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 .
DETAILED ACTION
Claims 1-2, 4-7, and 24-27 are pending.
Response to Amendment
Applicant amended claims 1, 5-6, 24-27 and canceled claim 3. Applicant added in claim 26 new limitation “wherein at least one of the one or more agents that increase an amount of bacteria consists of an amino acid mixture that increases microbiome-mediated cartilage regeneration”.
The objection to claims 1 and 24-26 is withdrawn in view of the amendment.
The rejection of claims 1-2, 24-25, and 27 under 35 U.S.C. 112(b) is withdrawn in view of the amendment.
The rejection of claim 5 under 35 U.S.C. 112(d) is withdrawn in view of the amendment.
Claim Objections
Claim 27 remains objected to because of the following informalities:
In claim 27, “49” in the last line should be deleted.
Appropriate correction is required.
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 1-2, 4-7 and 24-27 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-2, 4-7 and 24-25 are drawn to a method of preventing or treating osteoarthritis symptoms in a knee of a human patient having osteoarthritis comprising administering to the human patient a composition consisting of fecal transplant bacteria from the Actinomycetales order, the Coriobacteriaceae family, the Bacillales order, the Dehalobacteriaceae family, or any combination thereof, as determined by 16S ribosomal RNA (rRNA) gene sequencing. Claim 5 requires administering bacteria of Actinomycetales order, bacteria of Coriobacteriaceae family, bacteria of Bacillales order, bacteria of the Dehalobacteriaceae family, and bacteria of Dehalobacterium genus. Claim 6 requires administering bacteria of Bacteroidales order, bacteria of Christensenellaceae family, bacteria of Anaerostipes genus, and bacteria of Ruminococcaceae family. The claims are drawn to a large and variant genus of bacteria which includes any bacteria of Actinomycetales order, bacteria of Coriobacteriaceae family, bacteria of Bacillales order, and/or bacteria of Dehalobacteriaceae family.
Claim 26 is drawn to a method of preventing or treating osteoarthritis symptoms in a knee of a human patient in need thereof comprising administering to the human patient one or more agents that increase an amount of bacteria of Actinomycetales order, Coriobacteriaceae family, Bacillales order, or Dehalobacteriaceae family, in the altered intestinal flora of the human patient, wherein at least one of the one or more agents that increase an amount of bacteria consists of an amino acid mixture that increases microbiome-mediated cartilage regeneration. The claim is drawn to a large and variant genus of agents that increase an amount of bacteria of Actinomycetales order, bacteria of Coriobacteriaceae family, bacteria of Bacillales order, or bacteria of Dehalobacteriaceae family, and to any combination of any amino acid that increases microbiome-mediated cartilage regeneration.
Claim 27 is drawn to a method of preventing or treating osteoarthritis symptoms in a knee of a human patient comprising administering to the human patient one or more agents that decrease an amount of bacteria of Bacteroidales order, Christensenellaceae family, Anaerostipes genus, Ruminococcaceae family, or any combination thereof, in the altered intestinal flora of the human patient. The claim is drawn to a large and variant genus of agents that decrease the amount of at least one of bacteria of Bacteroidales order, bacteria of Christensenellaceae family, bacteria of Anaerostipes genus, or bacteria of Ruminococcaceae family.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014)
Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.").
The specification does not disclose a representative number of bacteria of the Actinomycetales order, the Coriobacteriaceae family, the Bacillales order, the Dehalobacteriaceae family capable of preventing or treating osteoarthritis symptoms in the knee of a human osteoarthritis patient as required by claims 1-2, 4-7, 24 and 25. The specification discloses bacteria of genus Adlercreutzia and genus Dehalobacterium correlated with osteoarthritis protection (Table 5). Actinomycetales order, Coriobacteriaceae family, Bacillales order, Dehalobacteriaceae family (also known as Peptococcaceae), and Adlercreutzia genus comprise several species as shown in Appendix B (Taxonomy of Actinomycetales order, Coriobacteriaceae family, Bacillales order, Dehalobacteriaceae family and Adlercreutzia genus, of record in Office Correspondence mailed on 05/23/2025). Dehalobacterium genus comprises at least 4 known species (Appendix B page 92).
The specification does not disclose a representative number of agents that increase an amount of bacteria of Actinomycetales order, bacteria of Coriobacteriaceae family, bacteria of Bacillales order, or bacteria of Dehalobacteriaceae family in the altered intestinal flora of the patient as required by claim 26. The specification does not disclose a representative number of combinations of amino acids that increase microbiome-mediated cartilage regeneration.
