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 28-36, 45 and 48-49 are presented for examination.
A request for continued examination under 37 C.F.R. §1.114, including the fee set forth in 37 C.F.R. §1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 C.F.R. §1.114, and the fee set forth in 37 C.F.R. §1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 C.F.R. §1.114. Applicant's submission filed on November 11, 2025 has been entered.
Claims 28-36, 45 and 48-49 are pending. Claims 26, 27, 39-44 and 46-47 are cancelled. Claims 45 and 48 are amended. Claim 49 is newly added.
Applicant’s arguments, filed November 11, 2025, have been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Requirement for Restriction/Election
Applicant is reminded of his election without traverse of the invention of Group I (original claims 1-19), directed to a stable pharmaceutical formulation for oral administration comprising a cannabinoid and a lipid, and the election of (i) cannabidiol (CBD) as the single disclosed species of cannabinoid, (ii) caprylic/capric triglyceride as the single disclosed species of lipid, and (iii) alpha-tocopherol as the single disclosed species of antioxidant, to which examination on the merits has been confined, as stated in the reply filed November 1, 2017, which is still in effect over the claims.
As claims 28-36 remain drawn to non-elected inventions not presently under examination, such claims remain properly withdrawn from consideration pursuant to 37 C.F.R. §1.142(b).
In the claim listing filed November 11, 2025, Applicant seeks the addition of new claim 49, which further defines the formulation of claim 45. As claim 45 defines a composition that comports with the originally elected invention, newly added claim 49 will be rejoined with those claims presently under examination.
Instant claims 45 and 48 remain, and newly added claim 49 is (with claims 26, 37, 39-44, 46 and 47 now being cancelled), directed to the elected subject matter and such claims are herein acted on the merits infra.
Information Disclosure Statement
Applicant’s Information Disclosure Statement filed November 11, 2025 (two pages total) has been received and entered into the present application. As reflected by the attached, completed copy of form PTO/SB/08a, the Examiner has considered the cited references.
Status of Rejections in the June 16, 2025 Final Action
In reply to the rejection of claims 26, 37 and 39-48 under the written description requirement of 35 U.S.C. §112(a) (pre-AIA first paragraph) for the addition of new matter, as set forth at p.4-13 of the previous Office Action dated June 16, 2025, Applicant now cancels claims 26, 37, 39-44 and 46-47 and amends claim 45 in a manner that necessitates withdrawal of the rejection to set forth a new grounds of rejection addressing the amended limitations. Accordingly, the rejection is now hereby withdrawn.
Upon further reconsideration of the claimed subject matter as amended in the most recent claim listing filed November 11, 2025, the following grounds for rejection are also now hereby withdrawn:
(i) the rejection of claims 26, 37, 39, 41-43 and 45-47 under 35 U.S.C. §103 as being unpatentable over Kottayil et al. (WO 2006/063109 A1; 2006) in view of Murty et al. (U.S. Patent Application Publication No. 2011/0092583 A1; 2011) and Goskonda et al. (U.S. Patent No. 8,222,292 B2; 2012), as set forth at p.13-16 of the previous Office Action dated June 16, 2025; and
(ii) the rejection of claims 40, 44 and 48 under 35 U.S.C. §103 as being unpatentable over Kottayil et al. (WO 2006/063109 A1; 2006) in view of Murty et al. (U.S. Patent Application Publication No. 2011/0092583 A1; 2011) and Goskonda et al. (U.S. Patent No. 8,222,292 B2; 2012), as applied to claims 26, 37, 39, 41-43 and 45-47, further in view of Ulrich et al. (WO 2002/072102 A1; 2002), as set forth at p.16-17 of the previous Office Action dated June 16, 2025.
This further reconsideration of the claimed subject matter as amended, however, necessitates new grounds for objection and rejection and such objections and rejections are set forth infra.
Objection to the Claims (New Grounds of Objection)
Claims 48-49 are objected to for reciting “[a] formulation of claim 45”, which is improper, as claim 45 already sets forth the formulation.
Appropriate correction is required.
Applicant may wish to consider amending claims 48-49 to recite ---[t]he formulation of claim 45--- to properly refer back to the formulation already set forth in claim 45, but is reminded that the adoption of such suggestion does not necessarily equate to the obviation of any other objection and/or rejection set forth infra.
