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 .
Claim Status
Claims 1-8 are currently pending and under examination.
Priority
Applicant’s priority claim is acknowledged:
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Information Disclosure Statement (IDS)
The IDS (1) filed on 09 August 2024 has been considered by the examiner. A signed copy is enclosed.
Applicant is reminded of their duty to disclose to the Office all information known to the
person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach
individual associated with the filing and prosecution of a patent application has a duty of candor
and good faith in dealing with the Office, which includes a duty to disclose to the Office all
information known to that individual to be material to patentability as defined in this section.”
Claim Objections
Claims 2-8 are objected to for the following informalities:
These claims reference the independent claim only by number. The claims should read, “[t]he composition according to claim 1” not “[t]he composition according to 1” as currently written.
Claim 6 is also objected to for an assumed typographical error. Claim 6 recites a list of acids suitable for the composition, however tartaric acid is included twice.
Claim Rejection - 35 USC § 112(a) – Written Description Requirement
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 1-8 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.
Independent claim 1 recites a composition for a hydrogel or cataplasma patch containing an “arnica extract,” the composition requiring the functionality of being effective for suppressing inflammation, alleviating pain, or alleviating hot plate pain. Dependent claim 2 further recites the arnica extract is included in an amount of 0.7% to 1.7% (interpreted as based on the total weight of the composition).
The specification defines “arnica extract” broadly as: “[t]he term ‘arnica extract’ herein does not have a particular specifications, and includes, for example, Arnica Montana extracts that are commercially available for ISO-certified supplements, foods, beverages, cosmetics, or pharmaceuticals” ([0034]-[0035]). This definition could apply to any extract and does not limit the term to a particular Arnica species, plant part, extraction solvent, extraction method, concentration, dry extract/tincture form, marker-compound content, sesquiterpene lactone content, flavonoid content, homeopathic dilution, or other chemical or biological characterizations.
The specification identifies the invention as an Arnica Montana fermented extract ([0008], [0016], [0075]) and the working disclosures are directed to that specific extract. However, the definition provided in the disclosure broadly encompasses any arnica extract. Furthermore, the claims are directed to any arnica extract, not the specific species identified in the disclosure. The specification does not disclose a representative number of arnica extract species, extracts from different plant parts, or extracts prepared using different solvents or extraction methods. Nor does the specification identify structural, chemical, or functional characteristics common to all arnica extracts that would allow one of ordinary skill in the art (‘POSITA’) to recognize the applicant possessed a representative number of species within the genus that performed the claimed functions.
A disclosure of a single species, Arnica Montana fermented extract, does not demonstrate possession of a representative number of species within the broader genus of all arnica extracts, particularly where botanical extracts may differ materially depending on species, plant part, extraction solvent, fermentation conditions, marker-compound content, and biological activity. Therefore, the specification does not provide written-description support commensurate with the scope of the claims. Accordingly, the specification supports, at most, a composition containing Arnica Montana fermented extract, not the broader claimed genus of compositions containing any arnica extract.
Claim Rejection - 35 USC § 112(a) – Scope of Enablement Requirement
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 1-8 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 a composition containing Arnica Montana fermented extract effective for suppressing inflammation, alleviating pain, or alleviating hot plate pain, does not reasonably provide enablement for a composition containing any arnica extract for suppressing inflammation, alleviating pain, or alleviating hot plate pain. 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.
Enablement is considered in view of the Wands factors (MPEP 2164.01(A)).
These include:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based
on the content of the disclosure
All of the Wands factors have been considered with regard to the instant claims as discussed below. The Wands factors support a finding of nonenablement.
(A)/(B) The breadth of the claims/The nature of the invention and (F)/(G) The amount of
direction provided by the inventor/The existence of working examples:
Claim 1 is directed to a composition suitable for hydrogel or cataplasma patch, the composition containing any arnica extract. In addition, the claimed composition requires a functional effectiveness for suppressing inflammation, alleviating pain, or alleviating hot plate pain. Therefore, the breadth of the claims is substantial. Claim 1 is not limited to a particular arnica species, plant part, extraction solvent, extract concentration, standardized active-marker content, or extraction method. As written, the claims encompass all arnica extracts, including extracts that may differ materially in chemical composition and biological activity.
The nature of the invention supports a need for detailed disclosure. The invention is directed to a composition formulated into a topical hydrogel/cataplasma patch, the claimed activity of which depends on the interaction of a botanical extract with a polymeric gel base and skin contact patch system. Botanical extracts are compositionally complex and can vary significantly depending on source material and extraction conditions. The functional result of suppressing inflammation or alleviating pain is not determined solely by the presence of any arnica extract.
