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 .
Information Disclosure Statement
The information disclosure statement (IDS) dated 05/06/2026 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Status of the application
Receipt of applicant’s remarks and claim amendments filed on 05/06/2026 are acknowledged.
In light of claim amendments, previous 112(b) rejection is withdrawn.
However, applicants’ arguments for the previous 103 rejection are found not persuasive. Accordingly, the previous rejections are maintained and modified to address claim amendments. Please see the examiners response to applicants arguments below.
Response to Arguments
Applicants’ argue that Shi is directed to medical applications and the disclosure focuses on treating wounds, skin lesions, and coating medical devices to prevent biofilm formation. A POSA in the medical field is concerned with biocompatibility, sterility, and therapeutic delivery. A POSA in the laundry field would not have looked to a reference on wound care or medical device coatings for a solution to biofilm on clothing. The problems are different, the environments are different, and the expectations of success are different.
Criticality is in the property of polypeptide having thermolysin activity. Shi teaches treating bacterial biofilm on the surface of medical devices by administering thermolysin, and so, thermolysin is expected to retain its property on the textile, unless applicants prove that the teachings of Shi cannot be extrapolated to textile.
Applicants argue that while Alekseyev discloses cleaning compositions, its disclosure is generic and does not provide the critical link. It does not teach or suggest that the specific thermolysin sequence (SEQ ID NO: 1) would be uniquely effective against biofilms on textiles, nor does it disclose the unexpected benefits of such an application as demonstrated in Applicant's specification.
In fact, SEQ ID NO:3 of Alekseyev is identical to applicants claimed SEQ ID NO:1 and the variants of SEQ ID NO:3 of Alekseyev are interpreted as applicants polypeptide having at least 80% sequence identity to SEQ ID NO:1. Further, composition of SEQ ID NO:3 of Alekseyev shows thermolysin property and its utility comprising contacting a surface or an item with a cleaning composition.
So, the property of thermolysin activity is common in both cases, i.e., Shi and Alexseyev, and so, the sequences from the teachings of Shi and Alexseyev are equivalents, and are exchangeable. Case law holds that the mere substitution of an equivalent (something equal in value or meaning, as taught by analogous prior art) is not an act of invention; where equivalency is known to the prior art, the substitution of one equivalent for another is not patentable. See In re Ruff 118 USPQ 343 (CCPA 1958).
Applicants argue that the claimed invention achieves unexpected and unpredictable results.
The shown data in Examples 5 and 8 are expected, since the recited product or composition is not different from the product or composition of cited art. Presence of a property not possessed by the prior art is evidence of nonobviousness. So, applicants fails to prove that the shown data is not expected from the teachings of cited art. Applicants need to compare the composition of cited art and not with detergent and bacteriocidal, since the rejection is based on the recited sequences.
Based on prior art disclosures, claimed sequences would have been expected to possess same activity. If the sequences from the prior art do not possess such activity, then claimed subject matter possess unexpected results, which is sufficient to establish unobviousness within the meaning of 35 U.S.C. 103.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-6 and 8-21 are rejected under 35 U.S.C. 103 as being unpatentable over Shi (WO2018/020435A1) in view of Alekseyev (US 2016/0060611 A1).
For claims 1:
Shi teaches a method of reducing or eliminating a bacterial biofilm on a non-biological surface, the method comprising administering to the non-biological surface a composition comprising thermolysin [see claim 15], wherein thermolysin is a thermostable metalloproteinase made by a fermentation process from a bacterial species called Bacillus thermoproteolyticus rokko that cleaves at the N-terminus of the hydrophobic residues leucine, phenylalanine, valine, isoleucine, alanine, and methionine and the CAS No. for thermolysin is 9073-78-3 [see 00029].
Shi also teach a method of treating a surface of an article of manufacture to prevent or reduce the likelihood of biofilm formation on said surface, the method comprising coating the surface with a composition comprising thermolysin, wherein article is a medical device [see claims 20-21].
Differences between Shi and instant claim are as follows:
(i) Shi is silent on removing biofilm on a textile;
(ii) Shi is silent on applicants recited sequences with respect to SEQ ID NO:1.
With regard to (i) of above, Shi teaches treating surface of medical devices. Since the property of the thermolysin is critical and it should not matter whether it is medical device or textile, unless applicants prove that the teachings of Shi cannot be extrapolated to textile.
