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 .
Election/Restrictions
Applicant’s election without traverse of Group (I) in the reply filed on 02/18/2025 is acknowledged and maintained.
Applicant’s election without traverse of Δ9-tetrahydrocannbinol as the elected first component, caffeine as the elected methylxanthine as the second component, and valerenic acid as the elected extract of valerian in the reply filed on 02/18/2025 is acknowledged is maintained.
Priority
This application is: a continuation-in-part application of U.S. Application No. 16/541731, filed on August 15, 2019; and a continuation-in-part application of U.S. Application No. 16/541,770, filed on August 15, 2019.
Claim Status
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on February 05, 2026. Claims 1-4 and 6-18 are pending. Claims 11-16 are withdrawn. Claims 5 and 19 are canceled. Claims 1-4, 6-10 and 17-18 are examined in accordance to the elected species.
Action Summary
The rejection of claims 1-4 and 6-10 under 35 U.S.C. 101 is maintained, but modified and revisited in light of the claim amendment.
Claims 1-4 and 6-10 rejected under 35 U.S.C. 101 because the claimed invention is directed to products of nature without significantly more, are maintained, but modified and revisited in light of the claim amendment.
The rejection of claims 2 under 35 U.S.C. 112(b) or 35 U.S.C. second paragraph with respect to the recitation of “mixtures thereof,” are withdrawn.
However, the rejection 1-4, 6-10 and 17-18 rejected under 35 U.S.C. 112(b) or 35 U.S.C. based on the dosage inconsistency is maintained, but rewritten for clarity in view of Applicant’s argument. The rejection is not based on any equivalency between THC and CBD, but rather the inconsistency between the broad recited dosage of the first component and the specific dosage ranges recited for THC and CBD within that component.
The rejection of claim 2 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn.
Claims 1-4, 6, 7, 9, and 10 rejected under 35 U.S.C. 103 as being un-patentable over Victor et al. (US2016/0324777 A1) In view of Hoffman et al (Journal of Neuroscience 13 January 2010, 30 (2) 545-555), Hindocha et al (Eur Neuro-psychopharmacol, 2015 Mar;25(3):325-34, Epub 2014 Dec 5), and Nam et al (Experimental Gerontology, Volume 48, Issue 11, November 2013, Pages 1369-13), are withdrawn in light of the claim amendment.
Claims 8, 17, and 18 are rejected under 35 U.S.C. 103 as being un-patentable over Victor et al. (US2016/0324777 A1) In view of Hoffman et al (Journal of Neuroscience 13 January 2010, 30 (2) 545-555), Hindocha et al (Eur Neuro-psychopharmacol, 2015 Mar;25(3):325-34, Epub 2014 Dec 5), and Nam et al (Experimental Gerontology, Volume 48, Issue 11, November 2013, Pages 1369-13) as applied to claims 1-4, 6, 7, 9, and 10 in view of Franklin et al (US2017/0189462 A1) and Victor et al. (US2016/0324777 A1), are withdrawn in light of the claim amendment.
Claims 1-4, 6-10 and 17-18 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,278,516B2 in view of Franklin et al (US2017/0189462 A1) and Nam et al (Experimental Gerontology, Volume 48, Issue 11, November 2013, Pages 1369-13), are maintained, but modified and revisited in light of the claim amendment.
Claims 1-4, 6-10 and 17-18 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,278,516B2 in view of Franklin et al (US2017/0189462 A1) and Nam et al (Experimental Gerontology, Volume 48, Issue 11, November 2013, Pages 1369-13), are maintained, but modified and revisited in light of the claim amendment.
Modified and Revested Rejection
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 1-4, 6-10, and 17-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without reciting significantly more, in accordance with the 2019 Revised Patent Subject Matter Eligibility Guidance.
The claims are directed to a nutraceutical composition comprising cannabinoids including Δ⁹-tetrahydrocannabinol (THC) and cannabidiol (CBD), a methylxanthine (e.g., caffeine), a valerian extract comprising valerenic acid, and an aqueous carrier. Each of these components is a naturally occurring substance. Cannabinoids are naturally occurring compounds found in Cannabis sativa (Spec. paragraph [[0028]). Methylxanthines such as caffeine are naturally occurring in coffee and tea (Spec. paragraph [0052]). Valerian extract and valerenic acids are plant-derived natural products (Spec. paragraph [0060]). Water is also a naturally occurring substance. Accordingly, the claims recite a combination of naturally occurring products, which constitutes a judicial exception.
The claims do not include additional elements that integrate the judicial exception into a practical application. The recited dosage ranges for the cannabinoid, methylxanthine, and valerian components represent result-effective variables. The recitation that the components are the “only active ingredients” merely excludes additional components and does not impose any meaningful limitation on the use of the natural products. The formulation of the composition as a powder dissolved or suspended in an aqueous carrier constitutes a conventional formulation technique. The specification itself describes routine formulation practices and conventional additives (Spec. paragraph [0135]) and describes the compositions as nutraceutical formulations for ingestion (Spec. paragraph [0081]). Accordingly, the claims merely describe the combination and formulation of natural products without imposing a meaningful limitation.
The claims do not recite additional elements that amount to significantly more than the judicial exception. The aqueous carrier and formulation steps are well-understood, routine, and conventional activities in the field of nutraceutical compositions (Spec. paragraph [0135]). The exclusion of additional active ingredients is a negative limitation that does not add an inventive concept. When considered as an ordered combination, the claim elements amount to no more than combining natural products using conventional formulation techniques.
Accordingly, the claims are directed to a judicial exception without significantly more, and are therefore not patent eligible.
