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 claims
Clams 1-4, 6, 7 and 10-19 as amended on 10/27/2025 are currently pending.
Applicant’s election without traverse of the Group I (original claims 1-12) in the reply filed on 5/29/2024 and of the species A (“probiotic having beta-glucosidase activity and an esterase”) was/is acknowledged.
Claims 13-19 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/29/2024.
Claims 1-4, 6, 7 and 10-12 as amended on 10/27/2025 are under examination in the instant office action.
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.
Claims 1-4, 6, 7 and 10-12 as amended are/remain rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0263139 (Horcajada et al), US 2016/0120891 (Horcajada et al), Santos et al (World Journal of Microbiology and Biotechnology, 2012, Vol. 28, No. 6, pages 2435-2440) and US 2008/0014322 (Ibarra et al).
With regard to claim 1: The cited US 2016/0263139 (Horcajada et al) and US 2016/0120891 (Horcajada et al) are relied upon for the disclosure of a method for the treatment or prevention of synovitis and/or cartilage loss in an individual, wherein the method comprises step of administering to the individual a therapeutic composition comprising 2 components: 1) oleuropein; and 2) probiotic as additional bioactive component including probiotics that are Lactobacillus and Bifidobacterium; for example: see abstracts of both documents, see ‘139 at par. 0083, 0090 and see ‘891 at par. 0052, 0079-0080).
In view of the reference by Santos, probiotic bacteria belonging to Lactobacillus and Bifidobacterium, that are incorporated in the therapeutic compositions of the cited documents, inherently provide for enzymes with beta-glucosidase activity and esterase activity (page 2436, col.1, par. 2) and convert oleuropein into hydroxytyrosol (abstract). The cited US 2016/0263139 (Horcajada et al) and US 2016/0120891 (Horcajada et al) recognize therapeutic effect not only of oleuropein on synovitis and cartilage degradation but also of its subsequent metabolite hydroxytyrosol. For example: see ‘139 at par. 0077, 0081. For example: see ‘891 at par. 0033.
The cited US 2016/0263139 (Horcajada et al) and US 2016/0120891 (Horcajada et al) do not explicitly recognize the role and/or specific effect of incorporating probiotic into the therapeutic composition together with oleuropein.
However, US 2008/0014322 (Ibarra et al) explicitly teaches a mix of enzymes including beta-glucosidase and esterase and/or a bacteria including Lactobacillus as a source of hydrolytic enzymes beta-glucosidase and/or esterase provide for enzymatic hydrolysis of oleuropein to obtain metabolites hydroxytyrosol and elanolic acid, thereby, providing a desirable effect in increasing antioxidant activity and providing metabolites that are better and easily absorbed by human body (0071-0073, 0010). The cited US 2008/0014322 (Ibarra et al) teaches that hydrolysis of oleuropein is desirable in order to probed from beneficial phenolic derivatives (0071). The cited US 2008/0014322 (Ibarra et al) teaches and suggests the use of enzymes as isolated enzymes and the use of microorganism which can hydrolyze the polyphenols as viable options (0073).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to add components that provide for enzymatic activities of esterase and of beta-glucosidase (in a form of enzyme and/or in a form of a probiotic as a source of enzymes) into the oleuropein-containing therapeutic composition in the method of US 2016/0263139 (Horcajada et al) and/or US 2016/0120891 (Horcajada et al) with a reasonable expectation of success in treating or preventing synovitis and cartilage degradation because US 2016/0263139 (Horcajada et al) and US 2016/0120891 (Horcajada et al) recognize beneficial therapeutic effect of not only of oleuropein on synovitis and cartilage degradation but also of its subsequent metabolites including hydroxytyrosol and because oleuropein is hydrolyzed to beneficial metabolites hydroxytyrosol and elanolic acid by enzymatic activities of esterase and beta-glucosidase (in a form of enzyme and/or in a form of a probiotic as a source of enzymes) as taught by (US 2008/0014322 (Ibarra et al)). One of skill in the art would obviously recognize that probiotics, that are present in the oleuropein-containing therapeutic composition in the method of US 2016/0263139 (Horcajada et al) for treating or preventing synovitis and cartilage degradation, are the source of enzymatic activities of esterase and/or of beta-glucosidase that hydrolyze oleuropein into its beneficial metabolites hydroxytyrosol and elanolic acid. One of skill in the art clearly recognize that in the lack of one of enzyme (esterase or beta-glucosidase) in a source component, the other enzymatic source should be added to the therapeutic composition for hydrolysis of oleuropein into its metabolites hydroxytyrosol and elanolic acid as it is clearly obvious from the combined teaching of the cited references. One of skill in the art would be motivated to combine esterase with probiotic having only beta-glucosidase but not esterase into the oleuropein-containing therapeutic composition to provide for hydrolysis of oleuropein into its metabolites tahtn are recognized as beneficial in the methods for treating or preventing synovitis and cartilage degradation.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
As applied to claims 2 and 12: in the methods of US 2016/0263139 (Horcajada et al) and/or US 2016/0120891 (Horcajada et al) the individual under treatment is elderly. For example: see document US 2016/0263139 (Horcajada et al) at par. 0013, 0080. For example: see US 2016/0120891 (Horcajada et al) at par. 0153, 0175.
