DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-7 are pending and under examination herein.
Priority
This application is a 371 of PCT/EP2023/075377 (9/15/2023) which claims priority to EP22198955.1 (9/30/2022).
Information Disclosure Statement
The information disclosure statement (IDS) filed on 3/28/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (p. 2 para. 4). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 6 is objected to because of the following informalities: claim 6 recites “joghurts”, which is not an English word. This should be amended to recite the English word, i.e. “yogurts”.
Drawings
The drawings are objected to for the following reasons:
37 CFR 1.84(u)(1) states “View numbers must be preceded by the abbreviation “FIG.”.
In the current case, the view numbers for Figures 1-3 are preceded by the word “Figure” instead of the abbreviation “FIG.”. View numbers should be updated to recite the abbreviation “FIG.”. Any changes to the drawings should also be reflected in the specification.
Additionally, Fig. 2 refers to colors (dark brown and blue) to differentiate high or low values on a heatmap. Differences in color cannot be interpreted in the black and white drawing. It is requested that Applicant label figure elements in a different way and/or provide higher quality drawings to differentiate elements in the drawing.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The disclosure does not enable one of ordinary skill in the art to practice the invention without access to the specific biological material, which is critical or essential to the practice of the invention but not included in the claims. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976).
The invention appears to employ novel biological materials, specifically bacterial strains Lactobacillus plantarum (Lactiplantibacillus plantarum) DSM 33363, Lactobacillus plantarum (Lactiplantibacillus plantarum) DSM 33364, Lactobacillus paracasei (Lacticaseibacillus paracasei) DSM 33373, Lactobacillus reuteri (Limosilactobacillus reuteri) DSM 33374, Bacillus megaterium (Priestia megaterium) DSM 33300, Bacillus pumilus DSM 33297, and Bacillus pumilus DSM 33355. Since the biological materials are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the biological material is not so obtainable or available, the requirement of 35 U.S.C. 112 may be satisfied by a deposit of the biological materials.
The specification does not disclose a repeatable process to obtain the biological materials and it is not apparent if the biological materials are readily available to the public. It is noted that the Applicant has deposited the strains with the Leibniz-lnstitut DSMZ Deutsche Sammlung von Mikroorganismen and Zellkulturen GmbH (instant specification p. 3), but there is no indication in the specification as to public availability. If the deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by the applicants, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strains have been deposited under the Budapest Treaty and that the strain will be irrevocably and without restriction or condition released to the public upon the issuance of a patent and a receipt showing that the appropriate biological material was received and entered into the depository, would satisfy the deposit requirement made herein.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. 1.801-1.809 applicants may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number indicating that:
a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
d) a test of the viability of the biological material at the time the deposit was made and that such test result indicated that said biological material was viable (see 37 C.F.R. 1.807); and;
e) the deposit will be replaced if it should ever become inviable.
A statement regarding deposition and acceptance under the Budapest Treaty and a statement that the biological materials will be irrevocably and without restriction or condition released to the public upon issuance of a patent; or a statement including (a)-(e) above, is required to satisfy the conditions set forth in 35 U.S.C. § 112(a).
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 4 and 6 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.
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 4 recites the broad recitation “a phytase activity of at least 5 phytase activity units”, and the claim also recites “preferably at least 10 phytase activity units, more preferably at least 15 phytase activity units” which is the narrower statement of the range/limitation.
Claim 6 recites the broad recitation “wherein said probiotic composition is
formulated for oral use”, and the claim also recites “preferably as pills, capsules, tablets, granular powders, opercula, soluble granules, bags, pills or drinkable vials” which is the narrower statement of the range/limitation. Claim 6 additionally recites the broad recitation “is
added to food” and the claim also recites “preferably cereals, gummies, bread, muesli, muesli bars, health bars, biscuits, chocolates, joghurts or spreads” which is the narrower statement of the range/limitation.
The claims are 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.
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.
Claim 3 is 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.
Claim 3 recites “wherein the probiotic composition further comprises Lactobacillus plantarum (Lactiplantibacillus plantarum) DSM 33363, Lactobacillus plantarum (Lactiplantibacillus plantarum) DSM 33364, Lactobacillus reuteri (Limosilactobacillus reuteri) DSM 33374”. Claim 3 depends on claim 1, which recites “A probiotic composition comprising one or more of the following strains: Lactobacillus plantarum (Lactiplantibacillus plantarum) DSM 33363, Lactobacillus plantarum (Lactiplantibacillus plantarum) DSM 33364, Lactobacillus paracasei (Lacticaseibacillus paracasei) DSM 33373, Lactobacillus reuteri (Limosilactobacillus
reuteri) DSM 33374, Bacillus megaterium (Priestia megaterium) DSM 33300, Bacillus pumilus DSM 33297, and Bacillus pumilus DSM 33355”. A probiotic composition according to claim 1 may include all of the strains recited in claim 1. Claim 3 recites that the strain further comprises strains which are already included in claim 1, and therefore does not further limit claim 1.
