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 .
Priority
Acknowledgment is made of a claim of foreign priority based on application serial number EP22170352.3 with a filing date of 4/27/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The claims are examined with an effective filing date of 4/27/2022.
Status of the Claims
Claims 1-19 are pending and under current examination.
Claim Objections
Claims 7 and 18 are objected to because of the following informalities:
Claims 7 and 18 recite the abbreviation “EPA//DHA”. The clarity of the record would be improved if the full term followed by a parenthetical abbreviation was provided at the first incidence of the term, as in “eicosapentaenoic acid (EPA)/ docosahexaenoic acid (DHA)” Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for and animal food composition comprising glycyrrhizin, , does not reasonably provide enablement for preventing and/or treating inflammatory diseases or disorders allergic inflammatory skin diseases.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (A)). These include:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based
on the content of the disclosure
All of the Wands factors have been considered with regard to the instant claims,
as discussed below:
(A) The breadth of the claims: The term “inflammatory disease or disorder” is astronomical. Diseases and conditions that include chronic inflammation include asthma, chronic peptic ulcer, tuberculosis, rheumatoid arthritis, periodontitis, ulcerative colitis, sinusitis, and active hepatitis. Chronic inflammation can eventually cause several diseases and conditions including some cancers, rheumatoid arthritis, atherosclerosis, periodontitis, and hay fever (Felman, Medical News Today, pg. 5). Acute inflammation can include acute bronchitis, a scratch or cut on the skin, high-intensity exercise, dermatitis, tonsilitis, and a physical trauma (Felman, Medical News Today, pg. 2). In summary, the term “inflammatory disease or disorder” embraces hundreds of different diseases having different molecular mechanisms driving pathology and different responsiveness to therapies.
(B) Nature of the invention: The invention pertains to preclinical and clinical drug development. Specifically, the nature of the invention is the use of a food composition comprising glycyrrhizin to treat an inflammatory disease or disorder or an allergic inflammatory skin disorder.
(C) The state of the prior art: In order to identify a pharmaceutical as both safe and effective for use in the general population, the skilled Artisan must discover a biological target, then validate the drug in pre-clinical testing, followed by phase I-III clinical trials to evaluate the drug’s safety and efficacy in humans (Hughes, pg. 1240, fig. 1 and 2). A drug intended for veterinary use must similarly undergo testing to figure out the dosage form and regiment and evaluate target animal safety, effectiveness, human food safety, chemistry, manufacturing and controls, and environmental impact (FDA, pg. 6, The Puzzle Pieces).
(D) The level of one of ordinary skill: The artisans in the field of drug development and patient treatment would be a collaborative team of physicians or veterinarians and basic researchers possessing an advanced degree in biomedicine or veterinary medicine and/or a doctor of medicine or veterinary medicine degree, thus the level of skill is high.
(E) The level of predictability in the art: The level of unpredictability in the art of drug development and patient treatment for all conditions, including inflammatory diseases and disorders, is very high. As noted above, in order to identify a pharmaceutical as both safe and effective for use in the general population, the skilled Artisan must discover a biological target, then validate the drug in pre-clinical testing, followed by phase I-III clinical trials to evaluate the drug’s safety and efficacy in humans (Hughes pg. 1240, fig. 1 and 2). Each state of the process is fraught with complexity. Inflammation is the body’s natural response to protect itself against harm. In settings regarding acute inflammation, such as an infection like the flue or pneumonia, inflammation is essential. However, chronic inflammation can also occur in response to other unwanted substances in the body (Harvard Health, pg. 2). Diseases and conditions that include chronic inflammation include asthma, chronic peptic ulcer, tuberculosis, rheumatoid arthritis, periodontitis, ulcerative colitis, sinusitis, and active hepatitis. Chronic inflammation can eventually cause several diseases and conditions including some cancers, rheumatoid arthritis, atherosclerosis, periodontitis, and hay fever (Felman, Medical News Today, pg. 5). Acute inflammation can include acute bronchitis, a scratch or cut on the skin, high-intensity exercise, dermatitis, tonsilitis, and a physical trauma (Felman, Medical News Today, pg. 2). In view of the above, there exists a great variability in mechanisms underlying the many conditions that may be classified as an inflammatory disease or disorder, and accordingly it would be difficult for a person of ordinary skill in the art to predict which diseases or disorders might respond to treatment with a food composition comprising glycyrrhizin.
