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 .
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 1-3, 6-7, 9, 20, 23, 26, 29-30 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: in the applicant's specification para. 0068-0073 which start with the header "imaging in vivo" it appears a comparison of images needs to be perform in order to determine fibrosis. Such comparison is not claimed.
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.
Response to Arguments
Applicant's arguments filed 06/29/2026 have been fully considered but they are not persuasive.
The applicant argues, as best understood, that because Hwang discloses a heating step, such step in Hwang is not suitable for in-vivo of LCHPs, However, such statement is contrary to Hwang own conclusions in that it states “We previously demonstrated CHP’s ability to target pathologic tissues in vivo (24) and the ease to prepare CHP-functionalized nanomaterials. (34, 63) With the results of this study, we propose that CHP could be further developed into a useful agent for in vivo imaging and drug delivery.” Therefore, it is unclear as to how would not be obvious to modify Hwang with the teachings of Ghosh to be applied in vivo. Further clarifications on this issue would be necessary.
Regarding arguments agains Ghosh, One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Ghosh discloses hybridize peptide administration for in vivo eye examination and the modifications is for in vivo use.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M SANTOS RODRIGUEZ whose telephone number is (571)270-7782. The examiner can normally be reached Monday-Friday 8:30am to 5:30pm.
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/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
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