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 .
Claim(s) 1-7 is/are currently pending and under examination.
Priority
Acknowledgment is made of Applicant’s claim for foreign priority to Chinese Patent Application No. 202310921375.0 (i.e. CN 116712444 A; see the instant Specification at “Cross-Reference to Related Applications”). However, the present application does not properly claim priority, as identified below.
Applicant must file a claim for such priority as required by 35 U.S.C. 119(b) or 365(b), and 37 CFR 1.55. If the application was filed before September 16, 2012, the priority claim must be made in either the oath or declaration or in an application data sheet; if the application was filed on or after September 16, 2012, the claim for foreign priority must be presented in an application data sheet.
If the application being examined is an original application filed under 35 U.S.C. 111(a) (other than a design application), the claim for priority must be presented during the pendency of the application, and within the later of four months from the actual filing date of the application or sixteen months from the filing date of the prior foreign application. See 37 CFR 1.55(d)(1). If the application being examined is a national stage application under 35 U.S.C. 371, the claim for priority must be made within the time limit set forth in the PCT and Regulations under the PCT. See 37 CFR 1.55(d)(2). Any claim for priority under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) not presented within the time period set forth in 37 CFR 1.55 is considered to have been waived. If a claim for foreign priority is presented after the time period set forth in 37 CFR 1.55, the claim may be accepted if the claim properly identifies the prior foreign application and is accompanied by a grantable petition under 37 CFR 1.55(e) to accept an unintentionally delayed claim for priority and the applicable petition fee under 37 CFR 1.17(m)(1) or (m)(2).
Please further note that applicant has not filed a certified copy of the application as required by 37 CFR 1.55. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Drawings
The drawings were received on September 7, 2023. Please note that due to the quality of some of the drawing(s), the information contained therein may not legible which may affect examination or Applicant’s reliance upon information contained therein (see for example, FIG.s 1-10). Applicant is encouraged to review the drawings and make appropriate corrections as needed.
Specification & Claim Objections
The claims and/or disclosure is objected to because of the following informalities:
The spacing of the lines of the specification is such as to make reading difficult. New application papers with lines 1 1/2 or double spaced (see 37 CFR 1.52(b)(2)) on good quality paper are required.
Claim 1 contains the abbreviation “UC” which appears to refer to “ulcerative colitis”. Recitation of the full term at first use in the independent claim is suggested for clarity of the record.
Claim 1 contains the phrase “An active ingredient group for treating UC, characterized by: the active group includes…” which appears to be a typographical/grammatical error. Appropriate correction is suggested for clarity record.
Claim 5 contains the term(s) “KA”, “PC” and “AA” which appear to be abbreviations for “kynurenic acid”, “phosphatidylcholine” and “arachidonic acid”, respectively. Recitation of the full term(s) is suggested for clarity of the record.
Claim 7 and the Specification (e.g. pgs 1-2) contain the term(s) “Codonopsis Radix”, “Atractylodis Macrocephalae”, Rhizoma”, “Poria”, “Corni Fructus”, “Coptidis Rhizoma”, “Curcumae Longae Rhizoma”, “Paederiae Scandentis Herba et Radix”, “Bletillae Rhizoma” and “Radix Glycyrrhizae”, should be properly capitalized and/or italicized throughout according to conventional scientific notation for genus and/or species names.
The above are considered necessary grammatical corrections; however, is not exhaustive of all possible informalities, as examination is not made for the purpose of securing grammatical perfection.
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.
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.
Claim(s) 1-3 and 5-7 is/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(s) 1 and 2 contain the term “includes”. It is unclear what is intended (i.e. which components are included and/or excluded). For the purpose of compact prosecution, the term “includes” has been interpreted as being equivalent to the term “comprising one or more of” but it is suggested that Applicant amend the claims to recite the conventional transitional phrasing for clarity of the record. See MPEP 2111.03.
The term(s) “strong binding” in claim 3 is/are relative term(s) which render the claim indefinite. The term “strong binding” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree such that one of ordinary skill in the art would be reasonably apprised of the scope of the invention.
Claim 5 recites the limitation "the biomarkers". There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
The term “CDD-2103” in claims 6 and 7 is/are relative term(s) which render the claim indefinite. The term “CDD-2103” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree (i.e. if the components listed are exemplary or required) such that one of ordinary skill in the art would be reasonably apprised of the scope of the invention.
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) 1-7 is/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) without significantly more.
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 recites an active ingredient group for treating UC, characterized by the active ingredient group including curcumin, berberine, atractylolactone III, glycyrrhizin and militarine (as disclosed in claim 1 of the instant application); and in some embodiments, the active ingredient group comes from CDD-2103, comprising Codonopsis Radix, Atractylodis Macrocephalae, Rhizoma, Poria, Corni Fructus, Coptidis Rhizoma, Curcumae Longae Rhizoma, Paederiae Scandentis Herba et Radix, Bletillae Rhizoma and Radix Glycyrrhizae (as disclosed in claim(s) 6-7 of the instant application). Thus, the claim does recite a product 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, the active ingredient group is a concentration of naturally occurring compounds in the plants which are soluble or insoluble in the particular solvent via extraction. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the plant. Thus, while the plant extract(s) themselves 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 the plant 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 composition(s) claimed are themselves mixtures of the naturally occurring compounds and naturally occurring compounds that are simply soluble in a particular solvent; i.e., the compound is not inventive or “man-made.” Thus, each of the composition(s) in turn is a mixture of the naturally occurring compounds found in the particular plants. Moreover, combining the individual plants leads to a combination of the naturally occurring compounds from each of the plants. Thus, the claims are drawn to mixtures of naturally occurring products.
