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 .
Election/Restrictions
Applicant's election with traverse of Group III, claims 12-20 and the following species: “the combination of L. paracasei DG® (CNCM 1-1572) and L. paracasei LPC-S01 ® (DSM 26760), without any additional species of bacteria, formulated for oral consumption, for treating inflammatory bowel disease (IBD)” in the reply filed on 12/23/2025 is acknowledged. The traversal is on the ground(s) that it would not be an undue burden to search and examine the elected claims to their full scope. This is not found persuasive because the restriction requirement was made based on lack of unity of invention for national stage application. 37 C.F.R. 1.499 Unity of invention during the national stage states: “If the examiner finds that a national stage application lacks unity of invention under § 1.475, the examiner may in an Office action require the applicant in the response to that action to elect the invention to which the claims shall be restricted.” (MPEP 1893.03 (d)). As described in the previous Office Action, the technical feature “a strain of bacteria inactivated by gamma irradiation and selected from recited strains” is not a special technical features based on prior art of Cremon (Cremon et al. United Eur. Gastr. J., 2018, 6, 604-613) and Vallejo-Cordoba (Vallejo-Cordoba et al. Advances in Food and Nutrition Research, 2020, 64, chapter 1, 1-34) and hence Groups I-III lack unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 14 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/23/2025.
Claims 1-20 are pending. Claims 12, 13, 15, 16 and 18-20 (claim set filed 09/07/2023) are examined on the merits herein.
Priority
This application is a 371 of PCT/IB2022/053057 filed 04/01/2022. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) based on application in ITALY 102021000008300 filed 04/01/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/07/2023 complies with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12, 13, 15, 16 and 18-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites: “gastrointestinal disease or symptom of …functional nature”. The specification describes preferable examples of such diseases: “a gastrointestinal pathology and/or symptom of a functional nature, preferably selected from: irritable bowel syndrome (IBS), constipated IBS, diarrhea IBS, alternating IBS, unclassified IBS, dyspepsia, pyrosis, disorders affecting the oesophagus, stomach and duodenum, bacterial overgrowth syndrome (SIBO), gastrointestinal disorders with sub-inflammatory states” (p. 15, 2nd paragraph). However, the meaning of “functional nature” is not clear. It is unclear whether “functional nature” refers to function of the whole body or to function of certain organ and/or organs and what type of functions are included in the scope of claim 12 and how one would understand when infringement occurs. The scope and boundaries of claim 12 are not certain making claim 12 indefinite.
Claims 13, 15, 16 and 18-20, dependent of claim 12, do not resolve the issue mentioned above and are rejected.
Regarding claim 13, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 13 recites the broad recitation of gastrointestinal disease or symptom: “chronic inflammatory bowel disease (IBD), … and duodenal ulcer”, and the claim also recites “preferably selected from: chronic inflammatory bowel disease (IBD, … and diverticulitis” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 15, 18 and 19 recite: “Lacticaseibacillus paracasei DG[Symbol font/0xD2] CNCM I-1572 (or Lacticaseibacillus paracasei DG I1572 DSM 34154)”. The specification describes: “the bacterial strain L. paracasei DG® (CNCM 1-1572) was redeposited on 2 February 2022 as Lacticaseibacillus paracasei DG 11572 DSM 34154 after the reclassification of the genus Lactobacillus published by Zheng et al. in the scientific journal Int. J. Syst. Evol. Microbial., 70(4):2782-2858, 2020. The two names mentioned above are interchangeable with each other because they always refer to the same strain of bacteria” (p. 4, 2nd paragraph). However, it is not clear if strain identifier in parenthesis is intended to be the synonym for the bacteria or is a different bacteria) in the scope of the claims.
Claim 16 recites: “Bifidobacterium bifidum MIMBb23sg (or BbfIBS01) DSM 32708”. The specification describes: “MIMBb23sg and BbflBS01 are synonymous and interchangeable identification names, and always indicate the same strain of bacteria” (p. 9, 4th paragraph). However, it is not clear if strain identifier in parenthesis is limiting the scope of the claims.
The scope and boundaries of claims 15, 16, 18 and 19 are not certain making claims indefinite.
For examination identification of the strain in parenthesis is not considered a claim limitation, however, for the search of prior art the identification in parenthesis is considered interchangeable with Lacticaseibacillus paracasei DG[Symbol font/0xD2] CNCM I-1572 as stated in the specification for claims 15, 18 and 19 and BbfIBS01 in parenthesis is considered interchangeable with MIMBb23sg as stated in the specification for claim 16.
