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 .
Election/Restrictions
To summarize the election, the applicant elected group II, with traverse.
The requirement is still deemed proper and is has been made FINAL.
Claims 1, 3-4, 14, and 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claim Objections
Claims 6 and 27 are objected to because of the following informalities: both claims recite a table and a figure. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience (see MPEP 2173.05(s)). Here the applicant has duplicated both a drawing and table into the claims which is impermissible.
As noted in MPEP 608.01(m), each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. Claims 6 and 27 both contain multiple periods in addition to the period at the end of each claim. Claim 6 also looks like it may contain two ending periods, since the final period was not shown to be deleted and a new period was added after the last word.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6-7 and 27-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 6 and 27 state that “at concentrations of the antibiofilm composition of 10%, 50% and 100% there is an efficacy relative to a concentration of 0.00% of the antibiofilm concentration measured in recovered colony forming units no greater than equal to the values in the table”. The values in the table were obtained after 24 hours of growing dilutions of the remaining bacteria that was able to be removed from a biofilm on coupons treated with various dilutions of an embodiment of the invention, according to instant example 4. The claims are worded as though these results are gleaned directly from treating the coupons as detailed in the text immediately preceding it starting with “where after a total 72 h of biofilm growth…”. This conflation of disparate steps and outcomes from the disclosure capture a functional embodiment that was not originally disclosed. Therefore the artisan of ordinary skill would not have deemed the applicant to be in possession of the invention as instantly claimed.
This is a new matter rejection.
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 6-7 and 27-28 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.
The use of the terms “ATCC 6538”, ‘ATCC27586” and “Falcon”, which are trade names or marks used in commerce, has been noted in claims 6 and 27. The claims’ scope is uncertain since a trademark or trade name cannot be used properly to describe any particular material or product.
The phrase “micro thin coating” in claims 6 and 27 is a relative phrase which renders the claims indefinite. The phrase “micro thin coating” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Here a coating thickness that qualifies as “micro thin” is not clear.
Claims 6 and 27 contain a number of parenthetical recitations, several of which make it unclear as to whether they are further limitations. The recitations of concern are “plates”, “Falcon tube”, “50.10, 50.50 and 50.100”, and “20-21 hours. The meaning of “50.10, 50.50 and 50.100” is not clear. The remaining highlighted recitations are narrower limitations following a broader limitation. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 6 and 27 recite a drawing of a bioreactor. It is unclear how the drawing limits the claims, given that it has not written details or descriptions in the claim.
Claims 6 and 27 are identical in language except for the biofilm bacteria and the tables of data. Therefore the deficiencies in clarity discussed below are addressed in regard to claim 6 with the understanding that they also apply to claim 27 with its recited bacteria and tables of data.
Claims 6 and 27 recite a preamble whose impact on the method is unclear. The new preambles combine text from two examples in the specification in a manner that makes it unclear which biofilm is required on the treated inanimate surface and the outcome that must occur due to the practice of the recited active steps. Claim 6 recites “a method of treating with antibiofilm composition a Pseudomonas aeruginosa (P. aeruginosa) ATCC 27586 biofilm on an inanimate surface that is the same as the mature biofilm that is established by…”. The preamble goes on to recite a process that inoculates a particular concentration of the bacteria in a particular volume of a particular broth in a reactor with a configuration according to a unlabeled drawing. Numerous other details of ancillary equipment, growth conditions, types and volumes of growth broth, growth broth flow rate, and growth times are also recited that originate from instant example 3. The broth is titled with a percentage, at times, but it is not clear if this implies a dilution of the broth itself or a proportion of a particular ingredient in the broth. The preamble goes further starting with the recitation “where after a total 72 h of biofilm growth” and recites portions of the testing procedure of an antibiofilm composition embodiment against the biofilms originating from example 4. This added recitation adds further confusion as to the requirements of the method.
The preamble prior to the recitation “where after a total 72 h of biofilm growth” is unclear in regard to which criteria must be met in order for a biofilm to be the ‘same’ as that generated via the bioreactor based growth procedure. No details are provided about the bioreactor (e.g., dimensions, component sizes, etc.) beyond a generic drawing, so the actual process conducted by the applicant cannot be repeated to make a biofilm in the same way as that generated in the instantly claimed bioreactor. The recitation starting with “where after a total 72 h of biofilm growth”, further treats a biofilm with dilutions of a antibiofilm composition such that by the end, the biofilms made in the bioreactor have been treated for a duration of 5 minutes to overnight. It is unclear if the biofilm that qualifies to be acted upon by the active steps later recited in the claim in steps a-c are the biofilms that result after this treatment or if this latter recitation is to indicate the efficacy of the composition that is to be applied from those recited in step a of the claim. Even if an efficacy level is intended, the requirements are not clear. The claim states that “at concentrations of the antibiofilm composition of 10%, 50% and 100% there is an efficacy relative to a concentration of 0.00% of the antibiofilm concentration measured in recovered colony forming units no greater than equal to the values in the table”. The claim is worded as though these results are gleaned directly from treating the coupons, which they are not according to instant example 4. Thus it is unclear if the cell counts in the results are required directly due to treatment with a claimed composition or if it is supposed to be implicit that they are the result after the unrecited additional steps. Steps a-c in the claim recite a collection of compositions to apply. It is unclear if this efficacy further narrows the applicable compositions to those that produce cell counts no higher than those in the table. To that end, it also is not clear if every value has to be achieved or if achieving one value or a subset of values is sufficient. Moreover, since the results in the tables did not originate from the treatment procedure recited in the preamble, it is not clear which compositions would yield their recited performance. As a result, the structural impact of the preamble on steps a-c of the claims is completely incomprehensible beyond Pseudomonas aeruginosa being present in the biofilm of claim 6 and Staphylococcus aureus being present in the biofilm of claim 27.
