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 .
Status of the Claims
Claims 1-6, 8-10, 18, 21-23, 29-33 are currently pending (claim set as filed on 6/7/2024). Claims 7, 11-17, 19-20, 24-28, and 34-35 are cancelled. Claims 21-23 and 29-30 are withdrawn due to a restriction/election requirement. Claims 1-6, 8-10, 18, 31-33 are under examination.
Election/Restrictions
Claims 21-23 and 29-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected composition, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/10/2026.
Applicant's election with traverse of a method for improving pain relief, antiaging effects, neuroprotective and antidepressant effects, improved vasodilatation and metabolic health, improved cellular health, and longevity, and/or reducing age-related memory loss of a subject in need thereof in the reply filed on 8/10/2026 is acknowledged. The traversal is on the grounds that the prior art reference Juno does not break unity of invention in the election requirement for species found in claims 2-5 and 31-32 as Juno does not teach the methods of claims 1 and 31. This is not found persuasive because the unity of invention between Groups I and II was defined as the composition comprising an isolated probiotic and arginine, not the method of administering the composition.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Acknowledgement is made of the applicant’s claim for priority benefit to provisional application no. 63/287,648 filed on 12/9/2021. Thus, the effective filing date of this application is 12/9/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6/7/2024 and 8/27/2025 were considered, initialed, and attached hereto. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 8 is objected to because of the following informalities: the word “Agmatine” is capitalized which is incorrect grammar and furthermore is inconsistent with capitalization in other claims. Appropriate correction is required to change to “agmatine”.
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 3, 5, 31-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain 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 invention appears to employ novel biological materials, Lactobacillus acidophilus NCC 2628 (CNCM I-2453). The applicant does not specify if the aforementioned biological materials were deposited and made available to the public. 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 readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific biological materials have been deposited under the Budapest Treaty and that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, 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, Applicant 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, showing 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 effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made
(see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant's attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that "the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination." The specification should be amended to include this information, however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
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 3, 9, and 31-33 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.
Regarding claims 3 and 31, the recited term "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 32-33 are rejected for depending on claim 31.
Regarding claim 9, the recited phrase “the isolated probiotic is filled into the composition” renders the claim indefinite as it is unclear what process is occurring. This is unclear since the composition comprises the isolated probiotic and thus it is unclear how the isolated probiotic may be filled into the composition that comprises the isolated probiotic itself.
Claim Rejections - 35 USC § 102
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 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)(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 1-2, 4, 6, 8-10, and 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Millet (Pre-Grant Publication No. US 2020/0360418 A1 – date of publication 11/19/2020) and as evidenced by Hernandez (Hernandez et al., “Diversity, properties and functions of bacterial arginases”, 2021 Jun 23, FEMS Microbiology Reviews, 45, pgs. 1-26).
Millet’s general disclosure relates to the administering of an autobiotic comprising a probiotic Lactobacillus acidophilus and an arginine postbiotic (see [0022], [0038], [0061]) to increase healthy gut microbiota (see [0041]) and improve gastrointestinal health (see [0074]) in mammalian subjects (see [0045]).
Regarding claims 1-2, Millet teaches the administering of an autobiotic composition comprising a postbiotic, such as a butyrate salt which includes arginine (see Millet [0022] and [0061]), and may further comprise a seedbiotic, such as probiotic Lactobacillus acidophilus (see Millet [0038]). Millet teaches the administering of the autobiotic and seedbiotic together can result in the growth of bacteria in the gut microbiome (see Millet [0041]). As bacteria naturally produce amino acids and their derivates such as agmatine upon culturing, one could expect if the growth of bacteria increased in the gut then the rate of production of agmatine would increase as well. Millet also teaches the administering of the autobiotic composition is intended to improve mood and digestive cellular health (see Millet [0074). Thus the composition can be considered to be administered at an effective amount as the instant specification defines it as an amount that prevents, treats, or reduces symptoms of a disease or medical condition (see instant specification [00137]).
Regarding claim 4, Millet teaches the autobiotic composition comprises an enzyme, which is a type of protein (see [0042]).
Regarding claim 6, Millet teaches the administering of the autobiotic composition comprising a seedbiotic probiotic Lactobacillus acidophilus (see Millet [0038]) and that this results in the growth of seeded bacteria in the gut microbiome (see Millet [0041]). Furthermore, bacteria naturally produce arginine and their derivates such as agmatine upon culturing and this conversion of arginine to agmatine would be inherently carried out by arginine decarboxylase, as evidenced by Hernandez (see Hernandez pg. 3, ¶ 10). Millet teaches that the concentration of postbiotics, including agmatine (see Millet [0061]), was administered daily, which is at least 24 hours, at a concentration of at least 500 mg which calculates to about 3840.5 µM and is at least 20 µM as claimed.
