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 .
Claim Status
The amendment of 08/03/2026 has been entered. Claims 1 and 3-20 are pending (claim set as filed on 08/03/2026). Claims 1, 3-12, and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. As previously acknowledged, Applicant elected invention Group II, claims 13-16, drawn to a method, and the pathological condition species: impairment of cognitive functions. Applicant timely traversed the restriction (election) in the reply filed on 02/09/2026.
Claims 13-16 are currently under examination and were examined on their merits.
Withdrawn Rejections
The previous rejections under 35 U.S.C. 112(a) and under 35 U.S.C. 112(b) as set forth in the previous Office action are withdrawn in light of the certificates of bacterial deposit, Applicant’s remarks regarding the bacterial deposits, and Applicant’s amendment filed on 08/03/2026.
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.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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 13-14 and 16 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Vitetta et al. (US 2017/0312232 A1, published on 11/02/2017), hereinafter Vitetta.
Vitetta’s general disclosure relates to methods and compositions for use in the
treatment of depression, anxiety or a depressive or anxiety related disorder (see entire document, including abstract).
Regarding claim 13, please note the elected species ‘impairment of cognitive functions’ under Claim Status above.
Pertaining to a method for prevention and/or treatment of acute or chronic pathological conditions related to stress, Vitetta teaches a method for prevention or treatment of impairment of cognitive functions, anxiety, postpartum depression, generalized anxiety disorder, and major depressive disorder (paragraphs [0010], [0015]-[0018],[0083]-[0084], claims 1, 11, and 14).
It is noted that Vitetta’s method for preventing or treating depression, anxiety or a depressive or anxiety-related disorder includes the inhibition or alleviation of one or more symptoms of depression, anxiety and related disorders, such as the symptom short-term memory loss (paragraph [0084]). The instant specification describes ‘short-term memory’ as a cognitive function (specification page 5, lines 5-10; claim 16).
Vitetta teaches “treatment-resistant depression, anxiety or a depressive or anxiety-related disorder” (paragraph [0029]), indicating the chronic nature of the depression, anxiety or depressive or anxiety-related disorder, and thus of associated cognitive impairment (paragraph [0084]). Vitetta further discloses “postpartum depression” (paragraph [0083]), indicating the acute nature of the condition and associated cognitive impairment. (paragraph [0084]). Vitetta discloses the anxiety-related disorder posttraumatic stress disorder (paragraphs [0059], [0083]), thus indicating that associated cognitive impairment is stress-related (paragraph [0084]).
Vitetta teaches wherein the method comprises administering to a patient in need thereof an effective dose of a composition comprising a probiotic combination comprising the strains Lactobacillus reuteri, Bifidobacterium breve, and/or Bifidobacterium lactis (paragraphs [0053]-[0054], [0060]-[0061]), wherein the bacterial strains are present in the composition in percentage by weight on the total weight of the composition from about 50% to 90% (paragraph [0125]), and wherein the composition comprises at least one physiologically acceptable excipient and/or carrier (paragraphs [0102], [0119], [0125]).
In addition, Vitetta discloses that “[t]he amounts of individual microbial strains to be administered to subjects or to be included in compositions disclosed herein will depend on a variety of factors including the identity and number of individual strains employed, the nature and extent of any condition suffered by the subject, and the form in which a composition is administered (paragraph [0103]).
Regarding claim 14, please note the elected species ‘impairment of cognitive functions’ under Claim Status above.
Pertaining to the condition, Vitetta teaches wherein the acute or chronic pathological condition is impairment of cognitive functions, anxiety, or postpartum depression (paragraphs [0083]-[0084]). It is noted that the instant specification describes ‘short-term memory’ recited by Vitetta (paragraph [0084]) as cognitive function (instant specification page 5, lines 5-10; claim 16).
Regarding claim 16, pertaining to the impaired cognitive functions, Vitetta teaches wherein the impaired cognitive function is short-term memory (paragraph [0084]).
From Vitetta’s teachings one would not immediately envisage a composition comprising a probiotic combination specifically comprising Lactobacillus reuteri and Bifidobacterium breve, or comprising Lactobacillus reuteri and Bifidobacterium lactis.
Vitetta does not teach wherein the Lactobacillus reuteri strain is present in the composition in percentages by weight on the total weight of the probiotic combination from 20% to 80%, and wherein the Bifidobacterium breve or Bifidobacterium lactis strain is present in the composition in percentages by weight on the total weight of the probiotic combination from 10% to 60%.
