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 .
Priority
The instant application is a U.S. Divisional 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.
Response to Amendment
Applicant’s amendment submitted 06/15/2026 is acknowledged. Claims 1 and 4-7 are currently amended. 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 Claims 33 and 40-42 remain withdrawn pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention.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 presently considered.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 06/15/2026 has been considered by
the examiner. The information submitted in the information disclosure statement was filed under
37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p).
Withdrawn
The objections to claims 4 and 8 are withdrawn in light of the amendments.
The rejections under 35 U.S.C. 112(b) are withdrawn in light of the amendments.
The rejections under 35 U.S.C. 112(d) are withdrawn in light of the amendments.
The non-statutory double-patenting rejection under 35 U.S.C. 101 has been withdrawn upon further consideration. See Response to Arguments for further discussion.
Claim Objections
Claim 1 is objected to because of the following informalities: For clarity, please amend the phrase “the surface of the solid substrate, the surface comprising the microorganisms” in lines 3-4 to recite “the surface of the solid substrate, wherein the surface comprises the microorganisms”. Appropriate correction is required.
Maintained Rejections
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.
Response to Arguments
Regarding the rejections under 35 U.S.C. 103, Applicant argues that the examiner’s conclusion that one of ordinary skill in the art would have been motivated to include the TM-417 secreted enzymes in a cleaning composition in view of Landry is erroneous, because neither Johansen nor Deinhammer disclose enzymes derived from TM-417, let alone teach or suggest the use of enzymes derived from TM-417 for reducing an amount or an activity of microorganisms on a solid substrate by removing biofilm from a surface of the solid substrate. Moreover, Landry does not teach or suggest using TM-417 enzymes for biofilm removal or for an antimicrobial application. Landry's work is focused entirely on enzyme purification methodology and characterization of enzyme properties such as optimal temperature, pH, and metal co-factor requirements. Landry does not teach or suggest any application of TM-417 enzymes for reducing an amount or an activity of microorganisms on a solid substrate by removing biofilm from a surface of the solid substrate. The only disclosure in Landry to possible applications of TM-417 enzymes is a speculative sentence that "secreted enzymes from thermophilic fungi have great biotechnological potential due to their high temperature optima and long shelf life." Here, Landry’s general statement about biotechnological potential does not provide a “specific motivation” to use TM-417 enzymes for biofilm removal.
Applicant’s arguments have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Johansen teaches a method for cleaning and disinfecting a surface covered by a biofilm layer using hydrolases, Deinhammer teaches that compositions for biofilm removal may further comprise enzymes such as deoxyribonuclease, invertase, and ribonuclease, and Landry discloses that the thermophilic fungus TM-417 produces enzymes including amylase, invertase, DNase, RNase, and protease, as discussed in the rejection. Johansen specifically teaches that "any enzyme having proteolytic activity" may be used in its method, including enzymes of "fungal origin." (see Johansen at col. 3, lines 41-49). This would clearly include the proteolytic enzymes produced by thermophilic fungus TM-417.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, a person of skill would have recognized from Landry that selecting the enzymes taught by Johansen and Deinhammer from a thermophilic fungus, such as TM-417, carries with it the advantages of high temperature optima and long shelf life. These are desirable properties for the enzymes to have when applying the teachings of Johansen and Deinhammer.
Applicant is reminded that 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). See also Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick, 464 F.3d 1356, 1368, 80 USPQ2d 1641, 1651 (Fed. Cir. 2006) ("Indeed, we have repeatedly held that an implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the ‘improvement’ is technology-independent and the combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient. Because the desire to enhance commercial opportunities by improving a product or process is universal—and even common-sensical—we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves.").
In the instant case, Landry clearly provides the expectation of some advantage when selecting proteolytic enzymes from TM-417, which is known to produce the enzymes taught by the other references, while Landry clearly suggests these enzymes can be used in other biotechnological applications. Express suggestion to substitute one equivalent for another need not be present in one or more of the prior art references to render such substitution obvious, particularly when there is an expectation of some advantage suggested by any of the references used in the rejection.
Regarding Applicant’s allegation that the motivation provided by Landry is based on a “speculative” statement ("secreted enzymes from thermophilic fungi have great biotechnological potential due to their high temperature optima and long shelf life”), Applicant is reminded that a prior art reference is presumed to be operable/enabling for all that it teaches. Once a prima facie case is made, the burden is on the applicant to rebut the presumption of operability. See MPEP 2121. In the instant case, Applicant’s argument fails to provide any objective evidence to support the alleged invalidity of Landry’s suggestion.