Claims 15, 18 and 19 contain the trademark/trade names L. paracasei DG[Symbol font/0xD2] CNCM I-1572 and LPC-S01[Symbol font/0xD2]. The specification describes L. paracasei DG[Symbol font/0xD2] as: “L. paracasei DG[Symbol font/0xD2] or L. casei DG[Symbol font/0xD2] (registered trademark by SOFAR S.p.A)” (p. 8 , 3rd paragraph). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade names are used to identify/describe specific bacterial strains and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 103
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 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.
Claims 12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Cremon (Cremon et al. United Eur. Gastr. J., 2018, 6, 604-613) in view of Vallejo-Cordoba (Vallejo-Cordoba et al. Advances in Food and Nutrition Research, 2020, 64, chapter 1, 1-34).
Regarding claim 12, Cremon teaches that Lactobacillus paracasei CNCM I-1572 (one of the instant strains) was shown in pilot clinical trial to modulate gut microbiota structure/function and reduce immune activation in irritable bowel syndrome (Abstract). Cremon mentions that irritable bowel syndrome is one of the most common gastrointestinal disorders (p. 605, left column, 1st paragraph). Cremon discloses that CNCM I-1572 induced a significant increase in short chain fatty acid acetate and butyrate and significant reduction in the pro-inflammatory cytokine interleukin-15 (Abstract). Cremon describes administration of CNCM I1572 in the form of gelatin capsules to patients twice daily for four weeks, followed by washout period of four weeks and alternate treatment twice daily for four weeks (p. 605, right column, last paragraph, Figure 1).
Cremon does not teach inactivated strain CNCM I-1572 and does not teach inactivation by gamma irradiation.
Vallejo-Cordoba teaches that inactivated or non-viable probiotics referred to as “paraprobiotics” have the ability to provide benefits to the host health and “may display anti-inflammatory, immunomodulatory, anti-proliferative and antioxidant activities, which can positively affect several metabolic and signaling pathways of the host” (p. 2, 2nd paragraph). Vallejo-Cordoba describes different methods to produce inactivated probiotics including gamma irradiation and provides instructions for the procedures (p. 6, Table 1). Vallejo-Cordoba provides examples of beneficial effects of various inactivated lactic acid bacteria including Lactobacillus paracasei. For instance, the heat-killed L. paracasei added to fermented cow’s milk showed increase in the genes involved in butyrate production and changes in gut microbiota associated with immune biomarkers (p. 17). Vallejo-Cordoba mentions that paraprobiotics are more stable for industrial use compared to viable microorganisms and describes LAC-Shield, a commercial heat-inactivated L. paracasei, to improve resistance to cold infections in subjects and to increase defense against infections in gut mucosal tissue of mice (p. 20, 1st paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow Vallejo-Cordoba teaching and use the CNCM I-1572 strain from Cremon teaching in inactivated form and try gamma irradiation as inactivation method. One would have been motivated to do so since Vallejo-Cordoba disclosed that the inactivated probiotics retain anti-inflammatory, immunomodulatory, anti-proliferative and antioxidant properties and inactivation of bacteria can prevent possible infection and increase bacterial products stability while maintaining the beneficial effects. Additionally, Cremon showed increased production of butyrate by L. paracasei I-1572 strain and Vallejo-Cordoba mentioned increased butyrate production by inactivated L. paracasei indicating that L. paracasei maintains its function in inactivated state. A skilled artisan would have reasonably expected success in the combination because Cremon and Vallejo-Cordoba teach probiotics and L. paracasei in treatment of various diseases or conditions.
Please note that inactivated by gamma irradiation strain CNCM I-1572 is interpreted as product-by-process limitation (MPEP 2113). The combination of prior art of Cremon and Vallejo-Cordoba makes inactivated strain CNCM I-1572 obvious as described above and the process by which the inactivation is reached is not considered critical. Since claim does not require specific structural characteristics of the inactivated strain the different methods of strain inactivation including gamma irradiation taught by Vallejo-Cordoba can be applied.
Thus, Cremon and Vallejo-Cordoba teachings render claim 12 obvious.
Regarding claim 20, Cremon teaches that the probiotic composition was formulated as a gelatin capsule containing 25 billion viable cells of I-1572 strain (p. 605, right column, last paragraph) which can be used for oral consumption (elected species). Thus, Cremon and Vallejo-Cordoba teachings render claim 20 obvious.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Cremon (Cremon et al. United Eur. Gastr. J., 2018, 6, 604-613) in view of Vallejo-Cordoba (Vallejo-Cordoba et al. Advances in Food and Nutrition Research, 2020, 64, chapter 1, 1-34) as applied to claim 12 above, and further in view of Liu (Liu et al. J. Immunol., 2000, 164, 3608-3615).
