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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 79-95) in the reply filed on 8/6/25 is acknowledged.
Claims 79-95 have been examined as being elected.
Claims 96-99 have been canceled by the amendment dated 8/6/25.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/12/25 and 4/24/23 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 79-95 are 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 treating intestinal dysbiosis in a subject wherein the subject has one or more symptoms of constipation, does not reasonably provide enablement for preventing intestinal dysbiosis. 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.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to:
The nature of the invention and breadth of the claims
Instant claims 79-95 are directed to “Instant claims are directed to a method of treating or preventing intestinal dysbiosis in a subject, comprising: administering to the subject an effective amount of a composition prepared from dried gold kiwifruit, wherein the dried gold kiwifruit is a Gold3 kiwifruit or a genetic derivative thereof, wherein the intestinal dysbiosis includes reduced levels of Faecalibacterium prausnitzii (F. prausnitzii) in the digestive tract of the subject, wherein the subject has one or more symptoms of constipation, and wherein the composition has a prebiotic effect that includes increasing levels of said F. prausnitzii in the digestive tract of the subject, thereby treating or preventing the intestinal dysbiosis in the subject”.
The present invention aims to treat and prevent disorders of the gastrointestinal system, including amongst others: inflammation, constipation, bowel irregularity, microbiota imbalances, irritable bowel syndrome, and inflammatory bowel disease. The preset claims recite “intestinal dysbiosis” which is the same as microbiota imbalance according to the description in the instant application [0146]. Further, instant claims require that the claimed method of prevention is in a subject suffering from one or more symptoms of constipation and that the prevention further increases the levels of F. prausnitzii.
Instant claims include not only treatment but also prevention. The breadth of the claim with respect to “preventing” is broad because the term “preventing” is defined as “to keep something from happening or arising or to stop or wend off or ward off”, and hence the scope of the claimed term extends to completely to stopping intestinal dysbiosis from occurring at any time point in future, and in any subject population being treated.
The state of the prior art and level of predictability
Instant application describes that the microbiota imbalance reduces or alters one or more beneficial microorganisms of the digestive system i.e., increase the deleterious organisms and reduce the beneficial microbiota [0146]. Applicants refer to Attaluri et al. 2011, Leung et al. 2011 and Liu 2011., in the instant specification, and submit that constipation remains a difficult challenge and that many individuals are dissatisfied with current therapies and medications such as lifestyle and dietary modifications (increased consumption of fruit and vegetables, fiber supplementation i.e., methylcellulose; Konjac glucomannan, psyllium), increased fluid intake and exercise, as well as pharmacological intervention with stool softeners, stimulant laxatives and osmotic laxatives. Applicants also describe that the use of laxative, enema and dietary fiber does not provide an efficient method of relieving chronic constipation, suggesting identifying more suitable alternatives [009-0014].
The amount of direction provided by the inventor and working examples
Applicants describe the use of dried powder of gold kiwifruit [0141-0142 & 0153] for improving laxation in healthy individuals (Example 5 and 6). Example 5 tested Gold3 gold kiwi powder in two groups of participants (healthy and functionally constipated) [0258 and 0265]. The treatment included 4X600 mg for 28 days [0268]. Example 6 describes the results of the treatment on improving regularity and states that the GOLD interventions were significantly higher compared to the washout [0276]. Applicants further describe that there were no serious adverse events after 28 days of intervention and that eight out of nine of the functionally constipated participants showed improvement in gastrointestinal health parameters [0282 and 0284 and Table 7]. [0287] further describes that a significant increase in F. prausnitzii in the functionally constipated group. Applicants stated that the composition are therefore useful for maintaining or improving bowel regularity and/or treating or preventing constipation. However, Applicants have not provided any evidence to show that administration of Gold3 powder completely prevents the occurrence of intestinal dysbiosis. In this regard, while several treatment options have been available in the prior art for treating the microbiota imbalance in subjects who one or more symptoms of constipation, the prior art does not provide a single treatment method, as claimed, for all types of subjects (adults, younger subjects, male, female, healthy, unhealthy, subjects being treated with different types of medication etc.). A skilled artisan would not be able envisage that a treatment of intestinal dysbiosis would be effective in inhibiting from occurring for an indefinite period i.e., prevention of the same. Even though Applicants observe that the Gold3 kiwifruit powder may be having a greater impact on the observed laxation effect than current convention treatments, the compositions tested have not been shown to preventing intestinal dysbiosis by increasing the levels of F. prausnitzii in the digestive tract of a subject. In the absence of any guidance regarding the conditions of administration, and/or the data with respect to prevention, one of an ordinary skill in the art would have to perform undue experimentation based on several factors such as patient’s age, sex, health condition, period of administration, number of doses, amount administered per dose, etc., to employ the composition for preventing intestinal dysbiosis as claimed. The level of one of ordinary skill in the art is high.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) 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 79-95 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10512663. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite administering a composition comprising dried gold kiwifruit which is a Gold3 kiwifruit or a genetic variant thereof, and administering the composition to a subject, and further maintaining the microbial imbalance in the subject. The patented claims recite the same amounts of the Gold3 gold kiwifruit powder, the combination of the additional digestive aid, probiotic, prebiotic or a symbiotic composition, digestive enzymes, etc., as that of instant claims. Further, the patented claims recite treatment of constipation and maintaining bowel regularity by administering a composition comprising dried gold kiwifruit which is a Gold3 kiwifruit or a genetic variant thereof. While patented claims do not explicitly recite that the subject has one or more conditions of constipation, the said claims recite treating a subject for constipation or bowel regularity or increase the levels of F. prausnitzii in the digestive tract of a subject and therefore it is implicit that the subject or population being treated in the patented method is not different from the instant claims and thus exhibit one or more symptoms of constipation.
