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 .
Priority
The instant application is a U.S. Continuation Application of 16/091,279 filed on 10/4/2018, now U.S. Patent No. 10,939,685, which is a U.S. National Phase of PCT/US17/26090 filed on 4/5/2017, and which claims priority to U.S. Provisional Application No. 62/318,597 filed on 4/5/2016.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 11/13/2025 has been entered.
DETAILED ACTION
Applicant’s amendment submitted 11/13/2025 is acknowledged. Claims 1 and 24 are currently amended. Claims 2-3, 9-13, 17-18, 20-23, 25-31, and 36-39 are canceled.
Claims 1, 4-8, 14-16, 19, 24, 32-35, and 40-43 remain pending in the instant application.
Claims 33 and 40-42 remain withdrawn pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claims 1, 4-8, 14-16, 19, 24, 32, 34-35, and 43 are the subject of this office action.
Claim Objections
Claims 4 and 8 are objected to because of the following informalities:
Claim 4 is correctly identified as “Previously Presented” in the claim set filed 11/13/2025, but the dash in “5’-ribonucleotide“ in line 9 is improperly marked with an underline, which had been previously amended in the claims submitted 12/1/2023.
Similarly, claim 8 is correctly identified as “Previously Presented” in the claim set filed 11/13/2025, but comprises an underline in line 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) – Indefinite
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 1, 4-8, 14-16, 19, 24, 32, 34-35, and 43 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 1 recites the limitation "the solid substrate comprising microorganisms" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites a method for reducing an amount or an activity of microorganisms on a solid substrate by removing biofilm from a surface of the solid substrate” in the preamble. The solid substrate “comprising microorganisms” as recited in line 3 does not agree with earlier recitations of a biofilm on the surface of the solid substrate as recited in the preamble and is further unclear whether the process step applies to another distinct solid substrate comprising microorganisms. Therefore, the claim limitation, “the solid substrate comprising microorganisms,” recited in line 3 lacks antecedent basis.
Claims 4-8, 14-16, 19, 24, 32, 34-35, and 43 are also rejected for being dependent on a rejected base claim and failing to remedy the issue set forth above.
Claim Rejections - 35 USC § 112(d) – Improper Dependent Claim
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.
Claims 4-7 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 4 recites “the one or more enzymes” in line 1. Claim 4 depends from claim 1, which recites “one or more secretory fungal enzymes derived from TM-417” in line 4. Since claim 4 does not specify the one or more enzymes are one or more secretory fungal enzymes derived from TM-417, the enzymes recited in claim 4 are not required to be secretory fungal enzymes derived from TM-417, and thus broader in scope than claim 1.
Claim 5 recites “wherein the one or more enzymes comprise two or more enzymes” in lines 1-2. Claim 6 recites “wherein the one or more enzymes comprise three or more enzymes” in lines 1-2. Claim 7 recites “wherein the one or more enzymes comprise a protease” in lines 1-2. Claims 5-7 depend from claim 1, which recites “one or more secretory fungal enzymes derived from TM-417” in line 4. Since claims 5-7 do not specify the one or more enzymes are one or more secretory fungal enzymes derived from TM-417, the one or more enzymes recited in claims 5-7 broaden the scope of the one or more secretory fungal enzymes derived from TM-417, as recited in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 (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 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.
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, 4-8, 19, 24, 32, 34-35, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Johansen (US6,100,080) in view of Deinhammer et al. (US2011/0104141) and Landry’s Masters Thesis (“Purification and Characterization of Novel Nucleases from a Thermophilic Fungus" (2012). Masters Theses 1911 - February 2014. 804; of record in the IDS filed 8/9/2021; hereinafter “Landry”).
