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 .
Remarks
The amendments and remarks filed on 02/19/2026 have been entered and considered. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior office action. The rejections and/or objections presented herein are the only rejections and/or objections currently outstanding. Any previously presented objections or rejections that are not presented in this Office Action are withdrawn. Claims 3 and 8-12 are pending; Claims 1-2 and 4-7 are cancelled; Claim 3 is amended; and Claims 3 and 8-12 are under examination.
Withdrawal of Rejections
The rejection of Claims 3 and 8-12 under 35 U.S.C. 112(a), as failing to comply with the written description requirement, is withdrawn due to the amendment to the claims filed on 02/19/2026.
The rejections of Claims 3 and/or 8-12 under 35 U.S.C. 103 over Tursi et al. either alone or in combination of Rautonen et al. and Hayes et al. are withdrawn in favor of the rejections listed below due to the amendment to the claims filed on 02/19/2026.
The provisional rejections of Claims 3 and/or 8-12 on the ground of nonstatutory obviousness-type double patenting over claims of copending Application No. 17/762017 in view of Tursi et al., Rautonen et al., and/or Hayes et al. are withdrawn due to the abandonment of the copending application.
Claim Rejections - 35 USC § 103
Claims 3 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Tursi et al. (J. Clin. Gastroenterol. 2006, 40: 312-316; cited in IDS filed 12/1/2020 of parent application No. 14916961) in view of Drago et al. (International Journal on Drugs and Therapy, 2002, Vol. XIX - n. 1/2: 72-76, of record), as evidenced by the European Food Safety Authority (EFSA) [EFSA Journal, 2012, 10(6): 2723, pages 1-15, of record], and Tursi-2016 et al. [J. Clin. Gastroenterol, 2016, 50(supp. 1): S9-S12, cited in IDS of parent application No. 14916961].
Regarding Claims 3 and 8-9, Tursi et al. teach a method for preventing the recurrence of symptomatic diverticular disease of the colon in a subject, comprising a step of orally administering a composition comprising probiotic Lactobacillus casei DG to the subject (abstract in page 312, the section of material and methods in page 313); wherein the L. Casei DG was administered orally in a dose of 16 billion viable lyophilized bacteria (i.e. 16 billion CFUs of live bacteria, reading on the claimed range of 15-30 billion CFUs in claim 3) in 2 capsules, 8 billion each (see Groups L and LM; bottom of left column to top of right column, page 313). It is noted that the preventing a recurrence in the method of Tursi et al. is interpreted to mean: prevention of the subject from getting or having a recurrence of intestinal diverticular disease in the future, wherein the subject, while being under the administration of L. Casei DG, does not have the intestinal diverticular disease. Tursi et al. further teach that 85 patients/subjects completed the study; and after being administered with the L. Casei DG compositions, 23/29 subjects in the group L and 29/29 subjects in the group LM were free of symptoms in the 12 month follow-up (“Results” in page 312). Tursi et al. conclude that the composition comprising the L. Casei DG is effective at preventing recurrence of symptomatic diverticular disease (see “Conclusion” in right column of page 312); and further teach that the L. casei DG maintains adequate and balanced colonization in the GI tract, inhibiting both colonic bacterial overgrowth and metabolism of pathogenic microbes, and reduces proinflammatory cytokines (page 315, left col., lines 3-7 from bottom).
Examiner notes that Lactobacillus casei DG is identified by the accession number CNCM I-1572 and is deposited at the Collection Nationale de Cultures de Microorganisms, as evidenced by EFSA (page 5, paragraphs 3-4). As further evidenced by the specification of the instant application (page 6, lines 16-22), the instantly claimed L. paracasei DG was known as L. casei DG when originally deposited. Thus, the Lactobacillus casei DG taught by Tursi et al. is a synonym of L. paracasei DG CNCM I-1572 recited in the claims.
