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 .
Status of Claims
The claim listing filed September 5, 2023 is pending. Claims 1-15 are pending. Claims 1-15 are rejected. Claim 13 is objected.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the provisional application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63403486, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The provision cover sheet in the provisional application is missing components of the composition such as a salt (sodium chloride or Dead Sea Salt), potassium citrate, a dicarboxylic acid (such as malic acid), water, and hypochlorous acid. It also does not mention specifically the issues the composition can treat such as joint pain and muscle pain and only encompasses treatment of skin disorders. No claims in the nonprovisional application have eligible subject matter that is supported by the provisional application. For the reasons listed above, it is also difficult to deduce whether the inventor had possession of the invention at the time of filing the provisional application. Thus, none of the claims get the priority date of October 18, 2022 and are judged by the effective filing date of the non-provisional application of September 5, 2023.
Information Disclosure Statement
An information disclosure statement has not been filed, failing to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement.
The applicant referred to three foreign patent publications in the specifications: CN305009664, CN305009665, and CN304526519. The information disclosure statement requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed.
Claim Interpretation
Using the mechanism described in the specification and the broadest reasonable interpretation, claim 12 is interpreted as the composition of matter that is the aerosol mist produced by ultrasonic vibration and electrolysis that results in the chlorine from the salt component of the composition in claim 1 to react with water to produce molecular hydrogen and hypochlorous acid.
[AltContent: rect]2Cl (aq) + 2H2O (l) H2 (g) + 2HOCl (g)
Thus, it is considered as the composition of claim 1 with hydrogen gas and hypochlorous acid in aerosol form for prior art searching purposes.
Claim Objections
Applicant is advised that should claim 11 be found allowable, claim 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Please see 112(b) and 112(d) rejections for further details.
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.
Claim 15 is 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 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, at the time the application was filed, had possession of the claimed invention. While the applicant details the way the composition is used in the performance testing section of the specification, the written description of improvement with treatment is not adequately supported. There is no support in the specification that detail the improvement process of a skin disorder, joint pain, or muscle pain. For example, how many times the composition was administered in a day, how long it was on the skin, or if it had to be washed off after a certain period of time. The lack of written description about the method of treatment makes knowing if the inventor has possession of the composition at the time of filing inconclusive.
Claim 15 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 present composition is not enabled to treat all skin disorders, joint pain and muscle pain. This is because the broadest reasonable interpretation encompasses conditions that are not enabled like articular and periarticular fractures. An articular or periarticular fracture happens when a bone breaks inside or around a joint. These injuries often damage cartilage at the ends of bones (articular cartilage) and other joint tissues [See pg Treatment for Articular and Periarticular Fractures].
Articular and Periarticular Fractures | Stanford Health Care. (2021). Stanfordhealthcare.org.
Fractures are fixed when the bones are back in place, and this done with a splint or cast, closed reduction, physical therapy, or surgery. Medication is also prescribed to control the pain [See section nonsurgical treatment]. Thus, there exists a lack of predictability that a topical treatment, such as the applicant’s, will treat joint pain due to a fracture, by putting the bone back together. Muscle pain due to stress fractures also lacks predictability of treatment by the applicant’s composition. ‘Like compression fractures, stress fractures often cause symptoms that are mistaken for other problems, such as muscle strain or foot pain from plantar fasciitis [see section Stress Fractures].”
Could You Have a Fracture and Not Realize It?: Powell Orthopedics and Sports Medicine: Orthopedic Surgery. (2023, May 1). Powell Orthopedics.
Stress fractures have similar treatments methods: Rest, ice application, elevation, bracing or casting, physical therapy, and medicine to help with pain and inflammation [see Section Fracture Treatment]. There is a lack pf predictability that a topical composition can internally fix a crack in a bone. Therefore, the invention is not enabled to treat all types of muscle and joint pain.