The specification does not provide sufficient guidance for selecting which arnica extracts will work, how to prepare or standardize such extracts, what chemical or biological properties are required, or how to determine whether a given extract will provide the claimed efficacy when incorporated into the recited hydrogel/cataplasma patch. The specification discloses a single species of Arnica Montana fermented extract at a single concentration used the formulation, experimental, and stability examples. In addition, the specification states the term ‘arnica extract’ as used does not have a particular specification, but does not provide meaningful guidance for selecting operative extracts. It does not disclose required marker compounds, acceptable extract profiles, preferred extraction solvents, extraction ratios, plant parts, a representative number of species, or standardization criteria.
(C)/(E) The state of the prior art/The level of predictability in the art:
Neither of these factors cure the enablement deficiency. While arnica-containing topical products were known, that general knowledge would not teach a POSITA that every possible arnica extract, regardless of species, plant part, concentration, marker content, or preparation method, would be suitable for the claimed hydrogel/cataplasma patch or would provide the recited anti-inflammatory or analgesic functions.
There are approximately 150 different bio-active components in arnica and while some have antioxidative and cytoprotective properties, other components of arnica, like helenalin, are cytotoxic (p. 2).1 In 2021, a review of studies on herbal therapies for osteoarthritis concluded that arnica gel is about as effective as topical NSAIDs for inflammation and pain relief, but the findings were not clinically significant (p. 2).2 More research is needed to fully understand arnica’s capacity to relieve pain (p. 2).3 In addition, there are many ways to formulate arnica, with topical preparations being the safest (p. 2).4 However, there isn’t a consistent dosage recommendation and the therapeutic dosing research that does exist is funded by arnica manufacturers, implying bias within that research (p. 2).5
The level of predictability in the art is limited. The performance of botanical extracts in topical formulations is not fully predictable as extract composition and biological activity vary with plant species, plant part, extraction method, and extract concentration. As previously cited, there are approximately 150 different bio-active components in arnica and no clear understanding of which components come together to provide pain relief in a human subject. In addition, there is no widely accepted or consistent dosage recommendation of arnica. The specification does not overcome the lack of prior art disclosure, as the specification fails to provide a correlation between any identifying chemical characteristic of arnica extracts and the claimed pain/inflammation activity.
D) The level of one of ordinary skill:
The level of ordinary skill in the art would allow for a formulator to prepare topical gel patches comprising botanical extracts, but possession of technical knowledge in formulation and/or medicinal science does not substitute for a disclosure identifying which members of the broad arnica extract genus were actually enabled.
(H) The quantity of experimentation needed to make or use the invention based on the
content of the disclosure:
A person of ordinary skill would need to identify such broadly claimed extracts, prepare, standardize, formulate, and test candidate extracts for their claimed properties. This amounts to undue experimentation as one would need to screen numerous arnica extract candidates, prepare each by different extraction methods, incorporate them into the claimed hydrogel/cataplasma matrix, evaluate formulation compatibility and stability, and conduct prolonged experiments using human and animal models to test the claimed functionality. Such experimentation extends far beyond routine optimization of a known operative species; rather, it would be required to determine which members of the broadly claimed genus are even operative as claimed.
Accordingly, while the specification may provide information relevant to the preparation
of a composition containing Arnica Montana fermented extract, the specification does not enable the full scope of claims 1-8 insofar as they encompass all arnica extracts. Therefore, the claims are not enabled commensurate with their scope and are rejected under 35 USC 112(a) for lack of enablement.
Claim Rejections - 35 USC § 112(b)
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 1-8 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.
Claim 1 recites the composition is effective for “…alleviating hot plate pain.” The phrase ‘alleviating hot plate pain’ is not defined in the specification and is only used in the context of a validation test ([0075]). This phrase is subjective and is typically used as an animal model endpoint, not a clinical condition or property of a composition. It could mean the following:
Activity in any hot-plate pain animal model;
Analgesic activity in a subject;
Specifically limited to the experimental conditions disclosed in the specification during the hot plate pain alleviation validation test; or
Human pain caused by a hot surface.
Claim 1 is therefore indefinite because the phrase ‘alleviating hot plate pain’ fails to clearly define the metes and bounds of the claimed composition. It is unclear whether the phrase refers to a clinical condition, an animal hot-plate assay endpoint, or a particular test method and threshold for analgesic efficacy.
