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 .
Applicant’s amendment and response filed on 1/14/2026 have been received and entered into the case. Claims 10, 12-13 and 20 have been canceled. Claims 1-9, 11 and 14-19 are pending, Claims 1-7 and 16 have been withdrawn, and Claims 8-9, 11, 14-15, and 17-19 have been considered on the merits, insofar as they read on the elected species of urinary tract infection. All arguments have been fully considered.
Withdrawn Rejections
Rejections of claims 8-15, 17-18 and 20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of applicant’s amendments.
Rejections of Claims 8-15 and 17-20 under 35 U.S.C. 103 as being unpatentable over Amir (US 2019/0000908 A1; 1/3/2019) in view of Bionity (https://www.bionity.com/en/encyclopedia/Serrapeptase.html. 2013;1-2.), Colgan et al (Am Fam Physician. 2011;84(7):771-776.) and Rawat et al (Research J. Pharm. and Tech. 2008;1(3):124-131.) are withdrawn in view of applicant’s amendments.
Claim Objections
Claim 19 is objected to because of the following informalities: the recitation of “antibiotices” on line 3 is suggested to read “antibiotics”. Appropriate correction is required.
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 11, 18 and 19 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 pre-AIA the applicant regards as the invention.
Claim 11 is dependent upon a canceled claim (claim 10).
Claim 19, line 3-4, the recitation of “active ingredients” is indefinite as it is unclear how the term “active ingredients” is being claimed, does a component has to have a therapeutic effect or an antibiotic effect, or other effects? However, in the interest of compact prosecution, claim 19 is interpreted as the method comprising administration of Serratiopeptidase, D-Mannose or salts thereof, and one or more antibiotics.
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 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 of this title, 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 8-9, 11, 14-15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Amir (US 2019/0000908 A1; 1/3/2019) in view of Bionity (https://www.bionity.com/en/encyclopedia/Serrapeptase.html. 2013;1-2.), Colgan et al (Am Fam Physician. 2011;84(7):771-776.) and Rawat et al (Research J. Pharm. and Tech. 2008;1(3):124-131.).
The instant claims recite a method of treating infectious disease, wherein said treatment comprises administration of 0.1 mg to 200 mg of Serratiopeptidase; 0.1 mg to 1000 mg of D-Mannose or salts thereof; and a therapeutically effective amount of one or more antibiotics, wherein said administration is in same composition and said treatment is administered to humans or animals.
Amir teaches a method of treating urinary tract microbial infection (para 0010, 0033) comprising administering to a subject a therapeutically effective amount of a composition comprises D-Mannose (a therapeutically effective amount) (para 0010, 0034, 0048) and an antibiotic (a therapeutically effective amount) (para 0035, 0037), wherein the subject is a human (para 0047), the D-Mannose is 250 mg (para 0075), the antibiotic includes Nitrofurantoin (para 0035, 0037, 0038), and the administration of the composition comprises D-Mannose with said antibiotic (a therapeutically effective amount) reduces the minimal effective dose of a urinary tract antibiotic in treating the subject afflicted with the urinary tract microbial infection (para 0012).
Amir does not teach the method wherein the composition comprises 0.1 mg to 200 mg, 10 mg to 200 mg, 30 mg to 120 mg of Serratiopeptidase (claims 8-9 and 17).
However, Amir does teach the method is for treating urinary tract microbial infection, wherein the method comprises administering antibiotic. Before the effective filing date of the claimed invention, it was well-known in the art that Serratiopeptidase is used to facilitate the therapeutic effect of antibiotics in the treatment of infection, that in urology Serratiopeptidase has been successfully employed to treat cystitis (see p.1 para 12 of Bionity), and that cystitis is a common type of urinary tract infection (see Abstract of Colgan). In addition, Rawat teaches Serratiopeptidase improves the delivery of antibiotics such that increased concentrations of the antimicrobial agents reach the site of the infection (p.127 col right – para 2), wherein recommended dosage of Serratiopeptidase is 1-3 tablets of 10 mg three times per day (p.128 col left – para 5).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate an optimized amount of Serratiopeptidase in the composition used in the method of Amir, since Amir discloses a method of treating urinary tract microbial infection comprising administering a composition comprises an antibiotic, and Rawat discloses that Serratiopeptidase improves the delivery of antibiotics such that increased concentrations of the antimicrobial agents reach the site of the infection. Furthermore, Bionity discloses that Serratiopeptidase has been successfully employed to treat cystitis, a common type of urinary tract infection as evidenced by Colgan. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited references to incorporate an optimized amount of Serratiopeptidase in the composition used in the method of Amir, with a reasonable expectation for successfully treating urinary tract microbial infection.
Regarding claim 18, Amir does teach the method wherein D-Mannose is 250 mg (para 0075), and the determination of a therapeutically effective amount is well within the capability of those skilled in the art (para 0062-0063). Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize the amount of D-Mannose as a matter of routine experimentation. Generally, differences in concentration will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. (MPEP 2144.05 II) Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to optimize the amount of D-Mannose, with a reasonable expectation for successfully treating urinary tract microbial infection.
Response to Arguments
Applicant argues that the term “active ingredient” is defined in the specification as in para 0010 and 0012.
These arguments are not found persuasive because para 0010 and 0012 in the instant specification do not prove a clear definition of “active ingredient”.
Applicant argues that Amir does not discloses a composition comprising Serratiopeptidase, D-mannose and an antiinfection agent, and that the examiner uses improper hindsight.
These arguments are not found persuasive because it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, Amir does teach the method of treating urinary tract microbial infection comprising administering a composition comprises D-mannose and an antibiotic, and Rawat does teach that Serratiopeptidase improves the delivery of antibiotics such that increased concentrations of the antimicrobial agents reach the site of the infection. Therefore, a skill in the art would incorporate Serratiopeptidase into the composition used in the method of Amir for treating urinary tract microbial infection.
Applicant argues unexpected results.
These arguments are not found persuasive. Affidavit filed on 1/14/2026 is acknowledged and reviewed. It is noted that evidence relied upon should establish that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. In the instant case, there was no comparison of the claimed invention with the closest prior art, and thereby lack of basis for judging the practical significance of data with regard to the disclosed unexpected results. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. (MPEP 716.02) In the instant case, evidence in the affidavit is not commensurate in scope with claims: 1) claim 8 is directed to administering Serratiopeptidase, D-mannose or salts thereof, and one or more antibiotics to humans or animals, but evidence in the affidavit demonstrates a different test; 2) claim 8 recites 0.1 mg to 200 mg of Serratiopeptidase and 0.1 mg to 1000 mg of D-Mannose or salts thereof, but evidence in the affidavit demonstrates 25 mg of Serratiopeptidase and 25 mg of D-Mannose (one data point over the claimed broad range); and 3) claim 8 recites one or more antibiotics, but evidence in the affidavit demonstrates Nitrofurantoin as the antibiotic (again, a single species over the claimed broad range).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached on (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759