Regarding claims 1, 4-7, 19, 24, 32, and 43, Johansen teaches a method for cleaning and disinfecting a surface at least partly covered by a biofilm layer comprising the steps of contacting the biofilm with a cleaning composition comprising one or more hydrolases in an amount effective for either fully or partly removing or releasing the biofilm layer from the surface; and contacting the biofilm with a bactericidal disinfecting composition comprising an oxidoreductase in an amount effective for killing the living bacterial cells present in the biofilm (see Abstract, Col. 1, line 56-Col.2, line 53). Fully removing the biofilm layer and killing the living bacterial cells present in the biofilm is interpreted as reducing an amount of 100% of microorganisms on a surface, which is considered to read on claims 19 and 24. Johansen further teaches a surface is any surface that may be covered in a biofilm layer, such as, metal, plastics, rubber, board, glass, wood, paper, concrete, rock, marble, gypsum, ceramic materials (see Col. 2, lines 28-33). Johansen further demonstrates removal of biofilms from stainless steel solid surfaces, reading on claim 32 (see Example 1). Johansen further teaches hydrolases useful in the invention including amylases and proteases (see Col. 2, lines 55-63). Johansen further teaches the hydrolytic enzyme may be a proteolytic enzyme of fungal origin (see Col. 3, lines 33-38).
Johansen does not specifically teach one or more secretory fungal enzymes derived from TM-417.
Deinhammer teaches methods for preventing, removing, reducing, or disrupting biofilm present on a surface by contacting the surface with alpha-amylase derived from a bacterium (see paragraph [0010]). Deinhammer teaches the surface may be any hard surface such as metal, plastics, rubber, board, glass, wood, paper, concrete, rock, marble, gypsum, and ceramic materials (see paragraph [0011]). Deinhammer further teaches the alpha-amylase composition may further comprise one or more other enzymes capable of degrading exo-polymeric materials generated by the biofilm, which together with the cells form a thick layer (see paragraph [0040]). Deinhammer teaches the one or more other enzymes capable of degrading exo-polymeric materials generated by the biofilm includes amylase, deoxyribonuclease, invertase, proteolytic enzyme, and ribonuclease (see paragraph [0041]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further included deoxyribonuclease, invertase, and ribonuclease, as taught by Deinhammer, in the cleaning composition used to clean and disinfect a surface covered in biofilm, as taught by Johansen. One of ordinary skill in the art would have been motivated to further include deoxyribonuclease, invertase, and ribonuclease to degrade the exo-polymeric materials generated by the biofilm, yielding predictable results.
Johansen in view of Deinhammer do not teach one or more secretory fungal enzymes derived from TM-417.
Landry teaches the thermophilic fungi TM-417 isolated from composted horse manure and teaches that TM-417 produces the enzymes amylase, invertase, DNase, RNase, and protease, reading on claims 4-7 (see p.32, last paragraph, p.55, 1st paragraph, and paragraph bridging p.57-58). Landry teaches that the enzymes amylase, invertase, DNase, RNase, and protease are secreted by TM-417 since extracellular activity by these enzymes are demonstrated (see p.v, 1st paragraph, p.55, 1st paragraph, and paragraph bridging pp.57-58). Landry teaches that the ultimate biotechnological potential of thermophilic fungi lies in their secretory enzymes, since they demonstrate high temperature optima and long shelf life (page 10, 1st paragraph). Landry teaches the purification of DNase with 98% recovery from a concentrated fraction and teaches the purification of RNase with 98% recovery from a concentrated fraction, reading on the limitations of claim 43 (see p.75, Table 4, and p.78, Table 5).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included the enzymes amylase, invertase, DNase, RNase, and protease secreted from TM-417, as taught by Landry, in the cleaning composition used to clean and disinfect a surface covered in biofilm, as taught by Johansen in view of Deinhammer, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to include the TM-417 secreted enzymes amylase, invertase, protease, DNase, and RNase because Johansen teaches hydrolytic enzymes are useful for cleaning compositions used to remove biofilms from surfaces and Deinhammer further teaches amylase, invertase, DNase, RNase, and protease help degrade exo-polymeric materials generated by biofilms, which would yield predictable results. Additionally, one of ordinary skill in the art would have been motivated to use the enzymes derived from TM-417 because Landry teaches secreted enzymes from thermophilic fungi have great biotechnological potential due to their high temperature optima and long shelf life.