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, product of nature, without significantly more.
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP § 2106:
Step (1): Is the claim directed to a process, machine, manufacture, or composition of matter?
Yes. Claims 1-7 are directed to a composition of matter, a probiotic composition.
Step (2A):
Prong 1: Does the claim recite a law of nature, natural phenomenon, or an abstract idea?
Yes. Claims 1-7 recite a probiotic composition comprising naturally occurring bacterial strains that do not exhibit markedly different characteristics from their natural state. Claims 5-7 recite limitations directed to the formulation of the composition. However, these formulations still read on the bacteria in their natural state. For example, a pharmaceutical product, a composition formulated for oral use, and a feed additive all read on the bacteria plus water, and thus read on a natural product.
Prong 2: If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
No. Claim 1 recites the limitation “for use in the treatment or prevention of a deficiency of total protein, L-lysine, L-asparagine, L-glycine, L-omithine, or minerals selected from Fe, Zn or Mg”. This is an intended use limitation which does not limit the composition structurally. Claim 4 recites the phytase activity of the composition, which is a natural property of the strains and does not integrate the exception into a practical application. The limitations in claims 5-7 do not integrate the product into a practical application, as they merely specify the form that the naturally occurring bacteria are in.
Step (2B): If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly more than the judicial exception?
No. Claims 1-7 do not include additional elements that are sufficient to amount
to significantly more than the judicial exception because the claims merely recite the naturally occurring bacteria in their natural state, which does not amount to significantly more. As discussed above, the intended use and functional limitations of claims 1 and 4 do not limit the composition structurally, and therefore these claims read on a natural product with no additional elements. Claims 5-7 specify the form the bacteria are in, but still read on the naturally occurring bacteria with no additional elements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Speckmann et al., WO 2021/129998 A1 (published July 1, 2021, cited in IDS); as evidenced by Barone et al., Biofactors. 2022 Mar;48(2):307-14.
Regarding claim 1, Speckmann teaches preparations comprising probiotic strains belonging to the genera Bacillus sp. and Lactobacillus sp. (Abstract). Speckmann teaches that the preparation comprises L. plantarum (Lactiplantibacillus plantarum) DSM 33363 and DSM 33364, L. paracasei (Lacticaseibacillus paracasei) DSM 33373, Lactobacillus reuteri (Limosilactobacillus reuteri) DSM 33374, Bacillus megaterium DSM 33300, Bacillus pumilus DSM 33297, and Bacillus pumilus DSM 33355 (p. 7 lines 34-37).
Regarding the limitation “for use in the treatment or prevention of a deficiency of total protein, L-lysine, L-asparagine, L-glycine, L-omithine, or minerals selected from Fe, Zn or Mg”, this is an intended use of the claimed probiotic composition. Any probiotic composition having the same structure as set forth in claim 1 must necessarily be capable of performing this intended use. As Speckmann teaches a composition comprising the same strains as recited in claim 1, this composition is capable of use in a treatment as claimed.
Regarding claim 2, Speckmann teaches that the preparation comprises L. paracasei DSM 33373, Bacillus megaterium DSM 33300, Bacillus pumilus DSM 33297, and Bacillus pumilus DSM 33355 (p. 7 lines 34-37).
Regarding claim 3, Speckmann teaches that the preparation comprises L. plantarum DSM 33363 and DSM 33364, and Lactobacillus reuteri DSM 33374 (p. 7 lines 34-37).
Regarding claim 4, the limitation “wherein the probiotic composition has a phytase activity of at least 5 phytase activity units, preferably at least 10 phytase activity units, more preferably at least 15 phytase activity units” is a functional limitation of the claimed probiotic composition. Phytase production and activity is a natural property of the probiotic strains used in the composition (see instant specification p. 2 lines 24-25; see Barone pp. 308-309 Section 2.1). Thus, the composition taught by Speckmann, which comprises the same strains recited in claim 1, must necessarily be capable of the phytase activity as recited in claim 4.
Regarding claim 5, Speckmann teaches that the probiotic composition is a food or feed supplement (p. 14 lines 20-26).