Claims 79-95 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11090348. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite administering a composition comprising dried gold kiwifruit which is a Gold3 kiwifruit or a genetic variant thereof, and administering the composition to a subject, and for increasing the levels of F. prausnitzii in the digestive tract of a subject in the subject. Further, the patented claims recite that the subject being treated exhibits bowel regularity. The patented claims recite the same amounts of the Gold3 gold kiwifruit powder, the combination of the additional digestive aid, probiotic, prebiotic or a symbiotic composition, digestive enzymes, etc., as that of instant claims. While patented claims do not explicitly recite that the subject has one or more conditions of constipation or do not recite a method of treating intestinal dysbiosis, the said claims recite treating a subject for increasing the levels of F. prausnitzii in the digestive tract of a subject and therefore it is implicit that the subject or population being treated in the patented method is not different from the instant claims and thus exhibit one or more symptoms of constipation.
Claims 79-95 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11642386. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite administering a composition comprising dried gold kiwifruit which is a Gold3 kiwifruit or a genetic variant thereof and administering the composition to a subject and the further, the patented claims (dependent claims) recite that the subject being treated exhibits one or more conditions of constipation. The patented claims recite the same amounts of the Gold3 gold kiwifruit powder, the combination of the additional digestive aid, probiotic, prebiotic or a symbiotic composition, digestive enzymes, etc., as that of instant claims. While patented claims do not explicitly recite a method of treating intestinal dysbiosis, the said claims recite treating the same population of subjects, and therefore the method inherently increases the levels of F. prausnitzii in the digestive tract of a subject as well as effectively treat intestinal dysbiosis.
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.
Claim(s) 79-86 and 92-96 are rejected under 35 U.S.C. 103 as being unpatentable over CN 101810651 to Zhao., in view of Chang et al. (cited on IDS dated 5/12/25), and Anan3859 (Blog of Sina, May 10, 2014, cited on IDS dated 5/12/25).
Zhao teaches a method of preparing kiwifruit frozen powder comprises the following steps of: (1) removing the peel of the Chinese kiwifruit or the qin mei kiwifruit, pulping, and freezing, subliming and drying fruit juice to obtain freeze dried powder; (2) extracting the peel to prepare solutions, filtering, concentrating the filter liquor to be the specific gravity of 1.15-1.8, adding alcohol till that the alcohol content is 75-80%, filtering and depositing, extracting to be dry, washing, vacuum drying, and smashing to obtain kiwifruit polysaccharide; and (3) filling the kiwifruit freeze dried powder and the polysaccharide into capsules or adding soluble maltodextrin to prepare into granular formulation. The preparation method is performed under low-temperature vacuum, remains all nutrition and active components in kiwifruit juice, prepares into grains and capsules, concentrates the application active components of the kiwifruit (abstract). Page 3 of Zhao describes capsules filled with granules obtained from kiwi fruit freeze-dried powder comprising 300 mg (300g filled into 1000 capsules), for oral administration. Further, Zhao teaches administering 3 capsules each time, twice a day.
Zhao teaches the kiwi fruit powder composition for anticancer and tumor inhibition effect, but not for the instant claimed intestinal dysbiosis.
