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
Claims 1-5, 8, 13-15, 18-19, 23, 28-33, 36 and 39 are pending following the Reply filed 05/12/2026. Claims 1, 28-29, 36 and 39 have been amended without introducing new matter. All pending claims have been examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 05/12/2026 has been considered by the examiner. The information submitted in the information disclosure statement was filed under 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p).
Withdrawn
The scope of enablement rejection under 35 U.S.C. 112(a) has been withdrawn in light of the amendments. In particular, the claims are no longer drawn to methods of administering a “component” of L. rhamnosus HN001. See Response to Arguments for further discussion.
Claim Objections
Claims 2 and 13-14 are objected to because of the following informalities: For clarity, “a subject”, in claim 2 at line 2 and claims 13-14 at line 1, should be amended to recite “the subject”. Appropriate correction is required.
Maintained Rejections and New Rejections Necessitated by IDS with Fee
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 5, 8, 14, 15, 23, 28-33, 36 and 39 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Mitchell et. al (WO 2018/220429 Al; previously cited), hereafter, “Mitchell”.
Regarding claim 1, Mitchell teaches a method of administering the exact same strain of bacteria, L. rhamnosus HN001, in an effective amount for treating or preventing postnatal depression or anxiety in adult female humans, (see claim 1; pg. 4, para. [0019]). Mitchell teaches that an efficacious dose of L. rhamnosus HN001 was determined to be 6 x 109 cfu per day (see pg. 20, para. [00105]), which is within the scope of an “effective amount” in view of the claims (see claim 15).
The examiner notes that increasing happiness and treating unhappiness are encompassed by treating depression and anxiety, because a person who is experiencing the negative emotional states of depression or anxiety, who is then effectively treated for those conditions is inherently in a more positive/happier emotional state or a state of increased mental well-being.
Nonetheless, the claim does not limit the subject to any particular patient population, and a subject suffering from depression or anxiety is within the scope of the claim.
Regarding claim 2, a subject suffering from unhappiness reasonably includes adult females suffering from post-natal depression or anxiety. In view of the instant specification, “happiness” is defined as “an emotion of joy, gladness, satisfaction, and well-being” (see pg. 8, lines 25-27). A subject lacking one or more of these emotional states (i.e., “unhappiness”) reasonably includes those suffering from depression or anxiety.
Regarding claim 5, Mitchell teaches that administration may include a single daily dose (see pg. 21, para. [00107]). In Mitchell’s examples, women received capsules containing HN001 on a daily basis (see pg. 30, para. [00140]).
Regarding claim 8, Mitchell teaches the subject is female, as discussed above.
Regarding claim 14, Mitchell does recite the method to comprise changes in levels of salivary cortisol (see claim 1).
Regarding claim 15, Mitchell teaches that an efficacious dose of L. rhamnosus HN001 was determined to be 6 x 109 cfu per day (see pg. 20, para. [00105]).
Regarding claim 23, Mitchell teaches the L. rhamnosus HN001 can administered separately or simultaneously with one or more prebiotics, which may include galacto-oligosaccharides (GOS), fructo-oligosaccharides (FOS), human milk oligosaccharides (HMO), inulin, and lactulose (pages 24-25, para. [00116]).
Regarding claim 28, Mitchell teaches the L. rhamnosus HN001 is administered in a pharmaceutical composition (see claim 6), which can be in the form of a tablet (see pg. 16, para. [0087]).
Regarding claim 29, Mitchell teaches the L. rhamnosus HN001 is administered in a composition comprising food (see claim 4).
Regarding claim 30, Mitchell teaches the method wherein the food is cultured milk, yoghurt, cheese, milk drink or milk powder (see claim 5), which meets the limitation of a dairy product.
Regarding claim 31, Mitchell teaches the method wherein the food is milk, yoghurt, or cheese (see claim 5).
Regarding claim 32, Mitchell teaches the method wherein the L. rhamnosus HN001 is administered in a maternal supplement (see claim 32).
Regarding claim 33, Mitchell teaches the L. rhamnosus HN001 is in a reproductively viable form (see claim 8).
Regarding claim 36, the AscI restriction enzyme digest profile of L. rhamnosus HN001 is an inherent feature of the strain, as disclosed in the instant specification (see, e.g., pg 6, lines 26-30). Therefore, this feature is necessarily present in the prior art strain.
