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 .
Response to Amendment
Applicant’s amendment and request for reconsideration July 9, 2026 is acknowledged.
Status of the Claims
Claims 7-10 are currently pending.
Claims 1-6 and 11-12 are cancelled.
Claims 7-10 are amended.
Claims 7-10 are under examination.
Withdrawn Objection (s) and/or Rejection (s)
--- In view of the amendment of the claims, all previous claim objections are withdrawn and all previous claim rejections under 35 USC 112(a), 112(b), 101 and 102 are withdrawn. Rejections and/or objections not reiterated from the previous office action is hereby withdrawn.
---Applicant’s amendment resulted in an updated search and the raising of new grounds of rejections.
--- Applicant’s arguments have been fully considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7-9 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 7-9 are dependent on claim 10 and therefore do not refer to a claim previously set forth.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over the Advanced Pro-Veflora 50 Billion as archived 28JAN21 (IDS, NPL document 1: hereinafter “Veflora”) alone and further in view of:
Cammarota et al. WO 2021/024216 A1 (pub: 2/11/21: IDS: hereinafter “Cammarota”);
Presti et. al., Appl Microbiota Biotechnol. (2015) Vol. 99: 5613-5626 (IDS: hereinafter “Presti”); and/or
Steiner et al. Int Arch Allergy Immunol (2021) 182 (9): 807–818 (newly cited: hereinafter “Steiner”).
Regarding claims 7-10 : Veflora discloses a probiotic composition comprising L. acidophilus PBS066 (also known as LA001), having deposit number DSM 24936 (also deposited under LMG p-29512), and L. rhamnosus LRH020, having deposit number DSM 25568 (also deposited under LMG p-29513); B. breve BB077 (also known as PBS077), having deposit number LMG P-30157 (also deposited under DSM 25173), and B.longum BLG240 (also known as PBS108), having deposit number LMG P-29511 (also deposited under DSM 25174); in the form suitable for oral or topical administration (as instant claim 7); and as a food supplement (as in instant claim 8)
Veflora discloses the following intended uses: as a medicament, in a method for modulating allergy-like inflammatory activity, prevention and/or treatment of allergies, respiratory allergies, seasonal allergies, such as hay fever, allergic rhinitis, chronic seasonal allergic rhinitis, allergic rhinoconjunctivitis and allergic asthma, or allergies related to Staphylococcus aureus and Clostridium difficile (instant claim 10: “treating” “allergic rhinitis”): in adults, the elderly and pediatric subjects (as in instant claim 9).
Accordingly, the Advanced Pro-VeFlora 50 Billion, is a probiotic composition that comprises the exact strains of instant claim 10, that has been available for purchase since at least 2019 in the form of a food supplement (instant claim 8) for oral/topical administration (instant claim 7) , as evidenced by the reviews on the manufacturer's website, snapshots are provide in the file titled AdvancedPro-VeFlora50Billion.pdf.
The Veflora reference differs from the instantly claimed invention as follows:
a. Having to select “allergic rhinitis” from a Markush listing of allergic inflammatory conditions; and
b. Failing to exemplify an actual method of treating “allergic rhinitis”.
Regarding item a. above: selection of a “species” (e.g. “allergic rhinitis”) from among a finite Markush listing is immediately envisaged or prima facie obvious. See e.g. MPEP 2131; and MPEP 2158 and In re Schauman, 572 F.2d 312, 197 USPQ 5 (CCPA 1978).
Regarding item b. above (the lack of a reference example), it is noted that “proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation. See e.g. MPEP 2121 (“prior art is presumed to be operable/enabling”); and MPEP 2122 and 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).
Accordingly, it would have been prima facie obvious to one of ordinary skill, before the effective filing date to utilize the Veflora probiotic combination of bacterial species for treating an allegic condition (i.e. allergic rhinitis) by administering orally/topically to a child or adult with a reasonable expectation of success.
The Cammarota, Prest and/or Steiner references provides an express motivation to employ Veflora probiotic bacterial formulation for its anti-inflammatory effects to treat allergies in an adult or child with a reasonable expectation of success.