As applied to claims 3, 4 and 11: In the method of the cited document US 2016/0263139 (Horcajada et al) the individual with synovitis has osteoarthritis, rheumatoid arthritis and the conditions of synovitis are associated with lupus, gout, arthritis and combination thereof (par. 0008). In the method of the cited document US 2016/0120891 (Horcajada et al) the individual has osteoarthritis, rheumatoid arthritis and the conditions of synovitis are associated with osteoarthritis, rheumatoid arthritis, lupus (par. 0008, 0125, 0175).
As applied to claims 6 and 7: In the method of the cited document US 2016/0263139 (Horcajada et al) the therapeutic composition is administered orally (0093) and daily for at least one month (0079). In the method of the cited document US 2016/0120891 (Horcajada et al) the therapeutic composition is administered orally (0112) and daily for at least one month (0248).
As applied to claim 10: In the method of the cited document US 2016/0263139 (Horcajada et al) the therapeutic composition is provided as food (0096, 0102) and as drinks (0102). In the method of the cited document US 2016/0120891 (Horcajada et al) the therapeutic composition is provided as food (0094, 0110) and as drinks (0107).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Response to Arguments
Applicant's arguments filed on 3/19/2025 have been fully considered but they are not all found persuasive.
With regard to claim rejection under 35 U.S.C. 103 as being unpatentable over US 2016/0263139 (Horcajada et al), US 2016/0120891 (Horcajada et al), Santos et al ( World Journal of Microbiology and Biotechnology, 2012, Vol. 28, No. 6, pages 2435-2440) and US 2008/0014322 (Ibarra et al) Applicants argue that the cited prior art does not teach or suggest a composition comprising 1) oleuropein, 2) esterase, and 3) probiotic having beta-glucosidase activity but without esterase activity for treating conditions including synovitis, loss of bone and cartilage as presently recited in the claims.
This argument is not found persuasive as applied to the claimed invention in view of as-filed specification and in view of combined teaching by the cited prior art references.
With regard to the cited prior art the facts are: The cited US 2016/0263139 (Horcajada et al) and US 2016/0120891 (Horcajada et al) disclose a method for the treatment or prevention of synovitis and/or cartilage loss in an individual, wherein the method comprises step of administering to the individual a therapeutic composition comprising 2 components: 1) oleuropein; and 2) probiotic Lactobacillus and Bifidobacterium as explained above. The cited US 2016/0263139 (Horcajada et al) and US 2016/0120891 (Horcajada et al) clearly recognize that therapeutic effect provided not only by oleuropein itself but also by its subsequent metabolite hydroxytyrosol. Oleuropein is hydrolyzed to metabolites hydroxytyrosol and elenolic acid by both enzymes esterase and beta-glucosidase that are provided for oleuropein hydrolysis in a form of enzymes and/or as probiotics such as Lactobacillus having esterase and/or beta-glucosidase as clearly taught by US 2008/0014322 (Ibarra et al) and Santos as explained above.
Thus, it would be obvious to combine 3 claim-recited components as now amended because both enzymatic activities are needed for oleuropein hydrolysis in order to provide for additional metabolites beneficial for treating synovitis and cartilage loss. One of skill in the art clearly recognize that in the lack of one of enzyme (esterase or beta-glucosidase) in a source component of a therapeutic composition, the other enzymatic source should be added to the therapeutic composition for hydrolysis of oleuropein into its metabolites hydroxytyrosol and elanolic acid. One of skill in the art would be motivated to combine “esterase” and “probiotic having only beta-glucosidase but not esterase” into the “oleuropein-containing therapeutic composition” to provide for hydrolysis of therapeutic oleuropein into its therapeutic metabolites that are recognized as beneficial in the methods for treating or preventing synovitis and cartilage degradation.
With regard to the presently claimed invention in view of as-filed specification:
The as-filed speciation does not describe a criticality or an importance of a claim-recited combination of “esterase” and “probiotic having only beta-glucosidase but not esterase” over other multiple alternative combinations of enzymes beta-glucosidase and/or esterase and/or probiotics having beta-glucosidase and/or esterase in the oleuropein-containing compositions.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
No claims are allowed.
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 VERA AFREMOVA whose telephone number is (571)272-0914. The examiner can normally be reached Monday-Friday: 8.30am-5pm EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Vera Afremova
February 12, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653