Relevant to claim 39, Mitchell teaches a method of administering the exact same strain of bacteria, L. rhamnosus HN001, in an effective amount for treating or preventing postnatal depression or anxiety in adult female humans, as discussed regarding claim 1. The present claim does not limit the subject to any particular patient population, only that it is intended to increase “mental well-being”. Therefore, a subject suffering from depression or anxiety is reasonably within the scope of the claim.
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.
The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id. See also MPEP § 2112.01 with regard to inherency and product-by-process claims and MPEP § 2141.02 with regard to inherency and rejections under 35 U.S.C. 103.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Mitchell as applied to claims 1, 2, 5, 8, 14, 15, 23, 28-33, 36 & 39 above, and further in view of Mousset, et. al. (US 2022/0249591 Al; previously cited), hereafter, “Mousset”.
Regarding claims 18-19, Mitchell, as previously discussed, teaches a method for treating or preventing postnatal depression or anxiety in a subject, the method comprising administering an effective amount of L. rhamnosus HN001. Mitchell further teaches the combination of L. rhamnosus HN001 with other probiotic agents, including: “Lactobacillus rhamnosus GG, Lactobacillus acidophilus (for example, Lactobacillus acidophilus (LA VRI-Al), Lactobacillus reuteri (for example Lactobacillus reuteri ATCC 55730) or Bifidobacteria lactis (for example, Bifidobacteria lactis strain HN019 or Bifidobacteria lactis strain BB 12) or a combination of any two or more thereof” (see pgs. 26-27, para. [00122]).
Mitchell does not explicitly teach the incorporation of those other probiotic agents as postbiotics.
However, Mousset teaches the incorporation of a list of L. rhamnosus strains (which includes L. rhamnosus HN001) as well as the incorporation of all their probiotics as live or inactivated forms (postbiotics) (page 4, paragraph [0073]). While Mitchell teaches the inclusion of other probiotic strains in the composition with L. rhamnosus HN001 (page 26 lines 25-30), Mousset teaches that probiotic refers to live or inactivated bacteria (postbiotics) (page 4 paragraph 0073) and the inclusion of additional strains of microorganisms chosen from the group consisting of Bacillus, Bacteroides, Bifidobacterium, Enterobacteriaceae, Enterococcus, Faecalibacterium, Fusobacterium, Kluyveromyces, Lactobacillus, Odoribacter, Parabacteroides, Pediococcus, Ruminococcus, Streptococcus and/or Saccharomyces (page 9 paragraph 0162). This suggests that a person of ordinary skill in the art would understand that including both live and dead forms of probiotic strains of bacteria are beneficial to human health, and thus would consider the inclusion of both live or dead bacteria in their probiotic compositions. One would have been motivated to do so, since inactivated bacteria are more stable for the purposes of a product’s shelf life, since the bacteria do not need to remain viable. Therefore, the inclusion of other probiotics or postbiotics in the composition, as recited in claim 1, are obvious over Mitchell in further in view of Mousset.
Claims 3, 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Mitchell as applied to claims 1, 2, 5, 8, 14, 15, 18, 19, 23, 28-33, 36 & 39 above, and further in view of Michalos et. al. (Alex C. Michalos (editor), Encyclopedia of Quality of Life and Well-Being Research, first edition, Springer Dordrecht, 04MAR14; previously cited), hereafter, “Michalos” and Taylor, et al. (“Upregulating the Positive Affect System in Anxiety and Depression: Outcomes of a Positive Activity Intervention,” Depress Anxiety, Vol. 34, Issue 3, March 2017, 23 pp; cited in the IDS filed 05/12/2026), hereafter, “Taylor”.
This is a new grounds of rejection necessitated by the IDS filed 05/12/2026.
Regarding claim 3, Mitchell, as previously discussed, teaches a method for treating or preventing postnatal depression or anxiety in a subject, the method comprising administering an effective amount of L. rhamnosus HN001. Mitchell further teaches the assessment of the emotional state of adult female human subjects using the “Edinburgh Postnatal Depression Scale (EPDS): The EPDS is a 10 item screening questionnaire widely used to assess maternal mood” and the “State Trait Anxiety Inventory 6 item version (STAI6): The STAI6 is a short 6 item scale validated as an anxiety screening questionnaire based on the longer State Trait Anxiety Inventory” (see pg. 31, paras. [00145]-[00146]). Mitchell also teaches the assessment of both male and female infant human subjects for infant colic (see pg. 32, para. [00148]).
