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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/10/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) filed 04/10/2026 has been considered here.
Status of Claims
The amendments and arguments filed on 04/10/2026 are acknowledged and have been fully considered. Claims 1, 3, 18, 56, 69-71, 130-132, 150, 186, and 222 are now pending. Claims 2, 4-17, 19-55, 57-68, 72-129, 133-149, 151-185, 187-221, and 223-263 are canceled; claims 1, 130-132, 150, and 186 are amended; claims 130-132, 150, 186, and 222 are withdrawn.
Claims 1, 3, 18, 56, and 69-71 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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, and constitute the complete set presently being applied to the instant application.
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, 3, 18, 56, and 69-70 are rejected under 35 U.S.C. 103 as being unpatentable over USPGPUB 20170172977 A1 (Kleidon, 2017; as submitted on IDS of 09/27/2022) in view of Pellati (2018).
In regards to claim 1, Kleidon teaches a composition comprising cannabinoids that are derived from hemp (see Kleidon, paragraph 0044) or hemp extract (see Kleidon, paragraph 0057) wherein the cannabinoids are a mixture of cannabidiol (CBD) and cannabidiolic acid (CBDA), among others (see Kleidon, paragraph 0047). As for the ratio of CBD to CBDA, it would be within the purview of one with ordinary skill in the art to use the teachings of Kleidon to use a mixture of CBD and CBDA with equal amounts and such the ratio of the CBD to CBDA would be within the instantly claimed range. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Further, it is taught that the composition comprises cannabigerolic acid and cannabichromene (see Kleidon, paragraph 0043). It is taught that the composition comprises lecithin (see Kleidon, paragraph 0103).
In regards to claim 3, the composition is taught to have alpha-pinene, beta-pinene, alpha-humulene, beta-caryophyllene, limonene, linalool, caryophyllene oxide (see Kleidon, paragraph 0054), beta-myrcene (see Kleidon, paragraph 0012), and guaiol (see Kleidon, paragraph 0086).
In regards to claim 18, it is taught the composition comprises fish oil (see Kleidon, paragraph 0013). It is also taught that the composition comprises linseed oil, grape see oil, olive oil, and coconut oil (see Kleidon, paragraph 0112).
In regards to claims 56 and 69, it is taught that the composition comprises additional pharmaceutically acceptable excipients (see Kleidon, paragraph 0114) and is administered orally or topically (see Kleidon, paragraph 0115). The composition is taught to be in a tablet or a chewable form (see Kleidon, paragraph 0107).
While Kleidon does teach that the composition has the claimed components of instant claims 1 and 3 and that the compositions are rich in cannabinoids, including food products with hemp oil or hemp seed oil (see Kleidon, paragraph 0042), it is not explicitly taught these compounds are from the hemp extract itself. As such, Pellati is relied on to show that hemp extract definitively comprises these compounds.
Pellati teaches that hemp oil comprises alpha-pinene, beta-pinene, beta-myrcene, limonene, linalool, beta-caryophyllene, alpha-humulene, caryophyllene oxide (see Pellati, Table 4, C4). Further, Pellati teaches that hemp oil comprises CBDA, CBD, and cannabigerolic acid (see Pellati, Table 2). It is also taught that the hemp used have a content of delta 9-THC below 0.2% (see Pellati, 3.2 Hemp Plant Material). Finally, while it is mentioned above that it would be within the purview of one with ordinary skill to use the teachings of Kleidon to use a mixture of CBD and CBDA with equal amounts and such the ratio of the CBD to CBDA would be within the instantly claimed range, it is noted that the hemp extract of Pellati has a CBD to CBDA ratio of 5.9 to 4.1, which is about 1:0.6 (see Pellati, Table 2, C2 and C4).
In regards to claims 1, 3, 18, 56, and 69, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to formulate a composition as instantly claimed using the teachings of Kleidon and Pellati, as Kleidon teaches the use of hemp oil along with the benefits of different compounds (see Kleidon, paragraphs 0063-0091), such as those listed in instant claim 3. Pellati teaches that these compounds are found in hemp extract itself (see Pellati, Table 4, C4) and as such it would be obvious to one with ordinary skill in the art to use the hemp extract of Pellati in the composition of Kleidon. Further, by using the hemp extract of Pellati, for example, the C4 extract, the ratio of claim 1 of CBD to CBDA, is also met. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). It would be obvious to one with ordinary skill in the art to combine the extract of Pellati with the composition of Kleidon according to the method of making a composition using hemp oil (see Kleidon, paragraphs 0128-0136) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
In regards to claim 70, a product-by-process claim drawn to a composition directed towards a dosage form, the patentability of a product does not depend on its method of production. The combination of Kleidon and Pellati teach the instantly claimed dosage form. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by- process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. The teachings of Kleidon and Pellati establish the dosage form as instantly claimed, thus the burden shifts to the applicant to come forward with evidence showing that the process of making the dosage form as instantly claimed produces a materially different product than dosage form of Kleidon and Pellati.