Claim 1 further recites the composition comprises “a partially neutralized polyacrylic acid product as a polymer.” This phrase is unclear because of the breadth and ambiguity of the terms ‘partially neutralized’ and ‘product’:
What is meant by product? The specification provides no definition of the phrase and only discloses examples of a partially neutralized polyacrylic acid product. Each of the disclosed examples are commercially available formulations and referred to by their trademarked/trade name only, not by their specific composition ([0044]). While trademarked/trade names are generally allowed in the specification, ambiguity arises when interpretation of claim language is reliant upon a trademarked/trade name because the composition of these products can retain their trademarked/trade name, but the formulation may be altered over time. Therefore, one of ordinary skill in the art could not determine the metes and bounds of the claim based on the claim language or disclosure.
How much neutralization would meet the threshold of partial? While claim 3 further clarifies the partially neutralized polyacrylic acid product has a neutralization degree of 25% to 70% by mole, this language is not present in claim 1. In addition, the specification provides no threshold for the term ‘partially.’ The disclosure simply states the partially neutralized polyacrylic acid product may have a neutralization degree of 25% to 70% by mole. Would a polyacrylic acid product with a neutralization degree of 71% by mole constitute infringement? Would 70.9% by mole constitute infringement?
Claims 2-8 are included in the rejection under 35 USC 112(b) because of their dependency on, and requiring every limitation of, independent claim 1 and failing to cure the defect.
Claim 2 recites “the arnica extract is included in an amount of 0.7% to 1.7%,” but does not specify a basis. It is therefore unclear whether the percentage is based on total composition, extract solids, patch weight, active concentration, or extract solution. For purposes of examination, this claim has been interpreted as requiring the arnica extract in a range based on the total weight of the composition.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 4-6 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kusunoki (JPH11180887A - machine translation relied upon, published: 07 June 1999).
Kusunoki discloses an anti-inflammatory analgesic patch which shows excellent anti-inflammatory effect (abstract).
Regarding claim 1, Kusunoki discloses working examples showing the anti-inflammatory effect of hydrogel patches, the patch of Example 1 comprising –
Arnica tincture (extract from Arnica Montana flowers);
Purified water at 52% w/w;
Partially neutralized polyacrylic acid; and
Glycerin (polyhydric alcohol) at 30% w/w.
([0029] – Table 1; Machine translation of Table 1 on p. 10 relied upon).
Regarding claim 2, Kusunoki discloses the arnica extract of Example 1 is included at 1.0% w/w ([0029] – Table 1; Machine translation of Table 1 on p. 10 relied upon).
Regarding claim 4, Kusunoki discloses glycerin is used in Example 1 formulation at 30% w/w ([0029] – Table 1; Machine translation of Table 1 on p. 10 relied upon).
Regarding claim 5, Kusunoki discloses dry aluminum hydroxide gel is used in Example 1 formulation at 0.1% w/w ([0029] – Table 1; Machine translation of Table 1 on p. 10 relied upon).
Regarding claim 6, Kusunoki discloses tartaric acid is used in Example 1 formulation at 1.0% w/w ([0029] – Table 1; Machine translation of Table 1 on p. 10 relied upon).
Therefore, the hydrogel patch formulation of Kusunoki anticipates the currently claimed invention in instant claims 1-2 and 4-6.
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.
Claims 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kusunoki (cited above).
As previously discussed, Kusunoki discloses an anti-inflammatory hydrogel patch and components which anticipate, under 35 USC 102(a)(1) and 102(a)(2), that which is currently claimed in instant claims 1-2 and 4-6. As it pertains to instant claim 3, while Kusunoki discloses a partially neutralized polyacrylic acid at 6.0% w/w in Example 1, Kusunoki does not expressly disclose the neutralization degree of 25% to 70% by mole as required by instant claim 3. Furthermore, while Kusunoki discloses use of sodium edetate in the formulation of Example 1, Kusunoki does not disclose sodium edetate in an amount that falls within the instantly claimed range of claim 8. However, these limitations are made obvious by the disclosures of Kusunoki.
Regarding claim 3, Kusunoki teaches use of a polyacrylic acid-based water-soluble polymer in the formulations ([0013]) as discussed regarding Example 1 above. Kusunoki further teaches a preferred degree of neutralization of the polyacrylic acid between 40-70% by mole ([0013]). The range disclosed by Kusunoki overlaps with the instantly claimed range (see MPEP 2144.05).
