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
Claims 1, 4-20 and 23 are pending in the application. Claims 1 and 4-20 are rejected. Claim 23 is withdrawn.
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. § 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1 and 4-20, drawn to methods for preventing or reducing acute or chronic neuroinflammation or neurodegeneration, and/or preventing or treating a disease or disorder associated with acute or chronic neuroinflammation.
Group II, claim 23, drawn to a composition comprising a therapeutically effective amount of CBD and a pharmaceutically acceptable carrier.
Election of Species
Claims 1, 4-20 and 23 are directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows: a species of a disease or disorder associated with acute or chronic neuroinflammation.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a composition comprising a therapeutically effective amount of CBD, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of The Daytona Beach News- Journal (www.news-journalonline.com/picture-gallery/news/2018/04/21/photos-hemp-oil-dilemma/818206007/) which teaches administering CBD to treat a patient with Sanfilippo syndrome (i.e., mucopolysaccharidosis IIIB) as discussed below in the rejection under 35 U.S.C. § 102(a)(1).
During a telephone conversation with HEATHER B KROONA on November 25, 2025 a provisional election was made with without traverse to prosecute the invention of Group I, claims 1 and 4-20, and further elect species of mucopolysaccharidosis IIIB (as recited in claim 14). Affirmation of this election must be made by Applicant in replying to this Office Action. Claims 1 and 4-20 read on the elected species. Claim 23 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Priority
This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2022/014583, filed on January 31, 2022, which claims benefit of Provisional Application No. 63/144,324, filed on February 1, 2021.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on December 13, 2023 and November 4, 2024 are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
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.
Claims 1 and 5-20 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.
Claim 1 recites the relative expression “functional equivalent” and is rejected as indefinite. The function of cannabinoid in the context of the claimed environment is inter alia one of preventing or treating a disease or disorder associated with neuroinflammation. Therefore, it is unclear whether Applicant intended a functional equivalent of cannabinoid to be limited to, for example, a) a compound which falls under the cannabinoid class of compounds or b) any potential therapeutic compound capable of preventing or treating a disease or disorder associated with neuroinflammation. Considering that the instant specification does not provide a standard for ascertaining the requisite degree of this relative expression, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. A claim that requires the exercise of subjective judgment without restriction may render the claim indefinite. In re Musgrave, 431 F.2d 882, 893, 167 USPQ 280, 289 (CCPA 1970). Applicant may overcome this issue of indefiniteness by, for instance, incorporating the limitations of claim 4 into claim 1. Dependent claims 5-20 do not correct this issue of indefiniteness and are likewise rejected.
Claims 5 and 7-9 recite the limitation “the CBD” and are rejected as indefinite. There is a lack of antecedent basis for “the CBD” in each claim as parent claim 1 does not recite a CBD. It is suggested Applicant amend the claim to be dependent on claim 4 (which provides for “CBD”) instead of claim 1 as this appears to be Applicant’s intent.
Claim 12 recites the limitation “the disease, disorder, or condition” and is rejected as indefinite. There is insufficient antecedent basis for this limitation in the claim. It is suggested Applicant replace “the disease, disorder, or condition” with -the disease or disorder associated with acute or chronic neuroinflammation- for sake of consistency. Dependent claims 13 and 14 do not correct this issue of indefiniteness and are likewise rejected.
Claims 15 and 18 recite “the reduction of severity or duration or both delayed onset of neuroinflammation” and is rejected as indefinite. Parent claim 1 does not provide for a reduction per se; therefore, there is a lack of antecedent basis for the above expression in the claim. Furthermore, the expression itself is ambiguous (perhaps due to grammatical and/or typographical errors). It is suggested Applicant amend claims 15 and 18 to be dependent on claim 11 as this appears to be Applicant’s original intent. Dependent claim 17 does not correct the issue of indefiniteness in parent claim 15 and is, therefore, rejected. Claim 18 is further rejected as indefinite as it recites the limitation “the secretion of inflammatory signaling molecules” without sufficient antecedent basis for this limitation in the claim. It is also suggested that Applicant amend claim 18 to replace “the secretion of inflammatory signaling molecules” with -secretion of inflammatory signaling molecules-.
Claim 16 recites the limitation “the expression of CD68” and is rejected as indefinite. There is insufficient antecedent basis for this limitation in the claim. It is suggested Applicant amend claim 16 to replace “the expression of CD68” with -expression of CD68- for sake of clarity and consistency.
