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 .
DETAIL ACTION
This office action is a response to a 371 application filed -----10/14/2022, which is a national stage application of PCT/CA2021/050516 filed 4/16/2021, which claims foreign priority to CA3078970 filed 4/16/2020.
As filed, claims 1, 2, 4-6, 9, 11-14, 18, and 20-28 are pending, wherein claim 1 is an independent claim; and claims 3, 7, 8, 10, 15-17, and 19 are cancelled.
Election/Restrictions
Regarding the election of species requirement, Applicant, without traverse, elected the species of PTS monomer for the compound of instant formula (I), which has the structure of:
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.
This elected species can be found in paragraph 0042 of the instant specification. The claims, which read on the elected species, are instant claims 1, 2, 4-6, 9, 11-14, 18, and 20-28, according to Applicant’s reply filed 1/2/2026.
Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species . Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does makes a contribution over the prior art. Therefore, according to MPEP 803.02: should the elected species appear allowable, the search of the Markush-type claim will be extended. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The Examiner need not extend the search beyond a proper Markush grouping.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/20/2023 has been considered by the Examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112(a)
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 1, 2, 4-6, 9, 11-14, 18, and 20-28 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 claim(s) contains 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation, “derivative thereof”, in reference to sterols or tocopherols of instant variable X or in reference to polyalcohols or polyethers of instant variable Y. Applicant has not described the claimed genus of "derivative thereof" in a manner that would indicate they were in possession of the full scope of this genus, or even to describe what this genus is comprised of.
Regarding the requirement for adequate written description of chemical entities, Applicant's attention is directed to the MPEP §2163. In particular, Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish or plain for obtaining the claimed chemical invention." Eli Lilly, 119 F.3d at 1566. The Federal Circuit has adopted the standard set forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent Applications under the 35 U.S.C. 112.1 "Written Description" Requirement ("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5, 2001), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including, inter aria, "functional characteristics when coupled with a known or disclosed correlation between function and structure..." Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. at 1106 (emphasis added)). Moreover, although Eli Lilly and Enzo were decided within the factual context of DNA sequences, this does not preclude extending the reasoning of those cases to chemical structures in general. Univ. of Rochester v. G.D. Searle & Co., 249 Supp. 2d 216, 225 (W.D.N.Y. 2003).
In the instant case, the claimed "derivative thereof" encompass sterols, tocopherols, polyalcohols or polyethers with a differing, limitless, and undefined variation quoted for the identical purpose. Applicants failed to provide any example of “derivative thereof”, in respect to sterols or tocopherols of instant variable X or in respect to polyalcohols or polyethers of instant variable Y, which are not described adequately enough to allow one skilled in the art to ascertain that Applicant is in possession of the entire scope of that genus. Applicants have not described this genus in a manner that would allow one skilled in the art to immediately envisage the derivative of sterols, tocopherols, polyalcohols or polyethers contemplated for use. As such, the claims lack adequate written description for the claimed “derivative thereof", in respect to sterols or tocopherols of instant variable X or in respect to polyalcohols or polyethers of instant variable Y.
Regarding claims 2, 4-6, 9, 11-14, 18, and 20-28, these claims are directly or indirectly dependent of claim 1, and they failed to correct the defective issue in claim 1, which rendered these claims improper.
Claim Rejections - 35 USC § 112(b)
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 11 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 11, the claim recites the phrase, “The formulation of claim 1, wherein when p, m and q are all equal to 1”. The formulation of claim 1 does not recite a variable m, which introduces ambiguity into the metes and bounds of this claim, which rendered the claim indefinite.
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)(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.
Claims 1, 2, 4-6, 9, 11, 13, and 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Foreign Patent Application Publication No. WO2020/232379, hereinafter Maggio.
Regarding claims 1, 2, 4-6, 9, 11, 13, and 18, Maggio, for instance, teaches a CBD suspension composition comprising CBD suspension, vitamin E TPGS (i.e. compound of instant formula I), etc. Maggio also teaches that the CBD suspension in the abovementioned formulation is made through the combination of the cannabinoid with a pharmaceutically acceptable oil formulation. All of which meet all the limitations of these claims.