Acknowledgement is made of the receipt and entry of Applicant’s remarks/arguments filed on February 05, 2026.
Applicant’s argument
Applicant contends that:
the claimed composition is not a product of nature,
the combination of Δ9-THC, CBD, methylxanthine, and valerian extract is not naturally occurring, and
therefore, the claimed composition is “markedly different” from naturally occurring products.
Examiner’s answer
In response, Applicant’s arguments have been fully considered but are not persuasive. Applicant asserts that the claimed nutraceutical composition is not a product of nature because there is no naturally occurring counterpart that contains Δ9-THC (tetrahydrocannabinol or THC), cannabidiol (CBD), a methylxanthine, and valerian extract together. However, the proper analysis under the 2019 Revisited Patent Subject Matter Eligibility Guidance (PEG) is not limited to whether the exact combination exists in nature, but whether the claimed subject matter recites a judicial exception, including a product of nature or a combination of natural products, and whether the claimed combination exhibits markedly different characteristics from its naturally occurring counterpart. In the present case, the claimed composition comprising multiple naturally occurring substances, including THC, CBD, methylxanthine (e.g., caffeine), and valerian extract components (e.g., valerenic acid), each of which is a naturally occurring compound derived from plant sources. As such, the claim recites a natura-based product, i.e., a combination of natural products, which falls within the product of nature exception. See MPEP 2106.04(c)
Applicant’s argument that the specific combination does not occur in nature is not sufficient to establish eligibility. A composition comprising multiple natural products does not become patentable-eligible merely because the exact combination is not found in nature. Rather, the relevant inquiry is whether the claimed combination as a whole exhibits characteristic that are markedly different from the naturally occurring components. See MPEP 2106.04(c). Here, the claimed composition does not recite any structural or functional modification of the naturally occurring components. The components are merely combined in aqueous carrier without any indication that the combination results in a change in structure, function, or properties beyond the expected additive effects of the individual components. The specification does not provide evidence of new or markedly different characteristic arising from the claimed combination, such as synergistic effect of a transformation of the component.
Furthermore, the additional elements recited in the claims, including the aqueous carrier, the recited dosage ranges, and the negative limitations, do not amount to significantly more than the judicial exception. The use of an aqueous carrier represents well-understood activity in the field of nutraceutical compositions. Similarly, the recited dosage ranges represent routine optimization of result-effective variables and do not impose a meaningful limitation of the judicial exception.
Applicant’s argument
Applicant argues that the claimed nutraceutical composition exhibits markedly different characteristics from naturally occurring products. Specifically, Applicant asserts that:
the claimed composition provides a distinct pharmacological performance profile and dose-dependent functional effects;
the specification (e.g., paragraphs [0033], [0036], [0040]-[0042]) demonstrates that the claimed blend:
provides a nootropic effect beyond cannabinoids alone,
reduces anxiety associated with xanthine ingestion, and
amplifies alertness and cognitive function; and
therefore, the claimed composition is “markedly different” from the isolated naturally occurring components, and is not directed to a product of nature.
Examiner’s answer
In response, Applicant’s arguments have been fully considered but are not persuasive. Applicant contends that the claimed composition exhibits markedly different characteristics based on the alleged distinct pharmacological performance profile and dose-dependent effects, citing portions of the specification (e.g., paragraphs [0033], [0036], [0040]-[0042]) describing purported nootropic and cognitive-enhancing effects of the claimed combination. However, the asserted differences are not sufficient to establish markedly different characteristics under the 2019-PEG.
First, Applicant’s arguments rely on alleged functional differences (e.g., improved cognitive, reduced anxiety, and increased alertness), but such differences must reflect a change in characteristics that is different in kind, rather than merely in degree, relative to the naturally occurring components. See MPEP 2106.04(c).
Second, the cited portions of the specification merely describe expected or additive effects of combining known components with known properties. For example, cannabinoids are known to effect anxiety and cognition, methylxanthines (e.g., caffeine) are known to enhance alertness and cognitive performance, and valerian extracts are known to influence neurological or calming effects. Thus, the alleged improvements represent predictable results of combining known natural products, rather the evidence of a new or markedly different characteristic.
Third, the alleged “dose-dependent functional effects” do not establish markedly different characteristics, as dosage optimization is routine and conventional activity in the formulation of nutraceutical compositions. Accordingly, the claimed composition remains a combination of natural products that does not exhibit markedly different characteristics from its naturally occurring components.
Furthermore, the additional elements, including the aqueous carrier and formulation features and the negative limitations, amount only to well-understood, routine, and conventional activity and do not provide significantly more than the judicial exception.
Applicant’s argument
Applicant argues that the claimed composition is patent-eligible because:
under the 2019-PEG and Example 44, mixture of natural products that change properties are not judicial exceptions;
the claimed composition allegedly produces non-natural pharmacological effects, including altered onset, duration, and therapeutic index;
the claimed dosage ranges demonstrate a practical application, rather than a judicial exception;
under Natural Alternative int’l v. Creative Compounds, claims reciting specific dosages of natural products are patent-eligible; and
no naturally occurring product contains the claimed combination of compounds in the recited dosage ranges.
Examiner’s answer
In response, Applicant’s arguments have been fully considered but are not persuasive.
1. Applicant relies on USPTO Example 44 to argue that the claimed composition exhibits markedly characteristics. However, Applicant’s reliance is misplaced. Example 44 involves a composition where the combination of components results in demonstrated new functional properties supported by evidence, such as improve glycemic control arising from a specific interaction between components. In contrast, the present claims do not provide objective evidence demonstrating that the claimed combination results in a new or non-additive property. The specification merely describes expected pharmacological effects of the individual components (e.g., cognitive enhancement, reduced anxiety, stimulation), which are well known in the art. Accordingly, the present case is more analogous to the situation where natural products are combined without a demonstrated change in kind, and thus, do not exhibit markedly different characteristics.