Claim 17 recites the limitation “the expression of GFAP” and is rejected as indefinite. There is insufficient antecedent basis for this limitation in the claim. It is suggested Applicant amend claim 17 to replace “the expression of GFAP” with -expression of GFAP- for sake of clarity and consistency.
Claim 19 recites the limitation “the secretion of inflammatory signaling molecules” and are rejected as indefinite. There is insufficient antecedent basis for this limitation in the claim. Applicant should amend parent claim 18 as suggested above to overcome the lack of antecedent basis issue in claim 19.
Claim 20 recites the limitation “the effective amount CBD” and is rejected as indefinite. There is insufficient antecedent basis for this limitation in the claim. It is suggested Applicant amend claim 20 to be dependent on claim 4 (which provides for CBD) as this appears to be Applicant’s original intent. In addition, Applicant should further amend the claim to replace “the effective amount CBD” with -the effective amount of CBD- for sake of clarity.
Claim Rejections - 35 USC § 112(d)
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 13 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 13 recites the limitation “wherein the disease, disorder, or condition is mucopolysaccharidosis III.” However, parent claim 12 from which claim 13 depends does not recite “mucopolysaccharidosis III” as a “disease, disorder, or condition.” Therefore, claim 13 fails to include all the limitations of parent claim 12. It is suggested Applicant amend claim 13 to further limit “Lysosomal Storage Disease” as opposed to further limiting “the disease, disorder, or condition.” Claim 14 which depends on claim 13 should also be amended accordingly to maintain consistency.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 4, 10-13 and 15-19 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Daytona Beach News (The Daytona Beach News- Journal. www.news-journalonline.com/picture-gallery/news/2018/04/21/photos-hemp-oil-dilemma/818206007/; April 21, 2018) as evidenced by Valstar et al. (J Inherit Metab Dis. 2010, 33(6):759-767).
Instant claim 1 is drawn towards i) a method for preventing or reducing acute or chronic neuroinflammation or neurodegeneration and/or ii) a method for preventing or treating a disease or disorder associated with acute or chronic neuroinflammation. It appears, based on support found throughout the instant disclosure, that Applicant differentiates between “neuroinflammation/neurodegeneration” and “a disease or disorder associated with neuroinflammation.” For instance, paragraph [0080] of the instant specification states “the neuroinflammation may be CNS and peripheral neuroinflammation” and also the following:
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Therefore, any prior art reference which reads on either i) or ii) as described above would read on instant claim 1 as a whole. For the purposes of examination, instant claim 1 is being interpreted as being drawn towards a method for treating a disease or disorder associated with acute or chronic neuroinflammation in a subject in need thereof [i.e., ii)].
Regarding ii), Applicant discloses in paragraph [0082] of the instant specification that “the term ‘treating’...refers to...reducing the signs or symptoms or both of the disease, disorder or condition.” Paragraph [0082] further provides the following:
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Regarding instant claims 1, 4, 10, 12 and 13, the prior art (i.e., Daytona Beach News) teaches administering CBD “in the form of edible gummies, honey and sublingual drops” (in other words an oral formulation comprising one or more pharmaceutically acceptable carrier ingredients) to “soothe the symptoms of Sanfilippo syndrome” in a patient with Sanfilippo syndrome. See e.g., pages 7, 11 and 12. Note: Sanfilippo syndrome is also known as mucopolysaccharidosis type III as evidenced by Valstar et al. which discloses “[m]ucopolysaccharidosis type III (MPS III, Sanfilippo syndrome) is an autosomal recessive lysosomal storage disorder.” See e.g., page 759. The prior art further teaches administering CBD to an individual with MPS III results in a “night and day” difference where the individual “rests all night and is able to focus.” See e.g., page 14. Therefore, the prior art- to the extent that it teaches administering CBD to a MPS III patient which results in a qualitatively measured decrease in symptoms associated with MPS III (i.e., “extreme hyperactivity, seizures and sleep and behavior issues”)- anticipates instant claim 1. See e.g., page 14.
Claims 11 and 15-19 are drawn towards characteristics (e.g., reduction of severity, duration, onset, etc. of neuroinflammation) that would necessarily be present from administering the claimed composition of parent claim 1 to an identical patient population and, therefore, do not further limit the scope of parent claim 1. See MPEP § 2112.01 which states: A chemical composition and its properties are inseparable; therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Accordingly, in view of the rejection of instant claim 1 under 35 U.S.C. § 102(a)(1), claims 11 and 15-19 that depend therefrom are also rejected.