The specification does not disclose a representative number of agents that decrease the amount of bacteria of Bacteroidales order, Christensenellaceae family, Anaerostipes genus, Ruminococcaceae family in the altered intestinal flora of the patient as required by claim 27.
The specification discloses in Table 5 the microbiome associated with conferring OA protection identified through genome sequencing and discloses 3 genera Adlercreutzia, Staphylococcus, and Dehalobacterium. Table 6 discloses the microbiome associated with worsened OA outcome identified through genome sequencing and discloses one genus Anaerostripes.
The recited “one or more agents” in claims 26 and 27 are described in terms of their function and not their structure. There is no guidance in the specification as to which structure is capable of the required effect. Due to the extremely broad nature of the encompassed agents, there is no description of a representative number of agents which have the required function. The prior art has not established a strong correlation between structure and function of agents and one skilled in the art is not able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function. Without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely.
In view of the above considerations, the claims do not comply with the written description requirement and therefore, Applicant as of the effective filing date was not in possession of the full genus of claimed bacteria conferring prevention or treatment of osteoarthritis symptoms in a knee, nor the full genus of agents that increase or decrease the amounts of recited bacteria in claims 26 and 27.
Scope of Enablement Rejection
Claims 1-2, 4-7, and 24-27 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating osteoarthritis, does not reasonably provide enablement for preventing the osteoarthritis symptoms in a knee of a human patient having osteoarthritis. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
In making a determination that a disclosure does not satisfy the enablement requirement, the factors that may be considered include: (A) the breadth of the claims, (B) the nature of the invention, (C) the state of the prior art, (D) the level of one of ordinary skill, (E) the level of predictability in the art, (F) the amount of direction provided by the inventor, (G) the existence of working examples, and (H) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. While it is not essential that every factor be examined in detail, those factors deemed most relevant should be considered.
Nature of the invention. Claims 1-2, 4-7, and 24-25 are drawn to a method of preventing or treating osteoarthritis symptoms in a knee of a human patient having osteoarthritis comprising: identifying a human patient and administering to the human patient a composition consisting of fecal transplant bacteria from the Actinomycetales order, the Coriobacteriaceae family, the Bacillales order, the Dehalobacteriaceae family, or any combination thereof, as determined by 16S ribosomal RNA (rRNA) gene sequencing. Claim 26 is drawn to a method of preventing or treating osteoarthritis symptoms in a knee of a human patient in need thereof comprising administering to the human patient one or more agents that increase an amount of bacteria of Actinomycetales order, Coriobacteriaceae family, Bacillales order, or Dehalobacteriaceae family, in the altered intestinal flora of the human patient, wherein at least one of the one or more agents that increase an amount of bacteria consists of an amino acid mixture that increases microbiome-mediated cartilage regeneration. Claim 27 is drawn to a method of preventing or treating osteoarthritis symptoms in a knee of a human patient comprising administering to the human patient one or more agents that decrease an amount of bacteria of Bacteroidales order, Christensenellaceae family, Anaerostipes genus, Ruminococcaceae family, or any combination thereof, in the altered intestinal flora of the human patient.
Breadth of the claims. The breadth of the claimed invention is exceedingly large and fails to receive adequate support in the specification. Claims 1-2, 4-7, and 24-27 encompass preventing osteoarthritis symptoms in a knee of a human patient having osteoarthritis.
State of the prior art and Unpredictability. The state of the art is limited to the treatment or alleviation of symptoms. Tan (International Journal of Rheumatic Diseases 24.8 (2021): 984-1003, of record in Office Correspondence mailed on 05/23/2025) reports a role of the gut microbiome profile and osteoarthritis in humans, and reports probiotics may modulate the symptoms of osteoarthritis and could be potential therapeutic approaches (Abstract, para. 4 and 5). Tan reports human with knee OA administered probiotic Lactobacillus casei Shirota showed a significant reduction in WOMAC pain score, stiffness, and function (Table 4). Perrin (Nature (2014): 423-425, of record in Office Correspondence mailed on 05/23/2025) reports more than 80% of potential therapeutics fail when tested in people even after animal studies suggest that a treatment will be safe and effective (page 423 first para.). Ramasamy (Nutrients 13.4 (2021): 1272, Office Correspondence mailed on 05/23/2025) reports knee osteoarthritis (KOA) is linked to gut microbiome dysbiosis and reports humans with KOA have higher abundance of Coriobacteriaceae unclassified than health individuals (Figure 2). Ramasamy reports vitamin D supplementation could exert a beneficial role on the KOA-altered gut microbiome (page 10 para. 3). Prior art Kim (KR101495602 B1) teaches Bacillus subtilis C43 strain is used to treat osteoarthritis (page 2 para. 7).