Also, brown spot discoloration, shingles and psoriasis do not represent the whole genus of skin disorders, joint pain and muscle pain like basal cell carcinoma (BCC). BCC is a type of skin disorder that is cancerous [see Section What is Basal Cell Carcinoma?].
Basal Cell Carcinoma: Causes, Symptoms & Treatment. (2023, August 31). Cleveland Clinic
However, there are no compositions analogous to that of the applicant’s that are used to treat it. Rather, physical intervention such as surgery, electrodessication, and cryotherapy are the line of treatment [see section How is basal cell carcinoma treated?] Thus, the present invention is not enabled to treat all skin disorders such as BCC because there is no predictability in the prior art that suggests a topical composition can cure skin cancer.
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.
Claim 11 is 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 11 recites “An aerosol mist produced by subjecting the composition of claim 1 to electrolysis, ultrasonic vibration, or a combination thereof.” However, the specification recites:
As used herein, “aerosol mist” means a suspension of microbubbles and/or nanobubbles of the composition disclosed herein in air. The microbubbles and/or nanobubbles are generated by application of ultrasonic vibration to the composition using devices designed to generate such aerosol mists [0012].
The specification defines an aerosol mist as solely a product of ultrasonic vibration and does not mention electrolysis. The conflicting definitions of what aerosol mist is fails to distinctly claim an aerosol mist, resulting in an indefinite claim.
Claim 13 is 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. There is no difference between claim 11 and 13 because the microbubbles and nanobubbles are inherent to the definition of the aerosol mist, as stated by the applicant [0012]. Therefore, the metes and bound of the claim are unclear and the claim is rendered indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In this case, claim 13 fails to further limit claim 11 as an aerosol mist innately comprises of microbubbles and nanobubbles, according to the applicant [0012].
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7 and 12 are rejected under 35 U.S.C. 101 because the claimed composition is a product of nature without any markedly different characteristics from any naturally occurring counterparts.
Laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature. The courts have often described these exceptions using other terms, including "physical phenomena," "scientific principles", "natural laws," and "products of nature." [MPEP 2106.04(c)]
Regarding claim 1, claim 1 recites a composition comprising of components a) through j) that are products of nature. See the analysis below.
Step 1: Does the claim fall into a statutory category of invention?
Yes, the claim is directed to a composition of matter, which falls into a category of invention.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea?
Yes, the claim is directed to a product of nature because every component can be found in nature. Some unapparent ones include potassium citrate and potassium sorbate.
Potassium is found in the form of potassium citrate in oranges
(Betz, M. (2022, November 30). Potassium Citrate in Food & Drinks. The Kidney Dietitian)
Potassium sorbate is mostly commercially synthesized as a preservative, but can be naturally be found in the berries of mountain ash as a salt of sorbic acid.
The Honest Team. (2013). What is Potassium Sorbate? | The Honest Company. Honest.com.
The markedly different characteristic analysis is part of Step 2A: Prong One. The markedly different characteristic analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state, the first step in the analysis is to select the appropriate counterpart(s) to the nature-based product.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
In the present case, the answer is yes because when a nature-based product is derived from a naturally occurring thing, then the naturally occurring thing is the counterpart.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
Because the markedly different characteristics analysis is based on comparing the characteristics of the claimed nature-based product and its counterpart, the second step in the analysis is used to identify appropriate characteristics to compare. Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. In the present case, each component found in nature is unmodified by a defining quantity (weight percentage) or a structural change. Thus, the claim does not recite additional elements that integrate the judicial exception.
Regarding claim 2, one of ordinary skill in the chemistry know non-essential amino acids are readily synthesized by the body.
In regards to claim 3, native type I-III, V, and X collagen are bovine-derived.
León-López, A., Morales-Peñaloza, A., Martínez-Juárez, V., Vargas‐Torres, A., Zeugolis, D., & Aguirre-Álvarez, G. (2019). Hydrolyzed Collagen—Sources and Applications. Molecules, 24
In regards to claim 4, the same source as claim 3 teaches that hydrolyzed collagen, known as collagen peptides, can be extracted from bovine or porcine.