While Vitetta does not expressly teach a composition comprising a probiotic combination comprising Lactobacillus reuteri and Bifidobacterium breve, or comprising Lactobacillus reuteri and Bifidobacterium lactis, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified Vitetta’s composition with Lactobacillus reuteri, Bifidobacterium breve, and Bifidobacterium lactis, as taught by Vitetta, in order to create a composition comprising a probiotic combination comprising Lactobacillus reuteri and Bifidobacterium breve, or comprising Lactobacillus reuteri and Bifidobacterium lactis. One would have been motivated to do so, in order to create a superior probiotic combination that beneficially affects preventing or treating cognitive impairment, depression, anxiety, postpartum depression, generalized anxiety disorder, and major depressive disorder (paragraphs [0010], [0015]-[0018], [0083]-[0084], claims 1, 11, and 14). A skilled artisan would have reasonably expected success in combining Vitetta’s probiotic composition with Lactobacillus reuteri, Bifidobacterium breve, and Bifidobacterium lactis, as taught by Vitetta since Vitetta suggests all three bacterial strains for a probiotic composition (paragraphs [0053]-[0054], [0060]-[0061], claims 1, 11, 14). Further, since the instant claims recite comprising language, one would have been motivated to add all the suggested bacterial strains including Lactobacillus reuteri, Bifidobacterium breve, and Bifidobacterium lactis in the probiotic composition because Vitetta clearly teaches the incorporation of several probiotic strains (see paragraphs [0053]-[0054]).
While Vitetta does not teach wherein the Lactobacillus reuteri strain is present in the
composition in percentages by weight on the total weight of the probiotic combination from 20% to 80%, and wherein the Bifidobacteria breve or Bifidobacterium lactis strain is present in the composition in percentages by weight on the total weight of the probiotic combination from 10% to 60%, the instantly recited ranges of amounts would be within the realm of routine experimentation since Vitetta teaches wherein the bacterial strains are present in the composition in percentage by weight on the total weight of the composition from about 50% to 90% (paragraph [0125]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine the optimal concentration ranges of the bacteria in the probiotic combination, in order to identify how much is needed for successfully preventing or treating cognitive impairment, depression, anxiety, postpartum depression, generalized anxiety disorder, and major depressive disorder. Further, one would expect success since Vitetta teaches that “[t]he amounts of individual microbial strains to be administered to subjects or to be included in compositions disclosed herein will depend on a variety of factors including the identity and number of individual strains employed, the nature and extent of any condition suffered by the subject, and the form in which a composition is administered” (paragraph [0103]), and therefore, manipulation of the bacterial concentration based on Vitetta’s teachings would be within the purview of an artisan. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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 (CCPA1955). See MPEP § 2144.05 part II A.
Vitetta does not teach wherein Lactobacillus reuteri, Bifidobacterium breve, or Bifidobacterium lactis are the deposited Lactobacillus reuteri PBS072, Bifidobacterium breve BB077, or Bifidobacterium lactis BL050, respectively.
The instant specification and claims describe that the claimed strains are used for prevention and treatment of impairment of cognitive functions, anxiety, postpartum depression, generalized anxiety disorder, and major depressive disorder, including impairment of the cognitive function ‘short-term memory’ (specification, page 4, line 24 - page 5, line 10; claims 13 and 16).
Based on Vitetta’s teachings, it is highly likely that Vitetta’s Lactobacillus reuteri, Bifidobacterium breve, and Bifidobacterium lactis, and Applicant’s Lactobacillus reuteri, Bifidobacterium breve, and Bifidobacterium lactis are the same strains, respectively, since Vitetta’s and Applicant’s strains are both used to prevent and treat impairment of the cognitive function short-term memory, anxiety, postpartum depression, generalized anxiety disorder, and major depressive disorder (Vitetta, paragraphs [0010], [0015]-[0018], [0053]-[0054], [0060]-[0061], [0083]-[0084], claims 1, 11, 14; instant specification, page 4, line 24 - page 5, line 10; claims 13 and 16).
However, Vitetta does not teach wherein Lactobacillus reuteri, Bifidobacterium breve, or Bifidobacterium lactis are the deposited Lactobacillus reuteri PBS072, Bifidobacterium breve BB077, or Bifidobacterium lactis BL050, respectively. If there should be a slight variation between Vitetta’s strains and the Applicant’s deposited strains, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have used the claimed Lactobacillus reuteri PBS072, Bifidobacterium breve BB077, or Bifidobacterium lactis BL050 to substitute Vitetta’s Lactobacillus reuteri, Bifidobacterium breve, or Bifidobacterium lactis in modified Vitetta’s method to prevent and treat impairment of the cognitive function ‘short-term memory’, anxiety, postpartum depression, generalized anxiety disorder, and major depressive disorder.
