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 .
CONTINUING DATA
This application is a DIV of 16/628,838 01/06/2020 PAT 11708388
16/628,838 is a 371 of PCT/EP2018/068663 07/10/2018
FOREIGN APPLICATIONS
EP 17180730.8 07/11/2017
EP 18152304.4 01/18/2018
Applicant’s election without traverse of Group I in the reply filed on October 14, 2025 is acknowledged.
Claims 7-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 14, 2025.
Claim Interpretation
Claims 1-6 are product-by process claims. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). See MPEP 2113.
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 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (a product of nature) without significantly more.
Claims 1-6 recites a composition comprising a saponin extracted or isolated from Gypsophila elegans M. bieb. These saponins are products of natures, being obtained from a plant.
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.
Step 2A, Prong One, asks if a claim recites a product of nature. In this case, the claimed compounds are naturally occurring in Gypsophila elegans M. bieb. Thus, the claims do 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…”. MPEP section 2106.04 (c-I-B) states “the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart…”.
In this case, extraction of saponins from Gypsophila elegans M. bieb. only concentrates and portions the naturally occurring compounds in the plant which are soluble or insoluble in the particular solvent. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the plant. Thus, while a solvent extract itself may not be found in the nature, the compounds which are present in the Bergamot fruit and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself can comprise only one or a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, while extraction of the compounds with the selected solvent would separate a portion of the saponins away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the Gypsophila elegans M. bieb. plant; i.e., the compound is not inventive or “man-made.” Thus, the claims are drawn to a natural product or mixtures of naturally occurring products.
The closest naturally occurring counterpart for the claimed extract is a mixture of the naturally occurring compounds that are present in the extract. Because, as discussed above, each Gypsophila elegans M. bieb. extract is only a mixture of the naturally occurring compounds found in the plant. In addition, there is nothing to show that providing the saponins in the any particular concentration or purity produces any sort of marked distinction. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. In this instance, claims 4 and 6 recite product-by-process claims wherein the saponin product is purified at least to some extent. Isolation or purification does not result in a product which is ‘markedly different’ from the naturally-occurring component. 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, the claims are directed to composition with no additional ingredients in addition to the natural products. Thus, the answer to Step 2A, Prong Two, is No.
The analysis must then 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 instance, the claims do not recite additional elements apart from the saponin or mixture of saponin obtained from Gypsophila elegans M. bieb.
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.
Claim(s) 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haddad (Helvetica Chimica Acta – Vol. 87 (2004), cited on IDS).
Haddad teaches compound 1 on page 74, which is a compound which is disclosed in the current specification to be obtainable from Gypsophila elegans M. bieb. Page 4 of the specification states that the saponins from Gypsophila elegans M. bieb have been described by Haddad, although they were obtained from a different plant. Haddad’s compound 1 meets the formula (I) recited on page 2 of the current specification. Haddad’s compound was subjected to purification including column chromatography (page 80, Experimental Part), so the compound was purified to at least some extent and is still the same compound as one recited in claims 1-6. Claims 1-6 are product-by-process claims, but the product (the saponin) is the same regardless of which plant it was obtained from.
Claim(s) 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sun (CN104688798A, 2015, machine translation).
Sun teaches a gypsophila elegans extract which comprises saponin. The extract is obtained by alcohol extraction. See abstract. The root is used as the raw material (claim 1). A macroporous resin is used to purify the product (paragraph 0017). The product is freeze-dried (claim 8), which removes solvent. Sun’s composition meets the limitations of claims 1-3 and 5 because it contains at least one saponin, obtained by solvent extraction from gypsophila elegans root. Sun’s composition meets the limitations of claims 4-6 because it is purified and dried.
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 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11 of U.S. Patent No. 11708388. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘388 patent claims a method of isolating a saponin from Gypsophila elegans M. bieb, comprising cutting roots, freeze-drying and grinding to a powder, extracting with a high-concentrated organic solvent, removing the solvent, dissolving in a low-concentrated solvent, subjecting to chromatography, and removing the solvent (claim 11). The same saponin is incorporated into a transfection composition (claim 3). The ‘388 saponin is also the same saponin described in the current specification. The ‘388 claims anticipate the current claims because the ‘388 claims cover compositions containing a saponin from roots of Gypsophila elegans M. bieb.
Conclusion
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693