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 .
Claims 1-19 have been presented for examination on the merits.
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 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, being enabling for slowing down infections, does not reasonably provide enablement for inhibiting or preventing infections of flowers. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1
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 Formal, 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 nature of the invention, relative skill level, and breadth of the claims
The instant invention is directed to a method of inhibiting or preventing infection of flowers during transport and storage. The complex nature of the claims is greatly exacerbated by the breath of the claims. The claims encompass broad ways that all microbial activity will be inhibited (prevented) at all times and in all circumstances. The relative skill of those in the art is high, that of an MD or PHD.
The state and predictability of the art
The state of the art recognizes that antimicrobial agents may reduce the possibility of infections in flowers and fruit. As illustrative of the state of the art, the examiner cites Van Velzen et al (WO 2012125023) and Instant specification. Van Velzen et al disclose a method of reducing the risk of infections including botrytis infection in cut roses by coating the flowers with a coating composition. It is disclosed that coating the flowers slows down infection of flowers and may increase the life span of flowers. As such it is evident that a coating composition cannot inhibit infection of flowers, but can slow down this process. Additionally, Applicant’s specification does not support a complete prevention or inhibition of infection for a long period of time.
The lack of significant guidance from the specification or the prior art with regard to inhibiting or preventing infection makes practicing the scope of the invention unpredictable. Inhibition as defined by Dictionary.com, means: “1. to restrain, hinder, arrest, or check (an action, impulse, etc.). 2. to prohibit; forbid” (See http://dictionary.reference.com/browse/inhibit).
The amount of direction or guidance provided and the presence or
absence of working examples
The specification provides no direction or guidance for inhibiting or preventing infection of flowers. Due to the difficulty/ impossibility of inhibiting or preventing all microbial activity, one of ordinary skill would not be able to practice the full scope of Applicant’s claims.
The working examples/tests of the specification are directed towards reducing microbial activity and coagulation. As such, the examples/tests do not enable one to utilize the full scope of claims.
The quantity of experimentation necessary
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 method could be predictably used to inhibit or prevent microbial activity as inferred by the claim and contemplated by the specification. 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.
Claims 1-12 and 18-19 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(s), at the time the application was filed, had possession of the claimed invention.
The specification discloses chemicals, such as certain polyols which meet the written description and enablement provisions of 35 USC 112, first paragraph. However, claims 1-12 and 18-19 are directed to encompass spacing agents, which only correspond in some undefined way to specifically instantly disclosed agents. Only the specifically disclosed polyol compounds meet the written description provision of 35 USC § 112, first paragraph. The broad genus however does not due to lacking chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities. The specification provides no guidance as to determine compounds which fulfill this description especially since metabolism varies in different parts of the body. The specification provides insufficient written description to support the genus encompassed by the claim.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
With the exception of the above specifically disclosed chemical structures, the skilled artisan cannot envision the detailed chemical structure of the encompassed derivatives, analogs, etc., regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The chemical structure itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
The Specification does not provide adequate description or examples for one of ordinary skill in the art to readily recognize all agents suitable as spacing agents for the claimed method and compositions.
Therefore, only the disclosed polyols and not the full breadth of the claim(s) meet the written description provision of 35 USC § 112, first paragraph. The species specifically disclosed are not representative of the genus because the genus is highly variant. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC § 112 is severable from its enablement provision. (See page 1115.)
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 5, 8, 10-12, 14 and 18-19 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, claim 5 recites the broad recitation “from 0.3 to 12 µm”, and the claim also recites “preferably from 1.5 to 3 µm” and “even more preferably 0.75 to 1.5 µm”, which are the narrower statement of the range/limitation. 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.
Also, claim 14 recites the broad recitation “polyol selected from the group of glycerol, sorbitol, …..”, and the claim also recites “preferably glycerol”, which is the narrower statement of the range/limitation. 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 8, 10-12 are indefinite for reciting a value including 7,5 (in claim 8); 2,5 (in claim 10); 0,01 (in claim 11) and 0,1 (in claim 12), which are not in a clear format. It is not clear if the said values should contain a decimal or comma.