Claim 71 is rejected under 35 U.S.C. 103 as being unpatentable over USPGPUB 20170172977 A1 (Kleidon, 2017; as submitted on IDS of 09/27/2022) in view of Pellati (2018) as applied to claims 1, 3, 18, 56, and 69-70 above, and further in view of WO 2015069763 A1 (Lindsay, 2015).
The teachings of Kleidon and Pellati have been described supra.
The teachings of Kleidon and Pellati are silent on the dosage form wherein the weight of the chew is about 0.5-10 g.
Lindsay teaches a sublingual dosage form comprising cannabis plant material in a chewable form (see Lindsay, abstract; paragraph 0004) wherein the total weight of the plant material accounts for substantially the entire weight of the dosage form, which is from about 0.05 grams to about 7 grams (see Lindsay, claims 5-6; paragraphs 0004-0005 and 0066). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claims 1, 3, 18, 56, and 69-71, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to formulate a composition as instantly claimed using the teachings of Lindsay with Kleidon and Pellati, as Kleidon teaches that the composition is in a chewable form as well as a sublingual form (see Kleidon, paragraph 0107). "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It would be obvious to one with ordinary skill in the art to combine the chewable composition of Kleidon and Pellati with the dosage form of Lindsay according to the known method of formulating a dosage form that ranges from 0.05 grams to about 7 grams (see Lindsay, Methods, paragraphs 0238-0262) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known method to yield predictable results.
Response to Arguments
Applicant's arguments filed 04/10/2026 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
In regards to applicant’s argument that the addition of lecithin promotes advantageous pharmacokinetic properties and the arguments against Chen and it’s teachings, applicant is reminded that whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). In the instant case, it is pointed out that lecithin in is known to improve drug bioavailability and is a known absorbance enhancer (see Chen, page 2, paragraph 4). Lecithin-based formulations improve the therapeutic efficacy of poor oral absorption drugs (see Chen, page 2, paragraph 4). With this in mind, the data presented in Table 17 of the instant specification is not unexpected. It is within the purview of one with ordinary skill in the art to understand that using lecithin would improve the bioavailability of the cannabinoids. A point of clarification in regards to the purpose of Chen: Chen is not a part of any rejection, rather the reference is included to show that one with ordinary skill in the art would know that lecithin is a compound that is used to increase the bioavailability of poor oral absorption drugs. As such, there is no motivation needed for the combination of the art as it’s not a part of the rejection.
In regards to applicant’s arguments that the ratio of CBD: CBDA ratios of Pellati are attributed to aged or non-optimally dried plant material, it is pointed out that "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). Even though the art teaches that it is not an optimal situation, the ratios are taught in the art. Further, it is also pointed out that it would be within the purview of one with ordinary skill in the art to use the teachings of Kleidon to use a mixture of CBD and CBDA with equal amounts and such the ratio of the CBD to CBDA would be within the instantly claimed range. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). The teachings of Kleidon also render the ratio obvious in this case. As such, the references are combined to show that the ratios are achievable using hemp extract rather than those taught generally in Kleidon.