2. Applicant asserts that the claimed composition produces “non-natural pharmacological effects,” including altered onset, duration, and therapeutic index. However, such statements are conclusionary and unsupported by evidence demonstrating that the claimed composition exhibits characteristics different in kind, rather than degree, from the naturally occurring components. Change in onset, duration, or therapeutic index are commonly associated with dosage variation, and routine formulation adjustments, and therefore, represent predictable and expected results, not markedly different characteristics.
3. Applicant argues that the recited dosage ranges demonstrate a practical application and confer eligibility. However, the recitation of dosage ranges:
does not alter the fact that the claim is directed to a combination of natural products, and
represent routine optimization of result-effective variables. The claimed dosage ranges do not transform the nature of the claimed composition and do not impose a meaningful limitation sufficient to render the claimed patent-eligible.
4. Applicant reliance on Natural Alternatives Int’l v. Creative Compounds is not
persuasive. In Natural Alternatives Int’l v. Creative Compounds, the claims were directed to a specific method of treatment using a natural product in a particular dosing regimen that produces a physiological effect not previously associated with the natural product in that context. In contrast, the present claims are directed to a composition of matter comprising natural products, without reciting a specific method of treatment or demonstrating a new functional use. Furthermore, the claimed effects (e.g., cognitive enhancement, reduced anxiety) are known properties of the individual components, and applicant has not demonstrated that the claimed combination produces a new or unexpected result.
5. Applicant’s argument that no natural product contains the claimed components in the recited amounts is not sufficient. A composition does not become patent-eligible merely because:
- it combines natural products that are not found together in nature, or
- it recites specific quantities.
The proper inquiry is whether the claimed composition exhibits markedly different characteristics, which, as discussed above has not been established. For
Applicant’s argument
Applicant argues that the Office Action factually inaccurate in asserting that Δ9-THC, CBD, methylxanthine, aqueous carrier, the extract of valerian or arugula are “found together in nature.” Applicant contends that no naturally occurring plant contains these components together, particularly, in the claimed arrangement and as the “only active ingredients.” Applicant further argues that the claimed composition is therefore not directed to a judicial exception under Step 2A, Prong One, and alternatively integrates any exception into a practical application due to the recited dosage ranges and functional effects.
Examiner’s answer
In response, Applicant’s arguments have been fully considered but are not persuasive.
Applicant’s argument mischaracterizes the basis of the rejection. The rejection under 35 U.S.C. 101 is not premised on a finding that the claimed components exist together in nature in the exact claimed combination. Rather, the rejection is based on the fact that the claimed invention is directed to a combination of naturally occurring substances, each of which individually exists in nature. As set forth in MEPE 2106.04(c), a claim directed to a nature-based product, including combination of natural products, must exhibit markedly different characteristics from its naturally occurring counterpart to be patent-eligible. The fact that the claimed combination does not exist in nature does not, by itself, render the claim patent-eligible. A composition comprising multiple natural products, even if not found together in nature, remains a nature-based product and must demonstrate markedly different characteristics. See Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948). Accordingly, Applicant’s argument that “no natural source contains the claimed combination together” is not dispositive of eligibility.
Applicant’s reliance on the limitation that recited components are the “only active ingredients” is not persuasive. This limitation merely defines the composition in terms of its constituent natural components and does not impart any structural or functional difference sufficient to render the claimed composition markedly different from tis naturally occurring counterparts. The recitation that the components are “homogenously” distributed in an aqueous carrier similarly does not confer eligibility. Formulating natural products in a carrier or dispersing them in a solution represents routine conventional activity and does not result in a composition having markedly different characteristics. See MPEP 2106.04(c). Because the claim recites a composition comprising natural products (Δ9-THC, CBD, methylxanthine, valerian extract), the claims are properly determined to be directed to a judicial exception under Step 2A, Prong One.
Applicant’s argument that dosage ranges and ratios integrate the exception into a practical application is not persuasive. The recited dosage ranges and ratios represent optimization of known parameters for administering known substances and do not amount to an inventive concept. Such limitations are considered routine and conventional and do not transform the nature-based product into patent-eligible subject matter. Furthermore, Applicant has not demonstrated that the recited dosage ranges result in a functional difference that is markedly different in kind from the effects of the individual components.
Modified and Revested Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 6-10 and 17-18 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.
The limitation that the recited components are the “only active ingredients present” renders the claims indefinite because the term “active” is not clearly defined in the specification. It is unclear whether the term includes or excludes trace bioactive compounds, impurities, or components that may have incidental biological activity. Therefore, the scope of the claims cannot be determined with reasonable certainty.
The claims further recite “psychotropic cannabinoid” and “nonpsychotropic cannabinoid.” The specification does not provide a clear standard or test for determining whether a given cannabinoid falls within either category. Accordingly, one of ordinary skill in the art would not be able to determine the scope of these limitations with reasonable certainty.
Claim 1 recites a first component comprising 1 to 300 mg/dose of cannabinoids and further recites that the same component comprises 1.5 to 25 mg/dose of THC and 10 to 75 mg/dose of CBD. It is unclear how these ranges relate to one another, including whether both THC and CBD must be present and how the total amount of the first component is determined relative to its subcomponents. Claim 9 similarly recites inconsistent dosage limitations for the first component. Accordingly, the scope of the claims is unclear.
