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 .
DETAILED ACTION
The office acknowledges Applicants filing of the amendments dated 9/28/2023. Claims 1-5 has been amended. Claim 6 is cancelled. For the sake of compact prosecution the examiner discussed allowable subject matter with attorney of record, Erin Regal Bobay. Applicants attorney on 1/6/2026 argued that the specification provides examples for prevention subject matter and advised that an action be mailed. Claims 1-5 are pending and are examined based on the merits herein.
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 1-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the effects of 3-(4-(benzyloxy)phenyl)hex-4-inoic acid derivative that can promote the expression of myogenic factors, MyoG and MyHC, inhibit the expression of a muscular atrophy factor, atrogin-1, promote the formation of myotubes, and inhibit myocyte apoptosis, resulting in the promotion of myogenesis and inhibition of muscle loss (see in vitro examples, Figures 1-9, experimental examples, 1-3), does not reasonably provide enablement for prevention of the conditions sarcopenia, muscular atrophy, myasthenia gravis, muscular dystrophy, myotonia, hypotonia, and muscle weakness as claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to the invention commensurate in scope with these claims.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: 1) the nature of the invention 2) the state of the prior art 3) the relative skill of those in the art 4) the breadth of the claims 5) predictability of the art 6) the amount of direction or guidance provided 7) the presence or absence of working examples and 8) the quantity of experimentation necessary.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
(1),(4) The nature of the invention and breadth of the claims:
The currently examined claims are directed to:
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The claims are broad in scope in regards to the diseases to be treated.
The term "preventing", as defined by the Applicants in page 3, “In the present invention, "prevention" refers to all actions of inhibiting or delaying the onset of muscle loss-related diseases by administering the composition”.
(2), (3) State of the art and Relative skill level of those in the art:
As per Medical News, muscular dystrophies (MDs) are a group of genetic conditions that cause progressive muscle weakness and atrophy. Although it is not possible to prevent MD, treatments can help to slow progression (see p 1, para 1). A person may inherit the genetic changes responsible for muscular dystrophy. These genetic changes can also occur due to spontaneous genetic mutations. In either case, the disease is not preventable (Abstract). MDs do not occur due to external factors, such as infection, activity levels, or injury, so they are not preventable. However, treatment can slow the progression of the disease and help prevent complications (See Summary, p 6) (https://www.medicalnewstoday.com/ articles/prevention-of-muscular-dystrophy, 2024).
Cleveland Clinic teach that muscular dystrophy refers to a group of more than 30 genetic conditions that cause muscle weakness and other muscle-related symptoms. The symptoms of muscular dystrophy get worse over time. It can be present at birth, develop in childhood or develop in adulthood depending on the type (See p1, overview). As muscular dystrophy is a genetic condition, there’s nothing you can do at this time to prevent it (see p 8, Prevention) (https://my.clevelandclinic.org/health/ diseases/14128-muscular-dystrophy, 2026).
Harvard Health teach that “Myasthenia gravis is a chronic (long-lasting) and rare disease that affects the way muscles respond to signals from nerves, leading to muscle weakness” (See p1, para 1). As to preventing myasthenia gravis the reference disclose that ‘Because the cause of myasthenia gravis is unknown, there is no way to prevent it. However, once the disease has developed, there may be ways to prevent episodes of worsening symptoms or flare-ups’. (see p5, Preventing myasthenia gravis) (Myasthenia Gravis - Harvard Health, 2024, https://www.health.harvard.edu/a_to_z/myasthenia-gravis-a-to-z).
Cleveland Clinic teach that sarcopenia is the age-related progressive loss of muscle mass and strength. The reference in Prevention Section, page teach that ‘You may not be able to completely prevent sarcopenia since the condition happens as part of the natural aging process. But you can take steps to slow the progression of the disease’ (See p7) (2022, https://my.clevelandclinic.org/health/diseases/23167-sarcopenia).