Claim 18 recites groups of Markush species using Markush format with the term “or” between two species, which is indefinite. Proper Markush language is “selected from the group consisting of A, B, C and D”. The examiner suggests rewording the claim to include the proper Markush language. Note: MPEP § 803.02.
Claim 19 is indefinite because it recites an amount of less than 5% by weight of the polymer within the composition. This is indefinite because it is not clear which polymer within the composition this range is based on. Claim 19 depends on claim 18 which depends on claim 1, which only recite s a homopolymer. The only recitation in this regard in the Specification is “Preferably the bioactive agents are used in a total amount of less than 5 wt. %, based on the total polymer mass forming the dispersion or coating composition” (See [0024]).
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.
Applicant’s claims
Claim 1 is directed to a method for inhibiting or preventing infection of flowers during transport and storage, comprising coating the flowers with a composition containing a polyvinyl acetate homopolymer, a spacing agent and water, the composition being in the form of a dispersion.
Claims 1-15 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Van Velzen et al (WO 2012125023) in view of Kolter et al (Polyvinyl acetate-based film coatings), and as evidenced by The Instant Specification.
Van Velzen et al ‘023 teach a composition for coating flower heads, especially roses, post-harvest, to inhibit or prevent infection of the cut flowers during transport and storage, by applying the composition to the flower heads, the said composition comprising a polymer produced from the monomers vinyl acetate and ethylene, glycerol and water (See Abstract, Summary and claim 1) (meeting claims 1-2).
Regarding claims 3-6, Van Velzen et al teach that the said method wherein the flowers are roses, the method inhibits or prevent Botrytis infection of the flowers, and the composition (dispersion) is applied to the flower heads by spraying or immersion, wherein the thickness of the coating is from 0.3 to 12 μm, preferably from 1.5 to 3 μm, even more preferably 0.75 to 1.5 μm (See at least claims 11-15).
It is disclosed that the said polymer is produced from the monomers vinyl acetate and ethylene, the polymer is a copolymer Vinnapas EP 400 or Vinnapas EF 3777 of Wacker Chemie AG (See page 7).
Regarding claims 7-15, Van Velzen et al teach that th said composition may comprise the polymer in an amount of from 1 to 25 % by weight of the composition, preferably from 0.75 to 6 % by weight, or more preferably in an amount of from 1.5 to 3 % by weight of the composition, glycerol in an amount of from 1 to 20 % by weight of the polymer content, more preferably from 5% to 10 % by weight of the polymer content, the balance of the composition being water (See page 8, 2nd para).
Typical values for the viscosity of the dispersion compositions are from 5 - 20 mPas (as determined according to the Hoeppler falling ball method, with a 3 wt % solution at 20°C) (See page 10, lines 24-27)
Regarding claims 18-19, Van Velzen et al ‘023 teach the coating composition further comprises one or more bioactive agents, including anti-microbiotics, fungicides, stabilizers, anti-parasitics, anti-infection means, other biologically active compounds, etc. Preferably the bioactive agents are used in a total amount of less than 5 wt.%, based on the total polymer mass forming the dispersion or coating composition (See paragraph bridging pages 10-11).
Van Velzen et al do not expressly disclose that the polyvinyl acetate is a homopolymer. These are known in the art as taught by Kolter et al, as evidenced by the Instant Specification and knowledge of one of ordinary skill in the art.
Kolter et al teach polyvinyl acetate-based film coatings and disclose that polyvinyl acetate-based colloidal aqueous polymer dispersion Kollicoat® SR 30 D results in coatings characterized by moderate swelling behavior, lipophilicity, pH-independent permeability for actives and high flexibility to withstand mechanical stress and is therefore used for controlled release coating (See abstract).
It is disclosed that “Polyvinyl acetate is manufactured from the corresponding monomer of vinyl acetate using a free radical polymerization procedure. … The monomer vinyl acetate is used to manufacture not only homopolymers but also copolymers”. And that, polyvinyl acetate is also used for the production of polyvinyl alcohol, an instant release film former. It is also disclosed that “Due to its high flexibility and low toxicity, polyvinyl acetate is widely used in the food industry for coating fruits and vegetables” (See page 470, 1st col. line 1 to 2 and 2nd col., line 9 to page 471, line 2).