Applicant also argues that the art does not teach lecithin as a carrier, instead only mentions it in a list of emulsifiers. It is pointed out that “a reference disclosure can anticipate a claim even if the reference does not describe "the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015).” (this is MPEP 2131 Genus/Species). In the instant case, the number of species recited is small and thus a person of ordinary skill in the art can immediately envisage the usage of lecithin as a surfactant. It is also noted that that "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). Further, applicant is allowed to be their own lexicographer, however one with ordinary skill in the art would reasonably expect the properties of a compound to be present regardless of what the role of the compound is called in the disclosure. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658. As the prior art teaches an identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Applicant further argues that the comparison of the claimed ratios of CBD: CBDA with lecithin and without lecithin is enough to establish unexpected results, however it is discussed above why the use of lecithin increasing bioavailability of poor orally absorbable drugs would be within the expectations of one with ordinary skill in the art. This point was raised to indicate that there is a need to establish the criticality of the ratio of CBD to CBDA as well and what is needed in order to do so (i.e., the criticality has to be established using data). To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
As such the rejections of record are maintained and the instant claims are rendered obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 18, 21, 56, and 69-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 51, 53-54, 64-65, and 70-71 of copending Application No. 18/829965 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application recite a hemp extract comprising a hemp extract comprising cannabidiol and cannabidiolic acid wherein the ratio of cannabidiol to cannabidiolic acid is about 0.6:1 to about 1:0.6 (see claims 1-7 of reference application) and a carrier selected from the group consisting of linseed oil, olive oil, fish oil, salmon oil, coconut oil, catnip oil, sesame oil, MCT oil, lecithin, NF-971P, and grapeseed oil (claims 51 and 53). Claim 54 of the reference application also recites the limitation of a dosage form comprising at least one of a pharmaceutically acceptable additives, a flavoring agent, a surfactant, and an adjuvant. Claims 64-65 of the reference application recite the limitation wherein the dosage form is formulated as hard or soft chew. Claims 70-71 recite the limitation wherein the dosage form is formulated as a chew for oral administration and where the chew is produced using cold extrusion. These claims recite limitations that are patentably indistinct from the instant claims. As claim 51 of the reference application is dependent on claim 50, which recites that the hemp extract of any one of claims 1-49, one with ordinary skill would be able to arrive at the instant invention using the teachings of the reference application. For example, claims 43-44 recite the additional components of instant claim 3.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 18, 21, 56, and 69-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 27, 46, 71, 73, 76, 84, 100, 102-105, and 138-146 of copending Application No. 18/625711 (reference application) in view of USPGPUB 20170172977 A1 (Kleidon, 2017; as submitted on IDS of 09/27/2022) and Pellati (2018). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application recites the limitation of a hemp extract comprising cannabidiol and cannabidiolic acid, as well as a carrier (see claim 2). While claim 1 of the reference application is drawn towards a hemp extract comprising cannabigerol and cannabigerolic acid, it is pointed out that Pellati teaches that the hemp extract comprises these in the claimed ratio (i.e., 0.1-0.3 mg/mL of CBGA to 0.2-0.4 mg/mL of CBG), along with the other compounds of reference claims 2 and 27, except for cannabichromene (see Table 2: C2 and Table 4). However, as discussed in the above rejections, cannabichromene is taught as part of the composition of Kleidon.
Kleidon teaches the use of lecithin (see paragraph 0103). Further, it is pointed out that Kleidon teaches that the composition is used to treat epilepsy, cancer (see Kleidon, paragraph 0097), and relieving pain (see Kleidon, paragraph 0116).
In regards to claims 1, 3, 18, 21, 56, and 69, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to formulate a composition as instantly claimed using the teachings of the reference application with Kleidon and Pellati, as Kleidon and the reference application teach the use of hemp extracts along with the benefits of the same compounds (see Kleidon, paragraphs 0063-0091), such as those listed in instant claim 3. Further Kleidon teaches the same method of use as the reference application as well (i.e., treating cancer, pain, etc…). Pellati teaches that these compounds are found in hemp extract itself (see Pellati, Table 4, C4) and as such it would be obvious to one with ordinary skill in the art to use the hemp extract of Pellati in the composition of Kleidon and the reference application. It would be obvious to one with ordinary skill in the art to combine the extract of Pellati with the compositions of Kleidon and the reference application according to the method of making a composition using hemp oil (see Kleidon, paragraphs 0128-0136) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