Claim Rejections - 35 USC § 112(a) (Pre-AIA First Paragraph)
Written Description, New Matter
(New Grounds of Rejection)
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.
(1) Claims 45 and 48-49 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new matter rejection.
There is insufficient written support for Applicant’s newly amended or newly added limitations directed to (i) the incorporation of “0 to 1% w/w of a flavoring agent” (claim 45), (ii) “wherein the formulation contains less than 0.3% w/w delta-9-tetrahydrocannabinol after storage under conditions selected from the group consisting of four weeks at 55°C + 2°C, four weeks at 40°C + 2°C with 75% + 5% relative humidity, and four weeks at 25°C + 2°C with 60% + 5% relative humidity” (claim 45), or (iii) “wherein said formulation contains less than 0.5% w/w total impurities after storage under said conditions” (claim 49).
At p.5 of the Remarks filed November 11, 2025, Applicant states that “[a]mended claim 45 allows for up to 1% w/w of a flavoring agent, but does not require a flavoring agent”.
Applicant does not identify those portions of the as-filed specification that he relies on to support amending the range of flavoring agent from “0.01 to 1% w/w” to now recite “0 to 1% w/w”.
In the as-filed specification at p.16, para.[000101]-[000102], Applicant describes “suitable flavoring agents” for incorporation into the liquid CBD formulation that contains a lipid (e.g., caprylic/capric triglycerides), and further discloses that “[i]f the formulations contain a flavoring agent, the formulations preferably contain from about 0.001 to about 1%”, or more preferably “about 0.005 to about 0.5%”, of the flavoring agent.
Applicant clearly describes the optional inclusion of the flavoring agent into the CBD and lipid formulation, which establishes possession of the concept in which 0% w/w of the flavoring agent is incorporated into the formulation. In addition, Applicant clearly describes inclusion of a flavoring agent within the range of “about 0.001 to about 1%” w/w of the formulation. It does not, however, describe incorporation of a flavoring agent in any amount up to 1% w/w because the as-filed specification fails to describe the use of flavoring agent in amounts that are both greater than 0% w/w, but less than the lower endpoint of “about 0.001 to about 1%” w/w.
As a result, newly amended claim 45 incorporates subject matter pertaining to the amount of flavoring agent that is not supported by the originally filed disclosure.
Also at p.5 of the Remarks filed November 11, 2025, Applicant states that “claim 45 recites a liquid formulation that requires the presence of caprylic/capric triglyceride and cannabidiol in Applicant’s most preferred concentrations of 66-74% w/w and 28-32% w/w, respectively”, citing to the as-filed specification at p.3, para.[0017] in support.
Applicant goes on to additionally state that “[c]laim 45 encompasses lipid formulations (LFs) exemplified in Applicant’s specification at Table 25 (#LF9-#LF12) and Table 26 (#LF37)” (Remarks, p.5).
There are only two lipid formulations at Table 25 of the as-filed specification that comport with the scope of formulations recited in claim 45:
(i) #LF10, which is defined at Table 25, p.51 of the as-filed specification as 31.09% CBD, 68.385% caprylic/capric triglyceride, 0.2% alpha-tocopherol, 0.025% saccharin, and 0.3% flavor; and
(ii) #LF11, which is defined at Table 25, p.51 of the as-filed specification as 31.09% CBD, 68.085% caprylic/capric triglyceride, 0.5% alpha-tocopherol, 0.025% saccharin, and 0.3% flavor.
Table 26 contains only a single formulation (#LF37) that comports with the scope of formulations recited in claim 45, but this #LF37 formulation is identical to that of #LF10 already provided for in Table 25.
Applicant further asserts that the original disclosure “presents data from storage stability experiments under the claimed storage conditions for lipid formulations #LF9-#LF12 in Applicant’s specification at Example 6, Tables 28-31 (55°C + 2°C), Tables 36-39 (40°C + 2°C and 75% + 5% relative humidity), and Tables 44-45 (25°C + 2°C and 60% + 5% relative humidity - #LF9 and #LF12 only)” (Remarks, p.6).
Applicant alleges that “[t]he data in Example 6 demonstrate that in each case the formulations tested were stable in that they contained less than 0.3% w/w delta-9-tetrahydro-cannabinol after 4 weeks at each of the claimed storage conditions” (Remarks, p.6).