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(paragraphs 00099-000100, Table 2, and Example 2)
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(structure of vitamin E TPGS)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Maggio.
Regarding claims 21-24:
Determining the scope and contents of the prior art:
Maggio, for instance, teaches the abovementioned CBD suspension composition.
Ascertaining of the difference between the prior art and the claim at issue:
For claim 21, Maggio, for instance, did not explicitly teach ratio of the compound of instant formula (I) to the cannabinoid composition is from about 1:1 to about 15:1, etc.
For claim 22, Maggio, for instance, did not explicitly teach the ratio of the compound of instant formula (I) to the cannabinoid composition and the carrier is from about 1:1:1 to about 15:1:1, etc.
For claim 23, Maggio, for instance, did not explicitly teach the ratio of the compound of instant formula (I) to a mixture of the cannabinoid composition and the carrier oil is from 1:1 to about 15:1, etc.
For claim 24, Maggio, for instance, did not explicitly teach at least 12.5 mg/ml of CBD.
Finding of prima facie obviousness --- rationale and motivation:
The Examiner does not find the abovementioned ratios as result-effective variables because the Applicant fails to demonstrate these parameters to impart any unexpected or novel aspect to the instant process (i.e. no comparative example). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05. Accordingly, these parameters are viewed as routine experimentation to optimize the instant formulation, and not a patentable distinction.
Claims 1, 2, 4-6, 9, 11, 13, 18, 20, and 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Foreign Patent Application Publication No. WO2016/044813, hereinafter Bromley.
Regarding claims 1, 2, 4-6, 9, 11, 13, 18, 20, and 25-28:
Determining the scope and contents of the prior art:
Bromley, for instance, teaches an emulsion containing a pre-emulsion concentrate that contains MCT oil, vitamin E TPGS (i.e. compound of instant formula I), one additional non-polar ingredient (i.e. vitamin K2), and a preservative (i.e. benzyl alcohol) dispersed in water in the form of micelles, wherein the micelles can have an average size of less than about 20 nm.
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(pg. 220, lines 5-13)
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(pg. 224, Table 102)
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(pg. 35, lines 17-29)
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(pg. 37, lines 1-16)
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Ascertaining of the difference between the prior art and the claim at issue:
In the abovementioned emulsion, Bromley, for instance, did not explicitly teach the additional non-polar ingredient to be cannabinoid.
Finding of prima facie obviousness --- rationale and motivation:
With respect to this difference, MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at ___, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
Based on the teachings of the MPEP and KSR above, by employing the rationale in (B) above, it would have been obvious for one of ordinary skill in the art to modify the abovementioned additional ingredient of Bromley (i.e. vitamin K2) to include cannabinoid, as taught by the preferred embodiment or blazemark of Bromley (shown below), in order to arrive at the instantly claimed formulation because there’s a reasonable expectation of success that about cannabinoid can be used to make the abovementioned emulsion, since both vitamin K2 and cannabinoid are both non-polar ingredients.
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(pg. 109, lines 24-25)
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(pg. 240, lines 14-19)
Claim Objections
Claims 26 and 28 are objected to because of the following informalities:
Regarding claim 26, the claim recites the phrase, “dispersed in the water in the form of micelles”.
Such expression can be clarified by reciting -- dispersed in the water in
Regarding claim 28, the claim recites the phrase, “or comprising a combination of any two or more thereof”.
Such expression can be clarified by reciting -- or comprising a combination of any two or moreof adjuvant, colorant, flavoring agent, preservative or buffer --.
Appropriate correction is required.
Conclusion
Claims 1, 2, 4-6, 9, 11-14, 18, and 20-28 are rejected.
Claims 26 and 28 are objected.
Claims 3, 7, 8, 10, 15-17, and 19 are cancelled.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621