Cleveland Clinic teach that myotonia happens when your muscles don’t relax as they should after they contract. It can impact muscles throughout your body and may cause other symptoms depending on the type of myotonia. All types happen because of a genetic change. With each type, a different gene is affected. (See Overview). As to prevention it is taught that ‘Myotonia happens due to genetic changes, so you can’t do anything to prevent it. If you have a biological family history of myotonia or have it yourself and are planning to have biological children, consider meeting with a genetic counselor. They can go over your risk of having or passing on the condition’ (see p 8, Prevention) (https://my.clevelandclinic.org/health/diseases/22334-myotonia).
According to ChoosePT article, “Hypotonia is the medical term for low muscle tone, which refers to the state of muscles throughout the body. Babies with hypotonia are generally diagnosed within the first 6 months of life. Often these infants are described as “floppy” or having a “rag doll” appearance” (See p1, para 1). Hypotonia cannot be prevented. It often is a symptom of another condition or genetic abnormality. However, there is a greater risk of hypotonia for children born too early (before 37 weeks gestation) (p 5, para 1) (https://www.choosept.com/guide/physical-therapy--guide-hypotonia).
In regards to hypotonia, Cleveland Clinic teach that hypotonia means decreased muscle tone, it is often the symptom of an underlying medical condition’ (see overview). There isn’t a way to prevent hypotonia because it’s often the symptom of an underlying condition, which can be genetic. Genetic conditions are not preventable. If you plan on becoming pregnant and want to understand your risk of having a child with a genetic condition, talk to your healthcare provider about genetic testing (See p 7, Prevention section) (https://my.clevelandclinic.org/health/diseases/22223-hypotonia-in-babies, 2021).
In a nutshell, the conditions claimed can be treated or the progression can be slowed down for the patients with the conditions but are not preventable.
(5) Predictability of the art:
While the state of the art is relatively high with regard to treatment of disease, the
state of the art with regard to prevention of such disorders is underdeveloped. In
particular, there do not appear to be any examples or teachings in the prior art wherein
a composition similar to the composition comprising the compound of claim 1 was administered to a subject to prevent a disease. The lack of significant guidance from the specification or prior art with regard to the actual prevention of any disease with the claimed composition makes practicing the claimed invention unpredictable in terms of prevention of a disease. Please note that the term "prevention" is an absolute definition which means to stop from occurring and, thus, requires a higher standard for enablement than does "treatment".
It is well established that "the scope of enablement various inversely with the degree of unpredictability of the factors involved," and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839 (1970). In the instant case the scope of the diseases to be prevented is large.
From the teachings as discussed above, for example, the claimed conditions muscular dystrophy, myasthenia gravis, sarcopenia, myotonia, hypotonia cannot be prevented. It is noted that many of the conditions claimed are genetic conditions and are not preventable.
(6) The amount of direction or guidance provided and (7) The presence or absence of working examples:
Applicants have provided guidance and data in regards to myogenesis promoting effect of Compound A ((3S)-3-(4- (3-(1,4-dioxaspiro[4,5]des-7-en-8-yl)benzyloxy) phenyl)hex-4-inoic acid, lysine salt), muscle loss inhibition effect of Compound A. Applicants have provided Xray diffraction pattern data in regards to the lysine salt.
(8) The quantity of experimentation necessary:
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the composition comprising the compound of formula I could be predictably used for preventing the disorders as claimed. In order to practice claimed invention, one of skilled in the art would have to first envision a combination of appropriate formulation, compound dosage, etc. and appropriate host model system for the claimed composition and test the combination in the model system to determine whether or not the combination is effective for prevention of a disease. If unsuccessful, which is likely given the lack of significant guidance from the specification regarding prevention of any diseases with any composition, one of skill in the art would have to then either envision a modification of the first combination of formulation, compound dosage, etc. and appropriate host model system, or envision an entirely new combination of the above, and test the system again. Therefore, it would require undue, unpredictable experimentation to practice the claimed invention of preventing the muscle diseases in a subject in need thereof.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 5712705239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Umamaheswari Ramachandran/ Primary Examiner, Art Unit 1627