DETAILED ACTION
The present application is a domestic application filed 26 June 2023, and claims foreign priority to CN2023105790496, filed 19 May 2023.
Claims 1-18 are pending in the current application. Claims 6, 9-10 and 13-18 are withdrawn as being drawn to a non-elected invention, see below. Claims 1-5, 7, 8, 11 and 12 are examined on the merits herein.
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
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). Also, see MPEP 706.02 (section VI).
The disclosures of the prior-filed application(s), CN2023105790496, fail to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application. Specifically, these applications fail to provide enablement for “maltooligosaccharide”. While the term “isomaltooligosaccharide” can be found in the ‘496 foreign priority document, the term “maltooligosaccharide” cannot be found. Therefore, the effective filing date of claims 1-18 is seen to be the effective filing date of the claimed invention, 26 June 2023.
If applicant disagrees, applicant should present a detailed analysis as to why the claimed subject matter has clear support in the earlier priority applications. Applicant is reminded that such priority for the instant limitations requires written description and enablement under 35 U.S.C. § 112, first paragraph.
In clarifying the priority date of the instant claims, applicant should note or address whether the art rejections are prior to the priority date of the instant claims and whether said art occurred more than one year prior to said priority date. Applicant will note that the art rejections are under both 35 U.S.C. § 102(a) and 102(b) because the priority date of the instant claims is in question
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-5, 7, 8, 11 and 12 in the reply filed on 30 December 2025 is acknowledged.
Claims 6, 9-10 and 13-18 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 30 December 2025.
Applicant’s election without traverse of a WSDF formed by fructooligosaccharide, xylooligosaccharide and malto-oligosaccharide in the reply filed on 30 December 2025 is acknowledged.
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, 7 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. (WO2019233202, cited in PTO-892).
Liu et al. teach a dietary fiber composition for reducing weight, promoting enterogastric peristalsis, preventing constipation, reducing blood lipid, reducing blood sugar, and absorbing/discharging heavy metals (abstract). The composition can function as a light healthy meal replacement (abstract). The composition comprises 0-1 parts xylooligosaccharide (XOS), 0-3 parts oligofructose (FOS) and 0-10 parts of isomaltooligosaccharide (isoMOS), (claim 1). Example 3 comprises 100 g XOS, 100 g FOS and 400 g isoMOS. Liu et al. teach the actual dietary fiber intake is 8-12 g/day, and the Chinese Nutrition Society recommends 25 g/day (para [0004]).
The recitation “A product that promotes metabolism of EA into urolithin A” in claim 7 is an intended use of the composition of claim 1.
Thus, the disclosure of Liu et al. anticipates claims 1, 7 and 8 of the present application.
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.
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.
Claim(s) 1, 3-5, 7, 8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (cited above) in view of Medeiros et al. (Journal of Functional Foods, 2020, vol. 74, no. 104169, 11 pages, cited in PTO-892) and Gonzalez-Sarrias et al. (Molecular Nutrition & Food Research, 2018, vol. 62, no. 11, p. 1800160, 10 pages, cited in PTO-892).
Liu et al. teach as discussed above.
Liu et al. do not expressly disclose ellagic acid (present claim 3).
Medeiros et al. teach dietary fibers like fructooligosaccharide (FOS) are well recognized prebiotics (p.1, first para). Medeiros et al. found “strong evidence in preclinical studies that dietary polyphenols can stimulate both the growth of microorganisms identified as prebiotic targets and an increase in the production of SCFA” (abstract). Medeiros et al. specifically found clinical trials showed the consumption of ellagic acid and anthocyanins showed an increased abundance of Lactobacillus acidophilus, Bifidobacterium and Faecalibacterium spp., and a reduction in plasma lipopolysaccharide-binding protein (abstract). Medeiros et al. teach ellagic acid from a pomegranate extract was administered at doses of 0.45 g or 1.8 g to overweight-obese subjects. The patients showed an increase in Faecalibacterium, and a decrease in plasma lipopolysaccharide-binding protein (LBP), (Table 2, citation to Gonzalez-Sarrias et al, discussed below).
Gonzalez-Sarrias et al. administered pomegranate extract (PE) to overweight-obese individuals, and found high doses of the extract improved their gut microbiome (abstract). Gonzalez-Sarrias et al. teach each PE-containing capsule had 72.9 mg free ellagic acid (D1) or 450 mg free ellagic acid (D2) (p.2, section 2.1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine ellagic acid with the dietary fiber composition of Liu et al.
