Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Election/Restrictions
Applicant’s election of the following cannabinoids: Cannabichromene (CBC), Cannabigerol (CBG) and Tetrahydrocannabivarin (THCV) and the election of the following terpenes: Limonene, Myrcene, and Terpinolene and that claims 11-16 read on the elected species in the reply filed on 11/21/2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the election of species, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claims are directed to a composition consisting essentially of a chewable matrix, sweetener, and a concentrate comprising at least 1 % of at least one cannabinoid and at least one terpenoid. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
See MPEP 2106.07.
Effective January 7, 2019, subject matter eligibility determinations under 35 U.S.C. § 101 follow the procedure explained in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No.4, 50-57), which is found at: https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf. Applicants are kindly asked to review this guidance as well as MPEP 2106.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on December 16, 2014 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012)), Diamond v. Chakrabarty, 447 U.S. 303 (1980)) and Funk Brothers Seed Co. v. Kalo Inoculant Co. - 333 U.S. 127 (1948)). (inter alia). See eg. MPEP 2106.04(b)
The Supreme Court has explained that the judicial exceptions reflect the Court’s view that abstract ideas, laws of nature, and natural phenomena are "the basic tools of scientific and technological work", and are thus excluded from patentability because "monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it." Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980 (quoting Myriad, 133 S. Ct. at 2116, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this "exclusionary principle" is pre-emption. Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980. The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural phenomena; i.e., one may not patent every "substantial practical application" of an abstract idea, law of nature, or natural phenomenon, even if the judicial exception is narrow.
While preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent in and resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to by the Office as Steps 2A and 2B). It is necessary to evaluate eligibility using the Alice/Mayo test, because while a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible.
Products of Nature: When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". Products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad 133 S. Ct. at 2116-17, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of nature" and "natural phenomenon" as inclusive of "products of nature".
PNG
media_image1.png
18
19
media_image1.png
Greyscale
It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart.
PNG
media_image1.png
18
19
media_image1.png
Greyscale
When a claim recites a nature-based product limitation, examiners use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A. Nature-based products, as used herein, include both eligible and ineligible products and merely refer to the types of products subject to the markedly different characteristics analysis used to identify product of nature exceptions.
The Markedly Different Characteristics Analysis
The markedly different characteristics analysis is part of Step 2A, because the courts use this analysis to identify product of nature exceptions. If the claim includes a nature-based product that has markedly different characteristics, then the claim does not recite a product of nature exception and is eligible. If the claim includes a nature-based product that does not exhibit markedly different characteristics from its closest naturally occurring counterpart in its natural state, then the claim is directed to a "product of nature" exception (Step 2A: YES), and requires further analysis in Step 2B to determine whether any additional elements in the claim add significantly more to the exception.
PNG
media_image1.png
18
19
media_image1.png
Greyscale
Nature-based Product Claim Analysis
PNG
media_image1.png
18
19
media_image1.png
Greyscale
Where the claim is to a nature-based product by itself, the markedly different characteristics analysis should be applied to the entire product.
PNG
media_image1.png
18
19
media_image1.png
Greyscale
Where the claim is to a nature-based product produced by combining multiple components, the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. Where the claim is to a nature-based product in combination with non-nature based elements, the markedly different characteristics analysis should be applied only to the nature-based product limitation. For a product-by-process claims, the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart.
The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception.
PNG
media_image1.png
18
19
media_image1.png
Greyscale
Because the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state, the first step in the analysis is to select the appropriate counterpart(s) to the nature-based product.
PNG
media_image1.png
18
19
media_image1.png
Greyscale
When there are multiple counterparts to the nature-based product, the comparison should be made to the closest naturally occurring counterpart. When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature).
Markedly changed characteristics can include structural, functional, chemical changes. In order to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 133 S. Ct. at 2111, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.
PNG
media_image1.png
18
19
media_image1.png
Greyscale
If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception.
The claims are directed to a composition consisting essentially of a chewable matrix, sweetener, and a concentrate comprising at least 1% w/w of at least one of cannabigerol, cannabichromene and tetrahydrocannabivarin and one terpenoid which is not markedly different from its closest naturally-occurring counterpart because there is no indication that their combination, amounts or preparation has caused the nature-based product to have any characteristics that are markedly different from the closest naturally-occurring product and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The rationale for this determination is explained below:
Step 1: Determine if the claims are directed to one of the four statutory categories of patentable subject matter identified by 35 U.S.C. 101: a process, machine, manufacture or composition of matter. YES, the claims are directed to a composition of matter (i.e., a chewable matrix, sweetener, cannabinoids and terpenoids), which is a statutory category within at least one of the four categories of patent eligible subject matter.