Mitchell does not explicitly teach the use of assessments directed specifically towards assessing happiness per se, or measuring salivary cortisol and thus does not teach the limitations of claims 3, 4 or 13.
Taylor teaches that research suggest that the positive affect system may be an important yet underexplored treatment target in anxiety and depression, and existing interventions primarily target the negative affect system yielding modest effects on measures of positive emotions and associated outcomes (e.g., psychological well-being) (see Abstract at Background). Taylor teaches that anxiety and depressive disorders are the most common mental health conditions, representing a major public health concern worldwide, and these conditions frequently co-occur, significantly impair functioning, and diminish quality of life and well-being (see pg. 2, para. 1). Taylor teaches that the positive affect system guides people toward situations with reward potential, and is characterized by positive emotions ( e.g., joy, excitement, happiness), cognitions (e.g., attentional bias for reward-relevant stimuli), and approach behaviors (e.g., curiosity, social initiation) that together facilitate the acquisition of psychosocial resources that promote overall health and well-being (see pg. 2, para. 1). Taylor teaches that accumulating research suggests that the positive affect system may serve as an important yet underexplored target in facilitating recovery from anxiety and depression (see pg. 2, para. 1). Taylor teaches that positive emotions serve a number of functions that both mitigate the adverse effects of negative emotions, the defining features of anxiety and depressive disorders, as well as garner positive outcomes that promote resilience and psychological well-being (see pg. 2, para. 2).
Taylor discloses that participants in the study completed the Quality of Life, Enjoyment, and Satisfaction Questionnaire—Short Form (Q-LES-Q-SF) to measure perceived overall enjoyment and satisfaction across numerous life domains (e.g., work, health, relationships), and the Satisfaction With Life Scale (SWLS), a well-established measure of global judgements of satisfaction with one’s life (see pg. 4, para. 5).
Michalos, as discussed in the previous rejection, is a standard reference in the field of quality of life and well-being research, and as such provides artisans of ordinary skill in the art the information required to understand and select the appropriate tests to measure the emotional state of happiness in a subject. Specifically, Michalos teaches the Oxford Happiness Questionnaire (page 4551), Subjective Happiness Scale (6420), Satisfaction with Life Scale (page 5660), Panas Scale (page 4918), Authentic Happiness Inventory (pages 4933-4938), Psychological Wellbeing Scale (page 5172), the Fordyce Emotions Questionnaire/Happiness Measure (pages 6452) and the testing of salivary cortisol (7101). This suggests that an ordinary artisan in the field would be able to select from any of the tests found within the chapters of this reference. Regarding the Oxford Happiness Questionnaire, Michalos teaches that “Greater professionalism has been shown in the development of the OHQ in terms of item selection, the inclusion of reverse-coded items, and the proper publication of psychometric properties. When time is short as well as space, the short 7-item form of the OHQ provides a reasonable approximation of the larger 29-item form” (see pg. 4551, last paragraph).
Therefore, Michalos teaches the Oxford Happiness Questionnaire, Subjective Happiness Scale, Satisfaction with Life Scale, Panas Scale, Authentic Happiness Inventory, Psychological Wellbeing Scale, the Fordyce Emotions Questionnaire and the testing of salivary cortisol. A person of skill would have recognized that any of these standardized tests could be selected to assess happiness and mental well-being in an individual.
It would have been obvious at the time of filing for a person of ordinary skill in the art to have arrived the claimed invention, because Taylor teaches that the positive affect system, associated with positive emotions, such as happiness, is an underappreciated prognostic indicator in individuals recovering from anxiety and/or depression. One would have recognized that assessing individuals using tests normally used to determine these positive emotions, such as the Oxford Happiness Questionnaire, would be particularly valuable in monitoring the progress of an individual being treated for postpartum anxiety or depression. Therefore, there would have been ample motivation to have selected such a test to assess the susceptibility and/or prognosis of such a subject when applying the method taught by Mitchell. Furthermore, there would have been a reasonable expectation of success, as it is well within the ordinary skill in the field of psychiatry to apply a variety of such assessments to determine progress of a treatment.
Regarding claim 4, Michalos teaches the Oxford Happiness Questionnaire, as discussed above.
Regarding claim 13, Mitchell suggests that hormonal changes, such as changes in cortisol, may be a potential cause of post-natal depression (see pg. 28, para. [00131]), and Michalos teaches the testing of salivary cortisol, as discussed above. Therefore, one would have been motivated to test salivary cortisol levels in addition to the subjective tests discussed above, because this is an objective measurement of changes of a hormone associated with post-natal depression that would be useful for monitoring and comparing the effects of administering LH001 on the positive affect system taught by Taylor.
