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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 31, 2024, has been entered.
Status of the Claims
Claims 1-3 and 5-8 are pending. Claim 1 was amended in the response filed December 31, 2024.
Claims 5-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election of Group I and homeopathic somatropin as a species of hormone supplement was made without traverse by telephonic election on August 10, 2023.
Claim Interpretation
Claim 1 recites the limitation “homeopathic somatropin diluted to a range of 18D-42D”. This language appears only once in the specification at paragraph [0173]: “In some aspects, the homeopathic formulation of somatropin may be in the range of 24D-36D, or in a range of 18D-42D.” The specification does not provide an explicit definition for the phrase including for “18D-42D”. Paragraph [0018] describes the general principle of homeopathy which involves the use of “highly-diluted and activated formulations”. The specification states in paragraph [0018] that “It is likely that the fact that homeopathy does not rely on the actual presence of large amounts of the target biomolecule, but rather it relies on the presence of an energetically- activated aqueous solution of small phytochemicals.”
The U.S. Patent and Trademark Office gives claims their broadest reasonable interpretation consistent with the specification (MPEP § 2111). For the purposes of examination “homeopathic somatropin diluted to a range of 18D-42D” is given its ordinary and customary meaning consistent with the specification and with the interpretation that those skilled in the art would reach.
The prior art directed to the field of homeopathy utilizes expressions of potencies including nX or D potency. On the website “Types of complementary medicines” the Australian Therapeutic Goods Administration (TGA) (Retrieved from the Internet on February 2, 2024: <URL: tga.gov.au/resources/resource/guidance/types-complementary-medicines> (hereafter “Australian TGA”) describes the expression of homeopathic potencies: “'nX' (or 'D') potency1: where each dilution of the mother tincture is a decimal or 10-fold dilution and 'n' is the number of dilutions, such that the total dilution is 10n. For example: a 1X potency represents a 1:10 dilution; 2X a 1:100 dilution; 3X a 1: 1,000 dilution; 4X a 1:10,000 dilution.”
In view of the definition of D potency provided by the Australian TGA, the claimed “homeopathic somatropin diluted to a range of 18D-42D” is a 1:1x1018 to 1:1x1042 fold dilution. This definition is consistent with paragraph [0018] of the instant specification which states that homeopathy uses “highly-diluted and activated formulations” and “does not rely on the actual presence of large amounts of the target biomolecule.”
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
MPEP § 2164.01 states: “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is ‘undue.’ These factors include, but are not limited to: (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. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)
The breadth of the claims
The claims are drawn to a composition for transdermal hormone supplementation, comprising an aqueous gel comprising therapeutically effective amounts of: a hormone supplement comprising homeopathic somatotropin diluted to a range of 18D-42D and 0.1% to 0.9% by weight of velvet bean extract; 0.5% to 3% by weight of cannabidiol (CBD); 0.1% to 3% by weight of eucalyptol; and 1% to 4% by weight of menthol, wherein the composition is formulated for transdermal application via a dispenser.
The claim term “hormone supplementation” and “therapeutically effective amounts” are construed under BRI to encompass a variety of conditions presented in the specification including growth hormone deficiency, chronic kidney disease, Turner syndrome, Prader-Willi syndrome, “preventing or mitigating the ravages of age”, healing of injuries and neurological trauma, pain relief (as in the healing of injuries, athletic augmentation, or treatment of skin-sensitive neuralgia as humans age), and physical augmentation of athletes (paragraphs [0003]-[0004]). In order to comply with the enablement provision of 35 U.S.C. 112(a), the specification must support at least one of these intended uses of the claimed composition.
The nature of the invention
The claimed invention falls within the field of homeopathy. Paragraph [0018] of the specification describes the general principle of homeopathy which involves the use of “highly-diluted and activated formulations”. The specification states in paragraph [0018] that “It is likely that the fact that homeopathy does not rely on the actual presence of large amounts of the target biomolecule, but rather it relies on the presence of an energetically- activated aqueous solution of small phytochemicals.”
