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
Pursuant to the preliminary amendment dated 7/14/2023, claims 5, 7, 8, 13, 16 and 17 are amended. No claims are newly added or canceled.
Claims 1-17 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/CN2021/142460, filed on 12/29/2021. The instant application claims foreign priority to CN 202110060432.2 filed on 1/18/2021. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application on 7/14/2023.
Information Disclosure Statement
The information disclosure statement (IDS) dated 7/14/2023, 12/19/2023, 4/30/2024 and 12/24/2024 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS has been placed in the application file and the information therein has been considered as to the merits.
Claim Objection
Claim 3 is objected to for the phrase “of the above”. Since claim 3 depends from claim 2 where the formulas F-7K, F-7Q, F-74Q and F-74K are defined, the phrase “of the above” is unnecessary.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7, 14 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) that does not integrate the judicial exception into a practical application, without significantly more. The rejected claims are directed to plant extracts comprising flavanoids, wherein the extract is obtained from the naturally occurring plant, Polygala japonica Houtt. The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Specifically, the claim recites an extract comprising flavanoids and optionally xanthone and glycolipid, which as explained in the specification was isolated from naturally occurring Polygala japonica Houtt. The compound extracted from Polygala japonica Houtt, are a nature-based product, so it is compared to its closest naturally occurring counterpart (i.e. Polygala japonica Houtt in its natural state) to determine if it has markedly different characteristics. Because there is no indication in the record that isolation of a composition comprising flavanoids and optionally xanthone and glycolipid has resulted in a marked difference in structure, function, or other properties as compared to its counterpart, the instant claims recite a product of nature exception. Moreover, the fact pattern in the instant case is similar to the fact pattern in Myraid: In Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different... The Supreme Court concluded that these isolated but otherwise unchanged genes were not eligible, because they were not different enough from what exists in nature to avoid improperly tying up the future use and study of the naturally occurring BRCA genes. See, e.g., Myriad, 569 U.S. at 585, 106 USPQ2d at 1977. The isolated genes of Myriad are comparable to the extracted compounds in the instant claims, in that they are obtained by the hand of man in a form that does not exactly exist in nature, but the human intervention in both scenarios does not rise to the level of resulting in the obtained product having markedly different characteristics, compared to the closest naturally occurring counterpart.
Claim Rejections - 35 USC § 112(a)
The following is a quotation 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.
Claims 13, 16 and 17 are rejected under 35 U.S.C. 112(a), because the specification, while being enabling for treating urolithiasis, urinary tract infections or kidney damage caused by urolithiasis, does not reasonably provide enablement for preventing urolithiasis, urinary tract infections or kidney damage caused by urolithiasis. 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. With respect to the claimed methods, attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. (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. All of the Wands factors have been considered and those most relevant to the cited claims are discussed below. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below. Nature of the invention: The rejected invention is drawn to methods for treating or preventing urolithiasis, urinary tract infections or kidney damage caused by urolithiasis. The full scope of the instant claims covers the entire definition prevention. Relative skill of those in the art: The relative skill of those in the art is high. Breadth of claims: The claims are broad with respect to the concepts of prevention. The term “prevention” is assumed to take on the customary meaning known to those skilled in the art. Specifically, “prevention” is defined according to the Institute for International Medical Education (Wojtczak, 2002, PTO-892) as: the goals within the field of medicine to promote health, to preserve health, to restore health when it is impaired, and to minimize suffering and distress. Customarily prevention is sub-classified as primary (the protection of health by personal and community wide effects), secondary (the measures available to individuals and populations for the early detection and prompt and effective intervention to correct departures from good health) and tertiary (the measures available to reduce or eliminate long-term impairments and disabilities, minimize suffering caused by existing departures from good health, and to promote the patient's adjustment to irremediable conditions). Tertiary prevention is most relevant as used in the context of the instant invention. Thus, the intent of the claimed method, as interpreted by a skilled practitioner of the medical or pharmaceutical arts, would include that which reduces the occurrence of, or eliminates, urolithiasis, urinary tract infections or kidney damage caused by urolithiasis.
Amount of guidance/Existence of working examples:
There are no working examples demonstrating elimination of urolithiasis, urinary tract infections or kidney damage caused by urolithiasis.
Quantity of experimentation: One of skill in the art would have to conduct a myriad number of experiments comprising trial and error administration of the claimed compositions to both healthy individuals and individuals having urolithiasis, urinary tract infections or kidney damage caused by urolithiasis, to determine if the claimed methods can be used in the fully claimed scope to treat and prevent such conditions. Genetech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent 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, e.g., the breadth of the claims, the amount of guidance provided, and the lack of working examples, one of skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims, with no assurance of success.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-17 are rejected for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 1-17 are indefinite due to the poor quality of the chemical structures, where bond connectivity, labeling of functional groups and labeling of variable groups are unclear.
