can be modified with a phospholipid and further incorporated into liposomes and since exosomes have lipid membranes like liposomes.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EMILY A CORDAS/Primary Examiner, Art Unit 1632