No prior art teaching shows preventing of osteoarthritis symptoms in a knee of a human patient having osteoarthritis by administering a composition consisting of probiotics from a fecal transplant selected from at least one of bacteria of Actinomycetales order, bacteria of the Coriobacteriaceae family, bacteria of the Bacillales order, or bacteria of the Dehalobacteriaceae family as determined by 16S ribosomal RNA (rRNA) gene sequencing, one or more agents that increase an amount of bacteria of Actinomycetales order, bacteria of Coriobacteriaceae family, bacteria of Bacillales order, or bacteria of Dehalobacteriaceae family in the intestinal flora of the human osteoarthritis patient as determined by 16S ribosomal RNA (rRNA) gene sequencing, or one or more agents that decrease the amount of bacteria of Bacteroidales order, bacteria of Christensenellaceae family, bacteria of Anaerostipes genus, or bacteria of Ruminococcaceae family in an intestinal flora of the human osteoarthritis patient as determined by 16S ribosomal RNA (rRNA) gene sequencing. Therefore, the claimed method of preventing osteoarthritis symptoms in a knee of a human patient having osteoarthritis is highly unpredictable.
Guidance in the specification and working examples. The guidance in the specification is not commensurate in scope with the claimed invention. The specification discloses microbiome transplantation from cecal contents from donor mice (OA-susceptible B6 or OA-protected MRL) was filtered and administered via oral gavage ([0036]). The microbiome from OA-protected MRL/MpJ mice conferred lower OARSI score and reduced OA histopathology in OA-susceptible C57BL/6J mice ([0033], FIGs 1A and C, FIG 2, Table 1). The microbiome from B6 mice increased the OARSI score of germ-free mice (FIG 1B and Table 2). The microbiome from the mice cecum was sequenced using 16S ribosomal RNA (rRNA) gene sequencing. Table 3 shows the OTUs in B6 transplant. Table 4 shows the OTUS in MRL transplant. Table 5 shows the microbiome composition seen in B6 animals following MRL transplantation which are associated in with OA protection and Table 6 shows the microbiome associated with worsened OA outcome. The specification fails to provide guidance pertaining to preventing osteoarthritis symptoms in a knee of a human patient having osteoarthritis.
Amount of experimentation necessary. The above-mentioned details establish that one skilled in the art would not be able to make or use the full scope of claimed invention with a reasonable expectation of success and without undue experimentation.
Taking these factors into account, undue experimentation would be required by one of ordinary skill in the art to practice the full scope of the claimed invention. Thus, the claims are not fully enabled by the disclosure.
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 5-7 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.
Claim 5 recites bacteria of the Dehalobacteriaceae family and bacteria of Dehalobacterium genus. The claim is indefinite because bacteria of Dehalobacterium genus is also bacteria of the Dehalobacteriaceae family as disclosed by Applicant in Table 5 last row and in claim 25. It is unclear if a bacterium of the Dehalobacterium genus fulfils the requirement of bacteria of the Dehalobacteriaceae family or if the claim requires the bacteria of the Dehalobacteriaceae family to be different from the bacteria of the Dehalobacterium genus.
Claims 5 and 6 recite “composition consists of administering”. The claim is indefinite because it is unclear how a composition can consist of an active step. Applicant may consider amending the claims to delete “administering” in order to obviate the rejection.
Claim 7 recites the limitation "progression of osteoarthritis" in lines 2 and 5. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 7 depends, recites osteoarthritis symptoms. Applicant may consider amending the claim to recite osteoarthritis symptoms in order to obviate the rejection.
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 6 remains 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 6 requires administering bacteria of Bacteroidales order, bacteria of Christensenellaceae family, bacteria of Anaerostipes genus, and bacteria of Ruminococcaceae family. These bacteria do not further limit the composition of claim 1 because they do not belong to any of the bacterial orders or families recited in claim 1.
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.
Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR101495602 B1, published 02/2015) in view of Tan (International Journal of Rheumatic Diseases 24.8 (2021): 984-1003, of record in Office Correspondence mailed on 05/23/2025).
Regarding claim 1, Kim teaches that Bacillus subtilis (i.e., bacteria of the Bacillales order) can be used to treat osteoarthritis (page 2 para. 7). Kim teaches the strain is formulated into food or suppository and the dose is dependent on the weight of the patient (page 2 para. 10-12). Thus, one of ordinary skill in the art would understand that Kim’s patient can be a human.
