Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Detailed Action
This application is a national stage application of PCT/GB2022/050975, filed April 19, 2022, which claims priority to foreign application GB2105574.4, filed April 19, 2021. Claims 1-6, 11-14, 18, 23-26, and 34-36 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted October 19, 2023, is acknowledged wherein claims 3-6, 11-14, 18, 23-26, and 34-36 are amended and claims 7-10, 15-17, 19-22, 27-33.
Claim Objections
Claim 18 is objected to because of the following informalities: the phrase “derived from the pith or immature bitter oranges.” This appears to be a typographical error, with the correct phrase being “derived from the pith of immature bitter oranges.” 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 1-5, 11-14, 18, 23-26, and 34-36 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 methods of treating diabetes and related disorders of blood sugar metabolism, and gastrointestinal disorders, does not reasonably provide enablement for methods of treating all possible metabolic disorders. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Nature of the invention: The claimed invention is a composition having a particular intended use for treating a class of diseases, as well as a method of treating said disorders using this composition. In order to be enabled for the full scope of the claimed invention, one skilled in the art must reasonably be able to treat all diseases falling within said scope using the information available in the disclosure and the art at the time of filing.
The state of the prior art: Metabolic disorders are recognized in the prior art as a diverse classification including many different types of conditions having different causes and symptoms. For example, Guerrero et al. (Reference included with PTO-892) discloses that metabolic disorders (or IEM, inborn errors of metabolism) include those which affect energy production and those which affect the synthesis or degradation of specific compounds. (p. 1 right column last paragraph) These can include for example organic acidureas, amino acidopathies, peroxisomal disorders, lysosomal storage disorders, glycogen storage disorders, and mitochondrial fatty acid disorders. (p. 2 right column first paragraph)
The relative skill of those in the art: The relative skill of those in the art is high.
The predictability or unpredictability of the art: As discussed above, a wide variety of heterogenous conditions fall within the heading of metabolic disorders. Due to this broad scope and lack of any specific central mechanism, the particular pathways, symptoms, and treatments of these disorders is highly unpredictable.
The Breadth of the claims: The scope of diseases encompassed by the term “metabolic dysfunction” is extremely broad, including any conditions which involves a defect or dysregulation in any metabolic process.
The amount of direction or guidance presented: Reference examples 1-4 on pp. 8-13 of the present disclosure describe the isolation of a composition according to the present claims and its effect on the gastrointestinal microbiome of animal subjects.
The presence or absence of working examples: Examples 1-5 on pp. 14-15 describe treatment of certain specific conditions, namely diabetes, prediabetes, duodenal ulcers, constipation, and hyperlipidemia. These specific examples are not representative of the full scope of possible metabolic dysfunctions which would fall within the scope of clams 1 and 2.
The quantity of experimentation necessary: In order to practice the full scope of the claimed invention, for all possible metabolic dysfunctions, one skilled in the art would have to develop methods of treating a wide variety of conditions related only in that they involve some aspect of metabolism, which extend significantly beyond the scope of conditions represented by the examples in the present specification. Therefore doing so would require an undue burden of unpredictable research necessary to practice the claimed invention.
Genentech, 108 F.3d at 1366, sates that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion.” And “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
Therefore, in view of the Wands factors, as discussed above, particularly the scope of the claims and the lack of guidance or working examples, Applicants fail to provide information sufficient to practice the claimed invention for all possible metabolic dysfunctions.
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 4, 11, and 35 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. Claim 4 refers to the range “at least 75% wt/wt,” and then the narrower range “for example 80-90% wt/wt.” This renders the claim indefinite because it is unclear whether the second range is limiting as to the percentage of naringin, or merely exemplary of a possible embodiment.
Claim 11 describes the ranges “100mg-5g/day, more aptly 250mg-2g/day, for example 0.5-1.5 g/day of the mixture of bioflavonoids, such as 1g/day.” In a similar manner, it is unclear from the claim language which of these four ranges should be applied to the amount of bioflavonoids in the composition. In addition, claim 11 is also indefinite because while it clearly defines the claimed invention as a composition of matter, it also defines the amount of flavonoid in the composition in terms of a particular daily dosage, a definition which only has meaning within the context of a method of use. It is therefore unclear whether these limitations refer to an actual structural limitation of the composition of matter or to an intended use.
Claim 35 includes the limitations “100mg – 2g,” “for example 250-1200 mg,” and “250-1000 mg,” which render the claim indefinite for the same reasons as claims 4 and 11.
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.
Claims 1, 3-6, 11, 12, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thomas et al. (PCT international publication WO2008/009956, Reference included with PTO-892)
Claim 1 is directed to an oral composition for ameliorating certain adverse medical conditions, comprising bioflavonoids, wherein at least 4% by weight of the bioflavonoids are naringin and at least 15% by weight are neohesperidin. Claim 3 further defines the percentages as at least 50% and at least 20%. Thomas et al. discloses flavonoid compositions with antibacterial activity suitable for oral use. (p. 1 line 31 -1 p. 2 line 11) The flavonoid compositions preferably a mixture which comprises 52% naringin and 27.8% neohesperidin, among various other minor flavonoids. (p. 9 lines 1-18) While Thomas et al. does not specifically describe the composition as a nutritional supplement for use by oral administration for treating particular medical disorders, the composition described by Thomas is an aqueous liquid that could reasonably be used in such a manner, by administering it orally to a patient, and therefore infringes the intended use limitation recited in claims 1 and 3.