Claims 2-4, 6-10, and 17-18 depend from claims 1 or 9 and therefore inherit these indefiniteness issues.
New Rejection necessitated by claim amendment
Claims 17 and 18 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 17 and 18 recite “one or more pure valerenic acids in an amount of 0.1 to 1.8 mg/dose.” Such language renders the claim indefinite. Although the specification discloses similar language (see, e.g., paragraph [0058]), the term “pure” is a term of degree for which the specification fails to provide an objective standard, such as redefined purity level, measurement method, or threshold, by which one of ordinary skill in the art could determine the scope of the claim. Additionally, the phrase “one or more valerenic acids” is unclear as to whether it encompasses a single valerenic acid compound, multiple distinct valerenic acid species, or mixtures thereof, and how the requirement of “pure” applies in such embodiments. For example, it is unclear whether each valerenic acid must be individually pure prior to combination, or whether the mixture itself must satisfy an undefined purity requirement. Furthermore, the recitation that the valerenic acids are “used in a total amount ranging from 0.1 to 1.8 mg/dose” introduces additional ambiguity as to whether the claimed range applies to each individual valerenic acid or to the combination total of multiple acids. Accordingly, one of ordinary skill in the art would not reasonably apprise of the scope of the claim.
New Rejection necessitated by claim amendment
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.
Claims 1-4, 6-10, and 17-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claims 1 and 9 recite nutraceutical compositions in which the recited cannabinoid component, methylxanthine component, and valerian component are the only active ingredients present. However, the specification does not reasonably convey to one of ordinary skill in the art that the inventor had possession of a composition limited to only these three active ingredients.
While the specification discloses cannabinoids (Spec. paragraph [0028]), methylxanthines (Spec. paragraph [0052]), and valerian extract (Spec. paragraph [0060]), the specification also teaches that compositions may include additional components such as flavoring agents, preservatives, stabilizers, sweeteners, vitamins, and other additives (Spec. paragraph [0135]). These disclosures indicate that the compositions are not limited to only the recited active ingredients. The specification does not describe or suggest compositions in which all other active ingredients are excluded.
Claim 9 further recites that the composition is free of non-cannabinoid active components of Cannabis sativa and contains no active components of coffee other than the methylxanthine. The specification does not describe the removal or exclusion of all such components, nor does it provide support for compositions defined by these negative limitations. Although the specification mentions certain exclusions (Spec. paragraph [0030]), it does not describe complete exclusion as required by the claims.
Accordingly, the specification does not provide adequate written description support for the claimed compositions.
Claims 2-4, 6-10, and 17-18 depend from claims 1 or 9 and therefore inherit these deficiencies.
New Rejection necessitated by claim amendment
Claim Rejections - 35 USC § 103
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 non-obviousness.
Claims 1-4, 6-10, and 17-18 are rejected under 35 U.S.C. 103 as being un-patentable over Victor et al. (US2016/0324777 A1) In view of Hoffman et al (Journal of Neuroscience 13 January 2010, 30 (2) 545-555), Hindocha et al (Eur Neuro-psychopharmacol, 2015 Mar;25(3):325-34, Epub 2014 Dec 5), and Nam et al (Experimental Gerontology, Volume 48, Issue 11, November 2013, Pages 1369-13).
Victor teaches a nutraceutical composition comprising 5-95 wt% of a plant-derived material including Cannabis sativa, wherein the composition may include cannabinoids such as cannabidiol (CBD) and Δ⁹-tetrahydrocannabinol (THC) (see Victor, claims 70–71), caffeine (a methylxanthine) (see Victor, paragraph [0081]), valerian extract (see Victor, paragraph [0029]), and water as part of an ingestible composition (see Victor, claim 1; paragraph [0081]). Victor further teaches that the composition may be consumed orally as a beverage or nutraceutical formulation. Victor teaches the plant material can be powder (see Victor, paragraph [0011]) and prepared as a beverage, including infusion of plant material in water (See paragraph [0081]), thereby forming an orally administrable liquid composition.
Victor therefore expressly teaches THC, CBD), caffeine, aqueous carrier, and oral liquid formulation, and valerian extract which Nam identifies as comprising valerenic acid as its active constituent responsible for cognitive effect (Nam, Abstract, p 1370, first paragraph).
Victor does not explicitly teach the specific combination of THC and CBD as a first component in the recited dose ranges, nor explicitly teach the cognitive interaction between THC and caffeine, nor explicitly teach the use of valerian extract for memory improvement.
Hoffman teaches that Δ⁹-THC interacts with caffeine at CB1 and adenosine receptors and that caffeine modulates the effects of THC on cognitive function and memory (see Hoffman, Abstract and Results).
Hindocha teaches that CBD may reduce adverse effects associated with THC and enhance therapeutic efficacy when co-administered with THC (see Hindocha, Abstract).
Nam teaches that valerian extract comprising valerenic acid improves memory and cognitive function and may be useful in treating Alzheimer’s disease (see Nam, Abstract and first paragraph of p. 1370).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to modify the composition of Victor to include THC and CBD in combination, caffeine as a methylxanthine, and valerian extract as a source of valerenic acid as suggested by Hoffman, Hindocha, and Nam, in order to provide a nutraceutical composition for affecting cognitive function, alertness, and memory. One would have been motivated to combine these teachings because each reference teaches components that act on the central nervous system and are used for similar purposes, combining such known agents with complementary or synergistic effects would have been a predictable use of the prior art elements according to their established functions. Including cognitive modulation, mood regulation, and memory enhancement. See KSR Int’l Co. v. Teleflex Inc. One of ordinary skill in the art would have had a reasonable expectation of success in making such a combination because the prior art demonstrates known interactions between THC and caffeine (Hoffman), known co-administration benefit of THC and CBD (Hindocha), and known cognitive effects of valerian extract (Nam). Further, combination of CNS-active agents (e.g., cannabinoids with methylxanthine, were already known in the art. See Hoffman, Hindocha; in re Kerkhoven. Accordingly, combining these known components would have predictable yielded composition wit CNS and cognitive effects.