Cammarota discloses a probiotic mixture comprising or consisting of 3 out of 4 of the instantly claim bacterial strains including: L. rhamnosus LRH020, B. breve BB077 and B.longum BLG240 (only PBS066 (LA001) is not taught) for for oral administration (including a “food supplements” for treating inflammatory processes related to Clostridium difficile (e.g. diarrhea). See e.g. pages 4-5 of this reference.
Cammarota further teaches recognized immunomodulatory effects of Bifidobaceria (especially B. bifdum and B. Longum) e.g. balancing TH1/TH2 ratio in newborns and to prevent (or treat) not only intestinal diseases but also “systemic diseases like allergies”. See page 8, lines 1-8. This reference further teaches suggested “doses” for each of the preferred bifidobacteria and Lactobaccilus strains including the three strains as instantly claimed as well as mixtures thereof . See e.g. pages 11-13; Tables 1 and 2; page 17 -18 Tables 3 and 4. See also claims 1-15.
Accordingly, the Cammarota reference teaching of the use of bifidobacteria and Lactobaccili strains including combinations encompassing three out of four of the instantly claimed strains for modulating allergy-type inflammatory activity would render obvious use in the prevention and/or treatment of allergies and respiratory allergies including allergic rhinitis and seasonal “hay fever” within the scope of the instantly claimed invention.
The Presti reference provides in vitro evidence of the immunomodulatory effect of bifido and Lacto bacteria for effecting inflammation. In particular the following specific strains were evaluated as enumerated in Table 1:
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The Presti reference study determined the properties of PBS066, PBS070 (LRH020) and PBS108 (i.e. BLG240) which corresponds to 3 of the 4 instantly claimed strains (except BB077). Presti shows that these strains induce the production of anti-inflammatory cytyokine IL-4, thus lowering TNF-alpha production (as disclosed in the examples of the instant application). Accordingly, the reference concludes that these bacteria can be used to promote resistance and modulation of inflammatory stress. See e.g. Abstract and page 5624 right hand column.
Similarly, Steiner reviewed 31 studies, 18 human trials and 13 mouse studies and concluded that:
“… probiotic bacteria, such as Lactobacillus species, have shown anti-allergic effects in various mouse and human studies. For instance, administration of some Lactobacillus species resulted in nasal and ocular symptom relief and improvement of quality of life in children and adults suffering from rhinitis. Different changes in cytokine profiles, such as elevated Th1 and decreased Th2 cytokines, reduced allergy-related immunoglobulins and cell immigration have been found in both human and murine studies. Positive effects on patients like less activity limitations or fewer rhinitis episodes and longer periods free from asthma or rhinitis were also described following oral administration of Lactobacillus bacteria. …” See Abstract.
More particularly Steiner teaches:
“Treatment with probiotic strains, such as L. paracasei, L. acidophilus, L. casei Shirota, L. helveticus, L. rhamnosus GG (LGG) showed alleviation of symptoms in AR or HDM patients. Generally, Lactobacillus bacteria studies were performed with adult or adolescent [6, 13-19] and numerous with young [20-26] AR patients. Table 2 presents human trials, which analyzed the effects of Lactobacillus strains on AR symptoms” (with emphasis). See e.g. page 809 and Table
Accordingly, Steiner would provide motivation to utilize probiotic formulations comprising L. acidophilus and (or) L. rhamnosus strains for treating allergies (e.g. allergic rhinitis) by inducing anti-inflammatory responses.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize the Veflora probiotic formulation to treat allergic rhinitis with a reasonable expectation of success in light of the Veflora reference suggestion to do so; or further in view of the separate or combined Cammarota, Presti and Steiner reference teachings of the immunomodulatory anti-inflammatory benefits of the instantly claimed bifidobacteria and lactobacillus strains as outlined above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENNETT CELSA whose telephone number is (571)272-0807. The examiner can normally be reached Monday-Friday 7-4.
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/BENNETT M CELSA/Primary Examiner, Art Unit 1600
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