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 .
Election/Restrictions
Applicant’s election without traverse of the species restriction, (species directed to claim 7, claim 20 and claim 26) within the species restriction. Therefore, claims 1-4, 6-7, 9, 20, 23, 26, 29 and 30 will be examined on the merits.
Claim Rejections - 35 USC § 112
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 1-4, 6-7, 9, 20, 23, 26, 29 and 30 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.
In claim 1, it is set forth a method of detecting fibrosis in a subject, but the only step provided is an imaging step, follow by “thereby detecting presence of progression of fibrosis); it is unclear as to how merely imaging an area having the LCHP will provide a detection of fibrosis; it appears an additional step is missing, for example, a step of processing the image to calculate the amount of LCHP in an area and determining if the amount is over a threshold, therefore it will be considered fibrosis; something along these lines.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4, 6-7, 9, 20, 23, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hwang et al. (“In Situ Imaging of Tissue Remodeling with Collagen Hybridizing Peptides” American Chemical Society, Vol. 11, pp. 9825-9835, 2017 in view of Ghosh et al. (US 2016/0297854, hereinafter Ghosh).
With respect to claim 1, Hwang discloses a method of detecting fibrosis in a subject, comprising administering a labeled collagen hybridizing peptide (LCHP) to the subject, and imaging the LCHPs, thereby detecting presence or progression of fibrosis (see Hwang abstract, “Collagen, the major structural component of nearly all mammalian tissues, undergoes extensive proteolytic remodeling during developmental states and a variety of life-threatening diseases such as cancer, myocardial infarction, and fibrosis. While degraded collagen could be an important marker of tissue damage, it is difficult to detect and target using conventional tools. Here, we show that a designed peptide (collagen hybridizing peptide: CHP), which specifically hybridizes to the degraded, unfolded collagen chains, can be used to image degraded collagen and inform tissue remodeling activity in various tissues: labeled with 5-carboxyfluorescein and biotin, CHPs enabled direct localization and quantification of collagen degradation in isolated tissues within pathologic states ranging from osteoarthritis and myocardial infarction to glomerulonephritis and pulmonary fibrosis,.”
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However, Hwang fails to explicitly disclose in vivo imaging for a subject.
In the same field of endeavor in the subject of peptides for eye examination Ghosh disclose that a peptide (which can by hybridize, para. 0055) is administered to a patient and used for eye examination including retinal examination while imaging (see para. 0004, 0005, 0032, 0222, 0104, 0265).
It would have been obvious to one skilled in the art before the effective filling date to modified Hwang to provide for in vivo imaging a subject for fibrosis detection having a peptide tagged as disclosed by Ghosh because doing so will allow for treating ocular diseases (see Ghosh abstract).
With respect to claim 2, Hwang in view of Ghosh disclose wherein the fibrosis is subretinal fibrosis (see Ghosh para. 0032).
With respect to claim 3, Hwang in view of Ghosh disclose wherein the LCHP is imaged on an eye of the subject (see para. 0265, Ghosh).
With respect to claim 4, Hwang in view of Ghosh disclose wherein the LCHP is administered to the subject by topical administration, local injection, or intravenous injection (see para. 0253, injected).
With respect to claim 6, Hwang in view of Ghosh disclose wherein the method detects the progression of fibrosis and further comprises administering another LCHP to the subject at another time point, imaging said another LCHP in-vivo, and comparing images from different time points (see Fluorescence microscopy and image analysis section Hwang).
With respect to claim 7, Hwang in view of Ghosh disclose wherein the imaging comprises angiography (see Ghosh para. 0223).
With respect to claim 20, Hwang in view of Ghosh disclose wherein at least one of the LCHP comprises the amino acid sequence of any one of SEQ ID NOs: 1-1009 (see para. 0006, Ghosh).
With respect to claim 23, Hwang in view of Ghosh disclose a method of diagnosing a fibrotic disease in a subject based on the presence or progression of fibrosis in the subject detected by the method of claim 1 (see Hwang abstract, Ghosh para. 0032).
With respect to claim 26, Hwang in view of Ghosh disclose wherein the fibrotic disease is selected from the group consisting of neovascular age-related macular degeneration(nAMD), diabetic retinopathy, glaucoma specifically fibrosis in the trabecular meshwork, neovascular glaucoma, corneal scarring, conjunctiva, post cataract surgery, retinopathy of prematurity, and proliferative vitreoretinopathy (see Ghosh para. 0032).
Claim(s) 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hwang et al. (“In Situ Imaging of Tissue Remodeling with Collagen Hybridizing Peptides” American Chemical Society, Vol. 11, pp. 9825-9835, 2017 in view of Ghosh et al. (US 2016/0297854, hereinafter Ghosh), as applied to claims 1, 23, in view of Murphy et al. (US 2017/0152560)
With respect to claims 29-30, Hwang in view of Ghosh disclose the invention as set forth above but fails to explicitly teach administering an antifibrotic drug to the subject.
In the same field of endeavor in the subject of method for diagnosing fibrosis, Murphy discloses after determining tissue fibrosis to administering an anti-fibrosis drug (see para. 0017).
It would have been obvious to one skilled in the art before the effective filling date to administer an antifibrotic drug as disclosed by Murphy because doing so will allow for treatment of the damaged tissue.
Conclusion
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/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797