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 .
Drawings
The drawings are objected to because the coloring for the bars in the graphs in the lower graph of figures 3 and 4 and figures 5A-5D cannot be clearly distinguished from one another. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 4 is objected to because of the following informalities: the claim recites “the at least two infectious microbes”. The word “the” should be deleted since a previous recitation of two microbes does not occur earlier in the claim. 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 1-3, 6, and 8-11 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The invention relates to methods of reducing or inhibiting the growth of a virus on a surface. The relative skill of those in the art is high, that of an MD or PhD. That factor is outweighed, however, by the unpredictable nature of the art. Rampersad et al. detail that viruses do not have the machinery to replicate or propagate themselves (see Replication and Expression Strategies of Viruses” in Viruses: Molecular Biology, Host Interactions and Applications to Biotechnology ed. Tennant et al. 2018 Academic Press pages 55-82; page 55). In order for growth, viruses must infect a host cell and then are able to employ the host cell machinery for energy, protein synthesis, nucleic acid synthesis and needed structural components (see page 55). All of these components and processes are required for growth. A virus on a surface has not infected a cell, thus the cell supplied required components for growth and replication would be absent and it would not be able to replicate. While the applicant exemplifies inhibition of viral attachment to a surface, they do not demonstrate an inhibition or reduction in growth of a virus on a surface (see instant specification paragraph 35).
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed product could be made. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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 3, 6, 9-10, and 12-15 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.
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). In the present instance, claims 3 and 12 recite the broad recitation “having antimicrobial activity”, and the claim also recites parenthetically, “with and without visible light” which is the narrower statement of the range/limitation. The claims 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.
Claim 6 recites the limitation "the virus" in line 3. There is insufficient antecedent basis for this limitation in the claim. The parent claim recites two infections microbes, wherein at least one of the infectious microbes is a multi-drug resistant bacteria”. “Virus” is not mentioned.
The term/phrase “fast acting” in claims 9 and 12 is a relative term which renders the claims indefinite. The term “fast acting” 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. The speed with which a disinfectant needs to act and against which microbes in order to qualify as “fast acting” is not discussed. Since the impact of antimicrobial compounds varies from microbe to microbe, in regard to efficacy and speed, the scope of the compounds that are embraced by the claims is unknown.
Claims 10 and 12 recite a concentration of porphyrin nanoparticles with units that re expressed as a mass per liquid volume. The parent claim does not recite liquid components or that the composition is a liquid or gel. Thus it is not clear if the recitation of units in this manner is an implicit limitation on the form of the composition that is applied.
Claims 6 and 12 recite “antimicrobial activity…on the surface for at least 24 hours after application of the formulation”. The scope of the limitations embraced by this limitation is unclear, given that the treatment of the surface after application would impact the maintenance of antimicrobial activity. The claim only recites porphyrin nanoparticles as a component in the composition and does not explicitly require any other component. A rigorous rinsing procedure after application of porphyrin nanoparticles to a surface could readily remove them such that a singular composition does not yield at least 24 hours of antimicrobial activity while an unrinsed version of a surface treated with the some composition could. Thus the impact of this claim recitation on the structure of the composition is unclear.
Claim 13 recites “the microbes include one or more viruses” The parent claim does not recite “microbes” explicitly. While the parent claim recites “antimicrobial activity” of its porphyrin nanoparticles, it is unclear of the recitation of claim 13 means that the antimicrobial activity must be effective against viruses, or is inadvertently recited and was meant depend from another claim, such as claim 4.
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.
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 4-6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Prestwich et al (US PGPub No. 2014/01797420 in view of Neuberger (US PGPub No. 2004/0052798).