With respect to predictability in the field of drug development in general, preclinical data is by and large a poor predictor of clinical outcome for various reasons, including differences in the physiology and anatomical organization between humans and experimental animals as well as the availability of disease models that recapitulate aspects of the analogous human condition in experimental animals (Lowenstein, page 3, lines 28-33). Due to the complexity of real patient populations relative to model systems in terms of genetic heterogeneity as well as differences resulting from age and gender, it is nearly impossible to predict which drugs, including those that exhibit outstanding preclinical results, will be effective in the patient population at large (Lowenstein, abstract). Thus, the skilled Artisan's awareness of the pharmacology underlying the effects of glycyrrhizin on inflammatory response does not provide sufficient information to allow one of skill to predict outcome in real patient populations for the broad variety of inflammatory diseases and disorders.
(F) The amount of direction provided by the inventor/(G) The existence of working examples: The specification provides in vitro experimental results that provide evidence of immunomodulatory potential of glycyrrhizin (Fig. 1 and Example 2). The results show that an aqueous extract of licorice root is able to inhibit release of IL-5 from activated T-cells within a concentration range which is non-cytotoxic and does not stimulate proliferation nor IL-2 release. The concentration range does not significantly impact the Th-1 cytokine IFN-γ nor the Th-17 cytokine IL-17 (Example 2).
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure: In view of the number of inflammatory diseases and disorders embraced by the instant claims and the extraordinary efforts required to determine whether a candidate composition can be used therapeutically in the clinic, as well as the narrow guidance provided by the instant specification, it would require undue experimentation for one of ordinary skill in the art to practice the claimed invention in the full broad scope rejected in the claims.
Claims depending from rejected claims have also been rejected because they incorporate all the limitations of the claims from which they depend, but fail to resolve the enablement concerns outlined above.
Claim Rejections - 35 USC § 112
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 1-9 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.
Applicant is referred to the Guidelines on Written Description published at FR 66(4) 1099-1111 (January 5, 2001) (also available at www.uspto.gov). The following passage is particularly relevant:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e. structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between structure and function, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within a genus, one must describe a sufficient number of species to reflect the variation within the genus. What constitutes a "representative number" is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. In an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.
For Example MPEP 2163 states, in part,
An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that “[w]ithout such disclosure, the claimed methods cannot be said to have been described.”).
Claim 1 is directed towards “a method for preventing and/or treating inflammatory diseases or disorders, or allergic inflammatory skin diseases in an animal in need thereof”.
With respect to the genus embraced by the claims, the phrase “inflammatory diseases or disorders, or allergic inflammatory skin diseases” is very broad embracing both known conditions as well as conditions yet to be discovered to initiate an inflammatory state. Accordingly, the breadth of the rejected claims is immense.
As discussed in more detail below, the specification provides inadequate and insufficient examples to show possession of an animal food composition capable of treating any inflammatory disease or disorder. The specification does not sufficiently describe the characteristics of inflammatory diseases that will render them responsive to treatment with the animal food composition.
Claim 1 embraces any inflammatory disease or disorder without limitation. The term “inflammatory disease or disorder” is astronomical. Diseases and conditions that include chronic inflammation include asthma, chronic peptic ulcer, tuberculosis, rheumatoid arthritis, periodontitis, ulcerative colitis, sinusitis, and active hepatitis. Chronic inflammation can eventually cause several diseases and conditions including some cancers, rheumatoid arthritis, atherosclerosis, periodontitis, and hay fever (Felman, Medical News Today, pg. 5). Acute inflammation can include acute bronchitis, a scratch or cut on the skin, high-intensity exercise, dermatitis, tonsilitis, and a physical trauma (Felman, Medical News Today, pg. 2). In summary, the term “inflammatory disease or disorder” embraces hundreds of different diseases having different molecular mechanisms driving pathology and different responsiveness to therapies.
The specification provides the general teaching that an animal food composition comprising glycyrrhizin may be used in a method of preventing and/or treating inflammatory diseases or disorders or allergic inflammatory skin diseases (4. Summary). The specification provides data from two experiments. Example 1 relates to the safety of glycyrrhizin in dogs and Example 2 demonstrates that an aqueous extract of licorice root is able to inhibit release of IL-5 from activated T-cells within a concentration range which is non-cytotoxic and does not stimulate proliferation nor IL-2 release. The concentration range does not significantly impact the Th-1 cytokine IFN-γ nor the Th-17 cytokine IL-17. The specification provides no discussion of how the claimed animal food composition may affect any inflammatory disease or disorder in any animal. Thus there is no structure-function information provided in the specification relating the demonstrated anti-inflammatory activity of glycyrrhizin to the treatment or prevention of inflammatory diseases or disorders or allergic inflammatory skin diseases such that the artisan of ordinary skill could determine which diseases would be susceptible to the recited animal food composition.