Kolter et al state that the colloidal aqueous polymer dispersion of polyvinyl acetate (Kollicoat® SR 30 D) is manufactured using an emulsion polymerization technique having composition presented in Fig. 1, reproduced below.
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In Table 1, the viscosity of Kollicoat® SR 30 D is stated as below 50 mPas and the minimum film forming temperature (MFT) of 18˚C.
The instant Specification also admits that: Polyvinyl acetate (PVA, PVAc) in the context of the invention can be prepared by the polymerization of vinyl acetate monomer and is an aliphatic synthetic polymer with the formula (C4H6O2)n. The degree of polymerization of polyvinyl acetate is typically 100 to 5000 (See PG pub version at [0015]).
It would have been prima facie obvious to one of ordinary skill in the art to have incorporated the teachings of Kolter et al into the methods and compositions of Van Velzen et al and as evidenced by Instant Application to arrive at the claimed method and composition with a reasonable expectation of success. It would have been obvious to do so because Van Velzen et al teach a coating composition that inhibits infection of the flowers especially roses from infections including Botrytis infections. The said aqueous coating composition comprises polyvinyl acetate and glycerol, as well as additional bioactive agents including antimicrobial agents. Kolter et al also teach polyvinyl acetate homopolymer coating composition and disclose that it is made by polymerization from vinyl acetate monomers, it’s formula, its benefits and use as a coating composition on fresh produce. Thus, one of ordinary skill in the art having possession of all references would have been motivated to have combined the teachings and select a homopolymer of polyvinyl acetate homopolymer for the compositions of Van Velzen et al with a reasonable expectation of success as both formulations are taught as coating compositions for fresh products such as cut flowers or produce.
In other words, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Jennings et al (GB 2287637) in combination with Van Velzen et al (WO 2012125023), Kolter et al (Polyvinyl acetate-based film coatings), and as evidenced by The Instant Specification.
Jennings et al teach methods and compositions for preserving cut flowers or foliage (See Title).
Regarding claims 1-2, it is disclosed that an advantage is that the said composition and method can be applied to freshly cut, partially dried or completely dried foliage or flowers. Unlike previous methods, the said method can be used to preserve variegated leaf material without loss of contrast between the differently colored portions of the variegated leaves (See page 6, lines 1-12).
It is disclosed that the dipping step coats the plant material with a thin layer of the polymer. The thin layer of the polymer helps to maintain the structure and flexibility of the plant material and, substantially prevents shrinkage of the plant material. This method is found to be particularly suitable for preserving cut flowers (See page 9, lines 15-20).
The aqueous solution or suspension can be an emulsion or latex of one or more polymers that are not themselves soluble in water. Preferably, the one or more polymers comprises a polyvinyl acetate or polyvinyl alcohol. More preferably, the aqueous solution or suspension comprises 5-15% w/v of carboxymethyl cellulose, 4-10% w/v of polyvinyl acetate, and a surfactant (See page 9, lines 23-32 and Claims 28-29).
Jennings et al disclose a method of preserving flowers by dip-coating them with a mixture of said polymers. A dip-coating aqueous suspension is made up containing 100g/l of carboxymethyl cellulose, 60g/l of polyvinyl acetate, and 10ml/l of liquid surfactant (See Example 5).
Regarding claims 1, 13-14 and 16-17, it is disclosed that preserved plant material may comprise from 5% to 60% by weight of propylene glycol and from 1% to 30% by weight of one or more C3 - C6 dihydric alcohols other than propylene glycol (See page 8, lines 24-32 and Claim 24). Preferably, the aqueous solution may also contain from 1% to 20% w/v, preferably from 2% to 10% w/v of polyethylene glycol, preferably in the molecular weight range 400 to 2000 (See page 5, lines 30-33).
Jennings et al teach a composition comprising polyvinyl acetate and propylene glycol and/or polyethylene glycol for coating cut flowers. However, Jennings et al do not expressly disclose a method of (preventing) infection in a flower; the flower is a rose or the infection is Botrytis; or that the polyvinyl acetate is a homopolymer. These are known in the art as taught by Van Velzen et al and Kolter et al, as evidenced by the Instant Specification and knowledge of one of ordinary skill in the art.