In regards to claim 70, a product-by-process claim drawn to a composition directed towards a dosage form, the patentability of a product does not depend on its method of production. The combination of the reference application, Kleidon, and Pellati teach the instantly claimed dosage form. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by- process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. The teachings of the reference application, Kleidon, and Pellati establish the dosage form as instantly claimed, thus the burden shifts to the applicant to come forward with evidence showing that the process of making the dosage form as instantly claimed produces a materially different product than dosage form of the reference application, Kleidon, and Pellati.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 18, 21, 56, and 69-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 20, 22-25, 31, 33, 35-41, and 66-68 of copending Application No. 18/162990 (reference application) in view of USPGPUB 20170172977 A1 (Kleidon, 2017; as submitted on IDS of 09/27/2022) and Pellati (2018). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application recites “A pharmaceutical composition comprising hemp extract, wherein the hemp extract comprises: cannabigerol and cannabigerolic acid, wherein the ratio of cannabigerol to cannabigerolic acid is from about 0.6:1 to about 1:06, wherein the pharmaceutical composition is formulated in an orally deliverable paste for oral administration”. Both sets of claims are drawn to hemp extracts cannabinoids, the difference being the copending application recites cannabigerol and cannabigerolic acid, while the instant application recites cannabidiol and cannabidiolic acid. However, the claims of the reference application also encompass these cannabinoids for example in claims 31, and 66-67, either in the same amounts or overlapping ratios. The instant application further requires lecithin as a carrier, however the reference application teaches this as well in claims 39-40. As such, both sets of claims recite limitations that have overlapping scope and it would be within the purview of one with ordinary skill in the art to come to the instant invention using the teachings of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 18, 21, 56, and 69-71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-10, 14-19, and 23-24 of U.S. Patent No. 11712456 B2 in view of USPGPUB 20170172977 A1 (Kleidon, 2017; as submitted on IDS of 09/27/2022). Patent 11712456 teaches “a pharmaceutical composition comprising hemp extract and a carrier, wherein the hemp extract comprises: cannabidiol; cannabidiolic acid; cannabigerolic acid; and D9-tetrahydrocannabinol, wherein the cannabidiol and the cannabidiolic acid are present in the pharmaceutical composition at a first ratio, and the D9-tetrahydrocannabinol and total cannabinoids are present in the pharmaceutical composition at a second ratio, wherein the first ratio is from about 0.6:1 to about 1:0.6, and wherein the second ratio is from about 1:50 to about 1:20.” Further, 11712456 teaches the same compounds in the extract as the instant claims. In regard to the carrier, 11712456 teaches the same carriers as the instant claim as well (see reference claim 8). Reference claims 17 and 24 recite the composition to be in the form of a chew, wherein the weight of the chew is about 0.5-10g, the same as the instant claims.
11712456 is silent on the use of lecithin.
The teachings of Kleidon have been described supra.
In regards to claims 1, 3, 18, 21, 56, and 69, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to formulate a composition as instantly claimed using the teachings of Kleidon and 11712456, as Kleidon teaches the use of hemp oil along with the benefits of different compounds (see Kleidon, paragraphs 0063-0091), which are the same as those in 11712456. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose …. [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It would be obvious to one with ordinary skill in the art to combine the extract of 11712456 with the composition of Kleidon according to the method of making a composition using hemp oil (see Kleidon, paragraphs 0128-0136) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
In regards to claim 70, a product-by-process claim drawn to a composition directed towards a dosage form, the patentability of a product does not depend on its method of production. The combination of Kleidon and 11712456 teach the instantly claimed dosage form. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by- process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. The teachings of Kleidon and 11712456 establish the dosage form as instantly claimed, thus the burden shifts to the applicant to come forward with evidence showing that the process of making the dosage form as instantly claimed produces a materially different product than dosage form of Kleidon and 11712456.
Response to Arguments
Applicant’s arguments filed 04/10/2026 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
In regards to applicant’s argument to hold the double patenting rejections of the instant claims over application 18/829965, application 18/625711 in view of Kleidon and Pellati, and application 18/162990 in view of Kleidon and Pellati in abeyance is acknowledged, however the rejections are maintained still.
In regards to applicant’s argument that the teachings of Kleidon do not teach the benefit of using lecithin the composition, it is pointed out that lecithin in is known to improve drug bioavailability and is a known absorbance enhancer (see Chen, page 2, paragraph 4). Lecithin-based formulations improve the therapeutic efficacy of poor oral absorption drugs (see Chen, page 2, paragraph 4). With this in mind, the data presented in Table 17 of the instant specification is not unexpected. It is within the purview of one with ordinary skill in the art to understand that using lecithin would improve the bioavailability of the cannabinoids. Applicant also argues that the art does not teach lecithin as a carrier, instead only mentions it in a list of emulsifiers. It is pointed out that “a reference disclosure can anticipate a claim even if the reference does not describe "the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015).” (this is MPEP 2131 Genus/Species). In the instant case, the number of species recited is small and thus a person of ordinary skill in the art can immediately envisage the usage of lecithin as a surfactant. It is also noted that that "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). Further, applicant is allowed to be their own lexicographer, however one with ordinary skill in the art would reasonably expect the properties of a compound to be present regardless of what the role of the compound is called in the disclosure. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658. As the prior art teaches an identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
As such the double patenting rejections are maintained.
Conclusion
No claims allowed.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611
/A.A.A./ Examiner, Art Unit 1611
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