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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/10/2025 has been entered.
Priority
The present application claims benefit of priority to Japan Application No. JP2020-101086 filed on June 10, 2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, a translation of the certified copy of the Japanese patent document was not provided. As such, the priority date of the instant application is June 09, 2021.
Amendment and Claim Status
In the reply filed on 09/10/2025, Applicant amended claim 13 and added new claim 21. Claims 1-12 were previously canceled.
Claims 13-21 are currently pending and under examination.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 13-18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Stenman et al. (US 20200330531 A1) (Of Record) in view of Kurihara et al. (JP 2018043986 A, 03/22/2018) (IDS Reference of 12/02/2022, 31 Pages).
Regarding claim 13, Stenman et al. disclose a method for preventing and/or treating a mental illness, a symptom affecting mental health and/or a condition associated with chronic stress in a mammal in need thereof, wherein the method comprises administering to the mammal bacteria of the species Lactobacillus paracasei (Claim 1 of Stenman et al.). It was further disclosed wherein the method comprises preventing and/or treating a mental illness selected from a mood disorder, an anxiety disorder and depression (Claim 2 of Stenman et al.). In preferred embodiments, the compositions are for use in a human (Paragraph [0095]).
Stenman et al. do not disclose wherein the Lactobacillus paracasei is Lactobacillus paracasei KW3110 strain.
However, Kurihara et al. disclose the use of Lactobacillus paracasei KW3110 as a viable treatment option for suppressing or improving eye fatigue (Claim 1 of Kurihara et al.).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized Lactobacillus paracasei KW3110 in the method of Stenman et al. because Stenman et al. disclose administering a strain of the genus Lactobacillus paracasei and Kurihara et al. disclose Lactobacillus paracasei KW3110, a strain within the genus disclosed by Stenman et al. Therefore, Lactobacillus paracasei KW3110 would have been an obvious choice of Lactobacillus paracasei for use in the method of Stenman et al. as it was disclosed in the prior art for therapeutic purposes as taught by Kurihara et al.
Regarding claim 14, Stenman et al. disclose the invention relates to bacteria of the species Lactobacillus paracasei and/or compositions comprising Lactobacillus paracasei for prevention and/or treatment of chronic or acute stress-related mental illness characterized, for example, by psychological symptoms of depression (Paragraph [0002]). As the treatment is described to be for the treatment of chronic mental illness, it corresponds with being a condition that occurs in daily life, as chronic indicates it is something prolonged or long lasting.
Regarding claim 15, Stenman et al. do not disclose wherein the depression is a condition which occurs in a person who is aware of eye fatigue. It is noted “wherein the depression is a condition which occurs in a person who is aware of eye fatigue” does not meaningfully limit the depression. This limitation does not require the person have eye fatigue, it merely requires the person be aware of eye fatigue.
Regarding claims 16 and 17, Stenman et al. disclose wherein the bacteria of the species Lactobacillus paracasei are administered to the mammal as part of a composition in the form of a food product, a dietary supplement or a pharmaceutically acceptable composition (Claim 16 of Stenman et al.).
Regarding claim 18, Stenman et al. disclose the dietary supplements may be found in many forms such as tablets, capsules, soft gels, gel caps, liquids, or powders (Paragraph [0058]). Applicant indicates in the Specification unit package form is one in which the ingestion amount per meal is predetermined (Paragraph [0023]). The examples disclosed by Stenman et al. listed above meet that limitation.
Regarding claim 21, Stenman et al. disclose a method for preventing and/or treating a mental illness, a symptom affecting mental health and/or a condition associated with chronic stress in a mammal in need thereof, wherein the method comprises administering to the mammal bacteria of the species Lactobacillus paracasei (Claim 1 of Stenman et al.). It was further disclosed wherein the method comprises preventing and/or treating a mental illness selected from a mood disorder, an anxiety disorder and depression (Claim 2 of Stenman et al.). In preferred embodiments, the compositions are for use in a human (Paragraph [0095]).
Stenman et al. do not disclose wherein the Lactobacillus paracasei is Lactobacillus paracasei KW3110 strain or wherein the depression is a condition which occurs in a person who has eye fatigue.
However, Kurihara et al. disclose the use of Lactobacillus paracasei KW3110 as a viable treatment option for suppressing or improving eye fatigue (Claim 1 of Kurihara et al.).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized Lactobacillus paracasei KW3110 in the method of Stenman et al. because Stenman et al. disclose administering a strain of the genus Lactobacillus paracasei and Kurihara et al. disclose Lactobacillus paracasei KW3110, a strain within the genus disclosed by Stenman et al. Therefore, Lactobacillus paracasei KW3110 would have been an obvious choice of Lactobacillus paracasei for use in the method of Stenman et al. as it was disclosed in the prior art for therapeutic purposes as taught by Kurihara et al.
Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized Lactobacillus paracasei KW3110 as a treatment for depression and eye fatigue because Stenman et al. disclose the genus Lactobacillus paracasei for treating depression and Kurihara et al. disclose Lactobacillus paracasei KW3110 for treating eye fatigue. Thus, one of ordinary skill in the art would reasonably utilize Lactobacillus paracasei KW3110 in a person having both depression and eye fatigue with a reasonable expectation of success in view of the teachings of Stenman et al. and Kurihara et al.
