DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/28/2026, has been entered.
Withdrawn Rejection
The rejection of claims 1-14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is overcome by the Applicant’s amendment, and is hereby withdrawn. Specifically, Applicants amended claim 1 so that claim 1 no longer recites the limitation “heating”.
The rejection of claims 1-7, 10 and 13 under 35 U.S.C. 102(a)(2) as being anticipated by Detzel of record (U.S. Pub. No. 20200315965), is overcome by the Applicant’s amendment, and is hereby withdrawn. Specifically, Applicant amended claim 1 so that claim 1 now requires an emulsifier consisting essentially of a Quillaja extract.
The rejection of claims 1-14 under 35 U.S.C. 103 as being unpatentable over:
1) Detzel of record (U.S. Pub. No. 20200315965) and Heller of record (U.S. Pub. No. 20200054702); and
2) Detzel (U.S. Pub. No. 20200315965) and Sinai of record (U.S. Pub. No. 20180042845),
is overcome by the Applicant’s amendment, and is hereby withdrawn. Specifically, Applicant amended claim 1 so that claim 1 now requires an emulsifier consisting essentially of a Quillaja extract.
Status of the Claims
Claims 1-14 are pending.
Applicants’ arguments filed on 01/28/2026, 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 Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn.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.
Applicants’ amendments filed on 01/28/2026, have been fully considered. Applicants have amended claims 1 and 14. Therefore, claims 1-14 are subject of the Office action below.
Claim Rejections - 35 USC § 112-2nd Paragraph
New Grounds of Rejection Necessitated by Applicants’ Amendments
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.
As per MPEP 2173.02, “[d]uring prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude (emphasis added). See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc).”
If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate (emphasis added). See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
Claims 1-14 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. Claims 2-14 depend from claim 1, and are therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for reasons set forth below.
Claim 1 recites:
i) “wherein the emulsion is stable in the product”; and
ii) “wherein stability of the emulsion in the product is indicated by the emulsion having less than 5% droplet size growth in average droplet size if the product is heated at 60 oC for 48 hours as measured by Dynamic Light Scattering”.
However, a person skilled in the cannot reasonably determine the meets and bounds of the recited limitations. This is because it is not clear from either the specification or the common teachings in the art how this limitation further limits the claims. For example, it is unclear to one skilled in the art as to what emulsion composition of claim 1, would be stable in a product of claim 1, and what emulsion composition of claim 1, would not be stable in a product of claim 1. The scope of the stability of an emulsion composition of claim 1 in a product of claim 1, is not defined by the claims or the instant specification. It is not clear to a person skilled in the art if this limitation is limiting to a certain emulsion composition potency, carrier oil, an emulsifier, water or product.
The specification does not teach or provide a nexus between the functional result that Applicant claims to achieve by the claimed emulsion for incorporation into a product, with any particular component of the emulsion or the manner in which it is formed or incorporated into a product. There is no description as to the pharmaceutical approach that makes these results possible, nor does the specification teaches any emulsion composition potency, carrier oil, an emulsifier, water or product, to avoid. The specification does not provide a standard for ascertaining the requisite degree. Thus, one of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claims.
Accordingly, for the purpose of examination, any emulsion composition of claim 1, is being included in the interpretation of: i) “wherein the emulsion is stable in the product”; and ii) “wherein stability of the emulsion in the product is indicated by the emulsion having less than 5% droplet size growth in average droplet size if the product is heated at 60 oC for 48 hours as measured by Dynamic Light Scattering”. Appropriate correction is required.
This lack of clarity makes it impossible to ascertain with reasonable precision when that claim is infringed and when it is not. Lacking such clarity, the skilled artisan would not be reasonably apprised of the metes and bounds of the subject matter for which Applicants seek patent protection. Rather, a subjective interpretation of the claimed language would be required. However, as such is deemed inconsistent with the tenor and express language of 35 U.S.C. § 112, second paragraph, the claims are deemed properly rejected.
Claim Rejections - 35 USC § 112-1st paragraph, Maintained
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.
The rejection of claims 1-14 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is maintained for the reasons of record set forth in the previous Office action, of which said reasons are herein reiterated. Claims 2-14 depend from claim 1, and are therefore, also rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for reasons set forth below.
MPEP 2163 states:
“An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention….one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process”.
. Applicants have amended claim 1 to introduced an emulsion composition that “comprises a ratio of Quillaja extract to total oil from 0.05 to 0.11”. Applicants cite ¶ 00194 and Table 26 of the specification, as allegedly providing support for the newly introduced emulsion composition (see page 7 of Remarks).