Applicant’s attention is also directed to In re Shokal, 113 USPQ 283 (CCPA 1957), wherein it is stated:
It appears to be well settled that a single species can rarely, if ever, afford sufficient support for a generic claim. In re Soll, 25 CCPA (Patents) 1309, 97 F2d 623, 38 USPQ 189; In re Wahlforss, 28 CCPA (Patents) 867, 117 F2d 270, 48 USPQ 397. The decisions do not however fix any definite number of species which will establish completion of a generic invention and it seems evident therefrom that such number will vary, depending on the circumstances of particular cases. Thus, in the case of small genus such as the halogens, consisting of four species, a reduction to practice of three, perhaps even two, might serve to complete the generic invention, while in the case of a genus comprising hundreds of species, a considerably larger number of reductions to practice would probably be necessary.
As stated in MPEP 2163 II: If the application as filed does not disclose the complete structure (or acts of a process) of the claimed invention as a whole, the Examiner must determine whether the specification discloses other relevant identifying characteristics sufficient to describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. The instant specification is devoid of a description of the treatment or prevention of inflammatory disease or disorder via the claimed animal food composition. Thus, Applicants have failed to demonstrate possession of the method for preventing and/or treating inflammatory diseases or disorders, or allergic inflammatory skin diseases. Disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing “a result that one might achieve if one made that invention”); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does “little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”).
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the written description concerns outlined above.
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 1-10 and 13-19 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 1-3 and 9 recite the limitations “at least about 0.02 mg/kg of bodyweight”, “about 0.02mg/kg of bodyweight to about 2 mg/kg of bodyweight”, and “about 0.03mg/kg to about 2mg/kg of bodyweight”. This renders the claims indefinite because it is not clear to which bodyweight the amount of glycyrrhizin is relative.
Claim 1 recites the limitation “at least about 0.02 mg/kg of bodyweight”. This renders the claim indefinite because it is not clear what the upper limit of the amount of glycyrrhizin may be, thus it is impossible to discern the metes and bounds of the claim.
Claim 7 recites the limitation “EPA/DHA”. This renders the claim indefinite because it is not clear if the limitation refers to a mixture of EPA and DNA or lists EPA and DHA as alternatives.
Claim 10 recites the limitation “at least about 5mg/kg”. This render the claim indefinite because it is not clear what the upper limit of the amount of glycyrrhizin may be, thus it is impossible to discern the metes and bounds of the claim.
Claim 18 recites the limitation “EPA/DHA”. This renders the claim indefinite because it is not clear if the limitation refers to a mixture of EPA and DNA or lists EPA and DHA as alternatives.
Regarding claims 5-6, 8, 13-17, and 19, claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 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.
Claims 10-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Watson (WO2021/00328A1, publication date: 1/7/2021, cited in the IDS filed 10/24/2024).
Regarding claims 10-12, Watson discloses an animal food composition comprising 0.0022% by weight glycyrrhizin (pg. 44 Table 2). 0.0022% is equivalent to 22 mg/kg (1mg/kg=0.0001%).
Regarding claim 13, Watson discloses that the animal food composition consists of a kibble (Claim 10).
Regarding claims 14 and 15, Watson discloses that the animal food composition was provided to dogs as the only provided food during a study (pg. 43 line 29). The instant specification defines “nutritionally complete” to mean that the composition provides the complete and balanced nutritional requirement to animals, and in particular embodiments to dogs. Therefore, a nutritionally adequate feed is a feed with which the said animal can be fed as the sole ration and is capable of sustaining life without additional food (pg. 13, lines 8-12). Therefore, the Examiner considers the animal food composition disclosed by Watson to read on the “nutritionally complete food composition” limitation of the instant claim.
With regards to the “formulated for oral administration” limitation of instant claim 15, the prior art teaches the same animal food composition as claimed and therefore, the “formulated for oral administration” properties are necessarily present; the Examiner directs attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Regarding claim 16, Watson discloses that the source of glycyrrhizin consists of licorice (Claim 12).
Regarding claims 17-19, Watson discloses an animal food composition comprising protein, taurine, lutein, EPA/DHA, linoleic acid, curcuminoids, and vitamin E (pg. 44 Table 2).
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 (i.e., changing from AIA to pre-AIA ) 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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Watson (WO2021/00328A1, publication date: 1/7/2021, cited in the IDS filed 10/24/2024).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1-3, Watson teaches the use of an animal food composition or a kit for preventing and or treating allergic inflammatory skin diseases (pg. 38, line 28). The food composition or kit is provided to animals, especially to dogs, on a daily basis (pg. 40 lines 25-26) and may contain 0.01g/Mcal to about 0.1g/Mcal or 0.01% to about 0.1% by weight of glycyrrhizin (pg. 20 line 17 and line 29). Watson also teaches that glycyrrhizin has been attributed numerous pharmacological effects like anti-inflammatory, anti-viral, anti-tumor, antioxidant and hepatoprotective activities (pg. 17 lines 6-8).