The U.S. Food and Drug Administration (US FDA) describes homeopathy on a website called “Homeopathic Products” (Retrieved from the Internet on February 3, 2024: <URL fda.gov/drugs/information-drug-class/homeopathic-products>). The US FDA states:
Homeopathy is an alternative medical practice that was developed in the late 1700s. Homeopathy is generally based on two main principles:
that a substance that causes symptoms in a healthy person can be used in diluted form to treat symptoms and illnesses, a principle known as “like-cures-like”; and
the more diluted the substance, the more potent it is, which is known as the “law of infinitesimals.”
Historically, homeopathic products have been identified through “provings,” in which substances are administered to healthy volunteers in concentrations that cause symptoms. Symptoms experienced by volunteers are recorded to indicate possible therapeutic uses for the substances. In other words, if a substance causes a particular symptom, individuals experiencing that symptom would be treated with a diluted solution made from that substance.
Notably there is not a single FDA-approved homeopathic product: “There are no FDA-approved products labeled as homeopathic; this means that any product labeled as homeopathic is being marketed in the U.S. without FDA evaluation for safety or effectiveness.”
The U.S. National Center for Complementary and Integrative Health (NCCIH) describes homeopathy on a website called “Homeopathy: What You Need to Know” (Retrieved from the Internet on February 3, 2024: <URL nccih.nih.gov/health/homeopathy>. The US NCCIH states: “There’s little evidence to support homeopathy as an effective treatment for any specific health condition.” In addition, the US NCCIH states: “A number of the key concepts underlying the theory of homeopathy are not consistent with fundamental scientific concepts as we understand them.”
In a 2012 review article, Vijayakumar Subash (“Alternative medicine: homeopathy - a review,” International Journal of Pharmacotherapy 2012; 2 (2) : 57-69, abstract only) discredits the scientific basis for the field (emphasis added):
Homeopathy is a form of alternative medicine originated by Samuel Hahnemann, based on the idea that a substance that causes the symptoms of a disease in healthy people will cure that disease in sick people. This axiom is known as the law of similars or like cures like. Scientific research has found homeopathic remedies ineffective and their postulated mechanisms of action implausible. Within the medical community homeopathy is generally considered quackery.
In summary, the nature of the invention is that it falls within a field that defies broad scientific understanding of medical concepts and which has failed to establish efficacy using art-recognized robust methodologies.
(C) The state of the prior art
The prior art establishes that there is no standard for the chemical composition of the claimed agent “homeopathic somatotropin”. As indicated by the article entitled “What is a Homeopathic human growth hormone?” (HealthGains, Retrieved from the Internet on August 18, 2023 <URL: healthgains.com/hgh-hormone-therapy/what-is-homeopathic-human-growth-hormone/>, cited PTO-892 08/23/2023), the American Association of Homeopathic Pharmacists does not recognize homeopathic human growth hormone [homeopathic somatropin] as a homeopathic drug (p. 2). There are no standardized processes or quality standards for homeopathic HGH. Id. The Homeopathic Pharmacopoeia of the United States (HPUS) does not list Homeopathic HGH as a recognized homeopathic drug. Medical literature does not provide any proof that homeopathic HGH works. Additionally, if a homeopathic HGH product actually contains any HGH and someone sells it without a prescription, it is illegal. Id.
HGH Doctor (Retrieved from the Internet on August 18, 2023 <URL: hghtherapydoctor.us/hgh/does-homeopathic-hgh-work/>, 13 pages (2019), cited PTO-892 08/23/2023) states that “[h]omeopathic HGH is not the same thing as doctor-prescribed human growth hormone injections. On a molecular level, bioidentical HGH has the same chemical structure as naturally produced pituitary somatotropin – the chemical name for growth hormone” (p. 2). Homeopathy practitioners believe that homeopathic HGH benefits are similar to those of HGH therapy. That is not the case. Homeopathic HGH contains no real human growth hormones so it cannot provide the GH receptor cells with any HGH for binding and activation of their functions. Pharmaceutical HGH injections consist of the same 191 amino acids in the same molecular structure as naturally secreted somatotropin (p. 5). As with any homeopathic product, there is no FDA evaluation of HGH sold in this form. The Federal Food and Drug Agency only regulates homeopathic products as drugs, yet it does not evaluate them for effectiveness or safety (p. 6). Homeopathic HGH is highly diluted, as with all forms of homeopathic products. However, that does not mean they are always properly diluted to the point they need to be for safety. Id.
