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 1-9 and 11-20 are pending (claim set as filed on 5/29/2026). Claim 10 is cancelled. Claims 11-20 are withdrawn after restriction/election requirement. Claims 1-9 are under examination.
Election/Restrictions
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected product and composition, there being no allowable generic or linking claim. Applicant timely traversed the restriction and election of species requirement in the reply filed on 5/29/2026.
Applicant's election with traverse of claims 11-20 and the election of species with traverse of claim 9 in the reply filed on 5/29/2026 is acknowledged. The traversal of the groups of inventions is on the grounds that the pending claims 1-9 and 11-20 are closely related inventions directed to overlapping subject matter and therefore are not properly divisible into independent and distinct inventions. The traversal of the election of species of claim 9 is on the grounds that species of disease conditions represent related therapeutic applications of the same inventive concept and therefore do not require materially different examination. The arguments are not found persuasive because the inventions are still distinct as they require different search strategies and keywords as well as separate search of prior art references. One could not prove that the prior art search for one group would also produce prior art results for the other group of inventions and therefore constitute a serious search burden for the examiner. Assuming there is overlapping subject matter between the groups of inventions, there still remains an undue search burden on the examiner to consider the different process, product, and composition claim groups and apply prior art references by writing separate rejections for each. Further, the groups of disease conditions are still distinct conditions and would require different keyword and classification searches to find and consider prior art for each. There is no evidence that these disease conditions could be searched together without a serious search burden for the examiner.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Acknowledgement is made of the provisional application no. 63/498,611 filed on 4/27/2023. Thus the effective filing date of this application is 4/27/2023.
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 4 and 6-7 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.
Claims 4 and 7 recite the limitation "the probiotic”. There is insufficient antecedent basis for this limitation in the claims as claims 4 and 7 are dependent on claim 1 which does not recite “a probiotic”. However the term “a probiotic” is recited in claim 3, but claims 4 and 7 do not depend on this claim and therefore one could not be certain if the probiotic they are referencing is the same one. It is suggested that the applicant correct the claim dependency of claims 4 and 7 to overcome the rejection.
Claim 6 recites the limitation "the pharmaceutical composition”. There is insufficient antecedent basis for this limitation in the claim as claim 6 is dependent on claim 1 which does not recite "the pharmaceutical composition”. However the term “a pharmaceutical composition” is recited in claim 5, but claim 6 does not depend on this claim and therefore one could not be certain if the pharmaceutical composition they are referencing is the same one. It is suggested that the applicant correct the claim dependency of claim 6 to overcome the rejection.
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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea, specifically a mental process without significantly more.
With regards to Step 1, the identification of bacterial strains in claims 1-9 is an abstract idea.
With regards to Step 2A, prong one, claim 1 is directed to an abstract idea of identifying bacterial strains.. The process of identifying bacterial strains is considered to be a judicial exception as it is an abstract idea of a mental process that can be performed in the human mind. See MPEP 2106.04(a)(2). For instance, under broadest reasonable interpretation, the claimed mental process could be performed by reading a health article about the benefits of probiotics and advising a person to consume yogurt. Dependent claims 2-9 are directed towards additional elements. Claim 2 recites the additional steps of obtaining a sample from a subject and isolating bacteria in the sample. Claims 3-7 recite form and route of administering the bacterial strain. Claim 8 recites the specified subject being administered the bacterial strain. Claim 9 recites the use of administering the strain.
With regards to Step 2A, prong two, dependent claims 2-9 do not recite any additional elements to claim 1 to practically integrate it into the instant application. Claim 2 merely recites additional steps of obtaining a sample from a subject and isolating bacteria in the sample and administering the bacteria to a subject, which are data gathering processes recited at a high degree of generality. See MPEP 2106.04. Claims 3-8 recite steps specifying how and to whom the process in claim 1 is carried out, but does not practically integrate it. Claim 9 merely states how the claimed process may be used and does not recite an action that definitively effects a certain treatment or prevention. See MPEP 2106.04(d)(2). As such, there are no additional elements integrated that apply or use the judicial exception in some other meaningful way.