Claims not explicitly expounded upon are also indefinite because they depend from an indefinite claim and do not add clarity.
For the sake of application of prior art, any coating thickness will deemed sufficient to meet the claim limitations of “micro thin coating”. A method of treating a biofilm containing Pseudomonas aeruginosa on an inanimate surface comprised of the recited steps a-c in claim 6 will be deemed sufficient to meet the claim’s limitations. A method of treating a biofilm containing Staphylococcus aureus on an inanimate surface comprised of the recited steps a-c in claim 27 will be deemed sufficient to meet the claim’s limitations. Clarification is still required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 6-7 and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Elfersy et al. (previously cited) in view of Fu et al. (CN 107412213 – English translation relied upon for citations), Gottenbos et al. (Biomaterials 2002 23:1417-1423), Blattner et al. (US PGPub No. 2013/0072419 – previously cited), and Hilliard et al. (US PGPub No. 2015/0328241).
Elfersy et al. teach disinfecting (cleaning) surfaces and providing an antimicrobial coating to article (hard and soft; inanimate) surfaces that provides long lasting biostatic protection by applying a composition to the surface (see column 2 lines 20-26). The composition may be applied by a variety of techniques that include spraying (see column 2 lines 32-37; instant claims 7 and 20). Elfersy et al. teach the composition to inhibit attachment, colonization, infection and reinfection by organisms (see column 2 lines 31-32). Broadly, the composition contains an organosilane quaternary ammonium compound at 0.01 to 42 wt%, a quaternary ammonium compound at 0.01 to 32 wt%, and water at 60-99 wt%, (see column 2 lines 47-59 and column 9 lines 59-63). The organosilane quaternary ammonium compound is envisioned as 3-(tri-methoxysilyl)propyldimethyl octadecyl ammonium chloride as well as 3-(tri-methoxysilyl)propyldimethyl tetradecyl ammonium chloride (see column 6 lines 44-48 and example 8; instant claim 1). Elfersy et al. teach the envisioned quaternary ammonium compounds to include benzalkonium chloride as a mixture of C12-C16 alkyl dimethyl benzyl ammonium chlorides (see column 8 lines 55-67 and example 7). The ratio of organosilane quaternary ammonium compound to quaternary ammonium compound is 10:1 to 1:10 (see column 9 lines 40-49). They additionally detail a narrower generalized embodiment of the composition with about 80 to 98 wt% water, about 0.0072 to 0.72 wt% organosilane quaternary ammonium compound, about 0.01 to 3 wt% quaternary ammonium compound, as well as some optional auxiliary components (see column 12 lines 39-53, considering specified strength of ingredients; instant claim 6). The composition may be diluted to various degrees prior to application, where 1:8, 1:25, and 1:50 are detailed as effective against a number of bacteria (see example 8). Elfersy et al. do on to teach applying their composition to a desired surface, then permitting it to dry (see example 1; instant claims 6). An example of a cleaner disinfectant and bacteria protectant is provided with a 32% benzalkonium chloride (C12-C16 alkyl dimethyl benzyl ammonium chlorides) source at 0.21 wt%, a 72% 3-(tri-methoxysilyl)propyldimethyl tetradecyl ammonium chloride source at 0.57 wt%, and water at about 97.495 wt% water (see example 7, column 8 lines 21-25, column 8 line 65-column 9 line 3, and column 14 lines 34-43; instant claim 6). The benzalkonium chloride is thus present at about 0.067 wt% and the organosilane quaternary ammonium compound is present at about 0.41 wt% in the example. Phenoxyethanol and deionized water are not explicitly recited as a components of the composition.
Fu et al. teach an antibacterial sterilizing composition composed of 0.05 to 0.2 wt% benzalkonium chloride, 0.05 to 2 wt% organosilicon quaternary ammonium salt, 97.8 to 99.9 wt% deionized water (see paragraphs 12-13 and 18). 3-(tri-hydroxysilyl)propyldimethyl octadecyl ammonium chloride is envisioned as a organosilicon quaternary ammonium salt (see paragraph 12). The composition is active against Pseudomonas aeruginosa and Staphylococcus aureus without the need for additional components (see paragraph 9).
Gottenbos et al. teach that 3-(tri-methoxysilyl)propyldimethyl octadecyl ammonium chloride is efficacious as an antibacterial active against several strains of bacteria including Pseudomonas aeruginosa and Staphylococcus aureus (see abstract and table 2).