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 1-2, 5, 8, 13-15, 18-19, 23, 28-33, 36 & 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 5-6 & 20-25 of U.S. Patent Application No. 18/832,675 (see most recent claim set filed 04/04/2025).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 3 (and its dependent claims 4-7, 9-11, 13, 16-18 & 21-25) of 18/832,675 recites the use of L. rhamnosus HN001 for “reducing or preventing stress, optionally chronic stress; (ii) reducing or preventing anxiety; (iii) reducing or preventing one or more symptoms of depression; (iv) decreasing or reversing certain changes caused by stress, anxiety or depression; (v) improving mood; (vi) increasing relaxation; (vii) increasing energy”. While ‘675 does not teach the increase in happiness or mental well-being of instant application; this claim recites an obvious variant of increasing happiness/mental wellbeing in a subject by administering L. rhamnosus HN001 (as in the independent claims 1, 36, & 39 and claim 1’s dependent claims, 2-5, 8, 13-15, 18-19, 23, & 28-33) since a subject who has been effectively treated for the reduction of depression, anxiety or both is by definition in a more positive/happier emotional state or otherwise in a state of increased mental wellbeing.
Regarding claims 1-2, 5, 8, 14-15, 18-19, 33, 36 & 39: the administration of 6x109 to 1x1010 CFUs of HN001 in viable form, derivatives or components thereof and other probiotic or postbiotic microorganisms for the purpose of increasing happiness, mental well-being or treating unhappiness, wherein increasing happiness does not comprise changes in salivary cortisol levels, are anticipated by claims 3, 5, 20, & 25 of ‘675. Claim 3 of ‘675 recites the administration of HN001 and/or B. lactis HN019 or derivatives thereof for reducing or preventing anxiety, one or more symptoms of depression or improving mood amongst other conditions. Claim 20 of ‘675 recites the composition of HN001 and or HN019 as reproductively viable, killed, lysed, fractionated or attenuated forms. Claim 3 of ‘675 teaches the administration of the exact same strain, HN001, plus another probiotic strain from the list found in claim 19 of instant application, for the purpose of treating anxiety and depression which are obvious variants of increasing happiness or treating unhappiness or increasing mental well-being since a subject that has been successfully treated for anxiety or symptoms of depression is inherently in a more positive/ happier state or a state of increased mental well-being. Neither claim comprises changes to salivary cortisol levels. The AscI restriction enzyme digest profile of L. rhamnosus HN001 is an inherent feature of the strain, since the locations of the AscI restriction sites are features of the bacteria’s genome, and thus the digest profile will always be the same if the genome is the same. A bacterial strain is the progeny from a single isolated parent cell and thus all subsequent daughter cells carry the same genome as the original mother. The lysed or fractionated cells of claim 20 of ‘675 encompasses the “components thereof” of the instant application since the fractions of the cells of ‘675 could include any or all of the components of the cell defined in the specification of instant application. A subject in need thereof from claim 3 of ‘675 encompasses the “is selected from an/a: infant, child, adolescent, adult and elderly adult” of claim 8 of the instant application. Claim 5: oral administration of the composition recited in the method of claim 1; is anticipated by claim 5 of ‘675 which also recites the oral administration of HN001 or derivatives thereof. Claim 15 of instant application is anticipated by claim 25 of ‘675 which recites administering a dose of at least 1.9x109 CFUs, which reasonably includes 6x109 CFUs.
Regarding claims 23, 28-32: the administration of HN001, with prebiotics, in various forms such as tablets, capsules…, a supplement or a food, such as a dairy product, such as milk, yoghurt…, or a formula such as infant, growing up…, for the purpose of increasing happiness. These claims are anticipated by claims 21-24 of ‘675 which recite the inclusion of HN001 (for the purpose of reducing or preventing anxiety or depression…) with prebiotics in a food product or supplement to include: cultured milk, yoghurt, cheese milk drink and milk powder as well as a maternal supplement, a dietetic product, and infant formula a follow-on formula and a growing up formula. Claim 23 of ‘675 anticipates claim 28 of the instant application in that a milk drink is a liquid and a milk powder is a powder form of HN001. Reducing or preventing anxiety and depression are obvious variants of increasing happiness or treating unhappiness or increasing mental well-being since a subject that has been successfully treated for anxiety or symptoms of depression is inherently in a more positive/ happier state or a state of increased mental well-being.