Regarding claim 5, sodium chloride is found in elements of nature, like the ocean.
Sodium Chloride | Encyclopedia.com. (2019). Encyclopedia.
Regarding claim 6, Dead Sea Salt is found in the Dead Sea.
Frequently Asked Questions. (2023). The Salt Cellar. https://salt-cellar.com/pages/faqs
In regards to claim 7, apples, among other fruits, are the naturally occurring counterpart of malic acid.
(Price, A. (2019, August 17). The Organic Compound that Boosts Energy & Skin Health.)
In regards to claim 12, hypochlorous acid is naturally found in humans. When white blood cells encounter pathogens, they produce HOCl to neutralize them.
Yan, P., Daliri, E. B., & Oh, D. H. (2021). New Clinical Applications of Electrolyzed Water: A Review. Microorganisms, 9(1), 136.
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Seidensticker et al. (Patent US11666639B2: Granted 2023) in view of Alashqar et al (Alashqar, M. B., Goldstein, N. (2019) Caffeine in the Treatment of Atopic Dermatitis and Psoriasis: A Review. SKIN The Journal of Cutaneous Medicine, 3(2), 59-71) and Gavilanes (Gavilanes, G. (2019, May 2). These Collagen Infused Water Recipes Will Keep You Hydrated. Vital Proteins).
Seidensticker et al. claim a dietary supplement to replace collagen broken down during physical activity in both a powder form and a ready-to-drink form. The powder form is designed to be dissolved in 24 fluid ounces of a dilutant [see Spec 8]. Seidensticker et al. aim to resolve the deficiency of collagen, amino acids, vitamins, minerals, and electrolytes due to strenuous physical activity and enhances the uptake of collagen peptides based on the components of the composition [see Spec 4]. Seidensticker’s composition teaches every component of claim 1 (detailed further in claim 10’s rejection) except for caffeine and water as a dilutant.
Alashqar et al. teaches caffeine has a positive effect on the symptoms of atopic dermatitis and psoriasis. Both skin disorders have “decreased intracellular cyclic adenosine monophosphate (cAMP) levels in cutaneous leukocytes, so it is very likely that being a methylxanthine, and hence a phosphodiesterase (PDE) inhibitor, caffeine raises intracellular cAMP levels, which suppresses inflammatory pathways and potentiates anti-inflammatory ones” [see Abstract] At the time before the effective filing date of the claimed invention, it would have been obvious to add caffeine to the Seidensticker’s composition. Alashqar et al. motivates one of ordinary skill to add caffeine to the Seidensticker’s composition to help treat in inflammation.
Both Seidensticker and Alashqar do not teach water as a dilutant.
Gavilanes teaches collagen infused water recipes for hydration [see pgh 1 and section Lavender Lemon Infused Water]. In the recipe, filtered water (potable water) and sparkling water are used in combination with a collagen powder. The collagen powder is analogous to that taught by the primary source, Seidensticker, because Seidensticker’s assignee is Vital Proteins and the website in which Gavilanes’s recipe is the Vital Proteins website. This prior art would made it obvious to one of ordinary skill in the art that water is a potential dilutant one can use in conjugation with Seidensticker’s collagen powder.
It would have been obvious to a person of ordinary skill before the effective filing date of the claimed invention to combine the composition of Seidensticker and the teachings of Alashqar and Gavilanes to make the claimed composition. There would have been a reasonable expectation of success of treating skin disorders, joint pain and muscle pain because the combination will decrease its inflammation (caffeine), along with increasing the uptake of collagen to repair the connective tissue in muscles and joints (Siedensticker), using filtered water for a hydration boost(Gavilanes).
The further limiting claims 2-7 are taught by Seidensticker. In regards to claim 2, Seidensticker’s teaches that the nonessential amino acid of choice used in the collagen powder is glutamine [claims 1-3].