With regard to (ii) of above, Alekseyev teaches a cleaning compositions and its utility comprising thermolysin and its variants, wherein variants having one or more substitutions as compared to a reference or parent sequence, which is represented by SEQ ID NO:3 [see abstract, 0003-0004, 0038 and 0142], wherein utility comprising contacting a surface or an item with a cleaning composition [0024].
The SEQ ID NO:3 of Alekseyev is identical to applicants claimed SEQ ID NO:1 and the variants of SEQ ID NO:3 of Alekseyev are interpreted as applicants polypeptide having at least 80% sequence identity to SEQ ID NO:1.
In the above teachings, cleaning surface can be interpreted as surface comprising biofilm and since the sequence is identical in both cases, the sequence of Alekseyev expected to remove biofilm on the surface. Even if the surface does not have biofilm, since the sequence is identical in both cases, and so, the sequence of Alekseyev expected to treat or prevent biofilm formation on the surface. In addition, thermolysins are known as highly thermostable zinc-metalloproteinase produced by Bacillus thermoproteinolyticus that functions as a robust protease, specifically cleaving peptide bonds at the N-terminus of hydrophobic amino acids (Leu, Phe, Val, Ile, Ala, Met), and so, in light of common properties, these thermolysins are equivalents and so, are exchangeable. Case law holds that the mere substitution of an equivalent (something equal in value or meaning, as taught by analogous prior art) is not an act of invention; where equivalency is known to the prior art, the substitution of one equivalent for another is not patentable. See In re Ruff 118 USPQ 343 (CCPA 1958).
For claim 4:
Shi teaches the concentration of thermolysin in their composition ranges from 0.00001 mg/mL to 10 mg/mL [see 00030 and example 1].
For claim 5:
Though Shi explicitly does not teach that their composition is laundry composition, however, the composition expected to clean biofilm on the surface of laundry machine and so, it can be a laundry composition and can be included in the laundry composition.
In addition, Alekseyev teaches their composition is laundry detergent composition [see claim 37].
For claim 6:
Shi teaches cleaning non-biological surface, and after cleaning, rinsing is a common sense and so this limitation is trivial.
For claims 8-9:
Shi teaches that their method reduces or eliminates a bacterial biofilm on a non-biological surface [see claim 15].
For claims 10-11:
Shi exemplified and quantified the amount of biofilm left on the surface after the treatment [see Fig.1], wherein more than 50% biofilm is removed with an amount ranges from 0.01 to 10 mg/mL.
For claim 12:
Shi is silent on pH in their disclosure. However, pH of composition is directly associated with the stability of active ingredient. Therefore, a skilled person in the art would determine suitable pH for the composition through a routine experimentation and arrive at applicants pH with a reasonable expectation of success.
Alternatively, Alekseyev teaches pH of 6 and 8 for their thermolysin compositions [see 0004 and claim 7], wherein the thermolysin sequence of Alekseyev is identical applicants claimed sequence.
For claim 13:
See For claim 1 above.
For claim 14:
Shi teaches that administering their composition comprising thermolysin by spraying or dipping [see 00046], that means thermolysin must be in the wash liquor.
For claims 15-16:
Shi teaches 16 hours of contact time and temperature at 37oC [see Example 1].
For claims 17-18:
Shi teaches that their composition further comprises surfactants [see 00033].
Alekseyev also teaches that their compositions comprises surfactants [0135 and 0224].
For claim 19:
Shi teaches that their composition is applied on surfaces to lower biofilm, and so, the composition is interpreted as detergent composition.
Alekseyev also teach their thermolysin composition is detergent composition [see 36].
For claim 20:
Shi silent on additional enzymes in their composition. However, Alekseyev teach that their thermolysin composition further comprises additional enzyme selected from acyl transferases, alpha-, beta-amylases etc. [see claim 44].
For claim 21:
Shi silent on contacting step takes place in a washing machine or a dishwasher.
Shi teaches a method of treating a surface of an article of manufacture to prevent or reduce the likelihood of biofilm formation on said surface, the method comprising coating the surface with a composition comprising thermolysin, wherein article is a medical device [see claims 20-21].
In this case, both medical device and applicants claimed surfaces are hard surfaces, and so teachings of Shi expected to treat applicants claimed surfaces, absent evidence to the contrary.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants sequences and their utility in treating biofilm, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed method with a reasonable expectation of success.
The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).
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 SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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