The teachings of Cremon and Vallejo-Cordoba have been set forth above.
Cremon and Vallejo-Cordoba do not teach administering the composition of I-1572 strain to a subject with inflammatory bowel disease (elected species).
Liu teaches that IL-15 is highly expressed in inflammatory bowel disease (IBD). Liu provided data indicating that: “IL-15 is overexpressed in the inflamed mucosa in IBD and that IL-15 enhances local T cell activation, proliferation, and proinflammatory cytokine production by both T cells and macrophages” (Abstract). Liu discloses that the described effects of IL-15 overproduction may result in chronic inflammation, an abnormal immune response and tissue damage (p. 3614, right column). Liu mentions that treatment directed against IL-15 have therapeutic potential in IBD (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow Liu teaching and use the composition of inactivated CNCM I-1572 strain based on Cremon and Vallejo-Cordoba teachings for subjects with IBD. One would have been motivated to do so since Cremon showed CNCM I-1572 strain to induce significant reduction in the pro-inflammatory cytokine IL-15 and Liu teaches overexpression of IL-15 in IBD patients and indicates that treatment directed against IL-15 have therapeutic potential in IBD. A skilled artisan would have reasonably expected success in the combination because Cremon, Vallejo-Cordoba and Liu teach treatment of gastrointestinal diseases, Cremon provides probiotic strain, Vallejo-Cordoba suggests inactivated form for the strain and Liu points to the mechanism of strain action in IBD. Thus, Cremon, Vallejo-Cordoba and Liu teachings render claim 13 obvious.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Cremon (Cremon et al. United Eur. Gastr. J., 2018, 6, 604-613) in view of Vallejo-Cordoba (Vallejo-Cordoba et al. Advances in Food and Nutrition Research, 2020, 64, chapter 1, 1-34) as applied to claim 12 above, and further in view of Ma (WO 2020018482 A1).
The teachings of Cremon and Vallejo-Cordoba have been set forth above.
Cremon and Vallejo-Cordoba do not teach Bifidobacterium bifidum MiMBb23sG DSM 32708 strain.
Ma teaches compositions of probiotic bacteria to decrease intestinal permeability in a subject having or at risk of having increased intestinal permeability and exhibiting symptoms or signs of an inflammatory condition in gut (Abstract, p. 1, lines 28-29). Ma mentions that the composition is administered to ameliorate at least one symptom or clinical sign of an inflammatory condition of the gut (p. 2, lines 17-18). Ma screened 30 probiotic bacteria and identified two strains, Lactobacillus acidophilus (ATCC 4356) and Bifidobacterium bifidum (ATCC 35914) exhibiting therapeutic efficacy in animal models of IBD. The combination of two strains worked in synergistic manner causing greater enhancement of intestinal permeability (p. 9, lines 21-26).
Ma does not teach the instant B. bifidum strain, however, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that B. bifidum strain of Ma teaching is an obvious variant of instant B. bifidum strain. One would have been motivated to expect that because strain of Ma teaching belongs to the same species as instant strain and can have similar properties and is used for the same purpose of treating inflammatory intestinal disease.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add inactivated B. bifidum ATCC 35914 strain of Ma teaching to the composition of inactivated CNCM I-1572 strain based on Cremon and Vallejo-Cordoba teachings for treatment of gastrointestinal disease or symptom of inflammatory or functional nature. One would have been motivated to do so since B. bifidum strain of Ma is used for the same purpose of treatment of inflammatory gastrointestinal disease or symptom as CNCM I-1572 strain of Cremon teaching and Ma showed synergistic action of B. bifidum strain in combination with Lactobacillus strain. A skilled artisan would have reasonably expected success in the combination because Cremon, Vallejo-Cordoba and Ma teach treatment of gastrointestinal diseases with probiotic strains. Thus, Cremon, Vallejo-Cordoba and Ma teachings render claim 16 obvious.
Claims 15, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Cremon (Cremon et al. United Eur. Gastr. J., 2018, 6, 604-613) in view of Vallejo-Cordoba (Vallejo-Cordoba et al. Advances in Food and Nutrition Research, 2020, 64, chapter 1, 1-34) as applied to claim 12 above, and further in view of Biffi (WO 2019111189 A1).
The teachings of Cremon and Vallejo-Cordoba have been set forth above.
