DETAILED ACTION
Status of the Application
Receipt is acknowledged of the Applicants’ Amendments and Remarks, filed April 14, 2025 which have been entered on the record.
Claim 2 is amended.
Claims 1, 6, and 8-9 were previously cancelled by Applicant.
Claims 2-5 and 7-8 are pending and under examination.
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 .
Information Disclosure Statement
One additional information disclosure statements (IDS) submitted on April 14, 2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitations are: Baclofen and pharmaceutical acceptable salts in claim 2.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
WITHDRAWN REJECTIONS
The examiner withdraws rejections to Claims 1, 6, and 9-10 under 35 U.S.C. 103 as the claims were cancelled by Applicant.
The examiner withdraws rejections to Claim 2 under 35 U.S.C. 112(b) based on amendments by Applicant.
The examiner withdraws rejections to claims 2-5 and 7-8 under 35 U.S.C. 103 as being unpatentable over Chervinsky (USPN 9,012,486 B2), in view of Sabati et al. based on claim amendments by Applicant.
MAINTAINED/MODIFIED REJECTIONS
Claim Rejections - 35 USC § 112(a)
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 2-5 and 7-8 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification does not reasonably provide enablement for preventing localized musculoskeletal pain due to fibromyalgia or mastocytosis. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
This is a scope of enablement rejection.
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. See MPEP § 2164.01 (a).
Upon consideration of the factors discussed below, the examiner concludes that one skilled in the art would be unable to practice the invention as disclosed for preventing a localized musculoskeletal pain without being burdened with undue experimentation based on the information provided by the applicant.
A discussion of these factors in relation to the pending claims follows:
The breadth of the claims
The breadth of instant claims 2-5 and 7-8 are directed to a method for treating or preventing localized musculoskeletal pain due to fibromyalgia or mastocytosis.
On page 5, Applicant defines that “by treatment is meant…. the inhibition of the development of, more particularly the regression of, preferably the disappearance of a musculoskeletal pain.”
On page 5 of the specification, Applicant defines “by prevention is meant…to prevent or delay the appearance of musculoskeletal pain.”
On page 4 of the specification, Applicant explains that “the term ‘musculoskeletal pain’ designates pain that affects the joints, muscles, entheses, ligaments and/or tendons.”
Applicant additionally specifies that the treatment or prevention “applies to humans or animals.”
Applicant specifies that the musculoskeletal pain is due to mastocytosis and fibromyalgia. It is well-known in the art that musculoskeletal pain is heterogenous and classified by mechanism. For example, it is known in the art that “pain can be classified into nociceptive, neuropathic, nociplastic, idiopathic, or mixed type (El-Tallawy, Salah N., Rohit Nalamasu, Gehan I. Salem, Jo Ann K. LeQuang, Joseph V. Pergolizzi, and Paul J. Christo. "Management of musculoskeletal pain: an update with emphasis on chronic musculoskeletal pain." Pain and therapy 10 (2021): 181-209).”
It is also known in the art that “Musculoskeletal pain is a collective term for a variety of conditions of different etiologies and different disease trajectories… (El-Tallawy, Salah N., Rohit Nalamasu, Gehan I. Salem, Jo Ann K. LeQuang, Joseph V. Pergolizzi, and Paul J. Christo. "Management of musculoskeletal pain: an update with emphasis on chronic musculoskeletal pain." Pain and therapy 10 (2021): 181-209).”
It is also well-known in the art that mastocytosis is heterogenous.
As Ali Komi explains: “Mastocytosis is a heterogeneous group of disorders involving MCs and their CD34+/CD117+ progenitors.”
“According to the 2008 World Health Organization (WHO) classification system, mastocytosis can be classified into several subtypes: (1) cutaneous mastocytosis, (2) extracutaneous mastocytosis, (3) mast cell sarcoma, and (4) systemic mastocytosis (SM). SM can be further subdivided into the following subcategories: (1) indolent systemic mastocytosis (ISM); (2) SM associated with another clonal hematological non-mast cell lineage disease (SM-AHNMD), most commonly chronic myelomonocytic leukemia (CMML); (3) aggressive SM (ASM); and (4) mast cell leukemia [68]. (Table 1).”
