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/Restriction
Applicant’s election without traverse of group I, claim(s) 1-2, 27, 46 and 138-139 in the reply filed May 12, 2026 is acknowledged. The requirement is still deemed proper and is therefore made FINAL.
Claim(s) 71, 73, 76, 84, 100, 102-105 and 140-146 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim(s) 1-2, 27, 46 and 138-139 are examined on the merits.
Information Disclosure Statement (IDS)
The information disclosure statements (IDSs) submitted on August 07, 2024 and May 12, 2026 are being considered by the examiner. The signed IDS forms are attached with the instant office action. However, the non-patent literature document Cite no. C47 from August 07, 2024 were line through and not considered. The information disclosure statement filed August 07, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Specification
The abstract of the disclosure is objected to because it is not a single paragraph preferably within the range of 50 to 150 words in length. The abstract of the disclosure is roughly 29 words. A corrected abstract of the disclosure within the preferred ranges disclosed is required. See MPEP § 608.01(b).
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, “cannbigerolic acid” should read “cannabigerolic acid”
In addition, applicant is reminded to update unexamined claims to include the language: Withdrawn. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered). See MPEP 1.121(c).
Appropriate correction is required.
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 Ormum, 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-disclaimor.
Claim(s) 1-2, 27, 46 and 138-139 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1 and 2 of U.S. Patent No. 11,712,456 in view of Lamensdorf (CA 3134241) and Koren (U.S. Pub. No. 20190133966 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a pharmaceutical composition claimed in the conflicting references ‘456 for example, each recite a pharmaceutical composition comprising:
A pharmaceutical composition comprising hemp extract and a carrier, wherein the hemp extract comprises: cannabidiol; cannabidiolic acid; cannabigerolic acid; and D9-tetrahydrocannabinol, wherein the cannabidiol and the cannabidiolic acid are present in the pharmaceutical composition at a first ratio, and the D9-tetrahydrocannabinol and total cannabinoids are present in the pharmaceutical composition at a second ratio, wherein the first ratio is from about 0.6:1 to about 1:0.6, and wherein the second ratio is from about 1:50 to about 1:20 (claim 1 of ‘456),
The pharmaceutical composition of claim 169, wherein the hemp extract further comprises cannabichromene (claim 2 of ‘456),
The claims of ‘456 do not include cannabigerol (CBG), as stated within the claims of the present invention. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pharmaceutical composition recited in claim(s) 1 and 2 of patent ‘456 to include cannabigerol (CBG) as taught by Lamensdorf in which, CBG is known to be administered in the form of a pharmaceutical composition treat pain and cancer within an animal. In addition to the cannabigerol taught by Lamensdorf, one would reasonably expect to optimize sufficient amounts of cannabigerol to cannabigerolic acid just as the other amounts of components of the hemp extract that would be present within the pharmaceutical composition. Moreover, one would’ve reasonably expected to use a carrier such as olive oil as taught by Koren that can be included within the patent ‘456 pharmaceutical composition. One would have reasonably expected to use the combinations, as described above, within the pharmaceutical composition, as described within patent ‘456 to create a pharmaceutical composition that would encompass treating pain for an animal in need.
Claim(s) 2, 27 and 138-139 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 2 and 8-13 of U.S. Patent No. 12,440,454 in view of Koren (U.S. Pub. No. 20190133966 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a pharmaceutical composition claimed in the conflicting references ‘454 for example, each recite a pharmaceutical composition comprising:
A pharmaceutical composition comprising hemp extract, wherein the pharmaceutical composition is formulated in an orally deliverable paste for oral administration and wherein the paste comprises 1-10 mg of cannabidiol per g of paste, 1-10 mg of cannabidiolic acid per g of paste, 0.01-1 mg of cannabigerol per g of paste, and 0.01-1 mg of cannabigerolic acid per g of paste (claim 1 of ‘454),
The pharmaceutical composition of claim 1, further comprising one or more of soy oil, dextrose, dried chicken liver, silica, inulin, polysorbate 60, potassium sorbate, sorbic acid, saccharin, mixed tocopherols, methylparaben, propylparaben, and combinations thereof (claim 2 of ‘454),
The pharmaceutical composition of claim 1, further comprising ∆9-tetrahydrocannabinol, wherein the ratio of ∆9-tetrahydrocannabinol to the cannabidiol, cannabidiolic acid, cannabigerol, and cannabigerolic acid is about 1:25 (claim 8 of ‘454),
The pharmaceutical composition of claim 1, further comprising ∆9-tetrahydrocannabinol, wherein the concentration of A9-tetrahydrocannabinol is less than about 1 mg per g of paste (claim 9 of ‘454),
The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is formulated with a carrier (claim 10 of ‘454),
The pharmaceutical composition of claim 10, wherein the carrier comprises one or more of: linseed oil, olive oil, fish oil, salmon oil, coconut oil, catnip oil, sesame oil, MCT oil, lecithin, carboxypolymethylene, grapeseed oil, and hemp seed oil (claim 11 of ‘454),
The pharmaceutical composition of claim 10, wherein the carrier comprises lecithin (claim 12 of ‘454),
The pharmaceutical composition of claim 12, wherein the lecithin is sunflower lecithin (claim 13 of ‘454).