Thus, Johansen in view of Deinhammer and Landry teach a method for cleaning and disinfecting a surface at least partly covered by a biofilm layer comprising the steps of contacting the biofilm with a cleaning composition comprising the TM-417 secreted enzymes amylase, invertase, protease, DNase, and RNase in an amount effective for either fully or partly removing or releasing the biofilm layer from the surface; and contacting the biofilm with a bactericidal disinfecting composition comprising an oxidoreductase in an amount effective for killing the living bacterial cells present in the biofilm; wherein the surface is any surface that may be covered in a biofilm layer, such as, stainless steel, metal, plastics, rubber, board, glass, wood, paper, concrete, rock, marble, gypsum, ceramic materials, which reads on claims 1, 4-7, 19, 24, 32, and 43.
Regarding claim 8, Johansen teaches the enzymes to be used in the method of invention may be monocomponent, i.e., isolated from other proteins or enzymes (Col. 8, lines 4-7). This is interpreted as isolating the enzymes to be used in the method prior to their use.
Johansen and Deinhammer do not teach that the one or more enzymes are purified using size exclusion chromatography in combination with an affinity-based membrane purification system.
Landry teaches DNase and RNase were purified 145.58-fold and 127.6-fold respectively using a combination of size exclusion chromatography and a novel affinity membrane purification system, which reads on claim 8 (see Abstract, p.v, 1st paragraph and p.78, Table 5).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have isolated the TM-417 DNase and RNase enzymes by the combination of size exclusion chromatography and novel affinity membrane purification system, as taught by Landry, to provide purified enzymes for the cleaning composition used in the method of Johansen in view of Deinhammer and Landry, to arrive at the claimed invention. One of ordinary skill would have been motivated to because Johansen suggests the enzymes comprised in the composition used in the method for cleaning and disinfecting a surface at least partly covered by a biofilm layer could be monocomponent and Landry teaches a high-purification method for obtaining enzymes which are useful in the composition of Johansen, yielding predictable results. Thus claim 8 is prima facie obvious.
Regarding claims 34 and 35, Johansen teaches biofilms are a severe problem in medical science resulting in contaminated endoscopes (see Col. 1, lines 24-28). Endoscopes are considered to read on a surgical tool medical device as recited in claim 35. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have decontaminated endoscopes with the cleaning composition of Johansen in view of Deinhammer and Landry to provide decontaminated surgical tools for medical science, yielding predictable results.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Johansen (US6,100,080) in view of Deinhammer et al. (US2011/0104141) and Landry’s Masters Thesis (“Purification and Characterization of Novel Nucleases from a Thermophilic Fungus" (2012). Masters Theses 1911 - February 2014. 804; of record in the IDS filed 8/9/2021; hereinafter “Landry”), as applied to claims 1, 4-8, 19, 24, 32, 34-35, and 43 above, and further in view of Bourguet et al. (Applied and Environ. Microbiol., (2012), Vol. 78(8), pp.3025-3027; of record).
Johansen in view of Deinhammer and Landry teach the invention of claim 1 as outlined in the rejection above.
Regarding claim 14, Johansen teaches the cleaning composition comprises one or more hydrolases (see Col. 1, line 56-Col.2, line 67).
Johansen in view of Deinhammer and Landry do not disclose that the composition further comprises ampD which is not derived from TM-417.
