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
This application is a National Stage entry of PCT/IB2023/052193, filed 03/08/2023, and claims foreign priority to IT102022000004376, filed 03/08/2022.
Information Disclosure Statement
The IDS filed on 9/4/2024 has been considered. See the attached PTO 1449 form.
Claim Status
Claims 1-18 are currently pending and under examination.
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 1-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating cutaneous inflammatory states or proctological pathologies, however, it does not reasonably provide enablement for treating injuries as the claim broadly recites treating “injuries” which encompasses any injury. 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 the invention commensurate in scope with these claims.
The claim broadly recites “treating injuries” which encompasses any injury (e.g. human or animal injury, external body or internal body injury). The examiner cannot find any evidence that butyric acid, zinc oxide or combination thereof can treat any known injury. While the composition can treat certain injuries (e.g. skin injuries), there is no evidence in the art that these ingredients in the composition are able to treat any known injury that occurs. For example, if an injury is to the internal body such as internal brain injury or lung, there is no evidence that a topical composition can treat all such types of internal injuries in the body.
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).
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 and relative skill level
The invention relates to a topical composition for treating injuries or cutaneous inflammatory states or proctological pathologies. The relative skill of those in the art is high, that of an MD or PHD and someone expert in inflammatory conditions or proctological pathologies.
The state and predictability of the art
The art however is unpredictable. The art requires the use of active ingredients which are both safe and effective for the subject being administered the claimed active ingredients. There are various parameters that need to be considered when administering the claimed components to a subject for treating injuries. For example, an internal injury may require a different route of treatment versus an external injury which may be treated with topical treatment. With the art being unpredictable, the specification needs to provide more details and evidence as to how the claimed topical composition can treat any known injure.
The breadth of the claims
Since the instant specification provides no limiting definition of the term “injury”, the examiner will adopt the broadest reasonable interpretation for it which is any disruption to the body of a human or animal.
The claim is thus very broad insofar as it recites “injury”, without clearly defining the type of injury which is treated with the topical composition. While treating any “injury” with the topical composition might theoretically be possible under strictly controlled laboratory conditions, as a practical matter it is nearly impossible to achieve in the “real world” to treat any known injury with the claimed composition.
The amount of direction or guidance provided and the presence or
absence of working examples
The specification provides no direction, guidance or evidentiary data showing how the claimed topical composition can treat any known injury.
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 agents could be predictably used to treat any injury 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.
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 1-10 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US20130004590A1) in view of Ward et al. (US20100069338A1).
Lin throughout the reference teaches zinc oxide containing compositions and methods for treating conditions such as diaper rash and atopic dermatitis.
Lin teaches a composition which can be topically applied and comprises zinc oxide, an acid, and a carrier. The amount of zinc oxide can range from about 5% to about 12.5%, which reads on and/or overlaps the claimed amount of zinc oxide. The acid is present in amount that ranges from 0.001% to 10%. Lin teaches the composition comprises water and the amount of water can range from about 50% to about 90%. Lin teaches the composition can further comprise emulsifier and the amount of emulsifier can range from 1% to 10%. Further, Lin teaches that any acid that would result in the release of zinc cation when reacted with zinc oxide can be used. Such acids include, but are not limited to, e.g., citric acid, acetic acid, salicyclic acid, carbonic acid, clucuronic acid, gluconic acid, lactic acid and malic acid. (see e.g. Abstract; Claims; Examples; Para 0048, 0056-0063, 0073; Entire document).
The teachings of Lin have been set forth above.
While Lin teaches the composition comprises an acid in combination with zinc oxide. Lin does not teach the composition comprises specifically butyric acid. However, Ward et al. cures this deficiency.
