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 .
Priority
Acknowledgments are made that this application claims the priority to the following:
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Claim objections
Claim 2 is objected to because of the following informalities: claim recites the name of formula (I). So, claim is not further limiting or claim is duplicate. Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Written Description
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 1-10, 12, 17-18, 21, 28, 39-40 and 42 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement for the claimed method. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The rejection is based on the requirement(s), i.e., the guidelines provided by the MPEP 2163.04. These are listed below:
(A) identify the claim(s) limitations at issue, and
(B) establish a prima facie case by providing reasons why a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed. The MPEP 2163 further provided or expanded the guidelines for the written description requirements.
(A) IDENTIFY THE CLAIM LIMITATIONS AT ISSUE:
Independent claim is drawn to a method of treating or preventing age-related macular degeneration (AMD) in a human subject, the method comprising administering to the human subject a therapeutically effective amount of a compound of formula (I), or its pharmaceutically acceptable salt or hydrate thereof.
Above claimed subject matter treats and prevents all possible AMDs in all possible human populations. Administration can be any known mode of administration to all possible subjects. Dosage amount of polypeptide is very generic. Compound of formula (I) is also known as danegaptide.
The meaning of “preventing” is completely eradicate the claimed AMD, both existing as well as from the future occurrence.
Dependent claims define or limit the method, i.e., treating or preventing, mode of administrations, characterization of AMD, patient population and dosage amounts etc.
To support the above broadly claimed subject matter, applicants described nexus between ‘gap junction dependent cellular modulators’ and the conditions which are at risk of developing AMD. Shown data or evidences are limited protecting diabetic retinopathy (DR), outer retinal thickening in rats with DR. Based on shown data applicants conclude that “these combined findings that danegaptide can protect from RPE barrier dysfunction as shown by danegaptide's ability to prevent increases in RPE monolayer permeability due to hyperglycemic and oxidative stress in a TJ associated manner, and its ability to prevent outer retinal layer thickening in rats with DR indicate the danegaptide could be an effective treatment for patients with d-AMD, wet AMD or neovascular AMD”. However, no actual treatment or prevention of AMD is shown.
Applicants can claim as broadly as possible for the claimed invention. However, if there is a divergency in the genus or broadly claimed subject matter, and if it expects unpredictability for the claimed method, then specification must describe the genus with divergent species, so that a skilled person in the art can understands claimed invention and can reproduce applicants claimed method. In this case, at least AMD is probably one of the most unpredictable areas in medicine, and consequently, shown data may or may not extrapolated to treat or prevent all possible AMDs and so, the claimed subject matter cannot be predicted. So, in absence of description for treating and preventing, which makes the invention unpredictable, and cannot be envisioned by a skilled person in the art.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient" (MPEP 2163).
A claimed genus, such as treating or preventing, AMDs, human population, mode of administration and dosage amounts etc., may be satisfied through sufficient description of a representative number of species or disclosure of relevant, identifying characteristics such as functional characteristics coupled with a known or disclosed correlation between function and structure. See MPEP 2163 II(A)(3)(a)(ii).
The number of species that describe the genus must be adequate to describe the entire genus. However, if there is substantial variability, a large number of species must be described.
The issue is that in light of several pathways play an important role in the pathogenesis of AMD, do applicants provide enough description for treating and preventing all possible AMDs in all possible human populations with all possible mode of administrations? Based on shown data or description, will a skilled person in the art understand the claimed invention?
(B) ESTABLISH A PRIMA FACIE CASE BY PROVIDING REASONS WHY A PERSON SKILLED IN THE ART AT THE TIME THE APPLICATION WAS FILED WOULD NOT HAVE RECOGNIZED THAT THE INVENTOR WAS IN POSSESSION OF THE INVENTION AS CLAIMED IN VIEW OF THE DISCLOSURE OF THE APPLICATION AS FILED:
The further analysis for adequate written description considers, see MPEP 2163, the following:
(A) Determine whether the application describes an actual reduction to practice of the claimed invention:
Not provided. Shown data or evidences are limited protecting diabetic retinopathy (DR), outer retinal thickening in rats with DR. No actual treatment or prevention of any AMD is shown. Mode of administration is limited to intravitreal eye injection. No concentration amounts or form of compound, i.e., in solution or gel or solid etc., is also not described.
So, the provided data is very limited.
Accordingly, applicants failed to describe actual reduction to practice of the claimed invention.