Kim does not teach osteoarthritis symptoms in a knee or the osteoarthritis is associated with an altered intestinal flora.
However, Tan teaches that osteoarthritis affects humans and that the knee is the most common site of osteoarthritis (Abstract, page 984 left column first para). Tan teaches a link between microbiome dysbiosis and osteoarthritis (Abstract). Tan teaches 16S ribosomal RNA gene deep sequencing is used to detect the microbial DNA (page 989 right column second para.)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Kim by sequencing the 16S ribosomal RNA gene of the strain to confirm its identity and administering the Bacillus subtilis strain to a human with symptoms of osteoarthritis in the knee and with a microbiome dysbiosis. One of ordinary skill in the art would be motivated to do so in order to treat osteoarthritis. Since Kim teaches a desire to treat osteoarthritis using Bacillus subtilis, and since Tan teaches knee is the most common site of osteoarthritis, there is a reasonable expectation of success.
The limitation of “probiotics from a fecal transplant” is not considered to contribute to the patentability of the claimed method. There is no indication that the source of the Bacillus subtilis affects its structure.
The limitation “wherein the composition prevents or treats osteoarthritis symptoms of the knee having osteoarthritis” is not given weight because it expresses the intended result of recited method steps. See MPEP 2111.04.
Regarding claim 4, Kim does not teach the patient receives a concurrent antibiotic or a probiotic therapy. Thus, the limitation of “wherein the human patient does not receive a concurrent antibiotic or a probiotic therapy” is met since the reference is silent to it.
Response to Arguments
Applicant argues that there is sufficient written description to inform a skilled artisan that applicant was in possession of the claimed invention and that the recited species are the various "representative examples", that is, the representative examples are bacterial families or orders (out of hundreds or thousands found in the gut intestine), that are selected for the treatment. Nothing in the law requires that the fecal transplants are delineated at the taxonomic genus and species level.
In response to the argument, the claims recite administering bacteria from the Actinomycetales order, the Coriobacteriaceae family, the Bacillales order, the Dehalobacteriaceae family, or any combination thereof. The claims are drawn to a large and variant genus of bacteria as explained above. Applicant did not show a representative number of bacteria of the Actinomycetales order, the Coriobacteriaceae family, the Bacillales order, the Dehalobacteriaceae family can prevent or treat osteoarthiristis in knee of a human having osteoarthritis. The claims encompass any bacteria of these orders or families. There is no support in the specification that the function of preventing or treating osteoarthritis is a trait shared by the members of these bacterial orders or families. MPEP 2163 states a patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated. The specification discloses microbiome transplantation from cecal contents from donor OA-protected MRL mice into OA-susceptible B6 mice reduces OA histopathology in these OA-susceptible B6 mice ([0050]), and discloses sequencing of the microbiome of B6 transplant bacteria (Table 3), MRL transplant (Table 4), B6 animals following MRL transplantation (Table 5). The specification does not provide support for written description of the claimed genus of bacteria or agents.
Applicant argues that Applicants followed the teachings in the specification and were able to make and use the invention as claimed, and as such, the skilled artisan is able to fully practice the claimed invention.
In response to the argument, the specification does not reasonably provide enablement for preventing the osteoarthritis symptoms in a knee of a human patient having osteoarthritis. The specification discloses microbiome transplantation from cecal contents from donor OA-protected MRL mice into OA-susceptible B6 mice reduces OA histopathology in OA-susceptible B6 mice ([0050]). Prior art Kim (KR101495602 B1) teaches Bacillus subtilis C43 strain (i.e., bacteria of Bacillales order) is used to treat osteoarthritis (page 2 para. 7). Thus, one skilled in the art would not be able to make or use the full scope of claimed invention with a reasonable expectation of success and without undue experimentation.
Applicant argues Kim teaches the making of Bacillus subtilis from soybean fermentation for mass producing s-adenosyl-methionine (SAM), and it is the SAM that "may be utilized as a variety of pharmaceuticals or food compositions containing it, and that Kim does teach the transplantation claimed herein for preventing or treating osteoarthritis symptoms in a knee of a human patient having osteoarthritis.
In response to the argument, Kim teaches Bacillus subtilis produces S-adenosyl-L-methionine used for treating osteoarthritis. Thus, one skilled in the art would be motivated to administer Bacillus subtilis which produces s-adenosyl-methionine to treat osteoarthritis as taught by Kim.
Conclusion
THIS ACTION IS MADE FINAL. 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 MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699