(D) The level of one of ordinary skill
The level of ordinary skill in the homeopathic art is low. The specification states in paragraph [0006] that the invention does not require a medical professional: “What is needed is a means of providing transdermal hormone supplementation, coupled with topical analgesic and antibiotic and/or antifungal treatment, via inexpensive methods that do not require medical professionals to be carried out.”
(E) The level of predictability in the art
The specification does not define “18D-42D”. As described above, the prior art directed to the field of homeopathy utilizes expressions of potencies including nX or D potency. On the website “Types of Complementary medicines” cited above Australian TGA describes the expression of homeopathic potencies: “'nX' (or 'D') potency: where each dilution of the mother tincture is a decimal or 10-fold dilution and 'n' is the number of dilutions, such that the total dilution is 10n. For example: a 1X potency represents a 1:10 dilution; 2X a 1:100 dilution; 3X a 1: 1,000 dilution; 4X a 1:10,000 dilution.” Based on the Australian TGA, the claimed “homeopathic somatropin diluted to a range of 18D-42D” is a 1:1x1018 to 1:1x1042 dilution.
There are two issues with claiming a 1:1x1018 to 1:1x1042 fold dilution that point to a high degree of unpredictability: 1) undefined concentration, and 2) the possibility that no molecules of the agent exist in the final product.
First, neither the prior art nor the specification define a standard concentration of homeopathic somatropin from which the claimed composition is diluted (i.e. the concentration of the starting mother tincture). Even if one of ordinary skill in the art understands how to perform a 1:1x1018 to 1:1x1042 fold dilution (i.e. 18-42 10-fold serial dilutions), if there is no common or standardized starting concentration, the concentration of the final claimed product is unknown. As a result, it is difficult to predict whether a given concentration is a therapeutically effective amount or even to compare compositions for efficacy in treating growth hormone deficiency, chronic kidney disease, Turner syndrome, Prader-Willi syndrome, preventing or mitigating the “ravages of age”, healing of injuries and neurological trauma, pain relief (as in the healing of injuries, athletic augmentation, or treatment of skin-sensitive neuralgia as humans age), and physical augmentation of athletes.
Second, the level of dilution required by the claim is so great that the “Avogadro’s limit” may be crossed, yielding a product that contains not even a single molecule of the active agent. Mahata (“Avogadro Limit Washed out by Nano-Associates of Water which Continue as Information Carriers in Serial Dilutions and End up with Generalized Concept of Medicine,” Int J Complement Alt Med 2017, 9(4): 00305) states in the first paragraph: “The dictate of Avogadro number is that chemically all potencies above 12c will be just the vehicle” (c is where each dilution of the mother tincture is a centesimal or 100-fold dilution and 'n' is the number of dilutions, meaning 12c is a 1:1x1024 fold dilution which equivalent to 24D). The claimed potency 18D-42D includes the Avogadro’s limit of 24D meaning that the claim includes embodiments that are so dilute that not even a single molecule of “homeopathic somatropin” is present in the composition.