“The heterogeneity of clinical presentations of mastocytosis relates to the tissue MC burden. There is much variation in the type of skin lesions, the patient’s age at the onset, and associated hematological disorders that—taken together—make the treatment of the disease challenging (Komi, Daniel Elieh Ali, Todd Rambasek, and Stefan Wöhrl. "Mastocytosis: from a molecular point of view." Clinical reviews in allergy & immunology 54, no. 3 (2018): 397-411).”
Consequently, it is reasonable to conclude that the instant claims are broad with respect to patient population (i.e.: all animals, humans, etc.), type of musculoskeletal pain, disease type and goal of treatment and prevention.
The nature of the invention
The nature of the invention is methods to treat or prevent localized musculoskeletal pain due to mastocytosis and fibromyalgia. To date, there are no pharmacological agents capable of preventing musculoskeletal pain and more specifically, all types of musculoskeletal pain due to fibromyalgia and mastocytosis.
The state of the prior art
The state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains. The relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed. See MPEP § 2164.05(b). See Pac. Biosciences of Cal., Inc. v. Oxford Nanopore Techs., Inc., 996 F.3d 1342, 1352, 2021 USPQ2d 519 (Fed. Cir. 2021).
The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification. See MPEP § 2164.05 (a).
To the best knowledge of the examiner, there is no general treatment method or pharmacological active agent that can prevent all or any types of musculoskeletal pain, including pain due to fibromyalgia and mastocytosis.
In fact, pharmacological treatments are not encouraged for fibromyalgia as explained: “the “drug prescription reflex” should be avoided as much as possible with patients presenting with fibromyalgia because drugs are poorly effective and associated with adverse effects. Drug treatments are not the best treatments for fibromyalgia, although they may be interesting to relieve symptoms, especially in case of comorbidities.”
Additionally, similarly fibromyalgia shows heterogeneity in symptoms, and “The pharmacological treatment of FM is largely an “off-label”, testament to the fact that, in the USA, only three drugs are currently Food and Drug Administration (FDA)-approved (pregabalin, duloxetine, and milnacipran). In comparison, two are approved by Health Canada (pregabalin and duloxetine) and none are approved by the European Medicines Agency. The efficacy of a broad range of pharmacological treatments has been investigated in randomized controlled trials. In general, pharmacological treatment, restricted to the shortest duration possible, should be reserved for cases of severe and uncontrolled symptoms, including pain, sleep, and mood disorders, when non-pharmacological options have been exhausted (Ranque-Garnier, Stéphanie, Carole Eldin, Caroline Sault, Didier Raoult, and Anne Donnet. "Management of patients presenting with generalized musculoskeletal pain and a suspicion of Lyme disease." Médecine et Maladies Infectieuses 49, no. 2 (2019): 157-166).”
Consequently, even within the art, there is still not a well-established understanding of musculoskeletal pain for the conditions recited in claim 2. In some cases, pharmacological approaches are highly discouraged.
Finally, Chou addresses issues in applying skeletal muscle relaxants for musculoskeletal conditions: “Unlike other drug classes such as statins, angiotensin-converting enzyme inhibitors, or beta-blockers, the skeletal muscle relaxants are a heterogeneous group of medications that are not chemically related. Because of this, there may be important differences in efficacy or safety that need to be considered in choosing a medication to treat patients with spasticity or musculoskeletal conditions. The current available literature provides only limited evidence to guide the prescribing physician in choosing an initial skeletal muscle relaxant, particularly for patients with musculoskeletal conditions. For these patients, clinicians might choose to avoid medications (chlorzoxazone, methocarbamol, metaxalone, dantrolene, and baclofen) for which there is very limited published evidence regarding their clinical effectiveness.