The method of Tursi et al. differs from the claimed method in that its human subject population have a history of intestinal symptomatic diverticular disease. Tursi et al. do not teach applying their method to a healthy subject without a history of intestinal symptomatic diverticular disease. However, human subjects under administration of L. Casei/paracasei DG CNCM I-1572 in the method of Tursi et al. do not have the intestinal diverticular disease; and Tursi et al. demonstrate that the administration of L. paracasei to the human subjects in their method successfully prevented recurrence of intestinal symptomatic diverticular disease in the subjects, which indicates that L. paracasei DG administered to the intestinal tract has ability to modulate intestinal microbiota, thus maintaining health of the subjects and preventing the intestinal diverticular disease. It would have been obvious to one of ordinary skill in the art to try administering the composition of L. paracasei DG to a healthy subject (without a history of intestinal symptomatic diverticular disease) for preventing diverticular disease in the healthy subject, because there are a limited number of healthy subject populations free of intestinal diverticula disease in the prior art, including a healthy subject population without a history of symptomatic diverticular disease. One of ordinary skill in the art would have recognized that any healthy subject populations without intestinal diverticular disease, including a healthy population without a history of symptomatic diverticular disease, are suitable for being administered with L. paracasei DG in the method of Tursi et al. for preventing diverticular disease. See MPEP 2143 I.E., the rationale “obvious to try” supports a conclusion of obviousness when there is a finite number of identified and predictable solutions in the prior art, and choosing from such a finite number of identified and predictable solutions would have a reasonable expectation of success.
Regarding the new limitation “daily for four weeks” in the amended claim 3, Examiner notes that a transitional phrase “comprising”, not “consisting of”, is recited in the claim 3, which indicates that the claimed method is not limited to the administration for only four week, Rather, the scope of claim is open to comprise administration of L. paracasei DG for any additional period of time (such as further comprising administration for another 4 weeks or additional 20 – 24 weeks). Tursi et al. teach that the administration of L. paracasei DG is conducted 15 days per month (e.g. every other day) for a 12-month period (i.e. accumulatively for 180 days or about 25 weeks) (page 313: col 1/last 2 lines total and col 2/lines 1-7). Tursi et al. do not teach administration of L. paracasei DG on a daily basis. However, it is considered that the oral administration frequency taught by Tursi et al. can be readily modified by routine optimization for achieving a desirable protection for preventing the diverticular disease, thus arriving at a continuously daily administration of L. paracasei DG to a healthy subject for four weeks or more than 4 weeks. It is well settled that routine optimization is not patentable, even though it results in significant improvement over the prior art (see MPEP 2144.05). Furthermore, it would have been obvious to modify the administration frequency of Tursi et al. to a daily basis because it is well known in the art that oral administration of probiotic L. paracasei DG CNCM I-1572 on a daily basis to healthy subjects leads to effective colonization of the probiotic in the human GI tract for delivering benefit effects of the probiotic, as supported by Drago et al. Specifically, Drago et al. teach orally administering probiotic L. casei/paracasei DG CNCM I-1572 to healthy human volunteers on a daily basis at a daily dose of 8.5 x 109 CFU for 7 days, which leads to the colonization of L. paracasei DG in the human GI tract; and L. casei DG can still be detected in the feces of all the healthy human volunteers even after the administration is stopped; and Drago et al. further teach that similar results were observed in a parallel animal study on mice (see Summary in page 72).
Regarding the limitation of preventing an intestinal butyrate and succinate-dependent pathological condition recited in Claim 3, this limitation is directed to the function or outcome of the claimed method. The method suggested by Tursi et al. and Drago et al. has the same step as the claimed method. It is inherent that methods having substantially the same steps will perform/generate substantially the same function/outcome. Indeed, the symptomatic diverticular disease prevented by the method of Tursi et al. is associated with an intestinal pathological condition of low levels of butyrate, as evidenced by Tursi 2016, who teaches that symptomatic diverticular disease is associated with low levels of butyrate (page S9, left column, “Results”). Therefore, Claims 3 and 8-9 would have been prima facie obvious to a person of ordinary skill in the art.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Tursi et al. (J. Clin. Gastroenterol. (2006) 40: 312-316; cited in the IDS of parent application No. 14916961, filed 12/1/2020) in view of Drago et al. (International Journal on Drugs and Therapy, 2002, Vol. XIX - n. 1/2: 72-76, of record), as applied to Claims 3 and 8-9, further in view of Rautonen et al. (US 20030157146, 2003, of record) and Hayes et al. (US 20080193603, 2008, of record), as evidenced by the European Food Safety Authority (EFSA) (EFSA Journal (2012) 10(6): 2723, pages 1-15, of record), and Tursi-2016 et al. (J. Clin. Gastroenterol, 2016, 50(supp. 1): S9-S12, cited in IDS of parent application No.14916961).