However:
1) ¶ 00194 only states that Quillaja extract is usually at least 0.05 times the total amount of cannabinoid(s) and carrier oil. A review of the specification, fails to provide adequate support for an emulsion composition that “comprises a ratio of Quillaja saponin to total oil from 0.05 to 0.11”, in ¶ 00194.
2) Table 26 is reproduced below.
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A review of the specification, fails to provide adequate support for an emulsion composition that “comprises a ratio of Quillaja extract to total oil from 0.05 to 0.11”, in Table 26.
Applicants’ response filed on 01/28/2026, has introduced new matter. Applicants have amended claim 1 to newly introduce a particular emulsion composition that is not described in the specification in such a way as to reasonably convey to one skilled in the art that the Applicants, at the time of the instant application, have possession of an emulsion composition that “comprises a ratio of Quillaja extract to total oil from 0.05 to 0.11”. In particular, a review of the specification and claims as originally filed (including ¶ 00194 and Table 26 of the specification, cited by the Applicants as allegedly providing support for the newly introduced emulsion composition), fails to provide adequate support for an emulsion composition that “comprises a ratio of Quillaja extract to total oil from 0.05 to 0.11”, recited in instant claim 1.
New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See MPEP § 608.04(a) to § 608.04(c). Accordingly, the claim is considered to lack sufficient written description and are properly rejected under 35 U.S.C. 112(pre-AIA ), first paragraph.
Claim Rejections - 35 USC § 103
New Grounds of Rejection Necessitated by Applicants’ Amendments
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 1-7, 10-11 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Woelfel et al (hereinafter “Woelfel”, U.S. Pub. No. 20190015383, published 01/17/2019).
By way of a background, Applicant’s invention (see, e.g., ¶ 0004 of the specification), is drawn to an emulsion composition comprising at least 30 mg/g of one or more active agents, a carrier oil, an emulsifier (e.g., Quillaja extract), and water, wherein the emulsifier can be at least 0.05 times the total amount of the one or more active agent and carrier oil by weight (see ¶ 0006 of the specification). Quillaja extract contains triterpenoid saponins (see ¶ 0043 of the specification).
Under the broadest reasonable interpretation (BRI), consistent with the specification, independent claim 1 is being interpreted as an emulsion composition for incorporation into a product (intended use, emphasis added), comprising:
1) at least 30 mg/g THC and/or CBD;
2) a carrier oil;
3) Quillaja extract as the only emulsifier; and
4) water,
wherein the composition comprises Quillaja saponin from 0.05 to 0.11 times the total amount of the one or more active agent and carrier oil by weight.
Regarding claim 1, Woelfel relates emulsion compositions that can be incorporated into a product (see abstract and ¶ 0023). Specifically, Woelfel teaches emulsion droplets composition comprising: i) 23.4% wt CBD, ii) medium chain triglyceride (MCT oil, a carrier oil, see ¶ 0043), iii) Quillaja extract as the only emulsifier and iv) water. Please see Example 8 and Table 10 below.
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The 23.4% wt CBD (23.4 g CBD/100 g total = 23400 mg CBD/100 g total), is equivalent to 234 mg/g, i.e., at least 30 mg/g recited in claim 1.
Quillaja extract is 0.73 times the total oil (CBD+MCT oil), i.e., 36.0/23.4+25.7 = 36.0/49.10 = 0.73.
Although Woelfel does not explicitly teach an exemplary emulsion composition, wherein the amount of Quillaja extract is from 0.05-0.11 times the total oil, the claimed ratio of 0.05-0.11 would have been obvious over Woelfel. This is because Woelfel (see ¶ 0012), discloses that the weight ratio of a water-soluble agent to hydrophobic component (i.e., purified oil distillate + carrier oil), may range from about 10.1 to about 1:100, such as from about 5:1 to about 1:50, from about 4:1 to about 1:20, from about 3:1 to about 1:15, from about 2:1 to about 1:10, or from about 4:1 to about 1:4, e.g., a ratio of about 10:1, 5:1, 4:1, 3:1, 5:2, 2:1, 4:3, 1:1, 3:4, 1:2, 2:5, 1:3, 1:4, 1:5, 1:10, 1:25, 1:50, 1:75, or 1:100. In some examples, the weight ratio of water-soluble agent(s) to the hydrophobic component ranges from about 1:5 to about 2:1, e.g., a weight ratio of up to about 1:1, up to about 1:2, up to about 1:3, up to about 1:4, or up to about 1:5.
For example, ratio of 1:20 = 0.05, ratio of 1:10 = 0.10 and ratio of 1:9 = 0.11.
CBD is a purified oil distillate (see ¶ 0140) and Quillaja extract is a water-soluble agent (see ¶ 0011).