A major limitation of the literature is that clinical trials of skeletal muscle relaxants have often used unvalidated or poorly described methods to measure important clinical outcomes such as spasticity, pain, or muscle strength. Studies that have used the same scale often reported results differently (for example, mean raw scores after treatment, mean improvement from baseline, or number of patients “improved”). All of these factors make comparisons across trials difficult.
Other limitations of the literature are relatively small numbers of head-to-head trials, lack of high-quality studies, generally poor quality of adverse event assessment, typically short duration of follow-up, and heterogeneity in study design and interventions. In addition, few studies have adequately evaluated functional outcomes.
Other specific areas have not been adequately investigated. For example, patients who are still ambulatory might do better with one skeletal muscle relaxant compared to another, because of differential risk profiles. There are also no data to judge the comparative efficacy or safety of skeletal muscle relaxants in patients for whom one agent has failed or who have had intolerable side effects. There may be other reasons (convenience, improved compliance, better sleep, or more consistent pain relief) for choosing a specific skeletal muscle relaxant, but these outcomes have not been adequately assessed.
The lack of high-quality evidence regarding this class of medications is concerning given their wide use. Without better evidence regarding differential efficacy or safety, payers may be forced to rely disproportionately upon cost as a differentiating factor in choosing between medications in this class (Chou, Roger, Kim Peterson, and Mark Helfand. "Comparative efficacy and safety of skeletal muscle relaxants for spasticity and musculoskeletal conditions: a systematic review." Journal of pain and symptom management 28, no. 2 (2004): 140-175).”
Chou illustrates the lack of predictability within applying muscle relaxants (i.e.: baclofen) towards treating musculoskeletal conditions. Chou also highlights the gaps in understanding and inconsistency across patient and clinical data for use of this class of drugs, baclofen included.
Therefore, it is reasonable to conclude that the current state of the art is highly unpredictable, indicating that more details, working examples and guidance would be required to practice the invention as disclosed.
The level of one of ordinary skill
The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the relevant time. Factors that may be considered in determining the level of ordinary skill in the art may include: (A) "type of problems encountered in the art;" (B) "prior art solutions to those problems;" (C) "rapidity with which innovations are made;" (D) "sophistication of the technology; and" (E) "educational level of active workers in the field. In a given case, every factor may not be present, and one or more factors may predominate." In re GPAC, 57 F.3d 1573, 1579, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995); Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962, 1 USPQ2d 1196, 1201 (Fed. Cir. 1986); Environmental Designs, Ltd. V. Union Oil Co., 713 F.2d 693, 696, 218 USPQ 865, 868 (Fed. Cir. 1983). See MPEP § 2141.03 (I)
The invention described pertains to the medicinal, veterinary and pharmaceutical arts. One of ordinary skill would be a person with considerable training in medicine, veterinary medicine, pharmacology, medicinal chemistry, biochemistry or a related technical discipline.
The level of predictability in the art
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). The "amount of guidance or direction" refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling.
Consequently, technologies involving physiological activity as opposed to mechanical or electrical inventions are generally regarded as being unpredictable sciences.
As aforementioned, both mastocytosis and fibromyalgia are heterogenous and highly variable from patient to patient. There is no general method for preventing pain caused by both conditions.
As aforementioned, mastocytosis and fibromyalgia show different types of pain, the pain is not well-understood, there are limited experimental data on pharmacological approach, and/or pharmacological approaches are known to be ineffective. Within the conditions recited in claims 2, there does not exist a generalized approach; each condition is treated differently and many conditions themselves do not present the same across all subjects. There are also gaps regarding muscle relaxants as aforementioned by Chou.
To the best of the examiner’s knowledge and consulting with the prior art, there is no suggestion that any pharmacological agent can prevent musculoskeletal pain, although it is well-known how agents such as baclofen can be used in methods for treating and alleviating pain in musculoskeletal disorders and conditions.
Consequently, based on these culminative factors, it is reasonable to conclude that the predictability in the art is very low.
Consequently, the applicant would need to provide more details, working examples and guidance in order for the claimed invention to be enabling based on the scope and nature of the claimed invention.