Claims 13 and 15 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Vitetta et al. (US 2017/0312232 A1, published on 11/02/2017), hereinafter Vitetta, in view of Siegrist (“Chronic psychosocial stress at work and risk of depression: evidence from prospective studies”, published in 2008, Eur Arch Psychiatry Clin Neurosci (2008), Vol. 258 (Suppl 5), pages115–119), hereinafter ‘Siegrist’.
Modified Vitetta’s teachings are set forth above.
Regarding claim 15, Vitetta teaches impairment of the cognitive function ‘short-term memory’ as a symptom of depression (paragraph [0084]).
Vitetta does not teach wherein the impairment of cognitive function is due to chronic stress affecting an employee in the workplace (instant claim 15).
Siegrist’s general disclosure relates to moderate association of chronic psychosocial stress at work, as defined by theoretical models, with depression (see entire document, including abstract).
Regarding claim 15, pertaining to chronic work stress, Siegrist teaches that chronic psychosocial stress at work is associated with significantly elevated risks of depression (page 117, left column, paragraph 5).
While modified Vitetta does not teach wherein the impairment of the cognitive function ‘short-term memory’ is due to chronic stress affecting an employee in the workplace, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have combined modified Vitetta’s method with Siegrist’s teachings on chronic work stress increasing the risk of depression, to have used Vitetta’s modified method for prevention or treatment of impairment of the cognitive function ‘short term memory’ wherein the impairment of the cognitive function is due to chronic stress affecting an employee in the workplace. One would have been motivated to do so to identify suitable prevention and/or treatment strategies for depression and its symptoms (i.e. short-term memory loss) in employees affected by chronic stress in the workplace. A skilled artisan would have reasonably expected success in combining Vitetta’s and Siegrist’s teachings since Vitetta teaches wherein the impaired cognitive function ‘short-term memory’ is a symptom of depression (paragraph [0084]), and Siegrist teaches depression being associated with chronic stress in the workplace (page 117, left column, paragraph 5).
Claims 13-14 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Bergonzelli et al. (EP 2609814 A1, published on 07/03/2011), hereinafter Bergonzelli, in view of Vitetta et al. (US 2017/0312232 A1, published on 11/02/2017), hereinafter ‘Vitetta’.
Bergonzelli’s general disclosure relates to Lactobacillus reuteri DSM 17938 for promoting the establishment of healthy and normal cognitive function in young mammals (see entire document, including abstract).
Regarding claim 13, please note the elected species ‘impairment of cognitive functions’ under Claim Status above.
Pertaining to a method for prevention of acute or chronic pathological conditions related to stress, Bergonzelli teaches a method for prevention and/or treatment of acute or chronic impairment of cognitive functions related to stress (paragraph [0001], [0003], [0028]-[0029], [0033]-[0034], [0042], [0045]-[0050]; see abstract), the method comprising administering to a patient in need thereof an effective dose of a composition comprising a probiotic combination comprising the strains Lactobacillus reuteri and Bifidobacterium lactis (paragraphs [0001], [0042], [0045]-[0046], [0051], claims 1, 16, 18-19), and at least one physiologically acceptable carrier (paragraph [0055]).
Pertaining to impairment of cognitive functions being acute or chronic, Bergonzelli teaches administering the probiotic short-term or long-term (paragraph [0067]), indicating wherein the condition can be acute or chronic.
Regarding claim 14, please note the elected species ‘impairment of cognitive functions’ under Claim Status above. Pertaining to the condition, Bergonzelli teaches wherein the acute or chronic pathological condition is impairment of cognitive functions (paragraphs [0001], [0028]-[0029], [0033]-[0034]; see abstract).
Bergonzelli does not teach wherein the Lactobacillus reuteri strain is present in the composition in percentages by weight on the total weight of the probiotic combination from 20% to 80%, and wherein the Bifidobacterium lactis strain is present in the composition in percentages by weight on the total weight of the probiotic combination from 10% to 60%.
Vitetta’s general disclosure relates to methods and compositions for use in the
treatment of depression, anxiety or a depressive or anxiety related disorder (see entire document, including abstract).