Regarding claim 8, Kusunoki discloses sodium edetate is used in Example 1 formulation at 0.1% w/w ([0029] – Table 1; Machine translation of Table 1 on p. 10 relied upon). Sodium edetate is a salt of edetic acid and Kusunoki discloses sodium edetate in an amount that approaches and is close to the instantly claimed range.
See MPEP 2144.05(I): 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 Americav.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.”).
While the disclosures of Kusunoki anticipate that which is currently claimed in claims 1-2 and 4-6, Kusunoki did not disclose the partially neutralized polyacrylic acid product neutralization degree or amount of sodium edetate in the working examples to amount to anticipation. In other words, the difference between the applied reference and the claimed invention is that the applied reference may not teach the instantly claimed method with particularity so as to amount to anticipation. See MPEP “[t]he identical invention must be shown in as complete detail as is contained in the ... claim.” Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).
However, a skilled artisan would have reasonable expectation of success in selecting these components in their claimed ranges or amounts because: 1) Kusunoki teaches the preferred neutralization degree is between 40% to 70% by mole, which overlaps with the instantly claimed range; and 2) Kusunoki teaches sodium edetate at 0.1% w/w as suitable in a hydrogel composition, which is extremely close to the instantly claimed range of 0.2% to 3% w/w. While Kusunoki does not expressly disclose the instantly claimed ranges or amounts in the working examples, both Kusunoki and the currently claimed invention are drawn to a hydrogel patch comprising overlapping ingredients at overlapping ranges, so it would be reasonable for a skilled artisan to rely upon Kusunoki’s teachings to arrive at the instantly claimed invention. The applied reference discloses the elements of the claimed composition with sufficient guidance, particularity, and with a reasonable expectation of success for the skilled artisan, that the invention would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date. Therefore, Kusunoki makes obvious that which is currently claimed in instant claims 3 and 8.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kusunoki (cited above) in view of Daehwa Pharmaceutical Co. (WO 2019/143114 A1 – machine translation relied upon, published: 25 July 2019).
As discussed above, Kusunoki discloses an anti-inflammatory hydrogel patch containing an arnica extract that either anticipate or make obvious the currently claimed invention in claims 1-6 and 8. However, Kusunoki does not expressly teach the specific penetration-enhancer species recited in claim 7. However, the limitations of claim 7 are made obvious in further view of Daehwa Pharmaceutical Co. (hereinafter ‘Daehwa’). Daehwa teaches hydrogel patch pharmaceutical compositions comprising an active ingredient, a polyacrylic acid partial neutralization product as a gel-forming agent, a crosslinking agent, and water as a solvent (p. 1). Daehwa further teaches additives commonly used in the field of percutaneous absorption preparations such as permeation enhancers (p. 4). Daehwa specifically teaches that the permeation enhancers diethylene glycol monoethyl ether and/or isostearyl glyceryl ether can significantly increase the skin penetration of a pharmaceutically active ingredient and cause little skin irritation (p. 4). Daehwa teaches the permeation enhancer in an amount between 0.5% to 20% w/w, thus overlapping with the claimed range (p. 4).
It would have been obvious to a person of ordinary skill in the art, before the filing date of the invention, to include a penetration enhancer taught by Daehwa in the Arnica-containing hydrogel patch of Kusunoki because both references concern hydrogel patch compositions comprising partially neutralized polyacrylic acid products and conventional hydrogel patch excipients. Kusunoki recognizes the importance of transdermal permeability/absorption of active components from the patch ([0014]), and Daehwa teaches penetration enhancers for improving percutaneous delivery in hydrogel patch compositions. A person of ordinary skill would have a reasonable expectation of success in using a penetration enhancer in Kusunoki to arrive at the instantly claimed invention because penetration enhancers were known formulation additives for hydrogel patch compositions and their addition would have been expected to improve skin delivery of the active ingredient as taught by Daehwa.
Conclusion
Claims 2-8 are objected to. Claims 1-8 are rejected. No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Julia A. Rossi whose telephone number is (571)272-0138. The examiner can normally be reached M-Th 7:30-5:30 (MST).
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, Robert A. Wax can be reached at (571)272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIA A. ROSSI/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
1 “Arnica: What It Is and How To Use It,” Cleveland Clinic. Published 20 February 2023. Found online here: https://health.clevelandclinic.org/arnica
2 Id.
3 Id.
4 Id.
5 Id.
Prosecution Insights