Ward is also directed to topical composition for treating dermatological conditions such as atopic dermatitis. Ward teaches the composition comprises a zinc salt and acid. The zinc salt in the compositions of the invention may be generated during the formulation of the compositions. The zinc salt can be generated from zinc oxide and an acid, wherein the acid can include citric acid, glyceric acid, glycolic acid, picolinic acid, tartaric acid, pantothenic acid, lactic acid, gluconic acid, pyruvic acid, salicylic acid, formic acid, acetic acid, propionic acid and butyric acid. Ward discloses the purpose of the present invention is to enable delivery of zinc ions to the stratum corneum. (see e.g. Abstract; Claims; Para 0019, 0062, 0069; Entire document).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Lin and Ward and include butyric acid as the acid (as taught by Ward) in the composition of Lin in the amount that ranges from 0.001% to 10%, as disclosed by Lin . As discussed supra, Lin teaches that any acid that would result in the release of zinc cation when reacted with zinc oxide can be used. Such acids include, but are not limited to, e.g., citric acid, acetic acid, salicyclic acid, carbonic acid, clucuronic acid, gluconic acid, lactic acid and malic acid. As discussed supra, Ward discloses the purpose of the present invention is to enable delivery of zinc ions to the stratum corneum and that the zinc salt in the compositions of the invention may be generated during the formulation of the compositions. The zinc salt can be generated from zinc oxide and an acid, wherein the acid can include citric acid, glyceric acid, glycolic acid, picolinic acid, tartaric acid, pantothenic acid, lactic acid, gluconic acid, pyruvic acid, salicylic acid, formic acid, acetic acid, propionic acid and butyric acid. Therefore, it would have been obvious to one skilled in the art substitute the acid taught by Lin with the butyric acid taught by Ward because Lin teaches using any acid that would result in the release of zinc cation when reacted with zinc oxide and Ward teaches purpose of the present invention is to enable delivery of zinc ions to the stratum corneum and that the zinc salt in the compositions of the invention may be generated from zinc oxide and an acid such as butyric acid. Thus, the use of butyric acid as the acid in Lin’s composition would have been prima facie obvious to one skilled in the art. see MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Regarding the claimed limitations wherein the composition is for treating injuries or cutaneious inflammatory states or proctological pathologies, and the treatment of conditions using the composition as recited in claims 14-15, these limitations are an intended use of the claimed composition and the prior art teaching the same topical composition as claimed would necessarily be capable of the intended use recited in the claims.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
Claims 1-10 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US20130004590A1) in view of Ernst (US20200360317A1).
Lin throughout the reference teaches zinc oxide containing compositions and methods for treating conditions such as diaper rash and atopic dermatitis.
Lin teaches a composition which can be topically applied and comprises zinc oxide, an acid, and a carrier. The amount of zinc oxide can range from about 5% to about 12.5%, which reads on and/or overlaps the claimed amount of zinc oxide. The acid is present in amount that ranges from 0.001% to 10%. Lin teaches the composition comprises water and the amount of water can range from about 50% to about 90%. Lin teaches the composition can further comprise emulsifier and the amount of emulsifier can range from 1% to 10%. Further, Lin teaches that any acid that would result in the release of zinc cation when reacted with zinc oxide can be used. Such acids include, but are not limited to, e.g., citric acid, acetic acid, salicyclic acid, carbonic acid, clucuronic acid, gluconic acid, lactic acid and malic acid. (see e.g. Abstract; Claims; Examples; Para 0048, 0056-0063, 0073; Entire document).
The teachings of Lin have been set forth above.
Lin does not teach the composition comprises butyric acid. However, Ernst cures this deficiency.
Ernst teaches carboxylic acids for treating skin diseases such as atopic dermatitis and diaper rash. Ernst teaches specifically butyric acid as the carboxylic acid for treating skin diseases such as atopic dermatitis and diaper rash. (see e.g. abstract; claims; para 0022, 0057-0058,
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Lin and Ernst and include butyric acid in the composition of Lin. As discussed supra, Lin teaches the composition is for treating conditions such as diaper rash and atopic dermatitis. Ernst teaches carboxylic acids for treating skin diseases such as atopic dermatitis and diaper rash. Ernst teaches specifically butyric acid as the carboxylic acid for treating skin diseases such as atopic dermatitis and diaper rash. Therefore, it would have been obvious to one skilled in the art to further include butyric acid in the composition of Lin because both Lin and Ernst teach treating the same types of skin conditions. As a general principle it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose, the idea of combining them flows logically from their having been individually taught in the prior art. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06.
Regarding the amount of butyric acid, as discussed supra, Ernst teaches carboxylic acid such butyric acid for treating skin diseases such as atopic dermatitis and diaper rash. It would have been obvious to one skilled in the art optimize the amount of butyric acid depending on the severity of the disease. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding the claimed limitations wherein the composition is for treating injuries or cutaneious inflammatory states or proctological pathologies, and the treatment of conditions using the composition as recited in claims 14-15, these limitations are an intended use of the claimed composition and the prior art teaching the same topical composition as claimed would necessarily be capable of the intended use recited in the claims.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
Claims 11-12 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US20130004590A1) in view of Ernst (US20200360317A1) as applied to claims 1-10 and 14-15 above and further in view of Joerger (US20070207113A1).
The teachings of Lin have been set forth above.
Lin does not teach the composition also comprises aloe vera and bisabolol and the amount thereof. However, Joerger cures these deficiencies.
Joerger teaches personal care compositions (e.g. diaper rash cream). Joerger teaches including an anti-inflammatory agent to the composition in the amount of 0.1% to 2% wherein the anti-inflammatory agent include aloe vera and bisabolol. (e.g. para 0141; 0080; abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Lin and Joerger and further include aloe vera and bisabolol in the amounts taught by Joerger. Lin teaches the present invention describes compositions and methods for treating and/or preventing inflammatory dermatoses, and in particular enzymatic dermatitis, such as diaper rash and atopic dermatitis (para 0034). Joerger also teaches personal care compositions (e.g. diaper rash cream). Joerger teaches including an anti-inflammatory agent to the composition in the amount of 0.1% to 2% wherein the anti-inflammatory agent include aloe vera and bisabolol. Since Joerger teaches aloe vera and bisabolol as having anti-inflammatory effect, one skilled in the art would have been motivated to include these two ingredient and the amounts thereof for treating inflammatory conditions disclosed by Lin.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
Claims 11-12 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US20130004590A1) in view of Ward et al. (US20100069338A1) as applied to claims 1-10 and 14-15 above and further in view of Joerger (US20070207113A1).