Regarding claim 13, pertaining to the composition, Vitetta teaches a composition comprising a probiotic combination for preventing or treating short-term memory loss (comprising the strains Lactobacillus reuteri and Bifidobacterium lactis ((paragraphs [0053]-[0054], [0060]-[0061], [0084]), wherein the bacterial strains are present in the composition in percentage by weight on the total weight of the composition from about 50% to 90% (paragraph [0125]),
In addition, Vitetta discloses wherein “[t]he amounts of individual microbial strains to be administered to subjects or to be included in compositions disclosed herein will depend on a variety of factors including the identity and number of individual strains employed, the nature and extent of any condition suffered by the subject, and the form in which a composition is administered (paragraph [0103]).
While Bergonzelli does not teach wherein the Lactobacillus reuteri strain is present in the composition in percentages by weight on the total weight of the probiotic combination from 20% to 80%, and wherein the Bifidobacterium lactis strain is present in the composition in percentages by weight on the total weight of the probiotic combination from 10% to 60%, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to combine Bergonzelli’s method with Vitetta’s teachings on probiotic concentrations in a composition, in order to have created a method for preventing and/or treating the impairment of cognitive functions comprising administering a composition comprising a probiotic combination comprising the bacterial strains Lactobacillus reuteri and Bifidobacterium lactis wherein the strains are present in the composition in percentage by weight on the total weight of the probiotic combination from about 50% to 90%. One would have been motivated to do so to increase the effectiveness of the method for treating and/or preventing the impairment of cognitive functions, since Vitetta’s probiotic composition comprising Lactobacillus reuteri and Bifidobacterium lactis is used for preventing or treating short-term memory loss (paragraphs [0053]-[0054], [0060]-[0061], [0084]).
While modified Bergonzelli does not teach wherein the Lactobacillus reuteri strain is present in the composition in percentages by weight on the total weight of the probiotic combination from 20% to 80%, and wherein Bifidobacterium lactis strain is present in the composition in percentages by weight on the total weight of the probiotic combination from 10% to 60%, the instantly recited ranges of amounts would be within the realm of routine experimentation since Vitetta teaches wherein the bacterial strains are present in the composition in percentage by weight on the total weight of the composition from about 50% to 90% (paragraph [0125]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine the optimal concentration ranges of the bacteria in the probiotic combination, in order to identify how much is needed for successful prevention and/or treatment of impairment of cognitive functions. Further, one would expect success since Bergonzelli’s teachings are directed to multiple different strains (Bergonzelli, claims 1,16, 18-19), and therefore, manipulation of the bacterial concentration based on Vitetta’s teachings would be within the purview of an artisan. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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 (CCPA1955). See MPEP § 2144.05 part II A.
Modified Bergonzelli does not teach wherein Lactobacillus reuteri and Bifidobacterium lactis are the deposited Lactobacillus reuteri PBS072 and Bifidobacterium lactis BL050, respectively.
The instant specification and claims describe that the claimed strains are used for prevention and/or treatment of impairment of cognitive functions, including impairment of the cognitive function ‘attention’ (specification, page 4, line 24 - page 5, line 10; claims 13 and 16).
Based on Bergonzelli’s teachings, it is highly likely that Bergonzelli’s Lactobacillus reuteri and Bifidobacterium lactis and Applicant’s Lactobacillus reuteri and Bifidobacterium lactis are the same strains, respectively, since Bergonzelli’s and Applicant’s strains are both used to prevent and/or treat impairment of cognitive functions including the impaired cognitive function ‘attention’ (Bergonzelli, paragraphs [0001], [0028]-[0029], [0033]-[0034]; instant specification, page 4, line 24 - page 5, line 10; claims 13 and 16).
However, modified Bergonzelli does not teach wherein Lactobacillus reuteri and Bifidobacterium lactis are the deposited Lactobacillus reuteri PBS072 and Bifidobacterium lactis BL050, respectively. If there should be a slight variation between Bergonzelli’s strains and Applicant’s deposited strains, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have used the claimed Lactobacillus reuteri PBS072 and Bifidobacterium lactis BL050 to substitute Bergonzelli’s Lactobacillus reuteri and Bifidobacterium lactis in modified Bergonzelli’s method to prevent and/or treat impairment of cognitive functions including impairment of attention.
Response to Arguments
Applicant has traversed the previous rejections of claims 13-16 under 35 U.S.C. 103 (remarks, pages 12-16). Vitetta and Bergonzelli are still relied upon in the above rejections. Applicant's arguments filed on 08/03/2026 have been fully considered but they are not persuasive.
In Applicant’s reply, Applicant states: “Vitetta does not disclose the specific deposited strains now claimed, namely Lactobacillus reuteri PBS072 and Bifidobacterium breve BB077 and/or Bifidobacterium lactis BL050. Nor does Vitetta disclose their use in the specific claimed combination and in the defined relative amounts for the presently claimed medical indications.” (remarks, page 13).
