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 . 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 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 15-29 and 31-37 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. 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding claim 15, there is no description of how the method can be used to predict angiogenesis in a subject, that is, there is no description in the application of what is meant by “predicting angiogenesis,” or what future events or outcomes are encompassed by “predicting angiogenesis”. There is no description or treatment protocols of how to use the invention to identify or predict angiogenesis in a subject across the genus of “labelled cell stress marker” wherein, according to he claimed subject matter, angiogenesis is identified or predicted if labelled cell stress marker positive cell(s) are identified in the image. Further regarding claim 16, there is no description in the application of what compounds are encompassed by “a fragment or variant” of annexin, including description of how far removed another compound can be from annexin and still be considered a “variant” and not another compound entirely, nor description if to be a variant within the meaning of the invention is based on structure only, or if the variant may be based on chemical behavior. Regarding claim 22, “is associated with previous exercise by the subject” is not adequately described. For two things to be “associated” with each other implies a link of some sort, but the application does not describe what the link is between angiogenesis and previous exercise that so as to define the claimed invention. Regarding claim 23, the link between angiogenesis and wound healing and/or integration of a tissue scaffold in the claim as encompassed by the recitation “is associated” is not described in the application, nor is description of the characteristics the angiogenesis must have to be considered “associated with” the latter. Similarly regarding claim 24, the recitation “associated with a disease, a stage of disease, is predictive of disease developing or of disease severity,” as the link between the angiogenesis and “a disease, a stage of disease, is predictive of disease developing or of disease severity” is not adequately described. Regarding claim 24, the recitation “the pathological angiogenesis is predictive of disease developing,” there is no description in the application of the term “is predictive,” or what characterstics or traits the pathological angiogenesis has in order to be predictive of disease developing.
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 15-29 and 31-37 are 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. The recitation in claim 15 “identifying labeled cell stress marker positive cell(s) in the image” renders the claim. It’s unclear why the (s)” is in parantheses (here and throughout the claims), and if what is being claimed is a single cell or multiple cells. The phrase (without the (s)) “identifying labeled cell stress marker positive cell” does not make grammatical sense, as the proper grammar for a single cell would be “identifying a labeled cell stress marker positive cell.” If applicant wishes to claim “cell” in the singular and plural, the examiner recommends reciting “identifying a labeled cell stress marker positive cell or cells.” Such language is clear and grammatically correct. Further regarding claim 16, it’s unclear what the scope of a “fragment or variant” of annexin is. A fragment can refer to a small molecule (low MW, few atoms, often <20 heavy atoms) used in drug discovery that binds weakly to targets, or alternatively and non-overlappingly, can refer to the pieces a larger molecule breaks into during analysis (in mass spectrometry, for example). As there is no set definition of or guidance in the application of the scope of “fragment or variant,” it’s unclear what he scope of the term in the claim is. Further regarding the term “variant,” it’s unclear how far removed another compound can be from annexin and still be considered a “variant” and not another compound entirely. Further, it’s unclear if the variant means a variant in chemical structure of annexin or a variant in chemical behavior. Further regarding claims 22-25, it’s unclear in what way physiological angiogenesis is associated with previous exercise, and unclear in what way pathological angiogenesis is associated with a disease, a stage of disease, is predictive of disease developing or of disease severity. To be “associated” means a link between two things. It’s unclear what previous exercise is used in the comparison, as “pervious exercise” includes exercise, or activity requiring physical effort, which people do on a regularly basis at different intervals and different stress levels throughout the course of their lifetime. It’s therefore unclear what “pervious exercise” falls under the scope of the claim, and in what way it is associated with physiological angiogenesis within the scope of the claim. It’s unclear in what way pathological angiogenesis is associated with a disease and stage of a disease, if this means that pathological angiogenesis is a disease or a stage of a disease. Further, it’s unclear in what way “pathological angiogenesis is predictive of disease developing.” Regarding the term “predictive,” human beings and certain