Cremon and Vallejo-Cordoba do not teach combination of CNCM I-1572 and LPC-S01 L. paracasei strains (elected species).
Regarding claims 15, 18 and 19, Biffi teaches probiotic Lactobacillus composition to prevent and treat disorders affecting the skin and in particular inflammatory disorders (Abstract). Biffi mentions that the use of the composition is due to immunomodulating action of probiotics, i.e. reduction of expression of cytokines and growth factors including inflammatory cytokines (p. 4, lines 17-26). The preferable Lactobacillus strains are Lactobacillus paracasei DG[Symbol font/0xD2] CNCM I-1572 and Lactobacillus paracasei LPC-S01 (instant strains) (p. 8, lines 19-21). Biffi discloses that these strains are particularly effective in combination where they show an additive and even synergistic effect (p. 8, lines 29-31). Biffi mentions that these two strains can be used when they are dead or tyndalized (heat inactivated) or used as paraprobiotics (p. 10, lines 4-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use combination of inactivated L. paracasei strains DG[Symbol font/0xD2] CNCM I-1572 and LPC-S01 as taught by Biffi for the composition of inactivated CNCM I-1572 strain based on Cremon and Vallejo-Cordoba teachings for treatment of gastrointestinal disease or symptom of inflammatory nature. One would have been motivated to do so since these strains belong to the same species and can have similar beneficiary properties, were shown by Biffi to provide anti-inflammatory effect and used as inactivated strains and are taught by Biffi to be particularly effective in combination and provide synergistic effect. A skilled artisan would have reasonably expected success in the combination because Cremon and Biffi teach the same L. paracasei strain providing anti-inflammatory action. Thus, Cremon, Vallejo-Cordoba and Biffi teachings render claims 15, 18 and 19 obvious.
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 12 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of copending application 18/865,784 (reference application) in view of Vallejo-Cordoba (Vallejo-Cordoba et al. Advances in Food and Nutrition Research, 2020, 64, chapter 1, 1-34).
Claim 12 of instant application is directed to a method of treating a gastrointestinal disease or symptom of an inflammatory or functional nature comprising administering a composition of inactivated by gamma irradiation bacterial strains selected from strains recited in claim 1 and including strain L. paracasei DG CNCM I-1572. Reference claim 1 teaches a method of treating dysbiosis of intestinal microbiota with subjects suffering from IBS with L. paracasei DG I-1572 DSM 34154 strain comprising administering a pharmaceutically effective amount of bacterial strain to the subjects. Thus, the reference claim 1 teaches administration of instant strain for treatment of IBS which is intestinal disease with inflammatory nature.
The reference claim 1 does not teach bacterial strain inactivated by gamma irradiation.
Vallejo-Cordoba teaches that inactivated or non-viable probiotics referred to as “paraprobiotics” have the ability to provide benefits to the host health and “may display anti-inflammatory, immunomodulatory, anti-proliferative and antioxidant activities, which can positively affect several metabolic and signaling pathways of the host” (p. 2, 2nd paragraph). Vallejo-Cordoba describes different methods to produce inactivated probiotics including gamma irradiation and provides instructions for the procedures (p. 6, Table 1). Vallejo-Cordoba provides examples of beneficial effects of various inactivated lactic acid bacteria including Lactobacillus paracasei as described above for 35 U.S.C. 103 rejection.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow Vallejo-Cordoba teaching and use the CNCM I-1572 strain from reference application in inactivated form and try gamma irradiation as inactivation method. One would have been motivated to do so since Vallejo-Cordoba disclosed that the inactivated probiotics retain anti-inflammatory, immunomodulatory, anti-proliferative and antioxidant properties and inactivation of bacteria can prevent possible infection and increase bacterial products stability while maintaining the beneficial effects. A skilled artisan would have reasonably expected success in the combination because reference claim 1 and Vallejo-Cordoba teach probiotics including L. paracasei in treatment of various gastrointestinal disease or conditions. Thus, claim 1 of reference application and Vallejo-Cordoba teaching render claim 12 obvious.
Claim 20 of instant application is drawn to the composition formulated for oral use (elected species). That correspond to claim 5 of reference application teaching oral administration of bacteria.
Therefore, since instant claims 12 and 20 encompass the subject matter of the reference claims 1 and 5, they are rejected under obviousness double patenting.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIOUBOV G KOROTCHKINA whose telephone number is (571)270-0911. The examiner can normally be reached Monday-Friday: 8:00-5:30.
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/L.G.K./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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