The amount of direction provided by the inventor
As aforementioned, the amount of direction provided depends on the prior art and predictability of in the art. Based on the scope of protection sought by the applicant and the discussion aforementioned, the inventor has failed to provide sufficient direction for one ordinarily skilled in the art to practice the disclosed invention as claimed.
The existence of working examples
The applicants’ working examples are directed towards:
• Preparation of Baclofen cream for topical application.
• Example I: Treatment of 19 patients with various conditions recited in claim 2 with topical application of baclofen cream. It is worth noting there are no details on pain treatment plans to know if any other pharmacological agents were administered, how Applicant evaluated “success,” the duration of the treatment, and pain recurrence.
• Example II: Treatment of 20 patients with various conditions recited in claim 2 with topical application of baclofen cream. It is worth noting there are no details on pain treatment plans to know if any other pharmacological agents were administered, how Applicant evaluated “success,” the duration of the treatment, and pain recurrence.
• Example III: Treatment of 3 patients, 1 using fentanyl and baclofen, 2 using fentanyl, naproxene and baclofen, 3 using naproxene, pregabalin, baclofen, and morphine. The first two examples shows combination therapy which does not meet the limitations of claim 2.
Applicant has demonstrated that topical application of baclofen can be used to treat different types of pain as defined by the location; however, Applicant has disclosed no examples for using the claimed invention for prevention. The examples show that baclofen can be applied topically when pain is present in patients; however, do not show that baclofen prevents pain from returning or prevents pain from presenting in patients at risk for the specific diseases or conditions recited in claim 2.
Applicant additionally has shown no examples encompassing treatment or prevention for subjects aside from humans.
There is no mention of details identifying a population of subjects at risk or in need thereof, which would include all populations. There is also no mention of populations that are at higher risk than others or any guidance for one in the art to identify who is at risk. In particular, although Applicant has shown baclofen can treat localized musculoskeletal pain due to the conditions recited in claim 2, Applicant has not shown how the methods claimed prevent localized musculoskeletal pain due to the conditions recited in claim 2.
Consequently, it is not reasonable to conclude a person of ordinary skill in the art would be enabled in practicing the invention for preventing musculoskeletal pain.
On this basis and the prior discussion, the working examples are both not commensurate with the scope of protection sought and are not enabling.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
As aforementioned, the quantity of experimentation depends on the prior art, the predictability of the art, and the direction provided by the inventor, which are factors that were already discussed.
In order for one ordinarily skilled in the art to practice the invention as disclosed, some attributes one would require, but are not limited to:
Methods to determine if a subject will develop or not develop musculoskeletal pain based on using the claimed invention.
Methods to determine if a subject will develop or not develop musculoskeletal pain based on using the claimed invention over the course of disease progression.
Methods for identifying population of subjects at risk and guidance for determining such populations.
Studies including other subjects aside from humans (i.e.: animals).
The examiner concludes that one ordinarily skilled in the art would require undue experimentation in order to practice invention based on the details provided and scope of invention defined in Claims 2-5 and 7-8.
Consequently, Claims 2-5 and 7-8 remain rejected for not being enabling for the scope of patent protection being claimed.
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 2-5 and 7-8 remain rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kopsky (USPN 11,147,799 B2) (herein referred to as Kopsky).
Regarding Claim 2, Kopsky teaches “a method for treating or preventing a localized musculoskeletal pain by means of topical administration to a patient in need thereof of an effective amount of a topical composition comprising a compound selected from Baclofen and pharmaceutically acceptable salts thereof as an active ingredient, and at least one pharmaceutically acceptable excipient, wherein said composition is administered topically and does not contain any other compound with analgesic and/or anti-inflammatory effects.”
Specifically, Kopsky teaches “The term “musculoskeletal pain” as used herein has its conventional meaning and here means a pain that affects the muscles, ligaments, tendons, bones, joints and/or soft tissues that are part of the musculoskeletal system. Musculoskeletal pain as used herein, includes all types of pain due to damage of muscle tissue as a result of wear and tear of daily activities. Trauma to an area (jerking movements, auto accidents, falls, sport injuries, fractures, sprains, strains dislocations, and direct blows to the muscle) also can cause musculoskeletal pain. Other causes of musculoskeletal pain include postural strain, repetitive movements, overuse, and prolonged immobilization, misuse of muscles, fibromyalgia, lumbar pain, pain due to increased muscle tone, and tendinitis due to overuse.”