Disclosures of Van Velzen et al, Kolter et al and references to Instant Application are delineated above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art to have incorporated the teachings of Van Velzen et al and Kolter et al into the compositions of Jennings et al as evidenced by Instant Application to arrive at the claimed method and composition with a reasonable expectation of success. It would have been obvious to do so because Jennings et al teach an aqueous coating composition for coating cut flowers comprising polyvinyl acetate, propylene glycol, optionally polyethylene glycol and water. It is disclosed that such coating is suitable for coating cut flower petals and leaves to preserve the said flowers. Van Velzen et al teach a coating composition that inhibits infection of the flowers especially roses from infections including Botrytis infections. The coating composition comprises polyvinyl acetate and glycerol, as well as additional bioactive agents including antimicrobial agents. Kolter et al also teach polyvinyl acetate homopolymer coating composition and disclose that it is made by polymerization from vinyl acetate monomers, it’s formula, its benefits and use as a coating composition on fresh produce. Thus, one of ordinary skill in the art having possession of all references would have been motivated to have combined the teachings and select a homopolymer of polyvinyl acetate homopolymer for the compositions of Jennings et al with a reasonable expectation of success as both formulations are taught as coating compositions for fresh products such as cut flowers or produce. It further would have been obvious to one of ordinary skill in the art to determine that the coating and preserving compositions of Jennings et al would have been effective as inhibiting (slowing down) infections of the cut flowers, as disclosed by Van Velzen et al.
In other words, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kramer et al (US 20070141214)
Kramer et al teach a process for the surface treatment of foods by applying a polymer film, in which, as film-forming polymer, a polyvinyl alcohol-polyether graft copolymer is applied in the form of an aqueous dispersion to the food (See abstract).
The said process and compositions comprise polyvinyl alcohol-polyether-graft copolymers (PVA-PEG-graft copolymers) and mixtures thereof with polyvinyl acetate dispersions having low residual monomer contents (PVAc) for the surface treatment of foods to enhance their quality and appearance, and in particular to increase their shelf life (See [0001]).
It is disclosed that the said aqueous dispersions can therefore have the following compositions; a) from 5 to 95% by weight of a polyvinyl alcohol-polyether graft copolymer, b) from 0 to 95% by weight of polyvinyl acetate, and c) from 0 to 40% by weight of aids (See [0036]-[0037] and claim 1).
Kramer et al teach that the PVAc is preferably used in the form of aqueous dispersions having a solids content of from 10 to 50% by weight (See [0043]).
The said surface-treatment compositions can also comprise plasticizers in amounts of from 0.1 to 10% by weight, preferably from 0.5 to 7.5% by weight, based on the dry weight of the coating. Suitable plasticizers include polyethylene glycols, propylene glycol, glycerol, etc (See [0055]).
The said aqueous surface-treatment compositions, in addition to the film-forming polymers, can comprise further aids, for example antimicrobial substances, preservatives, antioxidants, etc, which is present at an amount of from 0 to 40% by weight, preferably from 1 to 30% by weight, based on the dry weight of the surface-treatment composition (See [0044]).
Hagenmaier et al (6,162,475).
Hagenmaier et al teach compositions for preparing edible coatings for fruits, vegetables, and prepared foods, which include polyvinyl acetate (See abstract).
The said coating contains food-grade polyvinyl acetate. It has a high gloss as compared to commercially used coating formulations. It forms a glossy coating on fruits, vegetables, and prepared foods. Polyvinyl acetate has commercial advantages over certain other edible coating (See Col. 3, lines 3-11).
The concentration of polyvinyl acetate in the said coating composition ranges from about 4% to about 30% (wt:wt) (See Col. 3, lines 42-46).
The said compositions may also comprise a plasticizer including propylene glycol, glycerin, etc. The concentration of plasticizer is from about 0% to about 15% of the polyvinyl acetate concentration (See Col. 3, lines 55-67).
Claims 1-19 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616
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