The claims of ‘454 does not include the component cannabichromene (CBC), as stated within the claims of the present invention. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pharmaceutical composition recited in claim(s) 1, 2 and 8-13 to include cannabichromene (CBC) as taught by Koren in which, CBC is known to be used within a pharmaceutical composition to be administered to mammals. In addition, patent ‘454 claim 1 encompasses the ratios including a 1:1 ratio that is stated within claim 2 of the present invention. Thus, one would have reasonably expected to use the combination, as described above, within the pharmaceutical composition of patent ‘454 to create a pharmaceutical composition that can be administered to an animal in need.
Claim(s) 1 and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1 and 2 of U.S. Patent No. 12,440,454. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a pharmaceutical composition claimed in the conflicting references ‘454 for example, each recite a pharmaceutical composition comprising:
A pharmaceutical composition comprising hemp extract, wherein the pharmaceutical composition is formulated in an orally deliverable paste for oral administration and wherein the paste comprises 1-10 mg of cannabidiol per g of paste, 1-10 mg of cannabidiolic acid per g of paste, 0.01-1 mg of cannabigerol per g of paste, and 0.01-1 mg of cannabigerolic acid per g of paste (claim 1 of ‘454),
The pharmaceutical composition of claim 1, further comprising one or more of soy oil, dextrose, dried chicken liver, silica, inulin, polysorbate 60, potassium sorbate, sorbic acid, saccharin, mixed tocopherols, methylparaben, propylparaben, and combinations thereof (claim 2 of ‘454),
The claim(s) of ‘454 does overlap in scope with claim(s) 1 and 46 of the present invention because the claims of patent ‘454 does describe a pharmaceutical composition that does include the two components – cannabigerol (CBG) and cannabigerolic acid (CBGA) that also encompasses the ratios including a 1:1 ratio that is stated within claim 1 of the present invention. In addition, claim 2 of patent ‘454 discuss a surfactant, such as polysorbate 60 that can also be included within the pharmaceutical composition, thus, both claim(s) 1 and 2 of patent ‘454 effectively reads on claim(s) 1 and 46 of the present invention and are therefore anticipatory and not patentably distinct.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 8 and 36 of U.S. Pending Application No. 18/829,965. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a pharmaceutical composition claimed in the conflicting references ‘965 for example, each recite a pharmaceutical composition comprising:
A hemp extract comprising 20 mg/ml to 70 mg/ml of cannabigerol and 25 mg/ml to 70 mg/ml cannabigerolic acid; wherein other cannabinoids are present at less than 5 mg/ml individually (claim 8 of ‘965)
A hemp extract comprising: 20 mg/ml to 50 mg/ml of cannabidiol; 5 mg/ml to 25 mg/ml of cannabigerol; and 5 mg/ml to 25 mg/ml of cannabigerolic acid; wherein other cannabinoids are present at less than 5 mg/ml, individually (claim 36 of ‘965).
The claims of ‘965 does overlap in scope with claim 1 of the present invention because the claims of pending app ‘965 does describe a pharmaceutical composition that does include the two components – cannabigerol (CBG) and cannabigerolic acid (CBGA) that also includes sufficient amounts of the two components (CBG and CBGA) in the sense that the two components amount can equal to a 1:1 ratio in which, a 1:1 ratio is also stated within claim 1 of the present invention. Thus, claim(s) 8 and 36 of pending app ‘965 effectively reads on claim 1 of the present invention and are therefore anticipatory and not patentably distinct.
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.
Claim(s) 1-2, 27, 46 and 138-139 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. A composition comprising hemp extract and a carrier wherein the hemp extract comprises cannabigerol, cannabigerolic acid, cannabidiol, cannabidiolic acid, delta9-tetrahydrocannabinol (∆9-tetrahydrocannabinol) and cannabichromene of claim(s) 1-2, 27, 46 and 138-139 encompasses naturally occurring substances.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant's claims are directed to a product; thus, the answer to Step 1 is Yes. The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant's claim(s) 1-2, 27, 46 and 138-139 are drawn to a composition that comprises a hemp extract and a carrier wherein the hemp extract comprises cannabigerol, cannabigerolic acid, cannabidiol, cannabidiolic acid, delta9-tetrahydrocannabinol (∆9-tetrahydrocannabinol) and cannabichromene. In addition, claim(s) 46 and 138-139 further recite the combination of a hemp extract and a carrier wherein the hemp extract comprises cannabigerol (CBG), cannabigerolic acid (CBGA), cannabidiol (CBD), cannabidiolic acid (CBDA), delta9-tetrahydrocannabinol (THC) and cannabichromene (CBC) and a pharmaceutically acceptable additives (e.g. lecithin), flavoring agents, surfactants, and adjuvants. CBG, CBGA, CBD, CBDA, THC, CBC and a pharmaceutically acceptable additive like lecithin are all naturally occurring. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that "When a claim recites a nature- based product limitation, examiners should 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."