Thus, the teachings of Stenman et al. and Kurihara et al. meet the limitations of instant claim 21.
Claims 13-21 are rejected under 35 U.S.C. 103 as being unpatentable over Stenman et al. (US 20200330531 A1) (Of Record) in view of Kurihara et al. (JP 2018043986 A, 03/22/2018) (IDS Reference of 12/02/2022, 31 Pages) and further in view of Nishida et al. (US 20110038837 A1, 02/17/2011) (IDS Reference).
The teachings of Stenman et al. and Kurihara et al. are discussed above.
Regarding claim 19, neither Stenman et al. nor Kurihara et al. disclose wherein a daily intake amount of Lactobacillus paracasei is 1 mg or more in terms of dry cell mass for a human.
However, Nishida et al. disclose the relationship between the number of the lactic acid bacteria and the weight of dried bacteria, for example, L. paracasei KW3110, 1012 bacteria correspond to 1 g of dry weight (Paragraph [0046]). A composition for improving the intestinal microflora wherein the content of the lactic acid bacteria in a composition for improving the intestinal microflora comprising L. paracasei KW3110 or its variant as an active ingredient is adjusted to be 4 x 109 or more per amount of composition for improving the intestinal microflora to be ingested per day (Claim 11 of Nishida et al.). It was additionally disclosed, the composition exhibits an excellent intestinal regulation effect, intestinal environment-improving effect, and the intestinal microflora-improving effect, enabling to form healthy microflora in human intestine (Abstract).
Accordingly, it would have been obvious to one of ordinary skill in the art to utilize the treatment method of Stenman et al. with the daily intake amount of Lactobacillus paracasei KW3110 as taught by Nishida et al. with a reasonable expectation of success as Nishida et al. teach the specified daily intake amount to be sufficient for achieving a healthy microflora in the human intestine, making the same daily intake amount of Lactobacillus paracasei KW3110 obvious for suppressing and/or improving depression in humans.
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected a daily intake amount of Lactobacillus paracasei that falls within the claimed range, making the claimed amount obvious. In the case where the claimed ranges “overlap of lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 20, Stenman et al. disclose the bacterial strains were solubilized and administered orally at 9:00 a.m. each morning. It was further disclosed the duration of the treatment was 33 days in total (Page 8, Paragraph 3). The bacterial strains being administered every morning for 33 days reads on ingested continuously for at least one week.
It is also noted that 2144.05 II of the MPEP states: “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. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.")
The Supreme court acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable varition..103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions…
…the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) emphasis added.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton.").
The Examiner is therefore of the opinion that from the combined teachings of the references cited above, that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art especially in the absence of unexpected results.
35 USC § 103 – Response to Arguments
In the reply filed on 09/10/2025, Applicant argued treating a human subject with Lactobacillus paracasei KW3110 would not have been obvious with a reasonable expectation of success.
Applicants arguments have been fully considered but are not persuasive. It is the Examiner’s position that it would have been obvious to one of ordinary skill in the art to utilize Lactobacillus paracasei KW3100 with a reasonable expectation of success as set out in the rejection set forth above.
In the reply filed on 09/10/2025, Applicant argued the claimed strain, Lactobacillus paracasei KW3110 showed superior results compared to Lactobacillus paracasei Lpc-37.
Applicants arguments have been fully considered, but are not persuasive. There are many known strains of Lactobacillus paracasei. It would be expected that some strains would be effective and some strains would not be effective. One strain not being effective does not take away from the validity of Stenman et al. who disclose the genus of Lactobacillus paracasei as useful for depression.
In the reply filed on 09/10/2025, Applicant argued Zheng et al. does not teach a connection between depression and eye fatigue.
Applicants arguments have been fully considered and are persuasive. However, it is noted Zheng et al. is not used in the new rejection set forth above.
In the reply filed on 09/10/2025, Applicant argued there is doubt as to whether the mouse model for depression can appropriately reflect depressive states in humans.
Applicants arguments have been fully considered but are not persuasive. While it is acknowledged that the mouse model may not be a perfect model, the mouse model is still an acceptable and widely used model. To invalidate the mouse model, Applicant would have to provide evidence the scientific community as a whole rejects the use of the mouse model. The presentation of one document is not enough to disavow the mouse model.
It is additionally noted the document published after the filing date of the claimed invention is not taken into consideration as it was not available to one of ordinary skill in the art before the effective filing date of the claimed invention.
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 13-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. US 11389494 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to feeding a human Lactobacillus paracasei strain KW3110. Claim 1 of ‘494 is drawn to a method for suppressing or improving eye fatigue by feeding a human an effective amount of Lactobacillus paracasei strain KW3110. Instant claims 13 and 21 are drawn to a method for suppressing or improving depression by feeding a human an effective amount of Lactobacillus paracasei strain KW3110. It appears, absent evidence to the contrary, the composition of ‘494 would inherently suppress or improve depression as it is the same compound as instantly claimed. Claim 4 of ‘494 corresponds to instant claim 13. Claim 5 of ‘494 corresponds to instant claim 17.
This is an anticipation type double patenting rejection.
Conclusion
Claims 13-21 are rejected.
No claims are allowed.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653