The teachings of Tursi et al. and Drago et al. as being applied to the rejection of claims 3 and 8-9 are described above.
Regarding Claims 10 and 11, Tursi et al. do not specifically teach their probiotic L. paracasei DG composition comprises a prebiotic/dietary fibers, wherein the dietary fibers comprise inulin and/or guar gum.
It would have been obvious to one of ordinary skill in the art to include dietary fibers, specifically inulin and/or guar gum, in the prebiotic composition in the method suggested by Tursi et al. and Drago et al. for stabilizing the intestinal microbial population in favor of beneficial microbes and further enhancing the effect of the composition on preventing intestinal diseases, because it has been well established in the art that dietary fiber prebiotics (inulin and/or guar gum) have the benefits of promoting a healthy GI system, and it had been well known in the art that administration of inulin and guar gum reduces the risk of developing intestinal diseases. In support, Rautonen et al. teach that prebiotics are dietary fibers which stabilize the intestinal microbial balance in favor of beneficial microbes, and the beneficial microbes (e.g. Lactobacillus probiotics) create conditions unfavorable for growth of potentially pathogenic species (para 0005). Further in support, Hayes et al. teach that guar gum of Benefiber (i.e. partially hydrolyzed dietary fiber guar gum) is beneficial in maintaining bowel function, helping in the management of GI diseases, and producing substantial amounts of butyrate in the colon (paras 0139, 0141-142); and Hayes further teaches that inulin is a highly fermentable dietary fiber with strong prebiotic activity and has specific bifidogenic effects, and like Benefiber inulin it can reduce the risk of GI diseases/diarrhea (paras 0145).
Regarding Claim 12, Tursi et al. teach that their probiotic composition contains vitamins (see page 313, right column, lines 1-2). Thus, the claim would have been obvious over the cited prior art.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Response to Arguments
Applicant's arguments about the rejection of claims 3 and 8-12 under 35 USC 112(a) in the response filed on 02/19/2026 (page 5) have been fully considered but they are moot because the rejection is withdrawn, as indicated above.
Applicant's arguments about the double patenting rejections of claims 3 and/or 8-12 over claims of copending Application No. 17/762017 in the 02/19/2026 response (page 12) have been fully considered but they are moot because the rejection is withdrawn, as indicated above.
Applicant's arguments about the rejection of claims 3 and 8-12 under 35 USC 103 over Tursi in the response filed on 02/19/2026 (pages 5-12) have been fully considered, but they are not persuasive for the following reasons.
In response to Applicant’s arguments based on differences in subject populations and colonization of L. paracasei DG between Tursi’s method and the claimed method in the 09/02/2025 response (pages 5-8), these arguments are not persuasive for reasons indicated in the 103 rejection of this office action (see pages 3-7) and for the reasons of record (see pages 14/last para – page 15/full page in the previous office action dated 12/02/2025). Furthermore, Applicant’s arguments based on the “therapeutic objective” and “grounded in managing a known disease condition” in the method of Tursi et al. are misleading and not persuasive. Examiner notes that Tursi et al. administered L. paracasei DG CNCM I-1572 solely for the purpose of preventing recurrence of intestinal diverticula disease, not for therapeutic purpose of treating the disease or managing any known disease condition. Regardless of whether the subjects in the method of Tursi et al. had a previous a history of intestinal diverticula disease, they do not have the intestinal diverticula disease when being administered with L. paracasei DG. Tursi et al. demonstrate that the administration of L. paracasei DG to the human subjects successfully prevented recurrence of intestinal symptomatic diverticular disease in the subjects, and indicates that L. paracasei DG administered to the intestinal tract has ability to modulate intestinal microbiota, thus maintaining health of the subjects and preventing the intestinal diverticular disease. Thus, it would have been obvious to try the administration of L. paracasei DG to healthy human subjects for preventing the intestinal diverticular disease for the reasons indicated above.