Chang describes that irritable bowel syndrome (IBS) is a common functional disorder of the gastrointestinal system, characterized by abdominal pain, diarrhea (IBS/D), constipation (IBS/C), and alternating diarrhea and constipation (IBSC/A) (Introduction). Chang describes that kiwi fruit has 2% to 3% dietary fiber and possess significant laxative properties in healthy and chronically constipated individuals, without deleterious effects (p 451). Chang tested the effect of kiwi fruit patients diagnosed with irritable bowel syndrome (IBS) (Fig.1), as a 4-week dietary invention program. And states that consumption of two fruits a day improved bowel function and laxation (p 455). Chang states that kiwifruit improves bowel function in patients with irritable bowel syndrome with constipation.
Zhao and Chang do not teach Gold3 kiwifruit of the instant claims.
Anan3859 describe kiwifruits from New Zealand, ZESPRI® The kiwifruits include new varieties of kiwifruit such as Green14 sweetheart green fruit, Gold3 sunshine gold fruit and Gold9 sunshine gold fruit (page 1). Gold3 sunshine gold fruit has a transparent peel, rich juice, and a multi-layered refreshing mouth feel. Anan3859 teaches that Gold3 fruit is juicy, improve physical vitality, and provide intestinal peristalsis and empty toxins from the body (page 1).
Thus, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to modify the oral kiwifruit powder compositions of Zhao i.e., capsules comprising granules of kiwifruit powder, with a powder obtained from the Gold3 kiwifruit, for not only anti-cancer effect but also provide laxative effects or treat constipation in healthy as well as chronically constipated individuals because Chang teaches that kiwi fruit has 2% to 3% dietary fiber and possess significant laxative properties and hence improves bowel function, and Anan 3859 also suggests that gold kiwifruit provides intestinal peristalsis, remove toxins and improve the physical vitality. For claims 83-86, while the cited references do not teach the claimed dosages, one of an ordinary skill in the art would have been optimized the amount of gold kiwi powder to provide the desired laxative effect because Chang and Anan3859 recognize kiwi for providing laxative effect and intestinal movement respectively.
Even though Chang and Zhao do not explicitly recite that the subject do not recite a method of treating intestinal dysbiosis and increased levels of F. prausnitzii in the digestive tract of a subject, one of an ordinary skill in the art would have expected that the administering the composition of Zhao to treat constipation would increase the intestinal microbiota such as F. prausnitzii F. prausnitzii and further effectively treat intestinal dysbiosis because a product and its properties are inseparable. Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Accordingly, one skilled in the art would have expected that the substitution of kiwi fruit of Zhao with that of Gold3 kiwi of Anan3859 would be effective in providing laxative effect and further improve physical vitality. One of an ordinary skill in the art would have expected that the combined teachings of Zhao in view of Chang would be effective to healthy individuals as well as individuals having chronic constipation, irrespective of the underlying reasons causing bowel irregularity because Chang teaches kiwi fruit is very effective in providing laxative effect.
Claims 79-96 are rejected under 35 U.S.C. 103 as being unpatentable over CN 101810651 to Zhao., in view of Chang et al., and Anan3859 (Blog of Sina, May 10, 2014, cited on IDS dated 5/12/25) as applied to claims 79-86 and 92-96 above, and further in view of US 11470869 to Lu.
Zhao, Chang and Anan 3859, discussed above, fail to teach the ingredients of claims 87-91, in combination with Gold3 kiwifruit powder.
Lu teaches a food product that is rich in nutrition, wherein the composition comprises chia seeds (col. 1, l 50-67). The composition additionally comprises yogurt, fruit jellies such as kiwi, banana, cantaloupe, etc., coconut, avocado etc., seeds such as almond, sesame etc (col. 4, l 23-50 and claims 1-2). Thus, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare a kiwi powder composition (Zhao), wherein the source of kiwi is Gold3 variety (Anan3859), further modify the composition by including additional components such as yogurt (reads on probiotic), other fruit extracts or seeds such as almond, sesame etc., so as to arrive at the instant claimed combination of kiwi fruit powder with yogurt, fiber, anti-inflammatory agents or polyphenols or a combination of thereof because one of an ordinary skill in the art would have readily envisaged from the teachings of Lu that food preparations comprising combination of fruit extracts, yogurt, seeds and vegetables for providing enriched nutritional value, having natural ingredients, prepared from economical material and also is delicious. While Lu does not state prebiotics, fiber, anti-inflammatory agents and polyphenols of instant claims 87-91, Lu teaches yogurt, fruit extracts, coconut and almond etc., meet the claimed functional properties respectively. One of an ordinary skill in the art would have expected additional nutritional and flavor and/or taste to the kiwifruit powder made from Gold3.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKSHMI SARADA CHANNAVAJJALA whose telephone number is (571)272-0591. The examiner can normally be reached Generally M- F 9 AM to 6 PM.
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/LAKSHMI S CHANNAVAJJALA/Primary Examiner, Art Unit 1611