There is no indication that mixing the specified plants and plant compounds together as commensurate in scope with the stated claims changes the structure, function, or other properties of the extracts in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for each plant extract is a mixture of the naturally occurring compounds that are present in the extract. Because, as discussed above, each plant extract is only a mixture of the naturally occurring compounds found in the plant. Each composition comprising the plants and plant extract appears to maintain its naturally occurring structure and properties and is merely present in the combination. 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, in some embodiments, Applicant’s claim is directed to active ingredient group (i.e. extract solution) including curcumin, berberine, atractylolactone III, glycyrrhizin and militarine (as disclosed in claim 1 of the instant application) with an intended use of treating UC. Moreover, the claims do not integrate 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.” In this case, the claims do not integrate the active ingredient group composition into a distinguishing practical application (for example, do not broadly or specifically recite dosage form(s), unit dosage forms, preferred concentrations/dilutions, and/or the therapeutically-effective amounts of the material), but merely recites the natural materials themselves or a multiplicity of natural materials.
Moreover, the additional element in the claims is the non-natural mixing of the component ingredients. However, MPEP § 210.6.05(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. Mixing specific compounds does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field (see Almedia, et al., “Mixtures of medicinal plants from caatinga: Basis for further bioprospecting studies.” South African Journal of Botany, Vol 151, Part B, 2022, Pages 158-177). Thus, mixing the ingredients together does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine and conventional in the field.
In addition, applicant’s intended use of treating UC 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
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.
(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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bian (CN113827682A) (December 24, 2021).
The instant claim(s) 1-7 are of record, drawn to active ingredient group including curcumin, berberine, atractylolactone III, glycyrrhizin and militarine (as disclosed in claim 1 of the instant application); and in some embodiments, the active ingredient group comes from CDD-2103, comprising Codonopsis Radix, Atractylodis Macrocephalae, Rhizoma, Poria, Corni Fructus, Coptidis Rhizoma, Curcumae Longae Rhizoma, Paederiae Scandentis Herba et Radix, Bletillae Rhizoma and Radix Glycyrrhizae (as disclosed in claim(s) 6-7 of the instant application).
Bian teaches a green health drug combination for preventing and treating inflammatory bowel disease (broadly inclusive of ulcerative colitis) characterized in that it includes Codonopsis pilosula (i.e. broadly teaching Codonopsis Radix); Atractylodes (i.e. broadly teaching atractylolactone III which is broadly available from Atractylodis Macrocephalae); Poria cocos (i.e. broadly teaching Poria); Wine Dogwood (i.e. broadly teaching “Corni Fructus”); Coptis chinensis (broadly teaching berberine broadly available from Coptidis Rhizoma); turmeric (i.e. broadly teaching curcumin which is broadly available from Curcumae Longae Rhizoma); Chiyateng (i.e. “Jishiteng” broadly teaching Paederia Scandentis); Bletilla striata (i.e. broadly teaching Bletillae Rhizoma); and Zhigancao and/or Licorice root (i.e. “honey-fried licorice root”, broadly teaching glycyrrhizin broadly available from Radix Glycyrrhizae), as required in claim(s) 1, 6 and 7. Claim(s) 2-5 are further rejected as being dependent on rejected claim 1.
Consequently, the claim(s) appear to be anticipated by the reference. With regard to any differences between that which is claimed and that which is disclosed is so slight that the referenced method/composition is likely to inherently possess the same characteristics as of in the claimed method/composition(s).
Please note, Applicant cannot rely on a claim for priority under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) based upon the instant application filed in China on August 11, 2021. Under 37 CFR 1.55(c), the right of priority may be restored if the subsequent application was filed within two months from the expiration of the twelve-month period and the delay was unintentional. In the instant case, twelve months from the filing in China on August 11, 2021 is August 11, 2022. Two months from that date is October 11, 2022. This U.S. application was filed on September 7, 2023. Therefore, an option to petition under 37 CFR 1.55(c) to restore the right of priority is not available on the present record.
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.
Claim(s) 1-7 of the instant application is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-6 of copending Application No. US20240269211 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application is/are drawn to a composition comprising BUCD2103 (i.e. recited as “CDD-2103” in the instant application; broadly inclusive of the component ingredients as required in the instant claim 1 and claims dependent thereto), as evidenced in the instant application (see instant application Specification, pg 1 reciting “In the inventor’s previous patent application (application number 18/167842), the drug combination and clinical medical effects of BUCD2103 were recorded in detail. The publicly available drug combination BUCD2103 is referred to as CDD-2103 in this application”).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vani G. Verkhovsky whose telephone number is (571)272-3777. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm EST.
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/V.G.V./Examiner, Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655