The teachings of Lin have been set forth above.
Lin does not teach the composition also comprises aloe vera and bisabolol and the amount thereof. However, Joerger cures these deficiencies.
Joerger teaches personal care compositions (e.g. diaper rash cream). Joerger teaches including an anti-inflammatory agent to the composition in the amount of 0.1% to 2% wherein the anti-inflammatory agent include aloe vera and bisabolol. (e.g. para 0141; 0080; abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Lin and Joerger and further include aloe vera and bisabolol in the amounts taught by Joerger. Lin teaches the present invention describes compositions and methods for treating and/or preventing inflammatory dermatoses, and in particular enzymatic dermatitis, such as diaper rash and atopic dermatitis (para 0034). Joerger also teaches personal care compositions (e.g. diaper rash cream). Joerger teaches including an anti-inflammatory agent to the composition in the amount of 0.1% to 2% wherein the anti-inflammatory agent include aloe vera and bisabolol. Since Joerger teaches aloe vera and bisabolol as having anti-inflammatory effect, one skilled in the art would have been motivated to include these two ingredient and the amounts thereof for treating inflammatory conditions disclosed by Lin.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
Claims 13 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US20130004590A1) in view of Ernst (US20200360317A1) as applied to claims 1-10 and 14-15 above and further in view of Yontz (US20110300083A1).
The teachings of Lin have been set forth above.
Lin further teaches the composition comprising an emollient which ranges in the amount of from about 1% to about 20%. Lin discloses emollients refer to materials used for the prevention or relief of dryness, as well as for the protection of the skin. (e.g. para 0048, 0057-0063).
Lin does not teach the composition also comprises one or more of the compounds recited in claims 13 and 18 and the amounts thereof. However, Yontz cures this deficiency.
Yontz teaches personal care formulations (e.g. diaper rash cream; para 0345; Table 40). Yontz teaches the formulation comprises emollient wherein the emollient include lavender oil (para 0097).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Lin and Yontz and include lavender oil as the emollient in the composition of Lin because Lin teaches the composition comprising an emollient used for the prevention or relief of dryness, as well as for the protection of the skin. Yontz, which is also discloses personal care formulation such as diaper rash cream, teaches including lavender oil as an emollient in the formulation. Thus, it would have been obvious to include the known emollient in the personal care compositions as disclosed by Yontz. Regarding the amount of the essential oil such as lavender oil, Lin teaches including about 1% of emollient which merely overlaps the approximately 0.55% amount recited in claim 18. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). See: MPEP 2144.05(I). Further, Lin discloses emollients refer to materials used for the prevention or relief of dryness, as well as for the protection of the skin and it would have obvious to optimize the amount to achieve these result effect parameters.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
Claims 13 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US20130004590A1) in view of Ward et al. (US20100069338A1) as applied to claims 1-10 and 14-15 above and further in view of Yontz (US20110300083A1).
The teachings of Lin have been set forth above.
Lin further teaches the composition comprising an emollient which ranges in the amount of from about 1% to about 20%. Lin discloses emollients refer to materials used for the prevention or relief of dryness, as well as for the protection of the skin. (e.g. para 0048, 0057-0063).
Lin does not teach the composition also comprises one or more of the compounds recited in claims 13 and 18 and the amounts thereof. However, Yontz cures this deficiency.
Yontz teaches personal care formulations (e.g. diaper rash cream; para 0345; Table 40). Yontz teaches the formulation comprises emollient wherein the emollient include lavender oil (para 0097).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Lin and Yontz and include lavender oil as the emollient in the composition of Lin because Lin teaches the composition comprising an emollient used for the prevention or relief of dryness, as well as for the protection of the skin. Yontz, which is also discloses personal care formulation such as diaper rash cream, teaches including lavender oil as an emollient in the formulation. Thus, it would have been obvious to include the known emollient in the personal care compositions as disclosed by Yontz. Regarding the amount of the essential oil such as lavender oil, Lin teaches including about 1% of emollient which merely overlaps the approximately 0.55% amount recited in claim 18. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). See: MPEP 2144.05(I). Further, Lin discloses emollients refer to materials used for the prevention or relief of dryness, as well as for the protection of the skin and it would have obvious to optimize the amount to achieve these result effect parameters.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
Conclusion
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/ALI S SAEED/Examiner, Art Unit 1616
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