Applicant further argues that Landry’s general statement about biotechnological potential does not provide a specific motivation to use TM-417 enzymes for biofilm removal, because Landry does not disclose or provide any data showing that these secreted enzymes from TM-417 could have antimicrobial properties, including reducing an amount or an activity of microorganisms on a solid substrate by removing biofilm from a surface of the solid substrate, as required by claim 1. The fact that an enzyme has high temperature optima and long shelf life does not suggest that it would be effective for removing biofilm from surfaces of solid substrates. Biofilm removal requires enzymes capable of degrading the materials that comprise the biofilm matrix. Landry provides no teaching that TM-417 enzymes possess any biofilm-degrading activity on solid substrates or would be suitable for such applications. Applicant also argues that a person of ordinary skill would not have had a reasonable expectation of success in light of the cited references.
Applicant’s arguments have been fully considered but they are not persuasive.
Johansen specifically teaches that "any enzyme having proteolytic activity" may be used in its method, including enzymes of "fungal origin" (see Johansen at col. 3, lines 41-49), while Landry teaches that thermophilic fungi “have been shown to produce antibacterial and antifungal compounds and have the ability to release volatile molecules which regulate in situ growth behavior via fungistatic and auto-inhibition mechanisms” (see pg. 10, 1st para.). Hence, it was common knowledge at the time of filing that thermophilic fungi produce enzymes having antimicrobial properties, as evidenced by Landry, and it would have been readily apparent to an ordinary artisan to have selected such enzymes having these properties from thermophilic fungi for their disclosed advantages.
Applicant is reminded that conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")). In the instant case, it was known in the art that thermophilic fungi produce enzymes having antimicrobial properties, and the advantages of selecting such enzymes from thermophilic bacteria are also taught by Landry. Applicant’s arguments fail to provide any objective evidence that the results of the combination would not have been met with reasonably predictable results.
Applicant further argues that the Examiner has not explained why a person of ordinary skill in the art would look to Landry's work on TM-417 enzyme purification and characterization and apply it to biofilm removal on solid substrates as disclosed by Johansen and Deinhammer. Applicant argues that the Examiner's reasoning improperly equates Landry's general statement about "great biotechnological potential due to their high temperature optima and long shelf life" with a specific motivation to use TM-417 enzymes for biofilm removal from solid substrates. These are entirely different concepts.
Applicant’s arguments have been fully considered but they are not persuasive.
The examiner’s reasoning is not that the concept of “high temperature optima and long shelf life” is equivalent to the concept “biofilm removal”. The examiner’s reasoning is that a person of skill would have recognized an advantage when selecting enzymes having these properties (i.e., high temperature optima and long shelf life), which is sufficient to show there was a motivation to combine. Applicant’s argument fails to explain why these properties would not be advantageous in the products/methods taught by Johansen and Deinhammer. See arguments above.
Applicant further argues that the Examiner has analyzed the references in isolation rather than explaining how they would function as a combined whole. The Examiner points to Johansen and Deinhammer for cleaning compositions containing hydrolases for biofilm removal, and to Landry for the production of enzymes by TM-417, but does not explain how the combined teaching would actually arrive at the pending claims. Applicant alleges that the Examiner has not identified a "necessary bridge" between these references. Applicant argues that the examiner relies improperly on hindsight to arrive at the pending claims. The connection between these references exists only in Applicant's disclosure, and using that disclosure to bridge the gap between the references is the very definition of impermissible hindsight.
Applicant’s arguments have been fully considered but they are not persuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, 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).
Applicant fails to specifically point out how the rejection relies upon knowledge that was only present in Applicant’s disclosure in lieu of knowledge that was found in the prior art. As previously discussed, Johansen teaches a method for cleaning and disinfecting a surface covered by a biofilm layer using hydrolases, Deinhammer teaches that compositions for biofilm removal may further comprise enzymes such as deoxyribonuclease, invertase, and ribonuclease, and Landry discloses that the thermophilic fungus TM-417 produces enzymes including amylase, invertase, DNase, RNase, and protease, as discussed in the rejection. Johansen specifically teaches that "any enzyme having proteolytic activity" may be used in its method, including enzymes of "fungal origin." (see Johansen at col. 3, lines 41-49). This would clearly include the proteolytic enzymes produced by thermophilic fungus TM-417. A person of skill would have recognized from Landry that selecting the enzymes taught by Johansen and Deinhammer from a thermophilic fungus, such as TM-417, carries with it the advantages of high temperature optima and long shelf life, which would be desirable properties when used in a cleaning composition.
With respect to claim 14, Applicant argues that Bourguet teaches ampD as an antimicrobial protein for killing Bacillus anthracis cells, not for biofilm removal. Bourguet’s teaching of "disinfection of contaminated materials" relates to killing pathogenic bacteria, not degrading biofilm matrix. See Bourguet, page 3027. There is no teaching or suggestion in Bourguet to combine ampD with TM-417 enzymes for biofilm removal from solid substrates as recited in claim 1.