The claimed recitation of “first,” “second,” and “third” components merely identifies groups of ingredients within a single composition and does not require structural separation of the components. Victor’s composition therefore teaches or at least renders obvious a composition comprising the recited components.
With respect to recited amount of valerian extract (e.g., about 50-600 mg/dose), Victor teaches the inclusion of valerian extract in ingestible composition (see Victor, paragraph [0029]) and formulations suitable for oral consumption (paragraph [0081]). Although Victor does not explicitly disclose the exact claimed mg/dose range, the prior art recognizes that the amount of botanical extracts in nutraceutical composition affects the desired physiological and cognitive outcomes.
With respect to the recited dosage ranges and ratios, Victor et al. teaches cannabinoid and caffeine amounts that overlap or approximate the claimed ranges (claims 70-71; paragraph [0081]) expressed in weight percent, which correspond to mg-level quantities per serving depending on the total composition size. For ingestible composition such as beverages or nutraceutical formulations, such concentrations would reasonably correspond to amounts per dose that overlap or at least approximate the claimed mg/dose ranges. The prior art recognizes that the amounts and relative ratios of cannabinoids and methylxanthine directly affect physiological outcomes. Accordingly, these parameters constitute result-effective variables, including the selection of specific dosage ranges and ratios to achieve the desired effects, would have been within the level of ordinary skill in the art through routine experimentation. See in re Aller; in re Peterson.
With respect to “a powder dissolved in the aqueous carrier,” the powder is homogeneously distributed in the aqueous carrier” claimed. Victor teaches a powder form that is combined with water to form a beverage by infusion (paragraph [0081]) Victor teaches the composiont can be a green tea or a green juice (see paragraph [0109]). The infusion of plant-derived powder into water inherently results in dissolution and/or dispersion of active components in an aqueous carrier. Therefore, Victor teaches or at least render obvious a composition in which a powder dissolved or dispersed in an aqueous medium, as recited.
With respect to the recited volume of aqueous medium (e.g., about 20 ml to about 2,500 ml), the selection of a suitable volume for administration or infusion represents a result-effective variable relating to dilution or serving size, and optimization of such a parameter would have been within the level of ordinary skill in the art. See in re Aller, in re Peterson.
With respect to the recited cannabinoid as being a psychotropic cannabinoid or a nonpsychotropic cannabinoid, caffeine as methylxanthine, Victor expressly teaches THC, CBC, and caffeine which are species within the recited group of cannabinoids, non-psychotropic cannabinoids, psychotropic cannabinoids, and methylxanthines. A compound and its properties are inseparable; thus, caffeine inherently satisfies the recited methylxanthine. Selection of known species from known classes does not confer patentability.
With respect to the limitation that the composition contains only the recited active components, exclusion of additional active ingredients represents a matter of formulation design choice once the desired active agents are selected, and would have been obvious to one of ordinary skill in the art.
With respect to the limitation of homogeneous distribution in an aqueous carrier, such distribution is inherent in a properly prepared liquid composition formed by dissolving or dispersing component in a liquid medium.
With respect to the one or more pure valerenic acids in an amount of 0.1-1.8 mg/dose. Nam teaches valerenic acid as the active constituent responsible for the cognitive effects of the valerian extract. It would have been obvious to use the known active component (valerenic acid) directly in place of or in addition to the extract, as Nam identifies valerenic acid as responsible for the disclosed biological activity. Moreover, the recited range represents optimization of a result-effective variable and would have been within the level of ordinary skill in the art. Furthermore, the recitation of “pure” valerenic acid does not render the claim patentable, as isolating, purifying or enriching a known active from a natural extract to obtain higher purity or concentration is a routine and well-understood practice in the art, and would have been an obvious modification yielding predictable results. A compound and its properties are inseparable therefore, the purified form of valerenic acid would inherently exhibit the same known biological activity attributed to the compound in the extract.
Acknowledgement is made of the receipt and entry of Applicant’s remarks/arguments filed on February 05, 2026.
Applicant’s argument
Applicant argues that the combination of Victor et al. in view of Hoffman et al. Hindocha et al., and Nam et al. fails to render the claims obvious because:
1. The cited references do not teach that the fist, second, and third components are the ”only active ingredients present/”
2. Victor allegedly teaches compositions containing additional active ingredients, and removal thereof would be contrary to its teachings.
3. The cited references do not teach the specific dosage ranges recited in the claims.
4. Victor does not teach a powder “homogeneously distributed” in an aqueous carrier and a tea bag infusion is not equivalent.
5. The references do not teach the specific combination of THC, CBD, methylxanthine, and valerian extract in the claimed form.