Bourguet teaches that the glycosyl hydrolase ampD encoded from Bacillus cereus E33L gene has a very high lytic activity against Bacillus anthracis and other closely related Bacillus isolates, is very stable, and purified preparations were able to store at 4ºC for at least 8 months without loss of activity and did not appear to be degraded by proteases (see p.3025, left column, 1st-2nd paragraphs and p.3027, left column, 1st paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included B. cereus E33L ampD enzyme, as taught by Bourguet, in the cleaning composition comprising one or more hydrolases used in the method for cleaning and disinfecting a surface at least partly covered by a biofilm layer, as taught by Johansen in view of Deinhammer and Landry, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated because Johansen teaches the composition comprises one or more hydrolases and Bourguet teaches that ampD is a glycosyl hydrolase that has antibacterial activities against B. anthracis and other closely related Bacillus isolates, which would yield predictable results. Thus claim 14 is prima facie obvious.
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Johansen (US6,100,080) in view of Deinhammer et al. (US2011/0104141) and Landry’s Master Thesis (“Purification and Characterization of Novel Nucleases from a Thermophilic Fungus" (2012). Masters Theses 1911 - February 2014. 804; of record in the IDS filed 8/9/2021; hereinafter “Landry”), as applied to claims 1, 4-8, 19, 24, 32, 34-35, and 43 above, and further in view of Meijer et al. (Microbiol. Molec. Biol. Rev., 2001, Vol. 65(2), pp.261-287).
Johansen in view of Deinhammer and Landry teach the invention of claim 1 as outlined in the rejection above.
Regarding claims 15 and 16, Johansen teaches the cleaning composition comprises one or more hydrolases (see Col. 1, line 56-Col.2, line 67).
Johansen, Deinhammer, and Landry do not disclose lysozyme which is not derived from TM-417 or that the lysozyme is phi29 lysozyme.
Meijer teaches a Bacillus phage phi29 lysozyme encoded by gene 15 of phi29, which is also known as peptidoglycan hydrolase (see p.282, left column, 1st paragraph). Meijer further teaches at the end of the bacteriophage infection of bacteria, the lysozyme/peptidoglycan hydrolase is recruited to the cell wall, resulting in lysis of the infected cell and release of the phage progeny (see p.282, left column, 1st paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further included phi29 lysozyme, as taught by Meijer, in the cleaning composition comprising one or more hydrolases used in the method for cleaning and disinfecting a surface at least partly covered by a biofilm layer, as taught by Johansen in view of Deinhammer and Landry, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to because Johansen teaches the composition comprises one or more hydrolases and Meijer teaches a hydrolase from phi29 that is known to attack Bacillus cell walls and lyse the cells, which would yield predictable results. Thus, claims 15 and 16 are prima facie obvious.
Non-Statutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4-8, 14-16, 19, 24, 32, 34-35, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,939,685 to Sinclair in view of Donlan et al. (Clin. Microbiol. Rev., 2002, Vol. 15(2), pp.167-193) and Johansen (US6,100,080).
Claim 1 of Sinclair ‘685 recites a method for reducing an amount or an activity of microorganisms in a wound on a subject (lines 1-2), comprising: contacting the wound comprising the microorganisms with a composition comprising one or more enzymes derived from TM-417 (lines 2-5), thereby reducing the amount or the activity of the microorganisms (lines 5-6).