MPEP § 2106.04(c)(I) states that "if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states "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”.
In this case, extraction of plants only concentrates and portions the naturally occurring compounds in the plants which are soluble or insoluble in the particular solvent. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the plant. Thus, while a solvent extract itself may not be found in the nature, the compounds which are present in the plant and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, while extraction of the compounds with the selected solvent would separate a portion of the plant matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the plant material; i.e., the compound is not inventive or "man-made." Thus, the extract in turn is a mixture of the naturally occurring compounds found in the particular plant. The extract from the individual plant leads to a combination of the naturally occurring compounds from the plant. Thus, the claim is drawn to a mixture of naturally occurring products.
There is no indication that the specified extract as commensurate in scope with the stated claim changes the structure, function, or other properties of the extract in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for the extract is a mixture of the naturally occurring compounds that are present in the extract. Because, as discussed above, the plant extract contains only a mixture of the naturally occurring compounds found in the plant. The extract composition appears to maintain its naturally occurring structure and properties and is merely present in the combination. In addition, there is nothing to show that mixing the ingredients in the particular concentrations produces any sort of marked distinction. In addition, the closest naturally occurring counterpart for each ingredient is the ingredient itself. There is no indication that mixing the following ingredients together such as CBG, CBGA, CBD, CBDA, THC, CBC and a pharmaceutically acceptable additive (e.g. lecithin) as commensurate in scope with the stated claims changes the structure, function, or other properties of the components in any marked way in comparison with the closest naturally occurring counterpart. Thus, the claims are drawn directly to a product of nature. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant's claims are directed to a composition with an intended use as a pharmaceutical. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to "an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the 'treatment or prophylaxis' consideration." Therefore, applicant's intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by "Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself." However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. In this case, the additional element is the mixing of the claimed ingredients pharmaceutical composition. Mixing CBG, CBGA, CBD, CBDA, THC, CBC and a pharmaceutically acceptable additive (e.g. lecithin) does not amount to significantly more than a combination of judicial exception because mixing compounds and packaging a composition is well-understood, routine, and conventional in the field. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter. In addition, applicant's intended use of a pharmaceutical composition is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), "Generally linking the use of the judicial exception to a particular technological environment or field of use" is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 27 and 139 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koren (U.S. Pub. No. 20190133966 A1).
Koren teaches a composition comprising a therapeutically effective amount of at least one cannabinoid (claim 1). Koren teaches at least one cannabinoid is selected from the group consisting of tetrahydrocannabinol (THC) ([also known as ∆9-tetrahydrocannabinol]), cannabidiol (CBD), cannabidiolic acid (CBDA), cannabigerol (CBG), cannabigerolic acid (CBGA) and cannabichromene (CBC) (claim 7). Koren teaches [that] the compositions are formulated as pharmaceutical compositions, nutraceuticals, cosmeceuticals, nutricosmetics, cosmetics, or food products (abstract). Koren teaches [that] further preparations for oral administration can take the form of, for example, solutions, syrups, suspensions, and toothpastes. Liquid preparations for oral administration can be prepared by conventional means with pharmaceutically acceptable additives, for example, suspending agents, for example, sorbitol syrup, cellulose derivatives, or hydrogenated edible fats; emulsifying agents, for example, lecithin, xanthan gum (paragraph 0192). Koren teaches [that] the composition described herein may be provided [in a dosage form with] at least one dosage form comprising cannabis plant extract, cannabis plant essential oil, and/or at least one cannabinoid (paragraph 0116). Korean teaches [that] the disease, disorder or medical condition that is treatable, curable, mitigated or alleviated by any of the compositions provided herein is selected from nausea, appetite lose and pain associated with cancer and chemotherapy; nausea, appetite lose, pain and wasting associated with AIDS; toothache; cancer; arthritis and rheumatism; glaucoma; migraine; scurvy; muscle spasticity; alcohol and narcotics withdrawal; stress; asthma; Tourette syndrome, Cervical dystonia; epileptic seizures (paragraph 0033).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 46 and 138 are rejected under 35 U.S.C. 103 as being unpatentable over Koren (U.S. Pub. No. 20190133966 A1).
The teachings of Koren are above.
Koren does not teach that the pharmaceutical composition comprising hemp extract and a carrier that has the ratio of cannabigerol to cannabigerolic acid is about 0.2:1 to about 1:0.2 (as stated within claim(s) 1-2 of the present invention).
In regards to claim(s) 1-2 and based on the information provided by Koren above, the Koren reference does not teach the amounts in the form of a ratio of cannabigerol to cannabigerolic acid as claimed by the applicant within the claims of the present invention. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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NASHARA L MOREAUExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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