Step 2A: PRONG ONE: Evaluate whether the claim recites a Judicial Exception
(e.g., law of nature, natural phenomenon, or an abstract idea). YES, the claims are product claims reciting something that appears to be a nature-based product (i.e., a chewable matrix, sweetener, cannabinoids and terpenoids) which is not markedly different from the closest naturally-occurring counterpart (i.e., the individual nature-based products).
Note: with respect to extracts of natural products such as cannabinoids and terpenoids, the closest naturally-occurring counterpart is always the same compounds found in the extract, present in the non-isolated form in the source plant material. Extracts that are made simply by separating the extracted components from the non-extracted components, is a partitioning process that absent any specific chemical modification, merely separates the compounds leaving their activities unchanged (as is evidenced by the instantly claimed invention).
Ingredients recited in the claims are natural products that would occur naturally; thus, the claims involve the use of judicial exceptions. There is no indication in the record of any markedly different characteristics (either structural or functional) of the composition as broadly claimed. Being substantially free of THC type compounds does NOT impart a markedly different characteristic on the cannabinoids and terpenoids. For example, there is no evidence of record of a structural difference between the extract(s) in the claimed composition and that of their nature-based counterparts. Consequently, the claimed compositions are structurally the same as their closest naturally- occurring counterparts.
Nor is there any difference in functional characteristics. To show a marked difference, the characteristic(s) must be changed as compared it closest natural-occurring counterpart. Furthermore, inherent or innate characteristics of the naturally occurring counterpart cannot show a marked difference. Likewise, differences in the characteristics that came about or were produced independently of any effort or influence by Applicant cannot show a marked difference.
The recitation of specific amounts of the ingredients does not affect this analysis because it is well known and routine in the art to mix specific amounts of active ingredients with additional ingredients. The same holds true for whether the composition is a cosmetic, pharmaceutical or food composition since there is nothing which imparts a markedly different characteristic on the composition. In this case, there is only “a chewable matrix, sweetener, and a concentrate comprising a cannabinoid and a terpenoid. Therefore, the claim is not meaningfully limited and does not amount to significantly more than each product of nature by itself. Finally, the claimed composition is like the novel bacterial mixture of Funk Brothers, which was held ineligible because each species of bacteria in the mixture continued to have “the same effect it always had”, i.e., it lacked markedly different characteristics. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948), discussed in Myriad Genetics, 133 S. Ct. at 2117. While not discussed in the opinion, it is noted that several of the claims held ineligible in Funk Brothers recited specific amounts of the bacterial species in the mixture, e.g., claims 6, 7 and 13. Funk Brothers, 333 U.S. at 128 n.1.
Thus, there is no evidence of record to indicate that the claimed product is markedly different, structurally, chemically, functionally, then its closest naturally occurring counterpart.
PRONG TWO: Evaluate whether the judicial exception is integrated into a practical application. The claims are directed to a composition, not its practical use such as a particular treatment or prophylaxis for a disease or medical condition.
Thus, the cited claims are directed to a judicial exception to patentable subject matter.
Step 2b: Determine whether the claim directed to a judicial exception provides an inventive concept. For example, the claims may recite additional elements that amount to significantly more than the judicial exception. In the instant case, NO, the claims are directed to an extract composition without any other components that could add significantly more to the exception. No other specific limitations other than what is well-understood, routine and conventional in the field at a high level of generality have been added to the claimed nature-based product (e.g., addition of well-known ingredients).
Thus, the claimed composition is not eligible subject matter under current 35 USC 101 standards. See MPEP 2106.07.
Applicant argues that allegedly the amendment of “the chewable matrix and sweetener do not naturally occur with the cannabinoid compounds” makes the claims have a markedly different characteristic. The claims do NOT show that a markedly different characteristic has occurred by combining the claimed components, thus applicant’s argument is moot.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 11-16 are rejected under pre-AIA 35 U.S.C. 102 (b) as being anticipated by Freeman (US 2013/0295172) and as evidenced by “Cannabinoids in Cannabis” and Casano et al.
Freeman teaches that a capsule is prepared which contains cannabis, see abstract, paragraphs 9, 28-33, 52, 66, 77 and the claims. Note that cannabis will inherently contain the claimed and elected cannabinoids and terpenoids since they are all from cannabis.
Applicant in the specification at page 21 states, “[a]s used herein the term ‘concentrate’ when used in reference to a composition containing one or more compounds means that the one or more compounds are concentrated in the composition on a weight/weight basis as compared to a starting material, such as Cannabis plant material or trichomes”.
In other words, the capsule will read on a concentrate of cannabis since the cannabis is combined with other ingredients since technically the cannabis has been concentrated into a capsule.