Additionally, Kopsky discloses specific examples for methods for treating localized musculoskeletal pain in a patient with trigeminal neuralgia, neuropathic pain due to partial spinal cord injury, and Guillain-Barre syndrome by means of topically applying a 5% cream containing baclofen which does not contain other analgesics (page 35, Case 5; page 35, Case 7; page 37, Case 8).
Kopsky’s examples demonstrate that topical application of baclofen without any other active ingredients is well-known in the art for treating musculoskeletal pain.
In addition to the explicitly-named conditions named in Kopsky’s examples, Applicant recites the claim limitation “musculoskeletal pain is due to” specific diseases and conditions,” including fibromyalgia as in instant invention.
As aforementioned, Applicant clearly defines in their specification on page 4 that “the term ‘musculoskeletal pain’ designates pain that affects the joints, muscles, entheses, ligaments and/or tendons.” Applicant also defines that “treatment is meant…. the inhibition of the
development of, more particularly the regression of, preferably the disappearance of a
musculoskeletal pain.”
Additionally, Applicant is reminded that "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112, I.
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. See MPEP 2112, II.
"Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP 2112.01, II.
Applicant emphasizes that “the musculoskeletal pain is due to a disease selected from a list of specific diseases.” However, the instant invention simply discloses topical administration of a composition containing baclofen as the active ingredient. No additional steps or disease-specific steps are provided for the conditions recited in claim 2.
Therefore, it is reasonable to conclude that administering a composition containing baclofen will result in the outcome of treating musculoskeletal pain for any disease or condition characterized by musculoskeletal pain as it is well-known in the art and Kopsky also teaches that baclofen is used to treat localized musculoskeletal pain as an inherent property; therefore, it is reasonable to conclude baclofen could be used to treat any medical condition where localized musculoskeletal pain presents as a symptom such as the specific diseases recited by Applicant.
In cases like this, once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant. See MPEP 2112 (V). The applicant is therefore invited to explain how the method of topically administering a composition comprising baclofen as disclosed in the claimed invention is materially different from Kopsky.
Regarding Claims 3-5 and 7-8, Kopsky discloses “wherein the composition is in the form of….a cream,” “wherein the compound is in the concentration from 5% by weight,” “wherein the topical composition is formulated into a unit dosage form,” “wherein the topical composition is applied to the affected area twice daily,” and “further comprising a penetration enhancer.” (page 37, lines 1-5, Case 7 by example only).”
Consequently, claims 2-5 and 7-8 remain rejected as being anticipated by Kopsky.
Response to Arguments
The Remarks of April 14, 2024 have been fully considered but are not persuasive for the reasons below.
35 U.S.C. 112(a)
Applicant argues that “As shown in the specification, the topical administration of baclofen induces significant decreases of pain in patients suffering from mastocytosis (see Example I: patients 5a, 6a; Example II: patients 3b, 9b, 14b and 19b; Example III: third patient) and fibromyalgia (see Example II: patients 1b, 8b and 11b). Accordingly, in view of the above amendment, it is respectfully submitted that Claim 2 is enabled by the specification as required by 35 USC § 112(a). Claims 3-5, 7, and 8 depend from Claim 2, and so for at least that reason, Applicant respectfully submits that Claims 3-5, 7, and 8 are enabled by the specification as required by 35 USC § 112(a).”
As aforementioned and explained, although Applicant has demonstrated methods of treatment, Applicant has not demonstrated methods of prevention. Additionally, Applicant has not demonstrated methods of treatment across all subjects claimed.
Therefore, the claims remain rejected on grounds of lack of enablement pertaining the scope of the claims.