In regards to claim 3, Seidensticker says that collagen may be present in any available form and may be sourced from beef, chicken, fish, eggshell membrane, and chicken egg whites. [See column 2, line 50]. As the applicant says, bovine (beef) has the collagen types claimed by the applicant [0023], so Seidensticker teaches the composition of claim 3.
In regards to claim 4, Seidensticker states “the present invention preferably uses collagen peptides.” [Column 2 line 51]. It is prima facie obvious to claim hydrolyzed collagen because one of ordinary skill knows collagen peptides are made by hydrolyzing collagen. Therefore, Seidensticker teaches the composition of claim 4.
In regards to claim 5, Seidensticker’s composition may include electrolytes such as sodium, potassium, magnesium, and zinc [Claims 1-4 and column 2 line 13]. “Sodium may be present in any form, such as sea salt, iodized salt, Himalayan pink sea salt” [Column 3 line 61]. This is prima facie obvious because one of ordinary skill in the art knows that the above salts all mainly comprise of table salt or sodium chloride. Therefore, Seidensticker teaches the composition of claim 5.
In regards to claim 6, the rejection applied to claim 5 applies here, as Dead Sea Salt is a type of sea salt and Seidensticker teaches sea salt as a possible electrolyte.
In regards to claim 7, Seidensticker states “Additionally, other additives suitable for dietary supplements, including but not limited to, coconut water powder, malic acid… [Column 4 line 61]. Thus, Seidensticker teaches that the collagen powder may have malic acid as an additive.
The further limiting claims 8 and 9 are taught by Gavilanes. Regarding claims 8 and 9, Gavilanes teaches filtered water (potable water that is filtered). Gavilanes uses Seidensticker’s assignee’s collagen dietary supplement and teaches a recipe of collagen infused water for hydration. The recipe uses filtered water and sparkling water which are both potable or drinkable water. It would have been prima facie obvious to one of ordinary skill in the art to use potable water because Gavilanes teaches using a subtype of potable water that is filtered and sparkling water.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Seidensticker et al. (Patent US11666639B2) in view of Alashqar et al, as previously applied to claims 1-9, and in further view of Aguirre-Cruz et al. (Aguirre-Cruz, G., León-López, A., Cruz-Gómez, V., Jiménez-Alvarado, R., & Aguirre-Álvarez, G. (2020). Collagen Hydrolysates for Skin Protection: Oral Administration and Topical Formulation. Antioxidants, 9(2), 181), the NIH (National Institutes of Health. (2022, October 4). Zinc. Nih.gov.), Gupta et al (Gupta, M., Mahajan, V. K., Mehta, K. S., & Chauhan, P. S. (2014). Zinc therapy in dermatology: a review. Dermatology research and practice, 2014, 709152) , Nourian et al (US 20210169773 A1: Published 2021), Marion et al (US 20050004146 A1: Published 2005), and Bjarnadottir (Bjarnadottir, A. (2017, June 3). How Much Caffeine in a Cup of Coffee? A Detailed Guide (A. Seitz, Ed.). Healthline; Healthline Media).
The teachings of Alashqar and Seidensticker as applied to claims 1-9 are discussed above.
Seidensticker claims a dietary supplement to replace collagen broken down during physical activity in both a powder form and a ready-to-drink form [column 1 line 50]. The powder is dissolved in a dilutant. Table 1 summarizes the weight percentages calculated by using the mass of each component per serving, the 24 fluid ounces per serving, and the density of water (29.57 g/fl oz). All of the components except zinc and collagen are encompassed by, or overlap with the applicant’s claimed range of 0.02 wt%-1.5 wt%, and thus are prima facie 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].