Claim 2 of Sinclair ‘685 recites the method of claim 1, wherein the one or more enzymes comprise at least one enzyme selected from the group consisting of urease, DNase, RNase, exonuclease, endonuclease, ribonuclease, amylase, acetoin reductase, an indole-3-acetamide hydrolase, a tryptophan monooxygenase, an acetolactate synthetase, an α-acetolactate decarboxylase, a pyruvate decarboxylase, a diacetyl reductase, a butanediol dehydrogenase, an aminotransferase, a tryptophan decarboxylase, an amine oxidase, an indole-3-pyruvate decarboxylase, an indole-3-acetaldehyde dehydrogenase, a tryptophan side chain oxidase, a nitrile hydrolase, a nitrilase, a peptidase, a protease, an adenosine phosphate isopentenyltransferase, a phosphatase, an adenosine kinase, an adenine phosphoribosyltransferase, CYP735A, a 5′-ribonucleotide phosphohydrolase, an adenosine nucleosidase, a zeatin cis-trans isomerase, a zeatin O-glucosyltransferase, a β-glucosidase, a cis-hydroxylase, a CK cis-hydroxylase, a CK N-glucosyltransferase, a 2,5-ribonucleotide phosphohydrolase, an adenosine nucleosidase, a purine nucleoside phosphorylase, a zeatin reductase, a hydroxylamine reductase, a 2-oxoglutarate dioxygenase, a gibberellic 2B/3B hydrolase, a gibberellin 3-oxidase, a gibberellin 20-oxidase, a chitosanase, a chitinase, a β-1,3-glucanase, a β-1,4-glucanase, a β-1,6-glucanase, an aminocyclopropane-1-carboxylic acid deaminase, chitosanase, a cellulase, a lipase, a lignin oxidase, a glycoside hydrolase, a phosphatase, a nitrogenase, a nuclease, an amidase, a nitrate reductase, a nitrite reductase, an amylase, an ammonia oxidase, a ligninase, a glucosidase, a phospholipase, a phytase, a pectinase, a glucanase, a sulfatase, a xylanase, an endocellulase, an exocellulase, a β-glucosidase, phospholipase, acetate kinase, phosphotransacetylase, lactate dehydrogenase, pyruvate decarboxylase (PDC), alcohol dehydrogenase (ADH), xylose isomerase, xylulokinase, L-arabinose isomerase, L-ribulose-5-phosphate 4-epimerase, a glycan strand-cleaving enzyme/glycosidase, N-acetylglucosaminidase, acetylmuramyl-L-alanine amidase, lysozyme, lytic transglycosylase and peptidoglycan endopeptidase. Claim 2 of Sinclair ‘685 in view of Singh recites the invention of instant application claim 4.
Claim 3 of Sinclair ‘685 recites the method of claim 1, wherein the one or more enzymes comprises two or more enzymes (lines 1-2). Claim 3 of Sinclair ‘685 in view of Singh recites the invention of instant application claims 5-6.
Claim 4 of Sinclair ‘685 recites the method of claim 1, wherein the one or more enzymes have at least about a 25-fold increase in specific activity when purified using size exclusion chromatography in combination with an affinity based membrane purification system (lines 1-5), at least about a 100-fold increase in specific activity when purified using size exclusion chromatography in combination with an affinity based membrane purification system (lines 5-8). Claim 4 of Sinclair ‘685 in view of Singh recites the invention of instant application claim 8.
Claim 5 of Sinclair ‘685 recites the method of claim 1, wherein the one or more enzymes is at least about 50% pure (lines 1-2). Claim 5 of Sinclair ‘685 in view of Singh recites the invention of instant application claim 43.
Claim 6 of Sinclair ‘685 recites the method of claim 1, wherein the composition comprises ampD (lines 1-2). Claim 6 of Sinclair ‘685 in view of Singh recites the invention of instant application claim 14.
Claim 7 of Sinclair ‘685 recites the method of claim 1, wherein the composition comprises lysozyme (lines 1-2). Claim 7 of Sinclair ‘685 in view of Singh recites the invention of instant application claim 15.
Claim 8 of Sinclair ‘685 recites the method of claim 1, wherein the composition comprises phi29 lysozyme (lines 1-2). Claim 8 of Sinclair in view of Singh recites the invention of instant application claim 16.
Claim 9 of Sinclair ‘685 recites the method of claim 1, wherein the activity of the microorganisms comprises pathogenicity, viability, reproduction, metabolism, or toxin production (lines 1-3). Claim 9 of Sinclair ‘685 in view of Singh recites the invention of instant application claim 19.
Claim 10 of Sinclair ‘685 recites the method of claim 1, wherein the amount or the activity of the microorganisms is reduced by at least about 10% (lines 1-2). Claim 10 of Sinclair ‘685 in view of Singh recites the invention of instant application claim 24.