Prestwich et al. teach compositions that provide a porphyrin for killing or inhibiting growth of microbes when applied on surfaces as well as in a subject (see abstract and paragraph 20-21 and 30-32; instant claim 4). Envisioned microbes hat e affected include combinations of various bacteria such as methicillin resistant Staphylococcus aureus and Escherichia coli (see paragraph 22; instant claims 4-5). An additional disinfectant may be included the composition and contemplated varieties include chlorhexidine and benzoin (see paragraph 38; instant claim 12). They provide the porphyrin compound at 10, 30, and 300 mM which attain cytotoxicity in the dark that is increased when exposed to light (see paragraphs 50-52 and 53). The tested porphyrin called TMP has a methyl group on each of its pyridine groups and tosylate counterions, which yields a molar mass of approximately 1054 g/mol (see paragraphs 18 and 48). The tested porphyrin concentrations envisioned and tested then range from 10-5 to 0.3 mg/ml (as calculated by the examiner). Nanoparticles of the porphyrin are not detailed.
Neuberger teaches compositions with photosensitizers that are controllably released to reduce bacteria at a treatment site (see abstract and claim 1). They detail the photosensitizer on or encapsulated in nanoparticles or microparticles that provide protection and controlled release, particularly in the case of encapsulation (see paragraph 19-20). They detail durations of release over days or weeks, particularly when provided in a gel carrier (see paragraph 34; instant claim 6). Neuberger further detail porphyrins as an envisioned photosensitizer (see paragraph 26 and claim 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the porphyrin of Prestwich et al. encapsulated in nanoparticles, in light of the teachings of Neuberger. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. A viscous or gel carrier as also taught by Neuberger to support retention of the nanoparticles at the application site also would have been obvious based on the same rationale of improvement. The inclusion of a disinfectant as suggested by Prestwich et al. would follow as would employing their taught concentration for porphyrin because Prestwich et al. state to do so. This range of concentration overlaps with that instantly claimed, thereby rendering the claimed range 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). Therefore claims 4-6 and 12 are obvious over Prestwich et al. in view of Neuberger.
Claims 4-6, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Prestwich et al. in view of Neuberger as applied to claims 4-6 and 12 above, and further in view of Ronchi et al. (US PGPub No. 2022/0054910).
Prestwich et al. in view of Neuberger render obvious the composition of instant claim 12. While a disinfectant is included and envisioned as chlorhexidine, the presence of a quaternary ammonium compound is not detailed.
Ronchi et al. teach a surface applied composition that includes disinfectants (see abstract and paragraph 24). In addition to chlorhexidine, quaternary ammonium compounds are also envisioned in this role (see paragraph 24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to exchange a quaternary ammonium disinfectant for the chlorhexidine in the composition of Prestwich et al. in view of Neuberger in light of the teachings of Ronchi. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 4-6, 12, and 14 are obvious over Prestwich et al. in view of Neuberger and Ronchi et al.
Claims 12-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Compans et al. (US PGPub No. 2005/0090428 – see IDS).
Compans et al. teach a composition for application to surface as an antiviral composition (see abstract). The composition comprises a porphyrin where several were shown to be effective that include iron containing porphyrins (see paragraphs 181-182 and 190-192 and claim ). Tested concentrations of the porphyrin compounds include 0.5, 10, and 50 mg/ml where the highest concentration generally was most effective (see paragraph 148). They go on to teach the porphyrins included with a carrier that is envisioned as nanoparticulates, as well as the additional inclusion of microbicides, such as polyethylene hexamethyl biguanide (see paragraph 92 claims 13-15, 22-26, and 32-33). While a full example is not provided for each embodiment that follows from the teachings of Compans et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include their effective iron containing porphyrin in the composition at 50 mg/ml because they discuss this concentration as most effective for their porphyrins. It also would have been obvious to include such porphyrins in a nanoparticulate carrier along with an envisioned microbicide because they suggest to do so. According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an 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 Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). All the instantly claimed components and configurations are rendered obvious as part of the composition of Compans et al., therefore the associated properties of surface duration would also be present, absent evidence to the contrary. Therefore claims 12-13 and 15 are obvious over Compans et al.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/Examiner, Art Unit 1615