As stated previously, the composition is claimed as a homeopathic potency which is a dilution, in this case 18D-42D (1x1018 to 1x1042 fold dilution). Neither the claims, specification nor art define the concentration of the starting material (i.e. the mother tincture). To estimate the number of molecules in one embodiment of the claimed composition and illustrate the effect of the “Avogadro’s limit” on predictability of the claimed invention, we can assume that the maximum concentration of the mother tincture is limited by the solubility of the somatropin, which for human somatotropin in water is 1 mg/ml (MW 22,125 Da2), as evidenced by Ablinger et al. (“Effect of protamine on the solubility and deamidation of human growth hormone,” International Journal of Pharmaceutics 427 (2012) 209-216). Therefore, for a mother tincture of human somatropin in water the maximum number of molecules of human somatotropin in one milliliter is3:
1
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22125
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6.0221
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=
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An 18D composition (i.e. 1x1018 fold dilution) starting from a mother tincture of human somatropin in water contains a maximum of:
2.72
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10
16
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=
0.027
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Therefore, to administer a single molecule of human somatotropin from an 18D composition assuming a mother tincture concentration of 1 mg/ml, the practitioner would have to administer 37 ml of the composition:
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=
37
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A 42D composition (i.e. 1x1042 fold dilution) starting from a mother tincture of human somatropin in water contains a maximum of:
2.72
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10
16
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=
2.72
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26
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Therefore, to administer a single molecule of human somatotropin from a 42D composition assuming a mother tincture concentration of 1 mg/ml, the practitioner would have to administer 3.67 x 1025 ml of the composition:
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2.72
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26
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=
3.67
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42
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It is noted that this volume, 3.67 x 1025 ml, is more than the total volume of water on Earth.4
These calculations illustrate that the claim scope includes embodiments that for all practical purposes are missing the alleged active ingredient somatotropin. These calculations are not a fluke; the extreme dilution and effective absence of the alleged active agent is a feature of the field of homeopathy. On the website “Homeopathy: What You Need To Know” (accessed February 2, 2024, URL nccih.nih.gov/health/homeopathy) the NCCIH states that homeopathy is based in part on the “Law of minimum dose” which is “the notion that the lower the dose of the medication, the greater its effectiveness.” NCCIH goes on to say that “Many homeopathic products are so diluted that no molecules of the original substance remain.” NCCIH also states “homeopathic preparations can be so dilute that a substance considered to be the ‘active ingredient’ becomes unmeasurable, which creates major challenges to the rigorous investigation of such products.”
If the somatotropin is missing from the composition the claim merely states a functional characteristic (hormone supplementation) without providing any indication about how the functional characteristic is provided. The effectiveness of the claimed product at hormone supplementation is highly unpredictable because the claimed product is so dilute that the active agent is missing. As a result, it is difficult to predict whether a given composition is effective for the recited use or to develop a mechanistic understanding for efficacy. There is no established means to predict whether a composition that is missing the active ingredient can be effective at treating growth hormone deficiency, chronic kidney disease, Turner syndrome, Prader-Willi syndrome, preventing or mitigating the “ravages of age”, healing of injuries and neurological trauma, pain relief (as in the healing of injuries, athletic augmentation, or treatment of skin-sensitive neuralgia as humans age), and physical augmentation of athletes.
In a 2012 review article, Vijayakumar Subash (“Alternative medicine: homeopathy - a review,” International Journal of Pharmacotherapy 2012; 2 (2) : 57-69, abstract only) discredits the scientific basis for the field, especially the extreme dilution feature (emphasis added):
Homeopathic remedies are prepared by serial dilution of a chosen substance in alcohol or distilled water, followed by forceful striking on an elastic body, called succussion. Each dilution followed by succussion is supposed to increase the remedy's potency. Homeopaths call this process potentization. Dilution usually continues well past the point where none of the original substance remains. The low concentrations of homeopathic remedies, often lacking even a single molecule of the diluted substance, lead to an objection that has dogged homeopathy since the 19th century: Modern advocates of homeopathy have suggested that water has a memory— that during mixing and succussion, the substance leaves an enduring effect on the water, perhaps a vibration, and this produces an effect on the patient. However, nothing like water memory has ever been found in chemistry or physics. Furthermore, the claims of homeopathy contradict pharmacological science, which shows that higher doses of an active ingredient exert stronger effects. Homeopathic remedies have been the subject of numerous clinical trials, which test the possibility that they may be effective through some mechanism unknown to science. While some individual studies have positive results, systematic reviews of published trials have failed to demonstrate efficacy.
In summary, the degree of unpredictability is high because the art defies broad scientific understanding of medical concepts and has failed to establish efficacy using art-recognized robust methodologies.
(F) The amount of direction provided by the inventor
MPEP § 2164.03 states: “The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).”