Claim 16 of Sinclair ‘685 recites the method of claim 1, wherein the one or more enzymes comprise a protease (lines 1-2). Claim 16 of Sinclair ‘685 in view of Singh recites the invention of instant application claim 7.
Claims of Sinclair ‘685 do not recite a solid substrate, removing biofilm from a surface of the solid substrate, or wherein said solid substrate comprises a material selected from metal, stainless steel, plastic, ceramic, porcelain, rubber, wood, concrete, cement, rock, marble, gypsum, and glass.
Donlan teaches that more than 99.9% of bacteria grow in biofilms in a wide variety of surfaces (see p.167, right column, 1st passage). Donlan further teaches that the organisms that cause many medical and dental device-related and other chronic infections actually grow in biofilms in or on these devices (see p.168, left column, 2nd paragraph). Donlan further teaches bacteria form biofilms in natural and industrial systems to protect from antibacterial chemicals, environmental bacteriophages, and phagocytic amoebae (see p.168, left column, 2nd paragraph). Donlan further teaches chronic biofilm infections resist antibiotic therapy and mount life-threatening attacks on human bodies (see p.168, left column, 3rd-4th paragraphs). Donlan further teaches that in light of the fact that biofilms comprises both cells and extracellular polymeric substances, treatments that eradicate and penetrate the extracellular polymeric substances, such as a mixture of enzymes, are effective (see p.188, right column, last paragraph).
Johansen teaches a method for cleaning and disinfecting a surface at least partly covered by a biofilm layer comprising the steps of contacting the biofilm with a cleaning composition comprising one or more hydrolases in an amount effective for either fully or partly removing or releasing the biofilm layer from the surface; and contacting the biofilm with a bactericidal disinfecting composition comprising an oxidoreductase in an amount effective for killing the living bacterial cells present in the biofilm (see Abstract, Col. 1, line 56-Col.2, line 53). Fully removing the biofilm layer and killing the living bacterial cells present in the biofilm is interpreted as reducing an amount of 100% of microorganisms on a surface, which is considered to read on claims 19 and 24. Johansen further teaches a surface is any surface that may be covered in a biofilm layer, such as, metal, plastics, rubber, board, glass, wood, paper, concrete, rock, marble, gypsum, ceramic materials (see Col. 2, lines 28-33). Johansen also teaches animal and human skin as a surface (see Col. 2, line 35). Johansen further demonstrates removal of biofilms from stainless steel solid surfaces, reading on claim 32 (see Example 1). Johansen further teaches the one or more hydrolases useful in the invention include amylases and proteases (see Col. 2, lines 55-63). Johansen further teaches the hydrolytic enzyme may be a proteolytic enzyme of fungal origin (see Col. 3, lines 33-38).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized the composition for reducing an amount or an activity of microorganisms in a wound comprising one or more enzymes derived from TM-417 recited in claim 1 of Sinclair ‘685, in a method to remove a biofilm layer covering a surface such as metal, stainless steel, plastics, rubber, board, glass, wood, paper, concrete, rock, marble, gypsum, ceramic materials, as taught by Donlan in view of Johansen, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to because Donlan teaches 99.9% of bacteria produce biofilms that are implicated in bodily infections and that enzymes are effective at eradicating biofilms. One of ordinary skill in the art would have been further motivated to because Johansen teaches hydrolase enzymes are effective at removing biofilms one hard surfaces and porous surfaces like skin and Sinclair recites several hydrolytic enzymes, yielding predictable results. With regards to the limitation of the one or more enzymes being secreted by TM-417, the instant specification in the paragraph bridging pp.22-23 discloses that all of the enzymes recited in Sinclair ‘685 patent claim 2 are secreted.
Response to Arguments
Applicant’s arguments with respect to claims 1, 4-8, 14-16, 19, 24, 32, 34-35, and 43 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/J.P.S./
Examiner, Art Unit 1657