The claimed ratio of Quillaja extract to the total oil is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art, following the guidelines set forth in the Woelfel disclosure (see discussions above). Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
Therefore, claim 1 is obvious over Woelfel.
Regarding claims 2-3, Woelfel teaches, wherein the carrier oil is one or more oils such as MCT, sunflower oil, olive oil, coconut oil, palm oil and canola oil (see ¶ 0043).
Regarding claims 4-5, Woelfel discloses that a composition of the invention can further comprise terpene and THC (see ¶ 0010).
Regarding claim 6 Woelfel teaches 234 mg/g CBD (see discussions above).
Regarding claim 7 and 13, Woelfel discloses that the product can be in the form of a beverage or powder (see ¶ 0023fcos).
Regarding claim 10, the recitation of “wherein the product has an onset time of less than 30 minutes”, is a property of an emulsion composition of claim 1, when the composition is, for example, incorporated into a product and used. Since Woelfel discloses an emulsion composition of claim 1 (see discussions above), the composition of Woelfel must necessarily exhibit the same properties recited in claim 10.
An inherent characteristic may “be part of the prior art in an obviousness analysis even if the inherent characteristic was unrecognized or unappreciated by a skilled artisan.” Endo Pharm. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374, 1381 (Fed. Cir. 2018).
Therefore, claim 10 is obvious over Woelfel.
Regarding claim 11, the volume of the beverage and potency of the active agent per ml, is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art. For example, Woelfel (see, e.g., ¶ 0101), discloses that the beverage may contain the active agent in an amount of about 0.5 mg/serving to doses higher than 10 mg/serving.
Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
Regarding claim 14, Woelfel (see, e.g., ¶ 0064), discloses that emulsion composition can be processed using a high-pressure homogenizer at a pressure of up to 30,000 psi.
The claimed pressure range of 10,000-45,000 psi overlap or lie inside ranges disclosed by Woelfel because Woelfel discloses a pressure of up to 30,000 psi (see discussions above).
A prima facie case of obviousness exists in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" (see MPEP § 2144.05).
In the instant case, because the claimed pressure range of 10,000-45,000 psi, overlaps or lies inside ranges disclosed by the prior art (see discussions above), a prima facie case of obviousness exists.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Claims 1, 8-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Woelfel (U.S. Pub. No. 20190015383), as applied to claim 1 above and further in view of Heller of record (U.S. Pub. No. 20200054702).
The limitation of claim 1 as well as the corresponding teachings of Woelfel, are described above and are hereby incorporated into the instant rejection.
The invention of claims 8-9 and 12 are similar to claim 1, however, claims 8-9 and 12 differ slightly from claim 1 in that:
Claim 8 requires a cosmetic product
Claim 9 requires that the composition is certified according to current USDA guidelines.
Claim 12 requires a candy with an active agent potency of at least 1 mg/g.
Woelfel differs from claims 8-9 and 12 only insofar as Woelfel is not explicit in teaching the limitation of claims 8-9 and 12. However, a person skilled in the would have had a reasonable expectation of success in arriving at the invention of claims 8-9 and 12, because at the time of the instant invention, it was known in the art that a CBD emulsion formulation can be incorporated into a product of claims 8-9 and 12.
For example, Similar to Woelfel (see discussions above), Heller teaches use of 35 mg/g-100 mg/g (at least 30 mg/g) in emulsion formulation (see Example 4, ¶ 0192), that can be incorporated into a product (see abstract), such as cosmetics (see ¶ 0394), powder (see ¶ 0002), beverages (see ¶ 0379) and candies (see ¶ 0387).
Regarding claim 9, Heller discloses that the composition can be approved by a government regulatory body (see reference claim 8). USDA is a government regulatory body. Heller discloses onset time of less than 30 minutes (see ¶ 0387, also addressing instant claim 10).
Regarding claim 12, the potency of the active agent in the candy, is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art.
Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Non-Statutory Double Patenting Rejection-Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The provisional rejection of claims 1-14, on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. patent application Nos: i) 18/553,969; and ii) 18/301,603, is maintained for the reasons of record set forth in the previous Office action.
The rejection of claims 1-14, on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. patent No. 11,659,855, is maintained for the reasons of record set forth in the previous Office action Office action.
Response to Applicants’ Arguments/Remarks
Applicants have not properly addressed the specific grounds of rejections as discussed in the previous Office action setting. Applicants state that a terminal disclaimer will be filed upon the acceptance of the filed Power of Attorney (see page 9 of Remarks).
Response
Applicants’ comments are acknowledged. However, the rejections will be maintained until a terminal disclaimer is filed or the claims are amended to obviate the rejections.
Conclusion
No claim is allowable.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
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
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 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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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629