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, 5-10 and 12-20 are pending in the application. Claims 1, 5-10 and 12-20 are rejected.
Response to Amendments
Objections and rejections made in the Office Action mailed December 15, 2025 that do not appear below have been overcome by Applicant’s amendments to the claims and have been withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 should be amended to replace “wherein the effective amount of CBD” with -wherein the therapeutically effective amount of CBD- for sake of consistency.
Appropriate correction is required.
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 18 and 19 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 18 recites the limitation “The method according to claim 11” and is rejected as indefinite. There is insufficient antecedent basis for this limitation in the claim as “claim 11” was canceled by Applicant. Claim 18 also remains 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 suggested that Applicant amend claim 18 to replace “the secretion of inflammatory signaling molecules” with -secretion of inflammatory signaling molecules-. Dependent claim 19 is likewise rejected as being indefinite.
Response to Arguments - 35 USC § 102
In reply, Applicant traverses the claim rejections under 35 U.S.C. § 102 as presented in the Nonfinal Rejection mailed December 15, 2025. Applicant’s arguments, however, are in reference to newly amended claim 1. For instance, Applicant argues that “Daytona Beach News fails to mention the dosage, provide a purified CBD product, or teach a dosage range of 10-100 mg/kg/daily.” See page 7 of Applicant’s Remarks dated April 15, 2026. Therefore, Applicant’s arguments along with the claim rejections under 35 U.S.C. § 102 as presented in the Nonfinal Rejection mailed December 15, 2025 are rendered moot by Applicant’s amendment, filed on April 15, 2026, and the rejection is hereby withdrawn. Notwithstanding, it appears Applicant’s position is that a person of ordinary skill in the art would not have recognized the nexus between administering CBD and treating Sanfilippo Syndrome as suggested by the Daytona Beach News reference. For instance, Applicant argues that the documented effects may or may not be attributed to CBD since the reference is drawn towards an “unregulated full spectrum hemp extract having a variety of cannabinoids and infused with CBD” and “there is no way to know what was giving [the patient] the benefit claimed.” See page 7 of Applicant’s Remarks dated April 15, 2026. However, Daytona Beach News does not teach away from treating Sanfilippo Syndrome with CBD administration. On the contrary, the reference as a whole appears to be drawn towards promoting the use of CBD to alleviate the symptoms of Sanfilippo Syndrome. Furthermore, MPEP § 2144.04(VII) states: Purer forms of known products may be patentable, but the mere purity of a product, by itself, does not render the product nonobvious. Therefore, a person of ordinary skill in the art would be motivated to at least attempt administering CBD to a patient with Sanfilippo Syndrome with a reasonable expectation of success.
Response to Arguments - 35 USC § 103
In reply, Applicant traverses the claim rejections under 35 U.S.C. § 103 as presented in the Nonfinal Rejection mailed December 15, 2025. The newly applied 35 U.S.C. § 103 rejection of claims 1, 5-10 and 12-20 has been necessitated by Applicant’s amendment filed on April 15, 2026. The previously presented rejection under 35 U.S.C. § 103 in the Office Action mailed December 15, 2025 has been withdrawn and replaced with the rejection(s) below. Applicant’s remarks, dated April 15, 2026, relevant to the newly applied 35 U.S.C. § 103 are addressed below.
Applicant argues that “[w]ith respect to amended claim 1, the combined [prior art] references do not apparently teach wherein the composition is effective to reduce severity, duration, and/or delays onset of neuroinflammation in the subject.” See page 8 of Applicant’s Remarks dated April 15, 2026. As stated previously and as discussed below, 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. Furthermore, Daytona Beach News effectively teaches administering CBD to a MPS III patient which results in a qualitatively measured decrease in symptoms associated with MPS III. See e.g., page 14. Therefore, Daytona Beach News does teach administration of a CBD composition to apparently reduce the signs or symptoms of neuroinflammation (i.e., “extreme hyperactivity, seizures and sleep and behavior issues”) in a subject in need thereof.
Applicant also presents in vivo data obtained from a mouse model as constituting unexpected results. See pages 8-9 of Applicant’s Remarks dated April 15, 2026. However, the data provided by Applicant is drawn towards the effects of an oral CBD composition compared to a vehicle control with respect to MPS IIIB but does not necessarily demonstrate how Applicant’s invention is considered “unexpected” with regards to the prior art as a whole. Therefore, Applicant’s assertion for “unexpected results” with respect to the instantly claimed invention merely amounts to a beneficial result (e.g., “reduction in CD68 and GFAP associated with microglial and astrocyte cells activation, respectively”) which has not been shown to have a significance equal to or greater than the expected properties. “Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof.” In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967). Evidence of a greater than expected result may […] be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately. Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). Furthermore, Applicant’s assertions concerning these beneficial results (i.e., “reduction in CD68 and GFAP associated with microglial and astrocyte cells activation, respectively”) are directed towards non-limiting characteristics that would necessarily be present from administering the claimed composition of the instant invention to the claimed patient population. 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). Therefore, the instant claims are prima facie obvious over the prior art.
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, 5-10 and 12-20 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)
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. Based on support found throughout the instant disclosure, 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 meet the requirements of instant claim 1. 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, 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 effectively 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”). See e.g., page 14.
Note that the expression “wherein the composition is effective to reduce severity, duration, and/or delays onset of neuroinflammation in the subject”, as recited in instant claim 1, is drawn towards characteristics that would necessarily be present from employing the instant method and is, therefore, considered to be non-limiting. Similarly, claims 15-19 are also drawn towards non-limiting characteristics that would necessarily be present from administering the claimed composition of parent claim 1 to the claimed patient population. 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).
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claims 1, 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.” See e.g., page 3. Note: “synthetic CBD” as recited in the instant claims is defined in paragraph [0031] of the instant specification as “compris[ing] at least 98% (w/w) CBD.”
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 claims 1 and 20, Daytona Beach News does not teach the instantly claimed effective dosages (range) of CBD. However, Sekar et al. teach a CBD “target dose of 20 mg/kg per day” which is encompassed by the claimed ranges recited in instant claims 1 and 20. See e.g., page 4.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 1, 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 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) as one such option. Therefore, at least in the interest of utilizing a FDA approved CBD formulation, 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.
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 extension fee 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.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626
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