Table 29 (p.55) of the as-filed specification describes storage of the lipid formulation #LF10 at 55°C + 2°C, noting that delta-9-tetrahydrocannabinol was “not detected” after four weeks.
Table 30 (p.55) of the as-filed specification describes storage of the lipid formulation #LF11 at 55°C + 2°C, noting that delta-9-tetrahydrocannabinol was present in an amount of 0.01% after four weeks.
Table 37 (p.58) of the as-filed specification describes storage of the lipid formulation #LF10 at 40°C + 2°C, 75% + 5% relative humidity, noting that delta-9-tetrahydrocannabinol was “not detected” after four weeks.
Table 38 (p.58) of the as-filed specification describes storage of the lipid formulation #LF11 at 40°C + 2°C, 75% + 5% relative humidity, noting that delta-9-tetrahydrocannabinol was also “not detected” after four weeks.
None of the formulations subjected to storage at 25°C + 2°C, 60% + 5% relative humidity at Tables 44-45 (p.61) of the as-filed specification comport with the formulations circumscribed by claim 45 and, therefore, cannot inform the skilled artisan of the expected properties of the formulations of instant claim 45.
Accordingly, while Applicant demonstrates that the lipid formulations #LF10 and #LF11 (which fall within the scope of claim 45) exhibited “less than 0.3% delta-9-tetrahydrocannabinol” after four weeks of storage at 55°C + 2°C (Tables 29-30, p.55) or 40°C + 2°C, 75% + 5% relative humidity (Tables 37-38, p.58), there is no written support to now attribute this property of containing “less than 0.3% w/w delta-9-tetrahydrocannbinol” to the claimed CBD and lipid formulation after four weeks of storage at 25°C + 2°C, 60% + 5% relative humidity when no formulation within the limited scope of claim 45 was actually subjected to such storage conditions.
Applicant’s disclosure at p.14, para.[0089] of the as-filed specification states that “[i]n a most preferred embodiment, the cannabidiol formulation contains less than 0.3% delta-9-tetrahydrocannabinol”, but this statement is also insufficient to establish the necessary written support for Applicant’s amended limitations. This broader description of containing “less than 0.3% delta-9-tetrahydrocannabinol” fails to provide adequate written support to now attribute this same stability property to the formulation of claim 45 when subjected to very specific storage conditions of 25°C + 2°C, 60% + 5% relative humidity.
As a result, newly amended claim 45 incorporates subject matter pertaining to the stability of the formulation at 25°C + 2°C, 60% + 5% relative humidity that is not supported by the originally filed disclosure.
At p.6 of the Remarks filed November 11, 2025, Applicant states that “[d]ependent claim 481 recites a further limitation of 0.5% w/w total impurities after storage” and cites to “Examples 5 and 6 at [0235]-[0238]” of the as-filed specification in support.
At p.63, para.[000237] of the as-filed specification, Applicant states that “#LF9-LF12 demonstrate the ability of alpha-tocopherol (Vitamin E) to surprisingly achieve less than 0.5% total impurities after four weeks at 40°C + 2°C/75% + 5% relative humidity”.
As explained above, Applicant subjected the #LF10 and #LF11 formulations (the sole exemplified formulations that comport with the scope of instant claim 45) only to four weeks of storage at 55°C + 2°C and four weeks of storage at 40°C + 2°C, 75% + 5% relative humidity – not four weeks of storage at 25°C + 2°C, 60% + 5% relative humidity.
Per Tables 29-30 (p.55-56) and Tables 37-38 (p.58-59), only Applicant’s formulations #LF10 and #LF11 demonstrated total impurities of “less than 0.5% w/w” after storage at 40°C + 2°C, 75% + 5% relative humidity. See Table 37 (p.58-59), which reported 0.11% total impurities of #LF10 after four weeks of storage at 40°C + 2°C, 75% + 5% relative humidity, and Table 38 (p.59), which reported 0.22% total impurities of #LF11 after four weeks of storage at 40°C + 2°C, 75% + 5% relative humidity.
However, storage of #LF10 or #LF11 for four weeks at 55°C + 2°C demonstrated total impurities of > 0.5% w/w. See Table 29 (p.55), which reported 1.39% total impurities of #LF10 after four weeks of storage at 55°C + 2°C, and Table 30 (p.55-56), which reported total impurities of 1.64% of #LF11 after four weeks of storage at 55°C + 2°C.