Regarding claim 13: wherein increasing happiness comprises changes in salivary cortisol levels, is anticipated by claim 6 of ‘675 which recites the administration of HN001 (for the purpose of reducing or preventing anxiety or depression…) reducing cortisol levels. Reducing or preventing anxiety and depression are obvious variants of increasing happiness or treating unhappiness or increasing mental well-being since a subject that has been successfully treated for anxiety or symptoms of depression is inherently in a more positive/ happier state or a state of increased mental well-being.
Claims 3 & 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent Application No. 18/832,675 further in view of Michalos and Taylor.
This is a new grounds of rejection necessitated by the IDS filed 05/12/2026.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious over claim 3 of ‘675 (administration of the exact same strain, HN001, for the purpose of treating anxiety and depression) further in view of Michalos, which teaches all the tests for happiness described in claims 3 & 4 of instant application. Specifically, Michalos teaches the Oxford Happiness Questionnaire, Subjective Happiness Scale, Satisfaction with Life Scale, Panas Scale, Authentic Happiness Inventory, Psychological Wellbeing Scale, the Fordyce Emotions Questionnaire and the testing of salivary cortisol. A person of skill would have recognized that any of these standardized tests could be selected to assess happiness and mental well-being in an individual.
Taylor teaches that the positive affect system, associated with positive emotions, such as happiness, is an underappreciated prognostic indicator in individuals recovering from anxiety and/or depression. One would have recognized that assessing individuals using tests normally used to determine these positive emotions, such as the Oxford Happiness Questionnaire, would be particularly valuable in monitoring the progress of an individual being treated for postpartum anxiety or depression. Therefore, there would have been ample motivation to have selected such a test to assess the susceptibility and/or prognosis of such a subject when applying the method taught by Mitchell. Furthermore, there would have been a reasonable expectation of success, as it is well within the ordinary skill in the field of psychiatry to apply a variety of such assessments to determine progress of a treatment, and Taylor teaches the expectation that positive affect systems can be correlative to the recovery of a subject suffering from anxiety and/or depression.
Response to Arguments
Regarding the enablement rejection under 35 U.S.C. 112(a), Applicant argues that the Office Action acknowledges that the specification is enabling for the administration of an effective amount of L. rhamnosus HN001 or derivative thereof, but contends that the specification “does not reasonably provide enablement for the administration of an effective amount of a component of L. rhamnosus HN001.” Id. Without acquiescing to the rejections, Applicant has amended claims 1, 28, 29, 36 and 39 to delete reference to a “component” of L. rhamnosus, rendering the rejections moot.
Applicant’s arguments have been fully considered and they are persuasive.
The examiner agrees that the rejection is obviated by the removal of the “component” limitation in the amended claims. Accordingly, the rejection has been withdrawn.
Regarding the rejections under 35 U.S.C. 102, Applicant argues that while the Office contends that increasing happiness or well-being is encompassed by treating anxiety or depression, positive affect systems (which include mental well-being and happiness) and negative affect systems (which include mental illnesses such as anxiety and depression) are recognized as related but distinct constructs, not opposite ends of a single continuum. Happiness and mental well-being are distinct states compared to each of depression
and anxiety, as made clear in the specification as filed and also in the common general knowledge of the field (see, e.g., Raibley 2012 and Qayoom and Husain 2016, submitted herewith). Importantly, reductions in anxiety or depressive symptoms do not necessarily result in increases in happiness or positive well-being. Because negative affect (anxiety/depression) and positive affect (happiness/well-being) stem from distinct biobehavioral systems, treating one does not automatically boost the other. A person can be symptom-free but still lack a sense of purpose or joy (see, e.g., Taylor et al, 2020, submitted herewith). Applicant alleges that the claims are novel over Mitchell, because Mitchell does not teach the features of “happiness or well-being” as recited in the claims.
Applicant’s arguments have been fully considered but they are not persuasive.