The following calculations use the mass per serving of the powder form and calculates the weight percentage out of water’s weight, rather than the weight percentages given of the ready-to-drink form because the patent does not specify the solvent used for the ready-to-drink form. The mass per servings in Seidensticker are specific to the electrolyte portion of the compounds, such as sodium and potassium. Therefore, electrolyte’s given mass per servings is converted to mass per servings relevant to the applicant’s range using the total molar mass of the compounds. For example, the mass per serving given for sodium is converted to that of sea salt and the mass per serving given for potassium is converted to that of potassium citrate. Assuming the dilutant to be water, the calculations for the weight percentage of water are done according to claim 4, using the masses of the amino acids combined (26.879 g), 4 g of sugar and all of the components listed below (16.793-31.466) combined.
Component
Mass per serving (g)
Seidensticker (24 fl oz) wt%
Reference
a) Nonessential amino acid (glutamine)
0.5-1.5
0.0704-0.211
Claim 1-4
b) Collagen
17-23
2.40-3.24
Claim 1-4
c) Salt
Sodium: 0.20-0.325
Sea Salt*:0.508-0.826
0.0716-0.116
Claims 1-4 (electrolyte) and column 3-line 61
d) Zinc
0.001-0.02
1.41*10---4 - 2.82*10---3
Spec [0020]
e) Potassium citrate
Potassium: 0.05-0.25
Potassium Citrate: 0.392-1.96
0.0552-0.276
Claim 1-4 (electrolyte); Column 4-line 1
f) Dicarboxylic acid (Malic acid)
Exact range not mentioned
-
Column 4-line 61
g) Vitamin C
0.2-0.8
0.0281-0.113
Claim 1-7 and column 3-line 56
h) Potassium Sorbate
Potassium: 0.05-0.25
Potassium Sorbate: 0.192-1.96
0.0271-0.276
Claim 1-4 (electrolyte); Column 4-line 1
i) Caffeine
Not disclosed
-
-
j) Water
709.68 g
91.92-93.71
Claim 4
*The MW of sodium chloride is used to calculate the mass/servings because it is the main component of sea salt
The collagen in Seidensticker’s composition translates to 2.40-3.24 wt%, greater than range of the applicant’s claimed composition. This can be attributed to the fact that Seidensticker’s invention is an oral supplement. As Aguirre-Cruz et al explains, oral collagen supplements are more effectively absorbed by the body [Abstract].
Conversely, collagen is less effective topically because it is hard for it to permeate the skin.
“However, one of the main problems for topical applications is their low permeability to penetrate the skin. The larger the peptide (beyond six or seven amino acids), the less likely it is to reach the deeper layers [36]. It is well-known that permeation of the outer layers of the skin depends on different factors such as: physicochemical properties of the substance (molecular size, stability, binding affinity, solubility); the time-scale of permeation; thickness and components of the skin; cutaneous metabolism; site, area, and duration of application and properties of the transdermal device” [Pg 4 pgh 1].
It would be obvious to one skilled in the art to use a lower weight percentage of collagen because topical applications have slower time-scales of permeations in comparison to the digestive system, and a lower weight percentage may paradoxically be more effective moisturizing the skin and preventing water loss.
Siedensticker also mentions “Zinc may be present in any suitable form, such as a zinc sulfate. Zinc may be present in an amount of about 0.001-0.02 grams/serving or about 0.002-0.004 grams/serving, where the serving size is 36-38 grams/serving (or 24 fluid ounces/serving). This translates to 1.41*10---4 - 2.82*10---3 wt%. This is much lower than the applicant’s zinc weight percentage. The reasoning behind this is excess zinc consumption orally is toxic. As the NIH answers:
Yes, too much zinc can be harmful. Signs of too much zinc include nausea, dizziness, headaches, upset stomach, vomiting, and loss of appetite. If you take too much zinc for a long time, you could have problems such as lower immunity, low levels of high-density lipoprotein (HDL) (good) cholesterol, and low copper levels. Taking very high doses of supplemental zinc can reduce your body’s absorption of magnesium. [see section Can zinc be harmful?]