Examiner’s response
In response, Applicant’s arguments have been fully considered but are not persuasive for the reasons set forth below:
1. “Only active ingredients present” limitation. The limitation that the first, second, and third components are the “only active ingredients” is directed to the exclusion of additional active agents, which constitute a formulation choice rather than a structural distinction over the prior art. Victor expressly teaches compositions comprising cannabinoids, caffeine (a methylxanthine), and valerian extract. While Victor further discloses optional inclusion of additional botanicals, the reference does not require such additional actives. A person of ordinary skill in the art would be expected to omit optional ingredients and formulate a composition consisting essentially of the desired active components, particularly where the art recognizes those components as responsible for the intended physiological effects. The Federal Circuit has consistently held that elimination of ingredients from a known composition is an obvious matte of design choice, absent a showing of unexpected results. See In re Larson, 340 F.2d 965 (CCPA) 1965). Here, Applicant has not demonstrated that excluding additional actives yields any unexpected property. Accordingly, limiting the composition to only the recited active ingredients would have been obvious optimization of a known formulation.
2. Applicant’s contention that removing additional ingredients is “contrary to the teaching of Victor” is not persuasive. Specifically, Victor broadly teaches nutraceutical compositions comprising multiple optional plant-derived components. Such disclosures are expansive and permissive, not restrictive. A reference that discloses optional does not teach away from their omission. A person of ordinary skill in the art would have recognized that the relevant therapeutic effects raise from the cannabinoids, methylxanthine, and valerian extract, and additional botanical are non-essential adjuncts. Accordingly, modification of Victor to exclude non-essential components represent routine formulation refinement and does not constitute teaching away. See MPEP 2145 (IX)(D)(1) and KSR Int’l Co. v. Teleflex Inc. 550 US. 398 (2007).
3. Applicant’s argument regarding dosage ranges claimed are not persuasive. Specifically, Victor teaches cannabinoid and caffeine amounts in weight percent ranges (claims 70-71; paragraph [0081]), which correspond to mg-per-dose quantities depending on the serving size. For ingestible compositions such as beverages, these values reasonably overlap or approximate the claimed mg/dos ranges. Additionally, Hindocha teaches co-administration of THC and CBD and their dose-dependent effects. Nam teaches valerian extract and its active component (valerenic acid) in therapeutic relevant amounts. The prior art establishes that:
Optimization of such variable, including selecting specific mg/dose values within known workable ranges, would have been routine. See In re Aller, 200 F.2d 454 and in re Peterson, 315 F.3d 1325. Applicant has not provided evidence of criticality or unexpected results for the claimed ranges.
4. To the extent Applicant argues that the references fail to teach the claimed valerian extract or its amounts, the argument is not persuasive. Victor teaches inclusion of valerian extract, and Nam identifies valerenic acid as the active component responsible for the extract’s effect. One would reasonably expect to use valerian extract in amounts sufficient to achieve the known therapeutic effect and/or utilize enrich the active constituent (valerenic acid) directly. Isolating or enriching active compounds from plant extracts is a well-known and routine practice. Further, the claimed extract ranges overlap or are reasonably suggested by known dosing of valerian extract in humans, and routine scaling and optimization based on pharmacological effect.
5. Applicant argues that regarding the tea bag embodiment is not persuasive. Victor teaches powdered composition and use in aqueous media (beverages formed by infusion). A person of ordinary skill in the art would understand that once the composition is introduced into water, the active components become distributed within the aqueous medium. The distinction between “dissolved” and homogeneously distributed” does not impart a patentable structural limitation, as both described the state of dispersion in use rather than a structural difference in the composition itself. Moreover, preparation steps (e.g., dissolving or infusing) are method-of-use characteristics, not structural limitations of the claimed composition. Thus, the limitation does not distinguish over the prior art.
6. Applicant’s argument that the references do not teach the exact claimed composition is not persuasive. Specifically, Victor teaches the base composition (cannabinoids, caffeine, valerian extract, aqueous formulations). Hoffman teaches THC-caffeine interaction affecting composition. Hindocha teaches THC/CBD co-administration effects. Nam teaches valerian extract/valerenic acid cognitive effects. These references collectively demonstrate that each component affects the central nervous system and combining such agents would have expected to yield predictable modulation of cognitive function. Under KSR, combining known elements according to their known functions to yield predictable result is prima facie obvious.
Applicant’s arguments with respect to claim 8, 17, and 18 appear to be directed, at least in part, to Franklin et al. However, Franklin is no longer applied in the present rejection. Accordingly, arguments premised on the teachings or deficiencies of Franklin are not responsive to the grounds of rejection currently before the Office are therefore not persuasive. Notwithstanding the above, the newly added limitations recited in claims 8, 17, and 18, including the recitation of “one or more pure valerenic acids” and the associated dosage ranges, have been fully considered and are addressed in the rejection set forth above. As explained therein, these limitations are taught or suggested by the combination of Victor et al., in view of Hoffman et al., Hindocha et al., and Nam et al., and would have been obvious for the reasons discussed above. Accordingly, Applicant’s arguments have been considered but are not persuasive, and the new rejection is maintained.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-4, 6-10 and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,278,516B2 in view of Franklin et al (US2017/0189462 A1) and Nam et al (Experimental Gerontology, Volume 48, Issue 11, November 2013, Pages 1369-13). Although the claims at issue are not identical, they are not patentably distinct from each other.
The U.S. patent claims teach a medicinal composition comprising:
a first active component consisting of 10 to 400 mg/dose of tetrahydrocannabinol, cannabidiol, cannabinol, or a mixture thereof,
a second active component consisting of 1 to 300 mg/dose of caffeine, theobromine, or a mixture thereof; and
a third active component consisting of 1 to 30 mg/dose of yohimbine, yohimbine HCl, yohimbine monoglycine ester, yohimbine alkyl amine, or a mixture thereof;
wherein the first active component, the second active component, and the third active component are the only active ingredients present in the medicinal composition. (See claim 1.)