According to MPEP 2144.06: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Combining known therapies into a single therapy is a commonly applied method for identifying improved therapeutic outcomes with minimal adverse effect for the patient because each monotherapy is already known to be effective. Here, dietary fiber mixture comprising FOS, XOS and isomalto-oligosaacharide was observed to have a positive effect on reducing weight, promoting enterogastric peristalsis, preventing constipation, reducing blood lipid while a composition comprising ellagic acid was observed to increase Faecalibacterium, and decrease in plasma lipopolysaccharide-binding protein (LBP). Thus, the skilled artisan would have been motivated to combine the oligosaccharide fiber mixture with ellagic acid wherein they each produce similar effects as prebiotic agents, including reducing blood lipid and lipopolysaccharide-binding protein.
With respect to the amount, the ordinary artisan would have been motivated to use about 0.072 to 0.288 mg ellagic acid per 8-12 g dietary fiber, because Gonzalez-Sarrias et al. teach 0.072-0.288 g ellagic acid displayed a prebiotic effect, and Liu et al. teach most people consume 8-12 g dietary fiber per day. For a high dose of 0.288 g, the combination of active agents would result in a weight ratio of oligosaccharides to ellagic acid of (27.7-41.6):1 or (83.3-125.3):3. If the amount of fiber was increased to 25 g/day as recommended the Chinese Nutrition Society, the weight ratio could be as high as 86.8:1, or 260:3. These values encompass/overlap with the ratios recited in present claims 3, 4 and 12.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claim(s) 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al., Medeiros et al., and Gonzalez-Sarrias et al as applied to claims 1, 3-5, 7, 8 and 12 above, and further in view of Blahova et al. (Molecules, published April 2023, vol. 28, no. 3281, 25 pages, cited in PTO-892).
Liu et al. teach as discussed above.
While Liu et al. teach administering isomalto-oligosaccharide, Liu et al. do not expressly disclose maltooligosaccharide (present claim 2).
Medeiros et al. and Gonzalez-Sarrias et al. teach as discussed above.
Blahova et al. teach maltooligosaccharide (MOS) reduces intestinal pathological microorganisms and increases the levels of beneficial bacteria of the genus Bifidobacterium, thereby improving colon health and preventing constipation (p.1). Thus, MOS can be categorized as functional oligosaccharides, and provide health benefits as a fiber and prebiotic. It’s also commonly used in the food and beverage industry (p.2, first para).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine MOS with ellagic acid and the dietary fiber composition of Liu et al.
According to MPEP 2144.06: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Combining known therapies into a single therapy is a commonly applied method for identifying improved therapeutic outcomes with minimal adverse effect for the patient because each monotherapy is already known to be effective. Here, MOS functions as a prebiotic by promoting the growth of Bifidobacterium, reduces pathogenic bacteria, improves intestinal peristalsis, and prevents constipation. The dietary fiber mixture comprising FOS, XOS and isomalto-oligosaacharide was observed to have a positive effect on reducing weight, promoting enterogastric peristalsis, preventing constipation, reducing blood lipid. And a composition comprising ellagic acid was observed to increase Faecalibacterium, and decrease in plasma lipopolysaccharide-binding protein (LBP). The skilled artisan would have been motivated to combine the FOS, XOS, and MOS because they are all functional oligosaccharides that provide beneficial effects on the colon. The ordinary artisan would have been motivated to combine FOS, XOS, MOS and ellagic acid, because they function as prebiotic agents by promoting the growth of beneficial bacteria, improving intestinal peristalsis and preventing constipation.
With respect to the weight ratio of the oligosaccharides, Liu et al. teach combining 0-1 parts xylooligosaccharide (XOS), 0-3 parts oligofructose (FOS) and 0-10 parts of isomaltooligosaccharide (isoMOS). Furthermore, Liu et al. exemplify combining 1 part XOS, 1 part FOS and 4 parts isomaltooligosaccharide. Since MOS is a soluble oligosaccharide like XOS and FOS, one of ordinary skill in the art would have been motivated to use similar amounts of MOS as XOS and FOS, i.e. about a 1:1:1 ratio.
The ordinary artisan would have been motivated to optimize the amount of each oligosaccharide to modulate their effect on gastrointestinal microbiome, and digestibility of the oligosaccharide. See MPEP 2144.05 (II)(A), “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.”.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAHAR A CRAIGO whose telephone number is (571)270-1326. The examiner can normally be reached M-F: Noon-8pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699