Claims 1-13 are further indefinite due to the recitation of “celosyl” in claim 1. The term “celosyl” is not defined in the specification and is not known in the art. For purposes of search the saccharide “Api” will be interpreted as apiose.
Claims 2-4 and 10 are further indefinite due to the term “preferably”. The term "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. Preferences, options and examples are properly set forth in the specification, but when included in the claims lead to confusion over the intended scope of the claim. See MPEP § 2173.05(d). For examination purposes, the broadest claim limitation(s) will be considered without taking into account preferences or examples.
Claims 2-4 are further indefinite due to the presence of multiple different definitions for the same variable group. Claim 2 contains multiple different definitions of both “R1” and “R”, which results in one being unable to determine the metes and bounds of these variable groups.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6 and 7 are rejected under 35 U.S.C. 112(d), as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 6 depends from claim 5, where claim 5 limits the amount of flavanols to 30-100% of the total extract. Claim 6 then limits the amount of the flavanol of formula (I) to be 20-100% of the total extract. Since the flavanol extract of claim 5 comprises formula (I) and optionally formula (II) and formula (III), claim 5 encompasses an embodiment where formula (II) and formula (III) are absent. If formula (II) and formula (III) are absent, then claim 5 limits the amount of formula (I) to be 30-100% of the total extract. In this scenario, claim 6 thus broadens claim 5 by reciting an amount of formula (I) at 20-100% of the total extract. Therefore, claim 6 does not further limit claim 5. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 5, 6 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou et al. (CN 103432196 A, 2013, PTO-892).
Zhou et al. discloses extracts isolated from Lysimachia chinensis where the extract comprises rutin (at 51.39% as determined via HPLC) and quercetin, where both rutin and quercetin are members of the sub-genus defined by instant formula F-Q. (Examples 1-2; Claim 1) Zhou further discloses that the extract is effective for treating urinary stones, gallstones and kidney stones. (Claim 9)
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With respect to the limitation that the compound is obtained from Polygala japonica Houtt, this limitation is not afforded patentable weight. It is the structure of the claimed compound that governs the patentability of the claim. The instantly claimed compound is anticipated by Zhou regardless of the source from which it was obtained.
With respect to the limitations that the composition optionally comprises formula (II) and formula (III), the term “optionally” allows for these limitations to be absent. Thus, although the cited prior art is silent on compounds of formula(II) and formula (III), the prior art still anticipates the claims.
Accordingly, the instant claims are anticipated by the prior art.
Claims 1-4, 14 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (J. Asian Nat. Prod. Res., 2006, IDS).
Li et al. discloses extracts isolated from Polygala japonica Houtt where the extract comprises the flavanols 2-12 and 12a, where compound 12 is identical to instant compound F-74Q-1. (Sec. 3, Figure 3)
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With respect to the limitations that the composition optionally comprises formula (II) and formula (III), the term “optionally” allows for these limitations to be absent. Thus, although the cited prior art is silent on compounds of formula(II) and formula (III), the prior art still anticipates the claims.
Accordingly, the instant claims are anticipated by the prior art.
Claims 1-4, 14 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haraguchi et al. (Phytochem., 1988, IDS).
Haraguchi et al. discloses extracts isolated from Phytolacca thyrsiflora where the extract comprises the compound 5a-5g, where compound 5f is identical to instant compound F-7K-1. (p. 2994)
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With respect to the limitation that the compound is obtained from Polygala japonica Houtt, this limitation is not afforded patentable weight. It is the structure of the claimed compound that governs the patentability of the claim. The instantly claimed compound is anticipated by Haraguchi regardless of the source from which it was obtained.
With respect to the limitations that the composition optionally comprises formula (II) and formula (III), the term “optionally” allows for these limitations to be absent. Thus, although the cited prior art is silent on compounds of formula(II) and formula (III), the prior art still anticipates the claims.
Accordingly, the instant claims are anticipated by the prior art.
Claims 13 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ghodasara et al. (Pharm. Res., 2010, PTO-892).
Ghodasara et al. discloses a method for treating urolithiasis by administering rutin, which meets the limitations of instant formula (I) where R2=R3=R4=OH and R1=O-Glc-Rha. (Abstract)
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With respect to the limitation that the compound is obtained from Polygala japonica Houtt, this limitation is not afforded patentable weight. It is the structure of the claimed compound that governs the patentability of the claim. The instantly claimed compound is anticipated by Ghodasara regardless of the source from which it was obtained.