First, a claimed method must be analyzed with respect to its actual manipulative steps in order to determine patentability over a prior art reference. Here, claim 1 is directed to a method of “increasing happiness in a subject”. The only manipulative step that is explicitly recited is “administering” an effective amount of HN001 or a derivative to a subject. However, method claims reciting administering an agent to a subject implicitly require selection of said subject, and the subject’s identity (i.e., patient population) implied by the claim must be considered as a limitation. In view of the specification, the term “subject” is defined as being any animal (see pg. 4, line 30). However, the claim itself does not so limit the subject any further, because it merely recites the objective of “increasing happiness” which is directed to an intended use. The examiner has not found any reason that the intended use of “increasing happiness”, as recited in the preamble, results in any structural or manipulative difference when read in the context of the claim. The same interpretation applies to the recitation of “increasing mental well-being” as recited in claim 39. See MPEP 2111.02(II) regarding preamble statements reciting purpose or intended use.
Further, claim 2, which may be more relevant to Applicant’s argument, recites “wherein increasing happiness comprises treating unhappiness in a subject”. Therefore, it is reasonably interpreted that the subject must be one who is “unhappy” or is experiencing “unhappiness”. Applicant acknowledges in their argument that mental well-being and happiness are “related” to depression and anxiety. The fact that there is a distinction between how the scope of these terms are defined does not change the fact that subjects who fall within one scope (i.e., have depression) reasonably fall within the scope of the other (i.e., are unhappy). Applicant should consider the breadth of the term “unhappiness”, as discussed in the present rejection. For example, it is not apparent in view of Applicant’s arguments, or the originally filed disclosure, how one may have “depression” while also being “happy” (i.e., be free of unhappiness). Even if one were to argue that a subject suffering from depression may sometimes be happy, a subject suffering from anxiety or depression would have to be determined to be “happy” at the time of every administration in order to be clearly excluded from the claim. Hence, it is more reasonable to interpret “unhappiness” to be a feature of anxiety and/or depression, and therefore, the method taught by Mitchell reasonably falls within the scope of the claim.
It should be noted that Applicant cites several publications in their argument above (provided in the IDS filed 05/12/2026), but does not explicitly point out any specific passages from these references in order for the examiner to fully consider the context of these disclosures as they relate to Applicant’s argument. Furthermore, it should be noted that Taylor, et al. states, “the positive affect system… is characterized by positive emotions (e.g., joy, excitement, happiness)” and “accumulating research suggests that the positive affect system may serve as an important yet underexplored target in facilitating recovery from anxiety and depression” (see pg. 2, para. 1). In addition, Qayoom, et al. states, “Philosophers, intellectuals, doctors and alike, all are in search of the causes of happiness and ways to escape anxiety” (see pg. 1, col. 1, last para. to col. 2, first para.). Hence, these references appear to acknowledge happiness and anxiety/depression to share some relevant degree of scope.
Regarding Applicant’s argument that treating anxiety or depressive symptoms does not automatically boost happiness or well-being, Applicant is reminded that allegations that the prior art does not solve the same problem solved by the inventor(s) is not a relevant consideration for overcoming a rejection under 35 U.S.C. 102.
See MPEP 2131.05 which states: "Arguments that the alleged anticipatory prior art […] is not recognized as solving the problem solved by the claimed invention, [are] not ‘germane’ to a rejection under section 102." Twin Disc, Inc. v. United States, 231 USPQ 417, 424 (Cl. Ct. 1986) (quoting In re Self, 671 F.2d 1344, 213 USPQ 1, 7 (CCPA 1982)). See also State Contracting & Eng’ g Corp. v. Condotte America, Inc., 346 F.3d 1057, 1068, 68 USPQ2d 1481, 1488 (Fed. Cir. 2003) (The question of whether a reference is analogous art is not relevant to whether that reference anticipates. A reference may be directed to an entirely different problem than the one addressed by the inventor, or may be from an entirely different field of endeavor than that of the claimed invention, yet the reference is still anticipatory if it explicitly or inherently discloses every limitation recited in the claims.).
In the instant case, Mitchell teaches a method that lies entirely within the scope of the claims, and it is irrelevant whether Mitchell was concerned with solving the same problem disclosed by Applicant.
Regarding Mitchell's reference to "psychological well-being tests", Applicant further argues that Mitchell assesses outcomes exclusively using symptom-based instruments, namely the Edinburgh Postnatal Depression Scale (EPDS) and the State Trait Anxiety Inventory (STAI 6). These instruments are designed to screen for depression and anxiety symptoms. They are not measures of happiness, positive affect, or subjective well-being. By contrast, the present application explicitly targets happiness and positive well-being employing the Oxford Happiness Inventory.