Applicant’s arguments have been fully considered but they are not persuasive.
In response to applicant's argument that Bourguet does not teach ampD for degrading biofilms, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In the instant case, Johansen teaches the cleaning composition to comprise one or more hydrolases and to have bactericidal activity, while Bourget teaches the glycosyl hydrolase ampD to have high lytic activity against Bacillus anthracis and other closely related Bacillus isolates, as discussed in the rejection. Furthermore, Johansen and Deinhammer both teach combining different proteases, while Bourget teaches ampD to be very stable in the presence of other proteases.
It should also be noted that Bourget teaches ampD is a glycosyl hydrolase, specifically, an N-acetylmuramoyl-L-alanine amidase (see Bourget at pg. 3025, col. 1, paras. 1-2), while Johansen explicitly teaches that specific enzymes capable of biofilm degradation include N-acetylmuramoyl hydrolases (see Johansen at col. 3, lines 1-2 and 26-27).
Regarding claims 15 and 16, Applicant argues that Meijer merely teaches phi29 lysozyme in the context of bacteriophage infection and cell lysis at the end of the phage replication cycle, not for biofilm removal applications. There is no teaching or suggestion in Meijer to use phi29 lysozyme in a cleaning composition for removing biofilm from solid substrates.
Applicant’s arguments have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As discussed in the rejection, Johansen teaches the cleaning composition comprises one or more hydrolases, and Meijer teaches the phi29 lysozyme is peptidoglycan hydrolase which is responsible for the lysis of the bacteriophage infected cell (see p.282, left column, 1st paragraph). A person of skill would have recognized that this lysozyme would be useful for its activity against the cell wall of Bacillus in combination with Johansen. It is apparent that biofilms are formed by the bacteria themselves (see, e.g., Johansen at col. 1, lines 16-18) and that the lysing of the bacteria would predictably aid in the reduction of biofilm, because if the bacteria are killed they can no longer form biofilms. Furthermore, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In the instant case, Johansen teaches the cleaning composition to have the purpose of killing bacteria (as well as degrading biofilms), and it would have been advantageous to have included the lysozyme taught by Meijer.
Applicant argues that the working examples in the specification demonstrate that secretory fungal enzymes derived from TM-417 achieve striking and unexpected efficacy in inactivating pathogens on solid surfaces. Specifically, TM-417 enzyme extract was applied to B. anthracis Sterne spores dried onto the surface of stainless steel coupons (see FIG. 9) and glass coupons (see FIG. 10). TM-417 enzyme extract reduced viable B. anthracis Sterne levels by more than 3 logs (i.e., greater than 99.9% reduction) on both glass and stainless steel at room temperature, achieving this level of decontamination following only 120 minutes of treatment on glass and just 30 minutes on stainless steel. These results are unexpected because nothing in the cited art-individually or in combination-would have predicted that secretory fungal enzymes derived from TM-417 could achieve such dramatic biofilm removal and microbial inactivation on solid substrates.
Applicant’s arguments have been fully considered but they are not persuasive.
The evidence to support Applicant’s allegation of unexpected results is not commensurate in scope with the claims. 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. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
In the instant case, FIGs 9 and 10 show the efficacy of the fungal extract supplemented with ampD and phi29. None of the claims are limited to this specific combination. Furthermore, these experiments only demonstrate the reduction of Bacillus anthracis Sterne cells (CFUs), while the claims are directed to the removal of any biofilm and the reduction of an amount or activity of any microorganism. Therefore, this evidence insufficient to rebut the prima facie case of obviousness made against the claims.
See MPEP 716.02 which states that any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). 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. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) and MPEP § 716.02(d) - § 716.02(e) (Emphasis added). An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979).
Regarding the double patenting rejection over the claims of U.S. Patent No. 10,939,685, Applicant argues that, as discussed during the Examiner interview, this double patenting rejection should be withdrawn as the instant application is a properly filed divisional and should benefit from the § 121 safe harbor.
Applicant’s arguments have been fully considered and they are persuasive.
As agreed upon during the interview on 06/16/2026, the instant application is a proper Divisional application that is a result of a Restriction Requirement in the parent application of 16/091,279, and thus receives safe harbor as set forth in 35 U.S.C. 121. Accordingly, the rejection has been withdrawn.
Conclusion
No claims are allowed.
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 DENNIS ARMATO whose telephone number is (703)756-5348. The examiner can normally be reached Mon-Fri 11:00am-7:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DENNIS IGNATIUS ARMATO JR/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
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