35 U.S.C. 102
Applicant argues that “A claim is anticipated only if each and every element of the claim is found in a single reference. M.P.E.P § 2131 (citing VerdegaalBros. v. Union Oil Co. of California, 814 F.2d 628 (Fed. Cir. 1987)). "The identical invention must be shown in as complete detail as is contained in the claim." M.P.E.P. § 2131 (citing Richardson v. Suzuki Motor Co., 868 F.2d 1226 (Fed. Cir. 1989)).
The Office Action states that "Kopsky discloses pharmaceutical compositions containing phenytoin, an anticonvulsant and baclofen for treating conditions where pain is caused by 'Sjogren-associated and complex regional pain syndrome type I and II (reflex sympathetic dystrophy (claim 12)."' Office Action, page 34 (emphasis added).
Kopsky describes that "phenytoin acts as a co-analgesic compound boosting the analgesic effect of yet at least one further (co-)analgesic compound in a pharmaceutical composition for topical use." Kopsky, Col. 4 lines 29-32. The analgesic effect of phenytoin is evidenced by a recent article from Kopsky et al. (Kopsky II), which is included in an IDS filed herewith. Kopsky II, Pharmaceuticals, 2025, 18, 228.
In this manner, while the Office Action states that Kopsky discloses "applying a 5% cream containing baclofen which does not contain other analgesics (page 35, Case 5; page 35, Case 7; page 37, Case 8)," (Office Action, page 34), these compositions do include another analgesic at least because they also include the analgesic compound phenytoin.
Applicant respectfully notes that Claim 2 recites a "composition is administered topically and does not contain any other compound with analgesic and/or anti-inflammatory effects."
(Emphasis added). Thus, Applicant respectfully submits that Kopsky fails to describe each and every element of the claim, as required by the M.P.E.P., at least because the present claims explicitly exclude a composition comprising baclofen in combination with another compound with analgesic effects (such as phenytoin) as described by Kopsky.
Accordingly, Applicant respectfully submits that Claim 2 is novel over Kopsky. Claims 3- 5, 7, and 8 depend from Claim 2, and so for at least this reason, Applicant respectfully submits that Claims 3-5, 7, and 8 are novel over Kopsky.
Reconsideration and withdrawal of these grounds of rejection are respectfully requested.”
The examiner respectfully disagrees. Phenytoin is well-known in the art as an anticonvulsant. On page 7 of Applicant’s specification, Applicant does not provide a definition or examples for what is meant by any compound with analgesic and/or anti-inflammatory effects.
Aside from Kopsky’s examples pertaining phenytoin, Kopsky also teaches examples where baclofen alone is administered as cited in the previous Office Action.
In Case 7, Kopsky specifically teaches that “Baclofen 5% cream clearly had some effect on his pain. The first 10 minutes after application the pain aggravated where after the pain vanished completely. He had to apply baclofen 5% cream 2 to 4 times in the night.”
Consequently, topical application of baclofen is known in the art for treating musculoskeletal pain. As Kopsky teaches, that musculoskeletal pain can be caused by fibromyalgia.
On this basis, Applicant’s arguments are not found to be persuasive.
Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nickell (US PG-PUB 2016/0136120 A1) teaches kits for manufacturing drugs for transdermal delivery and specifically teaches baclofen without other compounds with analgesic and/or anti-inflammatory effects as the API in the form of an ointment, cream, rinse or gel in a concentration of 1-20% USP. Kopsky et al (Kopsky, David Jos, and Jan M. Keppel Hesselink. "Neuropathic pain as a result of acromegaly, treated with topical baclofen cream." Journal of pain and symptom management 46, no. 4 (2013): e4-e5.) teach that topical baclofen can be used to treat musculoskeletal pain associated with acromegaly. Kopsky et al (Kopsky, David J., Jan M. Keppel Hesselink, and Roberto Casale. "Walking with neuropathic pain: paradoxical shift from burden to support?." Case reports in medicine 2015, no. 1 (2015): 764950) further teach topical baclofen can be used for neuropathic pain treatment.
Conclusion
Claims 2-5 and 7-8 are pending and remain rejected. No claims allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.L.L./ Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622