The safe daily upper limit for an adult to ingest is 40 mg. However, there is no such limit for a topical application. For example, a 0.25% zinc pyrithione cream applied twice daily, is effective for localized plaque psoriasis [see Table 1].
Gupta, M., Mahajan, V. K., Mehta, K. S., & Chauhan, P. S. (2014). Zinc therapy in dermatology: a review. Dermatology research and practice, 2014, 709152.
Also, a statistically significant improvement was observed with a combination cream containing zinc sulphate (2.5%) and clobetasol (0.05%) over plain clobetasol (0.05%) cream in 47 patients of chronic hand eczema [see 7.4 Eczemas]. Seidensticker el al. could not put more zinc for their oral composition, but the applicant can, as it is a topical composition, to increase the efficacy of treating skin disorders. This prior art would have been sufficient motivation for the applicant to increase the weight percentage of zinc in Seidensticker’s composition. It is obvious to an artisan of ordinary skill, to use the teachings of the NIH and Gupta that adding more zinc in a topical composition is safe and effective, therefore increasing the weight percentage of zinc in Seidensticker’s composition,
A dicarboxylic acid, in the form of malic acid, is present in Seidensticker’s oral composition in claims 1-4. However, the exact range is not discussed in the patent. Thus, Nourian et al. (US 20210169773A1: Published 2021) is used to gauge what range of malic acid is used in skin compositions. Nourian et al. claims a skin enhancing composition with anti-oxidative, anti-inflammatory, and anti-aging properties. Claim 14 recites a composition with 0.02-0.05 wt% of malic acid [claim 16]. Therefore, the applicant’s weight percentage encompasses the range used in a skin composition and it would have been obvious to one of ordinary skill to have 0.02-1.50 wt% of malic acid in Seidensticker’s composition because it covers the weight range in which malic acid may be used topically, and therefore has a reasonable expectation of success.
While Seidensticker teaches components a through h, it does not teach a composition comprising of caffeine. As previously discussed in claim 8 and 9’s rejection, Alashqar motivates one of ordinary skill in the art to add caffeine to the Seidensticker’s composition to gear it towards treating skin disorders, joint pain and muscle pain because the combination will decrease its inflammation and increase collagen uptake. An analogous patent publication by Marion et al. (US 20050004146 A1: Published 2005) teaches a composition containing caffeine to treat skin redness. Claim 4 of the publication recites that the composition comprises of 0.1-1% by weight of caffeine. In light of this prior art, it would have been obvious to one of ordinary skill to claim a range close to this weight percentage and incorporate it with Seidensticker’s composition to yield a reasonable expectation of success at treating skin disorders.
It would also not have been an experimental burden to add caffeine to Seidensticker’s powder because it is designed to be dissolved in a dilutant, and this includes solvents like coffee and green tea. According to Bjarnadottir et al., a 8 oz cup of brewed coffee has 70 to 140 mg, which translates to 0.0296-0.0592 wt%, well within the range claimed by the applicant [see section Brewed Coffee].
Bjarnadottir, A. (2017, June 3). How Much Caffeine in a Cup of Coffee? A Detailed Guide (A. Seitz, Ed.). Healthline; Healthline Media.
The water weight percentage for component j is calculated by first calculating the total weight of the components set forth by claim 4 by Seidensticker. This is added to the weight of 24 fl 0z of water. The weight of the water divided by the total weight yields a range of 91.92-93.71%. This range is close to the upper limit of the range of 60-90% and is fits the limitation of “an amount greater than or equal to 70 wt%.” It would have been obvious for the applicant to create the claimed composition by dissolving Seidensticker’s powder composition in a caffeine source like coffee (water-based) and adding zinc because Seidensticker teaches that the powder is designed to dissolved in 24 fluid ounces of a dilutant.
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Seidensticker et al. (Patent US11666639B2) in view of Alashqar et al, as previously applied to claims 1, and in further view of UNC Pharmalabs.
Aerosols, Foams, & Sprays | UNC Pharmlabs. (2022, February 19). The Pharmaceutics & Pharmaceutical Compounding Laboratory.