In the instant case, the level of knowledge is low and unpredictability is high. However, the instant specification fails to provide any guidance that explains how the claimed composition works to in treat growth hormone deficiency, chronic kidney disease, Turner syndrome, Prader-Willi syndrome, preventing or mitigating the “ravages of age”, healing of injuries and neurological trauma, pain relief (as in the healing of injuries, athletic augmentation, or treatment of skin-sensitive neuralgia as humans age), and physical augmentation of athletes given that the active agent somatropin is absent. The specification does not provide any guidance on how to prepare the claimed homeopathic somatropin diluted to a range of 18D-42D and velvet bean extract. These claim elements are mentioned only once in the specification in paragraph [0172]. This section does not present information on how to obtain, isolate, purify and dilute these agents. This is consistent with the nature of the field of homeopathy which the US FDA and NCCIH teach has failed to demonstrate any evidence for efficacy to treat any condition using established scientific principals and robust methodologies.
(G) The existence of working examples
The specification fails to disclose a single working example or actual reduction to practice. There is no evidence anywhere in the specification that the claimed composition can be used for the claimed intended use of treating growth hormone deficiency, chronic kidney disease, Turner syndrome, Prader-Willi syndrome, preventing or mitigating the “ravages of age”, healing of injuries and neurological trauma, pain relief (as in the healing of injuries, athletic augmentation, or treatment of skin-sensitive neuralgia as humans age), and physical augmentation of athletes. This is consistent with the nature of the field of homeopathy which the US FDA and NCCIH teach has failed to demonstrate any evidence for efficacy to treat any condition using established scientific principals and robust methodologies.
(H) The quantity of experimentation
In view of the low level of knowledge and skill in the art, the high degree of unpredictability in the art, the general lack of scientific basis for homeopathy, the lack of guidance and working examples in the specification, an undue burden of experimentation would be required for one of ordinary skill in the art to use the claimed composition for hormone supplementation. Separate assays, animal models and/or clinical trials would be needed for any of growth hormone deficiency, chronic kidney disease, Turner syndrome, Prader-Willi syndrome, preventing or mitigating the “ravages of age”, healing of injuries and neurological trauma, pain relief (as in the healing of injuries, athletic augmentation, or treatment of skin-sensitive neuralgia as humans age), and physical augmentation of athletes. This constitutes years of effort especially considering that there is no established scientific basis for the use of a composition that dilutes its active agent away.
For these reasons, claims 1-3 fail to meet the enablement requirement of 35 U.S.C. 112(a).
Response to the Arguments
Applicant's arguments filed December 31, 2024, have been fully considered but they are not persuasive.
First, Applicant traverses the rejection on the grounds that the conditions mentioned in the specification all share a common underlying issue of hormone imbalance or deficiency related to growth hormone and that the claimed combination addresses this underlying issue. This argument is not persuasive because there is no evidence on record that the composition addresses hormone imbalance or deficiency or that doing so would treat these disorders. The reasons that the specification is lacking are identified in the Wands factor analysis above, which are not addressed in this argument.
Next, Applicant traverses the rejection on the grounds that the enablement of the invention should be considered for the entire composition not solely on the homeopathic somatotropin component. This argument is not persuasive because the homeopathic somatotropin is claimed as an active and essential ingredient of the composition. The issues with homeopathic somatotropin are addressed in the Wands factor analysis above, which are not addressed in this argument. The presence of other ingredients in the composition does not resolve the problems with homeopathic somatotropin.
Next, Applicant argues that transdermal delivery systems are a well-established field in pharmaceutical science. This argument is not persuasive because while transdermal delivery may be used in general, the claims are directed specifically to transdermal delivery of homeopathic somatotropin. The issues with homeopathic somatotropin are addressed in the Wands factor analysis above, which are not addressed in this argument. The use of a common delivery route does not resolve the problems with homeopathic somatotropin.
For these reasons, the rejection is maintained.
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 1-3 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. This rejection is modified in view of the amendment filed September 19, 2023.
The phrase “homeopathic somatropin diluted to a range of 18D-42D” in claim 1 is a relative phrase which renders the claim indefinite. The term “homeopathic somatropin diluted to a range of 18D-42D” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, there is no guidance in the specification or prior art that permits the skilled artisan to determine if a composition falls within or outside of the instant claim scope. There are two issues with the phrase “homeopathic somatropin diluted to a range of 18D-42D” that render it indefinite: 1) the chemical composition of the agent homeopathic somatotropin, and 2) the level of dilution or concentration of the homeopathic somatotropin in the composition.