With regards to Step 2B, the additional elements within claims 2-9 do not amount to an inventive concept as they considered to be routine and conventional within the subject matter field. Jones teaches that the additional elements recited in claims 2, 5-6, and 8-9 were already known and routine steps in the art. Jones teaches that the additional elements in claim 2 of obtaining a sample from a subject (see Jones [0052]) and isolating bacteria in the sample (see Jones [0046]) and administering the bacteria to a subject (see Jones [0052]). Jones teaches the additional elements of claims 5-6 and 8 which recite steps of administering a pharmaceutical (see Jones [0054]) orally (see Jones [0061]) to a human subject (see Jones [0044]). Jones also teaches (see Jones [0050]) the additional element of claim 9 of how the process is used to treat a disease (see Jones [0050]). Ghannoum teaches that the additional elements of claims 3-4 and 7 were routine and convention in the art. Ghannoum teaches the additional elements of claims 3-4 which recite steps of administering an oral probiotic (see Ghannoum [0018]) containing fiber (see Ghannoum [0117]). Therefore, claims 2-9 do not recite additional elements that alone or together amount to significantly more than the judicial exception itself (for prevention)and thus are not patent eligible.
For the following reasons, claims 1-9 are not deemed to encompass patent eligible subject matter under 35 USC § 101. Claims 2-9 are rejected for depending on claim 1.
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, 3-4, and 7-9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ghannoum (Pre-Grant Publication No. US 2021/0030818 A1 – date of publication 2/4/2021).
Ghannoum’s general disclosure relates to a method of balancing a subject’s microbiome by administering a probiotic composition (see abstract).
Regarding claim 1, Ghannoum discloses administering a non-pathogenic bacterial composition to a subject to modulate the microbiome by improving nutrient absorption and to promote a healthier microbial flora (see [0010]). Ghannoum discloses identifying non-pathogenic probiotic bacterial strains from isolated strains (see [0018]).
Regarding claim 3, Ghannoum discloses the bacteria is administered as a probiotic (see [0018]).
Regarding claim 4, Ghannoum discloses the probiotic is administered orally (see [0018]).
Regarding claim 7, Ghannoum discloses the composition comprises both bacterial species and apples which contain dietary fiber (see [0117]).
Regarding claim 8, Ghannoum discloses the subject the bacteria is administered to is a human (see [0015]).
Regarding claim 9, Ghannoum discloses that the bacteria is administered to treat inflammatory bowel disease (see [0029]).
Claims 1-2, 5-6, and 8-9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jones (Pre-Grant Publication No. US 2015/0050246 A1 – date of publication 2/19/2015).
Jones’s general disclosure relates to methods of microbiota restoration therapy (see abstract).
Regarding claim 1, Jones discloses identifying healthy bacterial flora from a donor and administering it to a subject to repopulate a healthier gut microbiota (see [0052]).
Regarding claim 2, Jones discloses obtaining a fecal sample from a health donor subject (see [0052]), isolating the bacteria from the sample through a filtration process (see [0046]), identifying the presence of bacterial strains such as Staphylococcus aureus in the sample (see [0045]), administering it to a subject to repopulate a healthier gut microbiota (see [0052]).
Regarding claim 5, Jones discloses administering the bacterial strain in the fecal transplant as a therapeutic administered in doses over the course of the treatment (see [0054]), which reads on a pharmaceutical under broadest reasonable interpretation.
Regarding claim 6, Jones discloses the pharmaceutical composition is administered orally (see [0061]).
Regarding claim 8, Jones discloses the subject of the fecal transplant being human (see [0044]).
Regarding claim 9, Jones discloses the fecal transplant method is done for the treatment of inflammatory bowel disease (see [0050]).
Pertinent Art
Below is a listing of prior art discovered during the examiner’s search that although was not used in the claims rejections above, was considered to be relevant to the record of prosecution.
Hirsch et al., “Effectiveness of fecal-derived microbiota transfer using orally administered capsules for recurrent Clostridium difficile infection” 2015 Apr 17, BMC Infectious Diseases, 15(191), pgs. 1-9
Mazahreh et al., “The Benefits of Lactic Acid Bacteria in Yogurt on the Gastrointestinal Function and Health”, 2009 Aug, Pakistan Journal of Nutrition, 8(9), pgs. 1404-1410
Nakatsuji et al., “Development of a human skin commensal microbe for bacteriotherapy of atopic dermatitis and use in a phase 1 randomized clinical trial”, 2021 Apr, Nature Medicine, 27, pgs. 700-709
Damak (Publication No. WO 2022/268759 – date of publication 12/29/2022)
Everett (Pre-Grant Publication No. US 2021/0244775 A1 – date of publication 8/12/2021)
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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/E.R.W./ Examiner, Art Unit 1653 /SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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