The originally filed disclosure, therefore, fails to provide adequate written support to attribute this newly recited property of “less than 0.5% w/w total impurities after storage” at each of the recited conditions of claim 45, which are (i) four weeks of storage at 55°C + 2°C, (ii) four weeks of storage at 40°C + 2°C, 75% + 5% relative humidity, and (iii) four weeks of storage at 25°C + 2°C, 60% + 5% relative humidity.
As a result, newly added claim 49 incorporates subject matter pertaining to the total impurities of the formulation following storage at each of the three recited conditions that is not clearly supported by the originally filed disclosure.
MPEP §2163 states that “[t]he subject matter of the claim need not be described literally (i.e., using the same terms of in haec verba) in order for the disclosure to satisfy the description requirement.” However, considering the teachings provided in the specification and claims as originally filed, Applicant has failed to provide the necessary teachings by describing the claimed invention in such a way as to reasonably convey to one skilled in the relevant art that Applicant had possession of the concepts directed to (i) the incorporation of “0 to 1% w/w of a flavoring agent” (claim 45), (ii) “wherein the formulation contains less than 0.3% w/w delta-9-tetrahydrocannabinol after storage under conditions selected from the group consisting of four weeks at 55°C + 2°C, four weeks at 40°C + 2°C with 75% + 5% relative humidity, and four weeks at 25°C + 2°C with 60% + 5% relative humidity” (claim 45), or (iii) “wherein said formulation contains less than 0.5% w/w total impurities after storage under said conditions” (claim 49).
Accordingly, the claims are considered to lack sufficient written description and are properly rejected under 35 U.S.C. §112(a) (pre-AIA first paragraph).
Claim Rejections - 35 USC § 112(b) (Pre-AIA Second Paragraph)
(New Grounds of Rejection)
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.
(2) Claim 49 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.
Applicant recites in claim 49 “[a] formulation of claim 45, wherein said formulation contains less than 0.5% w/w total impurities after storage under said conditions”.
The claim is indefinite because it fails to introduce any further limitation to the formulation defined in claim 45 that would account for this additional property. As a result, it is unclear whether claim 49 is directed to an inherent property of the formulation defined by claim 45 (as there is no further limitation on the product set forth and, thus, does not clearly further limit claim 45), or whether it intends to further limit the claim solely to narrower embodiments of the formulation that yield this more specific effect (in which case the claim is additionally indefinite for failing to clearly set forth the specific narrower scope of embodiments within the broader scope of claim 45 that yield the recited property).
Clarification is required.
For these reasons, the claim fails to meet the tenor and express requirements of 35 U.S.C. §112(b) (pre-AIA second paragraph) and is, thus, properly rejected.
Claim Rejections - 35 USC § 112(d) (Pre-AIA Fourth Paragraph)
(New Grounds of Rejection)
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.
(3) Claim 49 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.
As set forth in the §112(b) (pre-AIA second paragraph) rejection above, this rejection applies to the interpretation of claim 49 in which it recites an apparently inherent property of the formulation of claim 45 and, thus, fails to properly further limit the subject matter of parent claim 45.
Clarification is required.
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.
Response to Applicant’s Arguments
In reply, Applicant traverses the previously applied rejections in view of the submitted amendments and arguments (Remarks, p.6-11).
Applicant’s traversal and amendments have been fully and carefully considered, and the previously applied rejections have been withdrawn as indicated above.
Upon further reconsideration of the claimed subject matter as amended, however, new grounds for objection and rejection are necessitated and are set forth infra.
For these reasons supra, rejection of claims 45 and 48-49 is proper.
Conclusion
Rejection of claims 45 and 48-49 is proper.
Claims 28-36 are withdrawn from consideration pursuant to 37 C.F.R. 1.142(b).
No claims of the present application are allowed.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Leslie A. Royds Draper whose telephone number is (571)272-6096. The examiner can normally be reached Tuesday to Thursday (08:30 AM to 05:00 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, Jeffrey S. Lundgren can be reached at (571)-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Leslie A. Royds Draper/Primary Examiner, Art Unit 1629
December 6, 2025
1 It is assumed that Applicant intends to reference claim 49, as it is claim 49 that is directed to “total impurities after storage”, not claim 48.