In response to Applicant’s arguments based on reasonable expectation of success in modifying the method of Tursi et al. in the response (pages 7 and 8),
it is noted that the claimed method comprises only a single active step of administering L. paracasei DG to a healthy subject. Drago et al. teach a step of administering the probiotic L. paracasei DG to a healthy subject on a daily basis for establishing effective colonization of the probiotic in the GI tract of healthy human subjects, and Tursi et al. teach that L. paracasei DG administered to the intestinal tract modulates intestinal microbiota and maintains health of the GI tract of human subjects for preventing the intestinal diverticular disease in their method. In view of the cited prior art, a healthy subject without a history of diverticular disease would be suitable for being administered with L. paracasei DG of Tursi et al. for preventing diverticular disease, as indicated above. Per MPEP 2143 I.E., the rationale “obvious to try” supports a conclusion of obviousness when there is a finite number of identified and predictable solutions in the prior art, and choosing from such a finite number of identified and predictable solutions would have a reasonable expectation of success.
With regard to Applicant’s arguments based on difference in administration frequency between Tursi’s method and the claimed method throughout pages 7-10 of the response, these arguments are not persuasive for the reasons indicated in the 103 rejection of this office action (see pages 5-6). As indicated above, the instant claims are not limited to the administration for only four week and it is not distinct from the administration for about 25 weeks taught by Tursi et al. Furthermore, it is well known in the art that L. paracasei DG CNCM I-1572 is a probiotic bacterium and its administering to healthy human subjects on a daily basis achieves effective colonization of the probiotic bacterium in the GI tract for delivering beneficial effects of the probiotic, as supported by Drago et al. Moreover, Applicant failed to provide any factual evidence to support the criticality of the claimed administration frequency “daily for four weeks” for delivering physiological/microbiological effects of the probiotics and preventing intestinal diverticular in healthy subjects in the claimed method. Overall, this is the Examiner’s position that the claimed limitation “daily for four weeks” is deemed merely a matter of routine optimization for obtaining a desirable effect for preventing intestinal diverticula, which is well within the purview of one of ordinary skill in the art having the cited reference before him/her as a guide.
In response to Applicant’s arguments in pages 11-12 of the response, the cited prior art not only teaches the safety and tolerability of probiotic L. paracasei DG bacterium to a human subject, but also demonstrates that administering this probiotic bacterium to the human subject results in modulation of intestinal microbiota and maintaining a health GI tract by the probiotic bacterium, and preventing intestinal diverticular disease, as supported by Tursi et al. Regardless of whether it is a primary prevention in a subject without a history of diverticular disease or a secondary prevention in a subject with a history of diverticular disease, the preventions of the intestinal diverticular disease in these subjects all require L. paracasei DG administered to the GI tract to modulate intestinal microbiota and maintain health of the GI tract of human subjects. As such, there would be a reasonable expectation of success for applying an “obvious to try” rational for modifying the method of Tursi et al. by administering L. paracasei DG to a healthy subject without a history of diverticular disease, as indicated above.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reconstruction in the response (pages 8. 10 and 11), Examiner points out that the conclusion of obviousness is fully based on the teachings of the cited prior art. Further, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant's arguments about the rejection of claims 10-12 under 35 USC 103 over Tursi in view of Rautonen and Hayes in the 02/19/2026 response (page 12) are based on the arguments for the rejection of claims 3 and 8-9, which are previously presented in pages 5-12 of the response. They are not persuasive for the reasons indicated above.
Overall, the conclusion of the obviousness of the amended claims 3 and 8-12 has been established, and the claimed method has no novelty for all the reasons indicated above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Qing Xu, Ph.D., whose telephone number is (571) 272-3076. The examiner can normally be reached on Monday-Friday from 9:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached at (571) 272-0939. Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the receptionist whose telephone number is (571) 272-1600.
/Qing Xu/
Patent Examiner
Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
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