Regarding claim 4, Thomas discloses that the mixture preferably includes at least 75% neohesperidin and naringin. (p. lines 8-10) Regarding claim 5, these compositions can be obtained from the pith of immature bitter oranges. (p. 10 lines 7-11) Regarding claim 6, this claim merely describes the intended use of the composition and does not provide further structural limitations that would be seen as actually differentiating the claimed liquid compositions form those described by Thomas.
Regarding claim 11, this claim merely describes the amount of composition to be used in a particular intended use, which does not impose meaningful structural limitations on the composition itself. Claim 12 describes the composition as a “multidose liquid.” P. 4 lines 16-23 of Thomas describe the composition as being potentially a liquid. The description of the liquid as being multidose in claim 12 is another intended use which does not specifically limit the structure of the liquid. Regarding claim 18, p. 6 lines 10-11 describe the composition as further comprising biomass, which would be derived from the bitter orange which is the natural source of the bioflavonoids.
Therefore Thomas at al. anticipates the claimed invention.
Claims 1-6, 11, 12, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al. (Foreign publication CN102772424, Reference and English machine translation included with PTO-892, all citations herein are to the machine translation)
Claim 1 is directed to an oral composition for ameliorating certain adverse medical conditions, comprising bioflavonoids, wherein at least 4% by weight of the bioflavonoids are naringin and at least 15% by weight are neohesperidin. Claim 3 further defines the percentages as at least 50% and at least 20%. Claim 2 claims a method of treating a metabolic disorder comprising administering said composition to a subject.
Wu et al. discloses fruit extracts comprising neohesperidin for the purpose of treating diabetes, which is a metabolic disorder. (p. 2 paragraph 1) The composition further contains the flavonoids neohesperidin and naringin in a ratio of 1:1. (p. 2 fourth paragraph) Therefore the flavonoids in the composition comprise 50% naringin and 50% neohesperidin, anticipating the ranges recited in claims 1-3, as well as 100% of the bioflavonoids present as recited in claim 4.
Regarding dependent claims 5, this claim requires that the bioflavonoids be derived from the pith of bitter oranges. However, while Wu does not specifically describe bitter orange as a source for the flavonoids, the two flavonoids naringin and neohesperidin utilized in the compositions of Wu are ones described by the present disclosure as extractable from bitter orange. Therefore the compositions described by Wu anticipate claim 5. Regarding claim 6, as discussed previously Wu discloses treatment of diabetes. Regarding claim 11, this claim merely describes the amount of composition to be used in a particular intended use, which does not impose meaningful structural limitations on the composition itself. Regarding claim 12, this claim requires that the composition be in the form of a liquid. Embodiments 6 and 7 on pp. 8-9 describe administration of a 1:1 mixture of neohesperidin and naringin by intragastric administration. The composition administered by intragastric administration would necessarily be a liquid composition. The description of the liquid as being multidose in claim 12 is another intended use which does not specifically limit the structure of the liquid. Regarding claim 18, while Wu does not specifically disclose that the composition contains biomass form the pith of bitter oranges, Wu describes the composition as derived from pith of Fructus citri grandis, (p. 4 embodiment 1) which would reasonably be expected to therefore contain biomass from the pith of this fruit, which would overlap in at least some components with pith form bitter orange.
Therefore Wu et al. anticipates the present claims.
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.
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (Foreign publication CN102772424, Reference and English machine translation included with PTO-892, all citations herein are to the machine translation)
The disclosure of Wu et al. is discussed above. Wu et al. does not specifically describe the frequency of administration or specific dosage of the composition to be administered to the subject. However, it would have been obvious to one of ordinary skill in the art at the time of the invention to determine the appropriate dosage and frequency of administration for the compositions described by Wu et al. In particular, one of ordinary skill in the art would have expected that these parameters are result-effective variables that could be reasonably optimized through routine experimentation in order to determine the appropriate amount and frequency of administration.
Therefore the invention taken as a whole is prima facie obvious.
Claims 13, 14, 25, 26, and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. as applied to claims 1-6, 11, 12, 18, 23, and 24 above, and further in view of Guthrie. (US pre-grant publication 2009/0156661, cited in PTO-892)
The disclosure of Wu et al. is discussed above. Wu et al. does not specifically discloses a solid dosage form such as a tablet or capsule. However, Guthrie describes a composition of biomaterials including flavonoids for the treatment of metabolic syndrome. (p. 1 paragraphs 5-6) Pharmaceutical formulations comprising these active ingredients include tablets, capsules, and gelatin capsules, which are solid dosage forms as recited in claims 13, 14, 25, 26, and 34-36. (p. 5 paragraph 61)
It would have been obvious to one of ordinary skill in the art at the time of the invention to prepare the compositions described by Wu et al. as a solid dosage form, for example a capsule or tablet. One of ordinary skill in the art would have been motivated to prepare the pharmaceutical composition in these solid dosage forms because Wu et al. suggests that compositions of similar active ingredients for a similar purpose can be administered in this manner.