Moreover, the U.S. patent claims teach a beverage comprising a suspension of a medicinal powder composition in an aqueous carrier, wherein the powder comprises:
a first active component comprising 10 to 400 mg/dose of tetrahydrocannabinol, cannabidiol, cannabinol, or a mixture thereof,
a second active component comprising 1 to 300 mg/dose of caffeine, theobromine, or a mixture thereof; and
a third active component consisting of 1 to 30 mg/dose of yohimbine, yohimbine HCl, yohimbine monoglycine ester, yohimbine alkyl amine, or a mixture thereof;
wherein the first active component, the second active component, and the third active component are the only active ingredients present in the medicinal composition;
wherein the first active component is made by mixing THC oil with silicon dioxide. (See claim 12.) The 1-300 mg dose of caffeine touches the claimed 80-300 mg/dose of the elected caffeine. The 10-400 mg dose of the elected THC touches the claimed 80-300 mg/dose of the elected THC.
The U.S. patent claims do not teach an aqueous carrier. Additionally, the U.S. patent claims and Franklin collectively do not teach Valerian extract comprising valerenic acid.
Franklin teaches there is a need for a standardized and measurable dosage of THC and CBD in a powder form, a way to enable consumers of cannabis to accurately and repeatably deliver the same dose of THC and CBD to address their medical needs, a more socially acceptable, easier, and more convenient way to consume cannabis than Smoking it, a way to render the normally unpleasant tasting concentrated cannabis oil flavorless, a way to fully capitalize on the medical benefits of CBD in cannabis products, to eliminate or minimize the psychoactive effects of THC, if so desired, in cannabis products, or otherwise control the level of THC in a consumable form, a way for users to control the THC intake and its associated effects without the negative health aspects of inhaling Smoke, a way to select cannabis products made from sativa strains, indica Strains or combi nation thereof, and that enables users to achieve the Synergistic effect of caffeinated coffees or teas with cannabis, which can create a mildly euphoric effect in certain controlled doses. (See paragraph [0021].) Moreover, Franklin teaches Mix/dissolve THC powder into Hot water or Hot beverage. If beverage is not intended to be ingested hot, the liquid may be poured over ice or refrigerated/cooled as desired once the THC powder has already been dissolved. The THC powder will remain emulsified in the beverage after cooling; however, the initial application of the powder must be into a HOT liquid, due to the unique emulsification properties of the powderized oil. (See paragraph [0157] & [0158].)
It would have been prima facie obvious for a person of ordinary skill in the art at the time of the invention was filed to modify the composition taught by the U.S. patent by including water as the aqueous carrier for making a beverage (reading on nutraceutical) or a powder form for enhancing cognitive function and memory in Alzheimer’s disease and use the claimed amount of THC, CBD, and caffeine to give Applicant’s claimed invention. One would have been motivated to so, because the composition of Franklin teaches the method of making a nutraceutical containing THC can be in a powder form before mixing it with water or be in a form of beverage that include water to provide a more socially acceptable, easier, and more convenient way to consume cannabis than smoking it and also because the U.S. patent teaches the overlapping amount of THC, CBD, and caffeine. One would reasonably expect the inclusion of water as the aqueous carrier to provide a beverage (nutraceutical) formulation with a more socially acceptable, easier, and more convenient way to consume THC in order to successfully enhance cognitive function and memory in Alzheimer’s disease. The overlapping obvious amount of caffeine and THC would also render obvious the ratio claimed in claim 10.
Nam teaches the use of valerian extract comprising valerenic acid for treating Alzheimer’s disease and for improving memory. (See Abstract and the first paragraph of the left column of page 1370.)
It would have further been prima facie obvious for a person of ordinary skill in the art at the time of the invention was made to combine the composition taught by the U.S. patent and Franklin with that set forth by Nam because each is taught by the prior art to be useful for the same purpose (i.e., treat Alzheimer’s disease or improving memory in Alzheimer’s disease). See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Further, a person of ordinary skill in the art would reasonably have expected to be successful because both compositions were shown to be useful separately for the exact same purpose and thus would be expected to be similarly useful when used together.
The nutraceutical composition taught by the U.S. patent, Franklyn, and Nam would reasonably be free of non-cannabinoid active components of Cannabis sativa and contains no active components of coffee other than the methylxanthine.
With respect to recited amount of valerian extract (e.g., about 50-600 mg/dose), the U.S. patent claims teach the inclusion of valerian extract in ingestible composition (see claim.) Although the U.S. patent claims do not explicitly disclose the exact claimed mg/dose range, the prior art recognizes that the amount of botanical extracts in nutraceutical composition affects the desired physiological and cognitive outcomes.
With respect to the recited dosage ranges and ratios, the U.S. patent claims teach cannabinoid and caffeine amounts that overlap or approximate the claimed ranges (claim 1]) expressed in weight percent, which correspond to mg-level quantities per serving depending on the total composition size. For ingestible composition such as beverages or nutraceutical formulations, such concentrations would reasonably correspond to amounts per dose that overlap or at least approximate the claimed mg/dose ranges. The prior art recognizes that the amounts and relative ratios of cannabinoids and methylxanthine directly affect physiological outcomes. Accordingly, these parameters constitute result-effective variables, including the selection of specific dosage ranges and ratios to achieve the desired effects, would have been within the level of ordinary skill in the art through routine experimentation. See in re Aller; in re Peterson.
