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 . Claims included in the prosecution are claims 2 and 4-21.
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.
Claim 10 is 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.
Regarding claim 10, the phrases "preferably" and “more preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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 2, 4-15 and 17-21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Harootunian et al. (WO 2018/187429 A1, Oct. 11, 2018) (hereinafter Harootunian).
Harootunian discloses a method for detecting regions of biological activity in a biological specimen, the method comprising: a) contacting the biological specimen with a ratiometric fluorescent indicator of the biological activity; b) capturing a first fluorescence intensity image of the biological specimen at a first emission wavelength, and a second fluorescence intensity image of the biological specimen at a second emission wavelength; c) combining the first fluorescence image and the second fluorescence image to create a fluorescence ratio image; d) processing the fluorescence ratio image, the first fluorescence intensity image, the second fluorescence intensity image, or any combination thereof, using an image analysis algorithm to detect regions of biological activity, wherein the image analysis algorithm: i) uses a fluorescence ratio threshold, a first fluorescence intensity threshold, a second fluorescence intensity threshold, or any combination thereof, to create a mask image of the fluorescence ratio image, the first fluorescence intensity image, the second fluorescence intensity image, or any combination thereof, ii) performs an AND logical operation on two or more images selected from the group consisting of the mask image of the fluorescence ratio image, the mask image of the first fluorescence intensity image, and the mask image of the second fluorescence intensity image, if two or more mask images have been created in step (i), and iii) provides a classification of the biological specimen as either positive or negative for the biological activity, wherein the classification is based on a detection of a region of interest within the fluorescence ratio image, the first fluorescence intensity image, the second fluorescence intensity image, or the combination thereof that was used in step (i), that exhibits a fluorescence ratio value or a fluorescence intensity value that exceeds the value of the fluorescence ratio threshold, the first fluorescence intensity threshold, the second fluorescence intensity threshold, or the combination thereof that was used in step (i) (claim 1). The ratiometric fluorescent indicator may be SDM-25 (claims 17 and 30). Fig. 1 shows the structure of the SDM-25 molecule (¶ [0013]).
PNG
media_image1.png
698
1062
media_image1.png
Greyscale
The SDM is administered from about 30 minutes to about 24 hours prior to surgery (¶ [0233]). The imaging method is used to visualize regions of interest in real time. In some examples, the method is used during surgery (¶ [0038]). SDM- 25 is used in fluorescence imaging methods to deliver a pair of fluorescence donor and acceptor moieties (i.e., imaging agents) that are capable of undergoing fluorescence resonance energy transfer (for example, Cy5 and Cy7) to a tissue of interest, the method comprising contacting the tissue of interest with SDM-25 (e.g., administering SDM-25 to an individual intravenously), illuminating the tissue of interest with excitation light, and visualizing at least one of the imaging agents (¶ [0195] and [0009]). The long wavelengths of Cy5 and Cy7 are ideal for in vivo imaging, where excitation and emission wavelengths should be well above 600 nm to avoid the strong absorbance of endogenous hemes (¶ [0108]). One of the excitation wavelengths may be set at about 650 nm (¶ [0240]). Targeted delivery of an imaging agent to a cell or tissue enables a medical professional to remove (or, surgically excise) the tissue of interest (e.g., cancerous tissue) with a decrease in surgical margins (¶ [0205]). The biological activity to be detected may be breast cancer (claim 7). The breast cancer may be invasive ductal carcinoma (IDC) or ductal carcinoma in situ (i.e., non-invasive) (¶ [0211]). The amount of a given SDM varies depending upon factors such as the particular compound, the identity (e.g., weight) of the subject, the route of administration, and the duration of that the compound is needed for visualization. Exemplary doses include, but are not limited to, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, 11 mg, 12 mg, 15 mg, 18 mg, 20 mg, 25 mg, or 30 mg (¶ [0232]).
Accordingly, Harootunian anticipates the instant claims insofar as disclosing contacting a tissue of interest with SDM-25 labeled with imaging agents Cy5 and Cy7 18 hours prior to surgery, illuminating the tissue of interest with excitation light, visualizing at least one of the imaging agents, capturing fluorescence intensity images, comparing the fluorescence intensity images to a fluorescence intensity threshold, providing a classification of the tissue of interest as either positive or negative for a biological activity, such as cancer, and surgically excising the tissue of interest (e.g. cancerous tissue) (claims 1, 40 and 45, ¶ [0233], [[0009], [0195], and [0202]).
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.
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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Harootunian et al. (WO 2018/187429 A1, Oct. 11, 2018) (hereinafter Harootunian).
The teachings of Harootunian are discussed above. Harootunian does not disclose wherein the breast cancer is mixed breast cancer, wherein the mixed breast cancer comprises invasive and non-invasive breast cancer.
However, as discussed above, Harootunian discloses wherein the biological activity to be detected may be breast cancer (claim 7). The breast cancer may be invasive ductal carcinoma (IDC) or ductal carcinoma in situ (i.e., non-invasive) (¶ [0211]).
Since Harootunian discloses wherein the method detects both invasive and non-invasive breast cancer, it would have been obvious to one of ordinary skill in the art that a mixed breast cancer comprising both invasive and non-invasive breast cancer would be detectable as well since the method detects both individually.
Conclusion
Claims 2 and 4-21 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TRACY LIU/Primary Examiner, Art Unit 1614