Therefore the invention taken as a whole is prima facie obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-6, 11, 12, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 5 of U.S. Patent No. 12109292. (Cited in PTO-892, herein referred to as ‘292) Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 2, and 5 of ‘292 anticipate the present claims.
In particular, claim 1 of ‘292 claims a composition which comprises flavonoids among other ingredients, including naringin and neohesperidin. Dependent claim 2 defines the flavonoids as being 40-65% naringin and 20-35% neohesperidin, thereby falling within the scope recited in claim 1 of ‘292.
Regarding claims 3 and 4, the percentages recited in these claims substantially overlap with those recited in the claims of ‘292. Therefore the claimed ranges are prima facie obvious over the claims of ‘292. Regarding claim 5, this claim merely describes the source of the flavonoids, and does not impose further structural limitations onto the claimed compositions. Regarding the intended use limitations present in claims 1 and 6, these limitations merely describe an intended use to which the claimed compositions could be put and do not materially limit the actual structure of the claimed materials, and therefore do not differentiate the present claims from those of ‘292. Regarding claims 11 and 12, these claims merely describe a hypothetical dosage amount to be used in an intended use, and therefore does not materially limit the scope of the claim. In addition, regarding claim 12, claim 5 of ‘292 describes a liquid formulation. Regarding claim 18, in this case the “biomass derived from the pith or immature bitter oranges” could be infringed by the additional bioflavonoids recited in the claims of ‘292.
Claims 1, 3-6, 11, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 11980185. (Cited in PTO-892, herein referred to as ‘185) Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 4 of ‘185 anticipate the present claims.
In particular, claim 1 of ‘185 claims a composition which comprises flavonoids among other ingredients, including naringin and neohesperidin. Dependent claim 2 defines the flavonoids as being 40-65% naringin and 20-35% neohesperidin, thereby falling within the scope recited in claim 1 of ‘185.
Regarding present claims 3 and 4, the percentages recited in these claims substantially overlap with those recited in the claims of ‘185. Therefore the claimed ranges are prima facie obvious over the claims of ‘185. Regarding claim 5, this claim merely describes the source of the flavonoids, and does not impose further structural limitations onto the claimed compositions. Regarding the intended use limitations present in claims 1 and 6, these limitations merely describe an intended use to which the claimed compositions could be put and do not materially limit the actual structure of the claimed materials, and therefore do not differentiate the present claims from those of ‘185. Regarding claims 11 and 12, these claims merely describe a hypothetical dosage amount to be used in an intended use, and therefore does not materially limit the scope of the claim. In addition, regarding claim 12, claim 4 of ‘185 describes a liquid formulation.
Claims 1, 3-6, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 9913470. (Cited in PTO-892, herein referred to as ‘470) Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 2 of ‘470 anticipate the present claims.
In particular, claim 1 of ‘470 claims a composition which comprises flavonoids among other ingredients, including naringin and neohesperidin. Dependent claim 2 defines the flavonoids as being 40-65% naringin and 20-35% neohesperidin, thereby falling within the scope recited in claim 1 of ‘185.
Regarding present claims 3 and 4, the percentages recited in these claims substantially overlap with those recited in claims 1 and 2 of ‘470. Therefore the claimed ranges are prima facie obvious over the claims of ‘185. Regarding claim 5, this claim merely describes the source of the flavonoids, and does not impose further structural limitations onto the claimed compositions. Regarding the intended use limitations present in claims 1 and 6, these limitations merely describe an intended use to which the claimed compositions could be put and do not materially limit the actual structure of the claimed materials, and therefore do not differentiate the present claims from those of ‘470. Regarding claim 11, this claim merely describes a hypothetical dosage amount to be used in an intended use, and therefore does not materially limit the scope of the claim.
Claims 1, 3-6, 11, and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 10, 42, 43, and 47 of copending Application No. 18/287376 (reference application, US pre-grant publication 2024/0207298, cited in PTO-892, herein referred to as ‘376). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘376 anticipate the present claims.
In particular, claims 1 and 42 of ‘376 claim a composition which comprises flavonoids, including naringin and neohesperidin. The amounts are described as at least 45% naringin and at least 15% neohesperidin, falling within the scope of claim 1 and substantially overlapping claim 3 Dependent claims 5 and 43 of ‘376 define the total amount of bioflavonoids in a manner anticipating present claim 1.
Regarding claim 5, this claim merely describes the source of the flavonoids, and does not impose further structural limitations onto the claimed compositions. Regarding the intended use limitations present in claims 1 and 6, these limitations merely describe an intended use to which the claimed compositions could be put and do not materially limit the actual structure of the claimed materials, and therefore do not differentiate the present claims from those of ‘376. Regarding claims 11 and 12, these claims merely describe a hypothetical dosage amount to be used in an intended use, and therefore does not materially limit the scope of the claim. In addition, regarding claim 12, claim 47 of ‘376 describes a liquid formulation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed in this action.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 3/5/2026