Clearly mixing the cannabis, hemp seed and lecithin will form a concentrate since by combining the ingredients together the cannabis will be concentrated.
Casano teaches that the average relative contents of dominant compounds detected in the aroma volatiles of all the cannabis sativa strains were: β-myrcene (46.1±2.6%), α-pinene (14.0±1.5%), α-terpinolene (10.2±1.8%), limonene (7.3±1.3%), trans-β-ocimene (6.6±0.7%), β-pinene (6.1±0.4%), α-terpinene (3.6±1.0%), β-caryophyllene (1.2±0.2%), 1.8 cineole (1.1±0.2%), α-phellandrene (0.7±0.1%) and Δ-3-carene (0.6±0.1%), see entire reference, especially page 3.
Clearly cannabis contains limonene, myrcene and terpinolene (the elected terpenoids). The claims require at least 0.1 % of the above named terpenoids and note that Casano clearly teaches very high amounts of these compounds way above 0.1 %. Note also that since cannabis is used in Freeman that the amount of cannabinoids will be above 1 % in Freeman since cannabis is well known to have at least 1 % of total cannabinoids in it. Even if there is very little THC in the cannabis, clearly when adding up the other cannabinoids in cannabis will at least add up to 1 %.
Note also that the composition of Freeman is “substantially free of THC type compounds” since the specification at page 21 states that “substantially free of THC type compounds” means that the composition contains 2 % or less of THC which is a meaningless limitation since it is not clear how much THC is in the entire tablet or capsule, especially when one does not know what else in in the tablet or capsule besides the cannabinoids and the terpenoids. If one does not known how much THC is in the composition (tablet or capsule) then how can one evaluate if the concentrate is “substantially free of THC type compounds”. Thus, the limitation in claim 6 is given no patentable weight.
Clearly Cannabichromene (CBC), Cannabigerol (CBG) and Tetrahydrocannabivarin (THCV) will be in cannabis since they are inherently in cannabis.
Note the “chewable tablets” which are a type of chewable matrix, see paragraph 64. See sweeteners in paragraph 35 (sugars).
Applicant argues that allegedly since claim 11 states that a “composition consisting essentially of a chewable matrix, sweetener and concentrate comprising at least one % w/w of at least one cannabinoid selected from the group consisting of cannabigerol, cannabichrome, and Tetrahydrocannabivarin” limits the claim which it does NOT. By having “comprising” still in claim 11, it opens the claims up.
According to applicant, Freemen et al. (and likewise Casano) does not teach a chewable matrix comprising a sweetener or such or a composition that consists essentially of the claimed compounds in the claimed amounts.
As stated above, “comprising” is used in the claim which opens the claim up, thus the argument by applicant is moot.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 11-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Freeman (US 2013/0295172) in view of “Cannabinoids in Cannabis” and Casano et al.
Freeman teaches that a capsule is prepared which contains cannabis, see abstract, paragraphs 9, 28-33, 52, 66, 77 and the claims. Note that cannabis will inherently contain the claimed and elected cannabinoids and terpenoids since they are all from cannabis.
Applicant in the specification at page 21 states, “[a]s used herein the term ‘concentrate’ when used in reference to a composition containing one or more compounds means that the one or more compounds are concentrated in the composition on a weight/weight basis as compared to a starting material, such as Cannabis plant material or trichomes”.
In other words, the capsule will read on a concentrate of cannabis since the cannabis is combined with other ingredients since technically the cannabis has been concentrated into a capsule.
Clearly mixing the cannabis, hemp seed and lecithin will form a concentrate since by combining the ingredients together the cannabis will be concentrated.
Casano teaches that the average relative contents of dominant compounds detected in the aroma volatiles of all the cannabis sativa strains were: β-myrcene (46.1±2.6%), α-pinene (14.0±1.5%), α-terpinolene (10.2±1.8%), limonene (7.3±1.3%), trans-β-ocimene (6.6±0.7%), β-pinene (6.1±0.4%), α-terpinene (3.6±1.0%), β-caryophyllene (1.2±0.2%), 1.8 cineole (1.1±0.2%), α-phellandrene (0.7±0.1%) and Δ-3-carene (0.6±0.1%), see entire reference, especially page 3.
Clearly cannabis contains limonene, myrcene and terpinolene (the elected terpenoids). The claims require at least 0.1 % of the above named terpenoids and note that Casano clearly teaches very high amounts of these compounds way above 0.1 %. Note also that since cannabis is used in Freeman that the amount of cannabinoids will be above 1 % in Freeman since cannabis is well known to have at least 1 % of total cannabinoids in it. Even if there is very little THC in the cannabis, clearly when adding up the other cannabinoids in cannabis will at least add up to 1 %.