Regarding claim 8, Millet teaches administering the autobiotic composition comprising a seedbiotic probiotic Lactobacillus acidophilus (see Millet [0038]). As the prior art teaches a probiotic with the same structure as the claimed probiotic, it would inherently have the same functional limitation features as claimed. Furthermore, the instant specification states that an effective amount of the probiotic administered would be “at least 7 million CFU” (see specification [0022]), and the prior art states the probiotic was administered at a range of at least 250 million CFU (see Millet [0039]). Thus if the probiotics are structurally the same and administered at similarly effective amounts, one could expect them to function the same.
Regarding claim 9, Millet teaches the autobiotic composition may be administered in powder form (see [0047]), which is naturally dry. Millet also teaches the probiotic Lactobacillus acidophilus can be included within the autobiotic composition as a seedbiotic (see [0038]).
Regarding claim 10, Millet teaches the probiotic Lactobacillus acidophilus can be included within the autobiotic composition as a seedbiotic and has the effect of providing a starter culture in the gut (see [0038]), indicating that the probiotic is in an active state.
Regarding claim 18, Millet teaches the autobiotic composition may be administered to a subject once a day (see [0103]). Millet teaches the seedbiotic comprising the probiotic Lactobacillus acidophilus is administered at a concentration of 250 million to about 1 billion CFUs (see [0039]) and the postbiotic comprising arginine is administered at a concentration of about 500-2500 mg (see [0110]). The concentration range of the probiotic is at least 5 million CFU as claimed and the concentration range of arginine fully encompasses the claimed range of 500-700 mg.
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.
Claims 3, 5, and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Millet (Pre-Grant Publication No. US 2020/0360418 A1 – date of publication 11/19/2020), in view of Ballevre (Pre-Grant Publication No. US 2003/0049240 A1 – date of publication 3/13/2003), and as evidenced by Hernandez (Hernandez et al., “Diversity, properties and functions of bacterial arginases”, 2021 Jun 23, FEMS Microbiology Reviews, 45, pgs. 1-26).
Millet’s general disclosure has been set forth above.
Regarding claims 3, 5, and 31-32, Millet teaches the administering of an autobiotic composition comprising a seedbiotic probiotic Lactobacillus acidophilus (see [0038]) and a postbiotic such as a butyrate salt which includes arginine (see [0022] and [0061]) to mammalian subjects (see [0045]).
However, Millet does not teach wherein the Lactobacillus acidophilus probiotic was the strain NCC 2628.
Ballevre’s general disclosure relates to the administering of a Lactobacillus acidophilus NCC 2628 strain (see [0011]) for the treatment of gastrointestinal disorders in mammalian pets (see [0008]).
Regarding claims 3, 5, and 31-32, Ballevre teaches a composition comprising a probiotic Lactobacillus acidophilus NCC 2628 strain (see [0011]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the Lactobacillus acidophilus NCC 2628 strain as taught in Ballevre to the autobiotic composition taught in Millet. The ordinary artisan would have been motivated to do so because Ballevre teaches the Lactobacillus acidophilus NCC 2628 strain was selected for its therapeutic effects against pathogenic bacteria that causes gut disorders such as gastritis in dog and cat subjects (see Ballevre [0012] and [0014-0015]). This would have been advantageous to the Millet’s disclosure which promotes the administering of a Lactobacillus acidophilus probiotic to generally improve digestive health in mammalian subjects (see Millet [0045] and [0074]), and thus the addition of the specific strain would have improved upon this concept.
Regarding claim 33, the combined references teach the autobiotic composition, which contains arginine (see Millet [0061]), is administered to a subject via the gastrointestinal tract (see Millet [0096]). As evidenced by Hernandez, arginine is naturally converted to agmatine in prokaryotes by arginine decarboxylase (see Hernandez pg. 3, ¶ 10). The combined references teach the administering of the autobiotic composition is intended to improve mood and digestive cellular health (see Millet [0074). Thus the composition can be considered to be administered at an effective amount as the instant specification defines it as an amount that prevents, treats, or reduces symptoms of a disease or medical condition (see instant specification [00137]). The combined references further teach that the pH is 4.2 (see Ballevre [0125]) which is within the claimed range of about 4.0-8.0.
Conclusion
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emmalee R. Williams whose telephone number is (571)272-5472. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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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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/EMMALEE R WILLIAMS/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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