Applicant’s arguments have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “Oxford Happiness Inventory”) 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 the instant case, Applicant’s argument appears to relate to the subject matter recited in claims 3-4, which are not included in the rejection under 35 U.S.C. 102. Upon review of the previous Office Action, it is unclear how Applicant’s argument relates to the rejections under 35 U.S.C. 102.
However, if Applicant means to argue that the prior art of Mitchell would not have been operable for achieving the same goals as the inventors (e.g., Mitchell’s tests would have been insufficient for identifying the subject in need), Applicant is reminded that a prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006) (citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326, 75 USPQ2d 1297, 1302 (Fed. Cir. 2005)). Furthermore, allegations that the prior art reference does not solve the same problem that the present inventors are concerned with is not germane to a rejection under 35 U.S.C. 102, as previously discussed.
In the interest of compact prosecution, Applicant’s argument above (on pg. 7, paras. 2-3 of the Remarks) will be addressed further below regarding the rejections under 35 U.S.C. 103.
Regarding the rejections under 35 U.S.C. 103, Applicant argues that the instruments used in Mitchell’s “psychologically well-being tests”, namely the EPDS and STAI 6, are designed to screen for depression and anxiety symptoms and are not measures of happiness, positive affect, or subjective well-being. Mitchell does not disclose or teach increasing happiness per se, nor does it disclose measuring happiness as a distinct outcome. By contrast, the present application explicitly targets happiness and positive well-being as independent outcomes and employs the Oxford Happiness Inventory, which is designed to assess positive affect and life satisfaction rather than symptom severity. This reflects a fundamentally different therapeutic and measurement framework, rather than a mere substitution of questionnaires, as would be expected given the conditions being treated, measured and assessed are distinct and different. See Remarks at pg. 7, paras. 2-3.
Applicant’s arguments have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, the rejection of claims 3-4 rely upon the prior art of Michalos, who provides guidance on selecting the appropriate test, including the Oxford Happiness Questionnaire, which provides a reasonable approximation of happiness in a subject. It should also be noted that the “Oxford Happiness Questionnaire” is recited in the claims, not the “Oxford Happiness Inventory”.
Applicant argues that the Office's rejection relies on their assumption that Mitchell teaches a method of increasing happiness in a subject, while nothing in Mitchell suggests to a person having ordinary skill that the findings in Mitchell could or should be transferred to other conditions or states, let alone of different affect systems. Therefore, it has not been identified by the Office why the skilled person reading the cited art alone or in combination would be motivated to try L. rhamnosus to increase happiness or well-being, let alone how they could have a reasonable expectation of success in light of the common general knowledge in the field.
Applicant further argues that the existence of happiness questionnaires in general reference works (e.g., Michalos, cited in the Office Action) does not establish a motivation to specifically administer a treatment designed for conditions of the negative affect system (HN00l) for improving the positive affect system, including happiness or well-being. Even if the skilled person were to be motivated to use multiple tests for happiness in any general context, the Office has not specifically identified why a POSA would have been motivated to test for happiness in the context of L. rhamnosus administration.
Applicant’s arguments with respect to claim(s) 18-19 have been fully considered but they are not persuasive.
Mitchell explicitly teaches the combination of L. rhamnosus HN001 with other probiotic agents, including, Lactobacillus rhamnosus GG, Lactobacillus acidophilus, or Lactobacillus rheuteri, as discussed in the rejection. Therefore, it would have been prima facie obvious to have selected any one of these probiotics in a method for preventing or treating post-natal depression or anxiety. Applicant is reminded that the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In the instant case, a person of skill would have been motivated and had a reasonable expectation of success when applying the method taught by Mitchell to prevent or treat post-natal depression or anxiety, which is within the scope of the claims.
Applicant’s arguments with respect to claim(s) 3-4 and 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In the instant case, the matter specifically challenged in Applicant’s argument is whether a skilled artisan would have been motivated to test for factors of the positive affect system (e.g., happiness) when preventing or treating a condition of the negative affect system (e.g., depression and anxiety), and whether one would have had a reasonable expectation of success when doing so. Here, the prior art of Taylor is relied upon in the new grounds of rejection to show that these systems are substantially related and a person of ordinary skill would have been motivated to have selected these tests when preventing or treating post-natal anxiety and/or depression and would have also had a reasonable expectation of success when doing so. See the present rejection for further discussion.
Conclusion
No claims are allowed.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 05/12/2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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.
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/DENNIS IGNATIUS ARMATO JR/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
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