Blattner et al. teach the use of phenoxyethanol as a preservative in a household cleaner that provides a residual beneficial effect on the surface, a similar property also held by that of Elfersy et al. (see abstract and paragraph 124). The preservative is present at up to 1 wt% (see paragraph 123).
Hilliard et al. teach treating biofilm infected surfaces with a composition composed of a quaternary organosilane that penetrates and disrupts the biofilm, then leaves a coating that acts as a mechanical barrier to reinfection (see paragraphs 17-18, 32, and 35 and figures 3 and 7). 3-(tri-methoxysilyl)propyldimethyl tetradecyl ammonium chloride and 3-(tri-hydroxysilyl)propyldimethyl tetradecyl ammonium chloride are exemplified varieties of the organosilane (see paragraph 35). They detail these compounds as puncturing the cell wall of microbes (see paragraph 35). The compounds have the additional property of covalently bonding to surfaces (see paragraph 35).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition of Elfersy et al. consisting of 3-(tri-methoxysilyl)propyldimethyl octadecyl ammonium chloride, benzalkonium chloride, deionized water, and phenoxyethanol at up to 1 wt%. The choice of 3-(tri-methoxysilyl)propyldimethyl octadecyl ammonium chloride would have been obvious as an envisioned organosilane quaternary ammonium compound that is known to have an antibacterial effect on several varieties of bacteria as detailed by Gottenbos et al. The inclusion of the 3-(tri-methoxysilyl)propyldimethyl octadecyl ammonium chloride and benzalkonium at a proportion within the range Elfersy et al. teach would have been obvious, specifically at concentrations in the range of Fu et al. which is effective in the absence of additional components and embraces lower concentrations that are exemplified by Elfersy et al. The addition of phenoxyethanol to their composition would have been obvious in light of Blattner et al. as the application of the same technique to a similar product in order to yield the same improvement (e.g., preservation of the composition). This results in a range of proportions for the phenoxyethanol (up to 1 wt%), benzalkonium chloride (0.05 to 0.2 wt%), and 3-(tri-methoxysilyl)propyldimethyl octadecyl ammonium chloride (0.05 to 2 wt%) that overlap with or embraces those instantly claimed, thereby rendering the claims ranges obvious. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). In addition, the instantly claimed proportions are modified by the term “about” and no limiting definition has been provided for the term “about” which extends the scope of the claim beyond the exact numbers that are recited in the claims and generates broader overlap with the prior art. Routine modifications within the taught ranges would also have been obvious to the artisan of ordinary skill. Further, the exchange of deionized water for the water employed by Elfersy et al. would have been obvious based upon Fu et al. who show its utility in a similar composition. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. It then would have been obvious to apply this modified composition of Elfersy et al. to the surface of an inanimate object with a biofilm containing Pseudomonas aeruginosa or Staphylococcus aureus via spraying, and then permit the composition to penetrate and kill the bacteria as well as dry on the surface and form an antibacterial coating layer as Elfersy et al. and Hilliard et al. teach. Beyond the antibacterial effect for the composition actives noted by Elfersy et al. and Gottenbos et al., the teachings of Hilliard et al. direct their application to biofilm forms, in particular, with the expectation of success due to the structure of the organosilane quaternary ammonium compound and its ability to orient itself and bind to a surface. Therefore claims 6-7 and 27-28 are obvious over Elfersy et al. in view of Fu et al., Gottenbos et al., Blattner et al., and Hilliard et al.
Response to Arguments
Applicant's arguments filed July 18, 2025 have been fully considered. In light of the amendment, the objection to the specification and the previous rejections under 35 USC 112(a) and 35 USC 103 are hereby withdrawn. New grounds of rejection are detailed to address the new claim limitations. The applicant’s argument concerning the maintained rejection under 35 USC 112(b) and added traversal arguments concerning the restriction requirement are not persuasive.
Regarding the additional remarks concerning the restriction requirement:
The pending claims at the time of the restriction requirement recited liquid compositions, wound dressings, methods of treating an array of pathologies in living subjects each of which having its own non-prior art based considerations (enablement) which are not the same across all the recited pathologies, methods of cleaning inanimate object surfaces, and methods of protecting inanimate surfaces from biofilm formation. This is a wide array of inventions. While they share the underlying concept of applying a combination of two active components, they differ in regard to their configurations, the outcomes that are to occur, as well as the enablement considerations to achieve the outcomes. An examination of the totality of these inventions presents an undue burden as was noted in the restriction requirement. The applicant’s critique of the tools employed to search the amended claims has no bearing on the validity of the original requirement. The applicant is directed to MPEP 821 for the available avenues to dispute the requirement, if they so choose.
Regarding the rejection under 35 USC 112(b):
The applicant asserts that the cancellation of some claims addresses the rejection due to the recitation of “micro thin coating”. The phrase remains in the currently pending claims and no clarifying language has been added via the amendment to address its scope.
Conclusion
No claim is 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 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 CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615
/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615