(B) If the application does not describe an actual reduction to practice, determine whether the invention is complete as evidenced by a reduction to drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole:
Based on described figures 1-11, applicants conclude that “these combined findings that danegaptide can protect from RPE barrier dysfunction as shown by danegaptide's ability to prevent increases in RPE monolayer permeability due to hyperglycemic and oxidative stress in a TJ associated manner, and its ability to prevent outer retinal layer thickening in rats with DR indicate the danegaptide could be an effective treatment for patients with d-AMD, wet AMD or neovascular AMD”.
No actual either treating or preventing AMD is described in the drawings.
So, as evidenced from the above description of drawings, it is clear that the claimed invention is not complete by a reduction to drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole.
(C) If the application does not describe an actual reduction to practice or reduction to drawings or structural chemical formula as discussed above, determine whether the invention has been set forth in terms of distinguishing identifying characteristics, such as structure/function correlations, as evidenced by other descriptions of the invention that are sufficiently detailed to show that applicant was in possession of the claimed invention:
The specification provides no direction or guidance for treating and preventing AMD by administering danegaptide. The lack of significant guidance from the specification or the prior art with regard to treating and preventing AMD makes practicing the claimed invention unpredictable. While the state of the art is relatively high with regard to treating some stages of AMD, but the state of the art with regard to prevention of such diseases is underdeveloped. In particular, there do not appear to be any examples or teachings in the prior art wherein applicants claimed danegaptide was administered to a subject to provide prevent the development of AMD. See established facts on AMD in the teachings of following art:
Fleckenstein [Fleckenstein et al. Age-related macular degeneration. Nat Rev Dis Primers 7, 31, 2021] describes that AMD is a multifactorial disease encompassing a complex interplay between ageing, environmental risk factors and genetic susceptibility. Chronic inflammation, lipid deposition, oxidative stress and impaired extracellular matrix maintenance are strongly implicated in AMD pathogenesis. However, the exact interactions of pathophysiological events that culminate in drusen formation and the associated degeneration processes remain to be elucidated. Although there have been major breakthroughs in the treatment of exudative AMD, no efficacious treatment is yet available to prevent progressive irreversible photoreceptor degeneration, which leads to central vision loss. [see Abstract].
Hadziahmetovic [Front. Cell Dev. Biol., 24 January 2021, vol.8, 1-14] describes that no treatment options are available for the early and intermediate stages of AMD. The lack of treatments is in part due to the complexity of the disease, as not only multiple genetic and environmental risk factors but also different cell types within the inner and outer retina, have been shown to be involved in the pathophysiology of AMD. Further states that significant research is being done to investigate new therapeutics for both dry and wet AMD. The most successful therapies so far address aspects of wet AMD, leaving a large gap to be filled with therapies for dry AMD. Unfortunately, a large number of potential medications have been tested for dry AMD and have failed. Currently more candidates are undergoing clinical trials, some targeting the impact of stress on mitochondria as well as inflammation, emphasizing the importance of these pathways in the pathogenesis of AMD. Nevertheless, the very nature of the complex etiology of AMD dictates that future therapeutic protocols, will require treatments directed to more than one aspect of the pathobiology of AMD, thus advocating for additional effort to be invested in a multi-targeted approach to AMD treatment. [see Introduction and Conclusion].
Bandello [F1000Research 2017, 6:245] describes that the exact pathophysiological mechanisms behind AMD remain to be determined, but certainly AMD is a multifactorial pathology, in which genetic and environmental risk factors play a crucial role. Early/intermediate stages of AMD, clinical conditions without overt functional loss, are characterized by deposition of drusen and/or retinal pigment epithelium (RPE) alterations in the macular area. In the late stages, the disease may progress to either geographic atrophy (GA) or neovascular AMD (n-AMD). In contrast, no existing approved therapy for GA is available because no treatment is able to repair damaged RPE or photoreceptors. For this reason, all treatment approaches are only likely to slow down the progression of existing atrophy. [see Introduction].
In view of above evidences, applicants claimed subject matter is not well understood, and a skilled person in the art can expect unpredictability in the broadly claimed genus. There are no physical/chemical/structural features that applicants have tied to this property in a relevant teaching manner, making it impossible for an individual of ordinary skill in the art to determine what symptoms of AMD would be effectively treated or prevented. Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement.
Applicants have failed to provide guidance or data or evidence as to how the skilled artisan would be able to extrapolate from the disclosure species to make and possibly use of the claimed invention. “A description of what a material does, rather than of what it is, usually does not suffice." Rochester, 358 F 3d at 923; Eli Lilly, 119 at 1568. Instead, the “disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described.”
Vas-Cath Inc. Mahurkar, 19 USPQ2d 1111, makes clear the "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claimed subject matter and does not reasonably convey to one skilled in the relevant art that the inventors had possession of the entire scope of the claimed invention.
Conclusion
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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