Claim 11 is a product-by-process claim. As the MPEP states,
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) [See MPEP 2113].
Therefore, the patentability of claim 11 and its dependent claims is based on the product that is the aerosol mist, and not the process through which it is achieved. Claim 11 also has a claim interpretation on record to reference based on the broadest reasonable interpretation.
Seidensticker and Alashqar do not teach the benefits of an aerosol mist. UNC Pharmalabs teaches the advantages of pharmaceutic aerosols such as facility of using, cleanliness, protection from oxygen and moisture, and uniformity of application and particle size. The website motivates one of ordinary skill to use an aerosol for topical application because it is beneficial to sensitive skin conditions and protects the formulation.
In regards to claim 13, UNC Pharmalabs teaches that “Topical medications can be applied as a spray, foam, or semisolid in a uniform thin layer without having to touch or mechanically irritate the affected area. The use of an aerosol will also limit the potential for overuse of a product compared to lotions, creams, and ointments.” It also teaches that the particle size of a surface spray is 50-200 μm [see Introduction section]. These teachings motivate the applicant to make the mist comprise of microbubbles because the website makes obvious the typical size of an aerosol spray.
Claims 12, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Seidensticker et al.in view of Alashqar et al and UNC Pharmalabs, as previously applied to claim 11, and in further view of Yan et al.
Yan, P., Daliri, E. B., & Oh, D. H. (2021). New Clinical Applications of Electrolyzed Water: A Review. Microorganisms, 9(1), 136.
Yan teaches that electrolyzed water is a “sanitizer produced from tap water with sodium chloride (NaCl) without the addition of harmful chemicals” [see Pg 5 pgh 4]. Also, when teaching HOCl clinical application, they state the following:
Importantly, its [HOCl] pH neutralization can enhance therapeutic activity, stability and skin tolerability [Pg 6 pgh 2].
Yan et al motivates one of ordinary skill to produce hypochlorous acid, and as a side product molecular hydrogen, using the composition taught by Seidensticker et al., Alashqar and UNC Pharmalabs, to enhance the composition.
In regards to claim 14, according to Yan et al, electrolyzed water usually contains 20-60 ppm of hypochlorous acid. This translates to:
20
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. A range of hypochlorous acid less than or equal to 150 ppmw is an obvious range to claim because it largely overlaps with Yan et al’s range, yielding a reasonable expectation of success and one of ordinary skill can easily convert the parameters taught by Yan et al. from ppm to ppmw.
In regards to claim 15, both Seidensticker and Yan et al. teach applying their compositions to treating joint and muscle pain or skin disorders. Seidensticker’s composition is designed to increase the uptake of collagen and other nutrients to replace the collagen broken down from the connective tissue of muscles, tendons, ligaments, cartilage and bones during physical activity [ spec 4]. Yan et al. teaches that electrolyzed water can act as a topical antibacterial agent and has its “antimicrobial properties has been utilized as part of cell proliferation, anti-infection and anti-biofilm therapies in a wound healing agent.” “HOCl (active compound) is able to increase oxygenation (TcPO2) in wounds while breaking biofilms, which is an important key differentiator from other products.” [Pg 11 pgh 1] Thus, it would be obvious to combine Yan’s teachings with the claim 11’s prior art because the composition would have a reasonable expectation of being successful at treating joint and muscle pain and skin disorders.
Summary
Claim 15 is rejected under 35 USC 112 (a). Claims 11-15 are rejected under 35 USC 112 (b). Claim 13 is rejected under 35 USC 112 (d). Claims 1-7 and 12 are rejected under 35 USC 101. Claims 1-15 are rejected under 35 USC 103.
Conclusion
Any inquiry concerning this communication or earlier communications from the
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/SACHI JAUHARI/
Examiner, Art Unit 1654
/LIANKO G GARYU/ Supervisory Patent Examiner, Art Unit 1654