living organisms are capable of making predictions, but it’s unclear how a chemical compound can predict, be “predictive of disease develop.” “Disease developing” is a term that encompasses a myriad of diseases and stages of development. It’s unclear if “developing” refers to observed development, or includes latent diseases at the stage when there are no signs of development. Regarding claim 34, as the claim does not state in what way the location is determined using another image obtained using a second imaging device, it’s unclear how the location is determined using another image obtained using a second imaging device, and further unclear if the “another image” using “a second imaging device” means the analysis provided in claim 15, or if the claim is open to any “another image” using any “second imaging device.” Further regarding claim 32, it’s unclear in what way the identification “is computer implemented,” that is, in what way and in what step a computer is used within the scope of the claimed subject matter. Further regarding claim 37, the recitation “the first imaging device comprises a confocal scanner laser microscope, optionally a confocal scanning laser ophthalmoscope” is indefinite because it’s unclear if the optional confocal scanning laser ophthalmoscope is added in addition to the confocal scanner laser microscope, or if it is an alternative to the confocal scanner laser microscope.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 15-29 and 31-36 are rejected under 35 U.S.C. 102 as being unpatentable over Cordeiro (Brain, 2017; IDS filed 11/17/2023). Cordeiro teaches a method of identifying or predicting angiogenesis in a subject (page 35, line 15 to page 37, line 4), the subject having been administered a labelled cell stress marker such as annexin 1 (a variant of annexin 5, 11, 2, or 6) (page 36, line 3 to page 37, line 4), comprising the steps of: (a) generating an image from the subject using a first imaging device (page 12, lines 13 to 25); (b) identifying labelled cell stress marker positive cell(s) in the image; wherein angiogenesis is identified or predicted if labelled cell stress marker positive cell(s) are identified in the image (page 45, line 12 to page 50, line 14), which is the method of the present claims of identifying or predicting angiogenesis in a subject, the subject having been administered a labelled cell stress marker, comprising the steps of: (a) generating an image from the subject using a first imaging device; (b) identifying labelled cell stress marker positive cell(s) in the image; wherein angiogenesis is identified or predicted if labelled cell stress marker positive cell(s) are identified in the image WO ‘848 further teaches imaging of regular angiogenesis (physiological angiogenesis) (wherein the physiological angiogenesis is associated with previous exercise by the subject.) (page 4, lines 6-7), pathological angiogenesis (angiogenesis associated with a disease) (page 15, lines 5-19), and therapeutic angiogenesis (treatment of heart disease, ischemia, associated with wound healing) (page 16, lines 20-31), in addition to using annexin 5 labelled with fluorescent dye DY-776 for use in the identification of retinal cell apoptosis, and identification and treatment of pathological angiogenesis including treatment of macular degeneration or diabetic retinopathy (is predictive of treating age-related macular degeneration), which the artisan would understand involves administering an appropriate amount for treatment of the disease (page 38, line 3). The identification of labelled cell stress marker positive cell(s) is computer implemented (page 29, line 26 to page 30, line 6). The method further comprises determining a location of the labelled cell stress marker positive cell(s) in the subject (page 37, lines 15-16). The location is determined using another image obtained using a second imaging device including computer tomography optical imaging (pages 27, lines 2-4 and page 42, lines 2-7). WO ‘848 teaches the use of an agent of interest which comprises an imaging agent component and annexin A1 as a targeting agent component in the assessment of the presence of angiogenesis or neovasculature in a subject and in particular for the detection of neoplasms (abstract; paragraphs 49, first full paragraph to page 35, first full paragraph, page 13 to page 39). The administration is intravenous (page 37, first paragraph, lines 19-21).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 15-29 and 31-37 are rejected under 35 U.S.C. 103 as being unpatentable over Cordeiro (Brain, 2017; IDS filed 11/17/2023) in view of Spessotto (Probe-based confocal laser endomicroscopy for in vivo evaluation of the tumor vasculature in gastric and rectal carcinomas, Scientific Reports, 2017, 7:9879, pages 1-9). The relevant portions of Cordeiro are given above.
Gordeiro fails to teach “wherein the first imaging device comprises a confocal scanner laser microscope.”
Spessotto teaches that confocal scanner laser microscopes are able to identify angiogenesis (Abstract; Discussion).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use a confocal scanner laser microscope as the first imaging device of Gordeiro. The motivation for this would be to provide an appropriate means to identify angiogenesis, as desired by Gordeiro.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
December 30, 2025