With respect to “a powder dissolved in the aqueous carrier,” the powder is homogeneously distributed in the aqueous carrier” claimed. Victor teaches a powder form that is combined with water to form a beverage by infusion (paragraph [0081]) Victor teaches the composiont can be a green tea or a green juice (see paragraph [0109]). The infusion of plant-derived powder into water inherently results in dissolution and/or dispersion of active components in an aqueous carrier. Therefore, Victor teaches or at least render obvious a composition in which a powder dissolved or dispersed in an aqueous medium, as recited.
With respect to the recited volume of aqueous medium (e.g., about 20 ml to about 2,500 ml), the selection of a suitable volume for administration or infusion represents a result-effective variable relating to dilution or serving size, and optimization of such a parameter would have been within the level of ordinary skill in the art. See in re Aller, in re Peterson.
With respect to the recited cannabinoid as being a psychotropic cannabinoid or a nonpsychotropic cannabinoid, caffeine as methylxanthine, Victor expressly teaches THC, CBC, and caffeine which are species within the recited group of cannabinoids, non-psychotropic cannabinoids, psychotropic cannabinoids, and methylxanthines. A compound and its properties are inseparable; thus, caffeine inherently satisfies the recited methylxanthine. Selection of known species from known classes does not confer patentability.
With respect to the limitation of homogeneous distribution in an aqueous carrier, such distribution is inherent in a properly prepared liquid composition formed by dissolving or dispersing component in a liquid medium.
With respect to the one or more pure valerenic acids in an amount of 0.1-1.8 mg/dose. Nam teaches valerenic acid as the active constituent responsible for the cognitive effects of the valerian extract. It would have been obvious to use the known active component (valerenic acid) directly in place of or in addition to the extract, as Nam identifies valerenic acid as responsible for the disclosed biological activity. Moreover, the recited range represents optimization of a result-effective variable and would have been within the level of ordinary skill in the art. Furthermore, the recitation of “pure” valerenic acid does not render the claim patentable, as isolating, purifying or enriching a known active from a natural extract to obtain higher purity or concentration is a routine and well-understood practice in the art, and would have been an obvious modification yielding predictable results. A compound and its properties are inseparable therefore, the purified form of valerenic acid would inherently exhibit the same known biological activity attributed to the compound in the extract.
Applicant’s argument
Applicant argues that the claims of the '516 Patent do not include any recitation of the combination of THC and CBD as required by the instant claims, let alone at the instantly claimed amounts. Indeed, none of the claims of the '516 Patent require CBD. Franklin only teaches the need for standardization of CBD and THC. However, Franklin does not provide any suggestion to prepare a composition that combines methylxanthines with the particularly recited amounts of CBD and THC. While Nam may teach the effects of valerian extract to reduce memory loss, none of the claims of the '516 Patent require valerian or extracts thereof. Rather, the claims of the '516 Patent specifically require, inter alia, "a third active component consisting of 1 to 30 mg/dose of yohimbine, yohimbine HCl, yohimbine monoglycine ester, yohimbine alkyl amine, or a mixture thereof." There is no teaching or suggestion whatsoever in Nam to replace the yohimbine component with valerian. Indeed, as taught in the '516 Patent, the compositions described therein may optionally provide a reduction of the side effects associated with the exogenous ingestion of yohimbine and its derivatives. '516 Patent at 3:10-21. Thus, the Office Action has not shown a motivation to replace yohimbine with valerian extract as yohimbine is a key component of the compositions claimed in the '516 Patent.
Examiner’s answer
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the present case, the U.S. patent claims teach a first active component consisting of 10 to 400 mg/dose of tetrahydrocannabinol, cannabidiol, cannabinol, or a mixture thereof. The mixture can include both THC and CBD. That means the U.S. patent clearly teaches CBD and THC in amounts that overlap with the claimed amount. Specifically, Franklin teaches the method of making a nutraceutical containing THC can be in a powder form before mixing it with water or be in a form of beverage that include water to provide a more socially acceptable, easier, and more convenient way to consume cannabis than smoking it. Nam teaches the use of valerian extract comprising valerenic acid for treating Alzheimer’s disease and for improving memory. (See Abstract and the first paragraph of the left column of page 1370.) Therefore, one would reasonably expect the inclusion of water as the aqueous carrier to provide a beverage (nutraceutical) formulation with a more socially acceptable, easier, and more convenient way to consume THC in order to successfully enhance cognitive function and memory in Alzheimer’s disease. The overlapping obvious amount of caffeine and THC would also render obvious the ratio claimed in claim 10. Further, a person of ordinary skill in the art would reasonably have expected to be successful because both compositions were shown to be useful separately for the exact same purpose and thus would be expected to be similarly useful when used together.
Applicant’s argument
Applicant respectfully disagrees with the obviousness-type-double patenting rejection and requests that the rejection be held in abeyance. Applicant further asserts that the pending claims are not obvious over the cited references.
Examiner’s response
In response, Applicant’s arguments have been fully considered but are not persuasive. The obviousness-type-double patenting rejection is based on the claims of U.S. patent No. 11/278,516 in view of the applied prior art. The present claims, as amended, do not include limitations that render them patentably distinct from the claims of the ‘516 patent for the reasons set forth in the above rejection. Applicant has not identified any specific claim limitation that distinguishes the pending claims from the claims of the ‘516 patent in a manner sufficient to overcome the rejection A general assertion that the claims are not obvious, without identifying a patentable distinction, is insufficient. With respect to Applicant’s request to hold the rejection is abeyance, such a request is not granted. The rejection is properly maintained of record. However, it is noted that the rejection may be overcome by the filing of the a termina disclaimer, if appropriate.
Conclusion
Claims 1-4 and 6-10 and 17-18 are not allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JEAN P CORNET/Primary Examiner, Art Unit 1628
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