The Examiner responds that obviousness may be established by modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, Vitetta suggests all Lactobacillus reuteri, Bifidobacterium breve, and Bifidobacterium lactis for a probiotic composition, and teaches wherein bacterial strains are present in a composition in percentage by weight on the total weight of the composition from about 50% to 90%. It would have been obvious to have modified Vitetta’s composition with Lactobacillus reuteri, Bifidobacterium breve, and Bifidobacterium lactis, as taught by Vitetta, to improve prevention or treatment of cognitive impairment, depression, anxiety, postpartum depression, generalized anxiety disorder, and major depressive disorder. Since the instant claims recite comprising language, one would have been motivated to add all the suggested bacterial strains including Lactobacillus reuteri, Bifidobacterium breve, and Bifidobacterium lactis in the probiotic composition because Vitetta clearly teaches the incorporation of several probiotic strains, as discussed above under Claim Rejections - 35 USC § 103.
Pertaining to the relative amounts of the bacterial strains, the instantly recited ranges of amounts would be within the realm of routine experimentation since Vitetta teaches wherein the bacterial strains are present in the composition in percentage by weight on the total weight of the composition from about 50% to 90%, as discussed above under as discussed above under Claim Rejections - 35 USC § 103.
Pertaining to the specific deposited strains, based on Vitetta’s teachings, it is highly likely that Vitetta’s strains are the same as Applicant’s deposited strains, since Vitetta’s and Applicant’s strains are both used to prevent and treat impairment of the cognitive function short-term memory, anxiety, postpartum depression, generalized anxiety disorder, and major depressive disorder. If Applicant’s claimed deposited bacterial strains are structurally different from Vitetta’s strains, evidence is requested. However, even if there should be a slight variation between Vitetta’s strains and Applicant’s deposited strains, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have used the claimed strains to substitute Vitetta’s Lactobacillus reuteri, Bifidobacterium breve, and Bifidobacterium lactis in modified Vitetta’s method.
Applicant describes the technical effect of the claimed composition and its use (remarks, pages 13-14).
The Examiner responds that the recited features modulation of GABA-related mechanisms, LSDl enzymatic activity and serotonin production, and improvement in cortisol levels and skin conductance, upon which applicant relies, are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to Applicant's argument that the Examiner's conclusion of obviousness over Vitetta’s teachings is based upon improper hindsight reasoning (remarks, pages 14-15), 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 describes that Bergonzelli does not disclose or discuss the claimed combination of deposited strains in the claimed relative amounts for the claimed medical use (remarks, page 15).
The Examiner notes that claims 13-14 are rejected over Bergonzelli in view of Vitetta, and that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. In this case, Bergonzelli provides a method for prevention and/or treatment of impairment of cognitive functions related to stress, comprising administering a composition comprising a probiotic combination comprising the strains Lactobacillus reuteri and Bifidobacterium lactis, and Vitetta teaches a probiotic combination comprising the strains Lactobacillus reuteri and Bifidobacterium lactis, wherein the bacterial strains are present in the composition in percentage by weight on the total weight of the composition from about 50% to 90%, as discussed above under Claim Rejections - 35 USC § 103.
It would have been obvious to have combined Bergonzelli’s and Vitetta’s teachings to increase the effectiveness of the method for treating and/or preventing the impairment of cognitive functions. Pertaining to the relative amounts of the bacterial strains, the instantly recited ranges of amounts would be within the realm of routine experimentation since Vitetta teaches wherein the bacterial strains are present in the composition in percentage by weight on the total weight of the composition from about 50% to 90%, as discussed above under as discussed above under Claim Rejections - 35 USC § 103.
Based on Bergonzelli’s teachings, it is highly likely that Bergonzelli’s strains and Applicant’s strains are the same strains, respectively, since Bergonzelli’s and Applicant’s strains are both used to prevent and/or treat impairment of cognitive functions including the impaired cognitive function ‘attention’. If Applicant’s claimed deposited bacterial strains are structurally different from Bergonzelli’s strains, evidence is requested. However, even if there should be a slight variation between Bergonzelli’s strains and Applicant’s deposited strains, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have used the claimed strains to substitute Bergonzelli’s strains in modified Bergonzelli’s method.
Conclusion
No claims are allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANDRA ZINGARELLI whose telephone number is (703)756-1799. The examiner can normally be reached M-F 9-5.
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/SANDRA ZINGARELLI/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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