With respect to the limitations that the composition optionally comprises formula (II) and formula (III), the term “optionally” allows for these limitations to be absent. Thus, although the cited prior art is silent on compounds of formula(II) and formula (III), the prior art still anticipates the claims.
Accordingly, the instant claims are anticipated by the prior art.
Claims 13 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aslan et al. (WO 2020/204848 A1, PTO-892).
Aslan et al. discloses a method for treating urolithiasis by administering quercetin-3-O-glucoside, which meets the limitations of instant formula (I) where R2=R3=R4=OH and R1=O-Glc. (Claim 13)
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quercetin-3-O-glucoside
With respect to the limitation that the compound is obtained from Polygala japonica Houtt, this limitation is not afforded patentable weight. It is the structure of the claimed compound that governs the patentability of the claim. The instantly claimed compound is anticipated by Ghodasara regardless of the source from which it was obtained.
With respect to the limitations that the composition optionally comprises formula (II) and formula (III), the term “optionally” allows for these limitations to be absent. Thus, although the cited prior art is silent on compounds of formula(II) and formula (III), the prior art still anticipates the claims.
Accordingly, the instant claims are anticipated by the prior art.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (J. Asian Nat. Prod. Res., 2006, IDS), in view of Zhou et al. (CN 105943975 A, 2016, PTO-892).
The disclosure of Li et al. is referenced as discussed above. Li further discloses that the extract was obtained by a process comprising extraction by infiltration of the dried ariel parts of Polygala japonica Houtt with 70% aqueous ethanol, then partitioning the extract with petroleum ether, chloroform, ethyl acetate and aqua-saturated n-butanol, successively, where the n-butanol fraction was passed thru an AB-8 microporous resin column and eluted with water, 20%, 40%, 60% and 95% ethanol, successively, where the second and third eluates were further purified on a Sephadex LH-20 column to yield compounds 11 and 12. (Sec. 3.3)
Li does not teach an extraction involving refluxing ethanol.
Zhou et al. discloses a process for extracting active ingredients from several plant species, including Polygala japonica, comprising the raw materials being mixed with 4 to 6 times the amount of alcohol having an alcohol concentration of 70% to 80%, and refluxed for 2 to 4 times, each time for 1 hour to 3 hours, respectively, and filtered. The filtrates are combined, the ethanol is recovered, and the paste having a relative density of 1.20 to 1.22 is concentrated at 60 ° C, and dried under vacuum at 55 ° C to 65 ° C to obtain a dry powder. (pp. 4-5; Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the infiltration extraction of Li could be substituted with the reflux extraction of Zhou, thereby arriving at the instant invention. Both methods of extraction would reasonably be expected to extract the same flavanoids from the source plant material, particularly in view of the fact that the same extraction solvent was used. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Ghodasara et al. (Pharm. Res., 2010, PTO-892) with Aslan et al. (WO 2020/204848 A1, PTO-892), in view of Li et al. (J. Asian Nat. Prod. Res., 2006, IDS).
The disclosure of Ghodasara, Aslan and Li are referenced as discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the flavanoids of Li, including compound 12, would reasonably be expected to be effective for treating urolithiasis, thereby arriving at the instant invention. The disclosure of Ghodasara and Aslan shows that quercetin glycosides, within the scope of instant formula (I) are effective for treating urolithiasis. Thus, it is reasonable that other quercetin glycosides, such as compound 12 of Li, which bears close structural similarity to the quercetin glycosides of Ghodasara or Aslan, would be similarly effective at treating urolithiasis.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Ghodasara et al. (Pharm. Res., 2010, PTO-892), with Aslan et al. (WO 2020/204848 A1, PTO-892), in view of Haraguchi et al. (Phytochem., 1988, IDS).
The disclosure of Ghodasara, Aslan and Haraguchi are referenced as discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the flavanoids of Haraguchi, including compound 5f, would reasonably be expected to be effective for treating urolithiasis, thereby arriving at the instant invention. The disclosure of Ghodasara and Aslan shows that quercetin glycosides, within the scope of instant formula (I) are effective for treating urolithiasis. Thus, it is reasonable that other quercetin glycosides, such as compound 5f of Haraguchi, which bears close structural similarity to the quercetin glycosides of Ghodasara or Aslan, would be similarly effective at treating urolithiasis.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
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/DALE R MILLER/Primary Examiner, Art Unit 1693