Regarding claim 4, Watson teaches that the animal food composition or kit consists of a nutritionally complete animal food composition or a food supplement and/or a drug (pg. 36 lines 13-16).
Regarding claim 5, Watson teaches that a source of glycyrrhizin is Glycyrrhiza glabra root, e.g. licorice (pg. 35 lines 1-3).
Regarding claim 6, Watson teaches that the animal food composition and/or kit can include linoleic acid (pg. 24 line 30).
Regarding claim 7, Watson teaches that the animal food composition or the kit may comprise EPA/DHA, taurine, lutein, vitamin E, and/or a combination thereof (pg. 24 line 24).
Regarding claim 8, Watson teaches that the animal food composition is useful for preventing and/or treating an animal affected with atopic dermatitis (pg. 6 line 6).
Regarding claim 9, Watson teaches that the composition may be in the form of a kit comprising a first part comprising a source of glycyrrhizin and a second part comprising a source of one or more curcuminoids (pg. 34 lines 25-27). The food composition or kit is provided to animals, especially to dogs, on a daily basis (pg. 40 lines 25-26) and may contain 0.01g/Mcal to about 0.1g/Mcal or 0.01% to about 0.1% by weight of glycyrrhizin (pg. 20 line 17 and line 29).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 1-3 and 9, Watson does not teach an amount of glycyrrhizin present in the composition based upon bodyweight. The Examiner has interpreted the term “bodyweight” to refer to the bodyweight of the animal to which to composition is provided.
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 1-3 and 9, the amount of glycyrrhizin per kg bodyweight of the animal is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount per kg of bodyweight in order to best achieve the desired results as such would provide advantageous anti-inflammatory effect. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where 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, 105 USPQ 233 (CCPA 1955). In the instant case, Watson teaches that glycyrrhizin has an anti-inflammatory effect (pg. 17 lines 6-8). The Examiner considers it prima facie obvious to optimize the dosage of the active ingredient of the composition, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the amount of glycyrrhizin administered to the animal would have a direct effect on the anti-inflammatory activity of the composition and therefore be an optimizable variable.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10- of copending application no. 17/621,369. Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims render obvious the instant claims.
Inter alia, the claims of the ‘369 application embraces a dog food composition comprising about 0.01% to about 4% by weight of a source of glycyrrhizin, a source of one or more curcuminoids, linoleic acid, EPA/DHA, taurine, lutein, vitamin E, and proteins. The source of glycyrrhizin is present from 1 to about 30% by total weight of dry matter of the source of glycyrrhizin. The dog food composition is a kibble and a nutritionally completed dog food composition. The specification of the ‘369 application teaches that the animal food composition may be used for preventing and or treating allergic inflammatory skin diseases (pg. 38, line 28), including atopic dermatitis (pg. 6 line 6). The food composition or kit is provided to animals, especially to dogs, on a daily basis (pg. 40 lines 25-26). A source of glycyrrhizin is Glycyrrhiza glabra root, e.g. licorice (pg. 35 lines 1-3). The Examiner has relied upon the specification to delineate the scope of the invention embraced by the claims of the ‘369 application, consistent with the decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. U.S. Court of Appeals Federal Circuit, 95 USPQ2d 1797. Attention is directed MPEP 804 (II)(B)(2)(a) which states: In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
The claims of the ‘369 application do not embrace an amount of glycyrrhizin within the range embraced by the instant claims or in an amount based on bodyweight.
The amount of glycyrrhizin per kg bodyweight of the animal is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount per kg of bodyweight in order to best achieve the desired results as such would provide advantageous anti-inflammatory effect. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where 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, 105 USPQ 233 (CCPA 1955). In the instant case, Watson teaches that glycyrrhizin has an anti-inflammatory effect (pg. 17 lines 6-8). The Examiner considers it prima facie obvious to optimize the dosage of the active ingredient of the composition, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the amount of glycyrrhizin administered to the animal would have a direct effect on the anti-inflammatory activity of the composition and therefore be an optimizable variable.
Regarding the amount of glycyrrhizin as specified in instant claims 10-12, MPEP 2144.05 states:
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 Applicants' specification provides no evidence that the selected amounts in the instant claims 10-12 was not due to routine optimization and/or that the results should be considered unexpected compared to the prior art. Due to the anti-inflammatory activity, it would have been prima facie obvious to a person of ordinary skill in the art at the time of the invention to combine these teachings and alter the amount of glycyrrhizin present in the composition. One of ordinary skill in the art would have been motivated to change the concentration as this could be expected to be advantageous for adjusting the desired anti-inflammatory activity of the composition due to glycyrrhizin.
With regards to the “formulated for oral administration” limitation of instant claim 15, the prior art teaches the same animal food composition in the form of a kibble as claimed and therefore, the “formulated for oral administration” properties are necessarily present; the Examiner directs attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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