First, the prior art establishes that there is no standard for the chemical composition of the claimed agent “homeopathic somatotropin”. As indicated by the article entitled “What is a Homeopathic human growth hormone?” (HealthGains, accessed 8/18/2023 at URL healthgains.com/hgh-hormone-therapy/what-is-homeopathic-human-growth-hormone/), the American Association of Homeopathic Pharmacists does not recognize homeopathic human growth hormone [homeopathic somatropin] as a homeopathic drug (p. 2). There are no standardized processes or quality standards for homeopathic HGH. Id. The Homeopathic Pharmacopoeia of the United States (HPUS) does not list Homeopathic HGH as a recognized homeopathic drug. Medical literature does not provide any proof that homeopathic HGH works. Additionally, if a homeopathic HGH product actually contains any HGH and someone sells it without a prescription, it is illegal. Id.
HGH Doctor (accessed 8/18/2023 at URL hghtherapydoctor.us/hgh/does-homeopathic-hgh-work/, 13 pages (2019)) states that “[h]omeopathic HGH is not the same thing as doctor-prescribed human growth hormone injections. On a molecular level, bioidentical HGH has the same chemical structure as naturally produced pituitary somatotropin – the chemical name for growth hormone” (p. 2). Homeopathy practitioners believe that homeopathic HGH benefits are similar to those of HGH therapy. That is not the case. Homeopathic HGH contains no real human growth hormones so it cannot provide the GH receptor cells with any HGH for binding and activation of their functions. Pharmaceutical HGH injections consist of the same 191 amino acids in the same molecular structure as naturally secreted somatotropin (p. 5). As with any homeopathic product, there is no FDA evaluation of HGH sold in this form. The Federal Food and Drug Agency only regulates homeopathic products as drugs, yet it does not evaluate them for effectiveness or safety (p. 6). Homeopathic HGH is highly diluted, as with all forms of homeopathic products. However, that does not mean they are always properly diluted to the point they need to be for safety. Id.
Second, there is no standard for claimed dilution “18D-42D”. The specification does not define “18D-42D”. In an article “Types of complementary medicines” the Australian Government Therapeutic Goods Administration (TGA) (accessed February 2, 2024, URL tga.gov.au/resources/resource/guidance/types-complementary-medicines) describes the expression of homeopathic potencies: “'nX' (or 'D') potency: where each dilution of the mother tincture is a decimal or 10-fold dilution and 'n' is the number of dilutions, such that the total dilution is 10n. For example: a 1X potency represents a 1:10 dilution; 2X a 1:100 dilution; 3X a 1: 1,000 dilution; 4X a 1:10,000 dilution.” Based on the Australian TGA, the claimed “homeopathic somatropin diluted to a range of 18D-42D” is a 1:1x1018 to 1:1x1042 dilution.
There are two issues with claiming a 1:1x1018 to 1:1x1042 dilution that render the claims indefinite: 1) undefined concentration, and 2) the possibility that no molecules of the agent exist in the final product.
Regarding the undefined concentration, neither the prior art nor the specification define a standard concentration of homeopathic somatropin from which the claimed composition is diluted (i.e. the concentration of the starting mother tincture). Even if one of ordinary skill in the art understands how to perform a 1:1x1018 to 1:1x1042 fold dilution (i.e. 18-42 10-fold serial dilutions), if there is no common or standardized starting concentration, the concentration of the final claimed product is unknown. As a result, it is not possible to determine whether a given composition with a particular somatotropin concentration falls within or outside of the scope of the claim.
Regarding the absence of molecules of active agent, the level of dilution required by the claim is so great that the “Avogadro’s limit” may be crossed (see analysis above in the rejection under 35 U.S.C. 112(a)). The claim scope includes embodiments that for all practical purposes are missing the alleged active ingredient somatotropin. If the somatotropin is missing from the composition the claim merely states a functional characteristic (hormone supplementation) without providing any indication about how the functional characteristic is provided. The recited functional characteristic does not flow from (is not an inherent property of) the structure recited in the claim, i.e., somatotropin, because the somatropin is missing; it i