Regarding claim 6, Speckmann teaches that the probiotic composition is formulated for oral use in the form of a pill, capsule, tablet, powder or liquid (p. 14 lines 32-33) and is added to foodstuffs including chocolate products, gummies, mueslis, muesli bars, and dairy products (p. 14 lines 22-24).
Regarding claim 7, Speckmann teaches that the probiotic composition is a food additive (p. 14 lines 20-31). Regarding the limitation “to increase the feed conversion rate and reduce the luminal content of phytic acid to increase the bioavailability of one or more of the micronutrients iron, copper, zinc and magnesium and one or more of the amino acids L-lysine, L-aspartic acid, L-glycine and L-ornithine” this is an intended use of the claimed probiotic composition. Any probiotic composition having the same structure as set forth in claim 7 must necessarily be capable of performing this intended use. As Speckmann teaches a composition comprising the same strains as recited in claim 7 formulated as a feed additive, this composition is capable of use as claimed. Further, as evidenced by Barone, bacterial phytases produced by lactic acid bacteria are capable of releasing bioavailable forms of inorganic minerals, such as calcium, magnesium, iron, and phosphorous, following the hydrolysis of phytic acid, and probiotic treatments can be used to improve nutrient deficiencies (Barone Abstract; pp. 308-309 Section 2.1; Fig. 1).
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 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18 and 22-25 of copending Application No. 17/788,239 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both recite compositions comprising the same bacterial strains.
Regarding instant claims 1-3, claim 18 of ‘239 recites a composition comprising Bacillus and Lactobacillus strains, wherein the strains consist of L. plantarum DSM 33363 and DSM 33364, L. paracasei DSM 33373, L. reuteri DSM 33374, B. megaterium DSM 33300, B. pumilus DSM 33297, and B. pumilus DSM 33355 (MC16).
Regarding instant claim 4, phytase activity is an inherent functional property of the claimed bacterial strains, and as the composition recited in claim 18 of ‘239 recites the same strains, they must necessarily have the same functional properties.
Regarding instant claims 5-7, claims 22-25 recite that the composition is provided in an amount sufficient to degrade gluten in the gastrointestinal tract of a subject. Thus, it would have been obvious for a skilled artisan to formulate the composition as a food or pharmaceutical product for oral use, to deliver the product to the gastrointestinal tract.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12-13, and 18-19 of copending Application No. 18/704,505 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both recite compositions comprising the same bacterial strains.
Regarding instant claims 1-3, claim 1 of ‘505 recites a method of administering a preparation, wherein the preparation comprises Lactobacillus plantarum DSM 33363, Lactobacillus plantarum DSM 33364, Lactobacillus paracasei DSM 33373, Lactobacillus reuteri DSM 33374, Bacillus megaterium DSM 33300, Bacillus pumilus DSM 33297, and Bacillus pumilus DSM 33355.
Regarding instant claim 4, phytase activity is an inherent functional property of the claimed bacterial strains, and as the composition recited in claim 1 of ‘505 recites the same strains, they must necessarily have the same functional properties.
Regarding instant claims 5-7, claims 12-13 and 18-19 of ‘505 recite that the composition is a food or feed supplement or food product or pharmaceutical product, formulated for oral use as pills, capsules, tablets, granular powders, opercula, soluble granules, bags, or drinkable vials.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 9-10, and 15 of copending Application No. 19/115,010 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both recite compositions comprising the same bacterial strains.
Regarding instant claims 1-3, claim 1 of ‘010 recites a method of treatment of IBS comprising administering a preparation comprising at least one probiotic strain Lactobacillus plantarum (Lactiplantibacillus plantarum) DSM 33363. Claim 2 of ‘010 recites that the preparation further comprises strains selected from Lactobacillus plantarum (Lactiplantibacillus plantarum) DSM 33364, Lactobacillus paracasei (Lacticaseibacillus paracasei) DSM 33373, Lactobacillus reuteri (Limosilactobacillus reuteri) DSM 33374, Bacillus megaterium (Priestia megaterium) DSM 33300, Bacillus pumilus DSM 33297, and Bacillus pumilus DSM 33355.
Regarding instant claim 4, phytase activity is an inherent functional property of the claimed bacterial strains, and as the composition recited in claims 1-2 of ‘010 recites the same strains, they must necessarily have the same functional properties.
Regarding instant claims 5-7, claims 9-10 and 15 of ‘010 recite that the composition is a food or feed supplement or food product or pharmaceutical product, formulated for oral use as pills, capsules, tablets, granular powders, opercula, soluble granules, bags, drinkable vials, syrup, and a beverage.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-7 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY F EIX/Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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