Note also that the composition of Freeman is “substantially free of THC type compounds” since the specification at page 21 states that “substantially free of THC type compounds” means that the composition contains 2 % or less of THC which is a meaningless limitation since it is not clear how much THC is in the entire tablet or capsule, especially when one does not know what else in in the tablet or capsule besides the cannabinoids and the terpenoids. If one does not known how much THC is in the composition (tablet or capsule) then how can one evaluate if the concentrate is “substantially free of THC type compounds”. Thus, the limitation in claim 6 is given no patentable weight.
In the event it is seen that Freeman’s cannabis is not concentrated (which is not being admitted) then it would have been obvious to do so since one would want a concentrated form of the cannabis to be in a capsule to make the capsule more effective in treating pain as taught by Freeman. Clearly the mixing of the components in Freeman will result in a composition which is more concentrated in the mixed composition on a weight/weight basis as compared to the starting material of cannabis.
In the event it is seen that Freeman’s cannabis is not “substantially free of THC type compounds” (which is not being admitted) then it would have been obvious to use a cannabis strain which is not “substantially free of THC type compounds” since “Cannabinoids in Cannabis” clearly teaches that THC content varies based on the part of the plant (cannabis) it contains: 10‐12% in flowers, 1‐2% in leaves, 0.1‐0.3% in stalks. Note that this was noted as referenced in 2009. Thus, making it obvious for one having ordinary skill in the art to use a cannabis strain or part of the cannabis having a lower amount of THC (below the 2% as noted by applicant’s as having substantially no THC type compounds) in an effort to yield a concentrate having lower THC levels in an effort to comply with federal regulations regarding THC content.
Clearly Cannabichromene (CBC), Cannabigerol (CBG) and Tetrahydrocannabivarin (THCV) will be in cannabis since they are inherently in cannabis.
In the event it is seen that Cannabichromene (CBC), Cannabigerol (CBG) and Tetrahydrocannabivarin (THCV) will not be inherently in cannabis (which is not admitted) then it would have been obvious to use a strain or part of the plant which contains these cannabinoids (see “Cannabinoids in Cannabis”) since they are well known cannabinoids to be used for medicinal purposes. In the event it is still felt that these are not in cannabis the claims still clearly encompass many other cannabinoids which are clearly found in cannabis. Note the huge number of cannabinoids found in cannabis both in the references and the claims themselves. Note that such a number will clearly add up to at least 1 %.
In the event it is seen that the terpenoids: Limonene, Myrcene, and Terpinolene will not be inherently in cannabis (which is not admitted) then it would have been obvious to use a strain or part of the plant which contains these terpenoids since they are well known terpenoids to be used for medicinal purposes (see Casano). In the event it is still felt that these are not in cannabis the claims still clearly encompass many other terpenoids which are clearly found in cannabis. Note the huge number of terpenoids found in cannabis both in the references and the claims themselves. Note that such a number will add up to at least 0.1 %.
Note the “chewable tablets” which are a type of chewable matrix, see paragraph 64. See sweeteners in paragraph 35 (sugars).
Applicant argues that allegedly since claim 11 states that a “composition consisting essentially of a chewable matrix, sweetener and concentrate comprising at least one % w/w of at least one cannabinoid selected from the group consisting of cannabigerol, cannabichrome, and Tetrahydrocannabivarin” limits the claim which it does NOT. By having “comprising” still in claim 11, it opens the claims up.
According to applicant, Freemen et al. (and likewise Casano) does not teach a chewable matrix comprising a sweetener or such or a composition that consists essentially of the claimed compounds in the claimed amounts.
As stated above, “comprising” is used in the claim which opens the claim up, thus the argument by applicant is moot.
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 11-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,792,318. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims the same cannabinods and terpenoids as claimed herein and a tablet or capsule have a concentrate of the original cannabis extract in them.
Applicant argues that allegedly the amended claims are different than the compounds claimed in the patent which is NOT true. Note the above reasoning of applicant using “comprising” which opens up the entire claim thus it will still read on the claimed subject matter.
Claims 11-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,752,184. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims the same cannabinods and terpenoids as claimed herein and a polymeric thin film or chewing gum have a concentrate of the original cannabis extract in them.
Applicant argues that allegedly the amended claims are different than the compounds claimed in the patent which is NOT true. Note the above reasoning of applicant using “comprising” which opens up the entire claim thus it will still read on the claimed subject matter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL V MELLER whose telephone number is (571)272-0967. The examiner can normally be reached on M-F 9 am-5:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terry McKelvey can be reached on 571-272-0995. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
MICHAEL V. MELLER
Primary Examiner
Art Unit 1655
/MICHAEL V MELLER/Primary Examiner, Art Unit 1655