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 5-9, 14 and 20 are rejected under 35 U.S.C. § 103 as being unpatentable over Daytona Beach News (The Daytona Beach News- Journal. www.news-journalonline.com/picture-gallery/news/2018/04/21/photos-hemp-oil-dilemma/818206007/; April 21, 2018) in view of Valstar et al. (J Inherit Metab Dis. 2010, 33(6):759-767) and Sekar et al. (F1000Res. 2019 Feb 28;8:F1000 Faculty Rev-234).
Determining the scope and contents of the prior art (See MPEP § 2141.01)
Daytona Beach News teaches administering CBD “in the form of edible gummies, honey and sublingual drops” to “soothe the symptoms of Sanfilippo syndrome” in a patient with Sanfilippo syndrome. See e.g., pages 7, 11 and 12. Note: Sanfilippo syndrome is also known as mucopolysaccharidosis type III as evidenced by Valstar et al. which discloses “[m]ucopolysaccharidosis type III (MPS III, Sanfilippo syndrome) is an autosomal recessive lysosomal storage disorder.” See e.g., page 759. The prior art further teaches administering CBD to an individual with MPS III results in a “night and day” difference where the individual “rests all night and is able to focus” (i.e., a qualitatively measured decrease in symptoms associated with MPS III). See e.g., page 14.
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claims 5 and 7-9, Daytona Beach News does not teach the instantly claimed limitations regarding CBD purity. However, Sekar et al. teach “the FDA approval of Epidiolex- a new, 99% pure, oral CBD extract” which satisfies all limitations recited in instant claims 5 and 7-9. See e.g., page 3.
Regarding instant claim 6, Daytona Beach News does not teach Cannabis sativa. However, Sekar et al. teach “[c]annabis, derived from the plant Cannabis sativa.” See e.g., page 3.
Regarding instant claim 14, Daytona Beach News does not specify that the Sanfilippo syndrome (i.e., mucopolysaccharidosis type III, MPS III) is either the mucopolysaccharidosis IIIA or IIIB (i.e., MPS IIIA or MPS IIIB) disease subset. However, Valstar et al. provides clinical data demonstrating that a majority of MPS III patients “showed a much more attenuated course of the disease” wherein the attenuated phenotype corresponds to “MPS IIIB [which] comprises a remarkably wide spectrum of disease severity.” See e.g., page 759.
Regarding instant claim 20, Daytona Beach News does not teach the instantly claimed effective dosages of CBD. However, Sekar et al. teach a CBD “target dose of 20 mg/kg per day” which reads on the limitations of instant claim 20. See e.g., page 4.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 5-9 and 20, it would have been obvious to a person of ordinary skill in the art to arrive at the instantly claimed methods based on the teachings of the prior art. Considering that Daytona Beach News teach “CBD gummies” being administered to a patient to reduce or “soothe the symptoms of Sanfilippo syndrome” (see e.g., page 7), it would be within the ability of a person of ordinary skill to take into consideration other forms of CBD available on the market to also treat the same disease. Accordingly, a person of ordinary skill would readily consider the FDA approved, 99% pure, oral CBD extract derived from Cannabis sativa (i.e., EPIDIOLEX®) as taught by Sekar et al. (see e.g., page 3) to be one such option. Therefore, at least in the interest of utilizing a FDA approved CBD formulation as a viable starting point, a person of ordinary skill would be motivated to employ the instantly claimed methods.
Regarding instant claim 14, although Daytona Beach News does not describe a subtype of MPS III (e.g., MPS IIIA or MPS IIIB), it would, nevertheless, have been obvious to a person of ordinary skill in the art to arrive at the instantly claimed method in view of the teachings of Valstar et al. which teach a large proportion of MPS III patients exhibit the MPS IIIB phenotype. Therefore, a person of ordinary skill in the art would expect that the MPS III patient population in need of treatment would also include patients with MPS III subtypes, such as MPS IIIB, as “[c]linical signs, symptoms, and course of the disease are indistinguishable among the MPS III subtypes.” See e.g., page 759. Accordingly, at least in the interest of providing treatment to a larger portion of the MPS III patient population, a person of ordinary skill would be motivated to employ the instantly claimed method.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID SHIM whose telephone number is (571)270-1205. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM EST.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626