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 .
Applicant’s preliminary amendment filed 05/15/2023, are acknowledged. Claims 1-4, 12, 14, 30, 35, 36, 39, 41, 46, 50, 64, 68, 69, 71, 74, 76 and 77 are pending.
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 2, 4, 10, 14, 30, 35, 36, 39, 41, 68, 69, 71, 74 and 76 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.
Regarding claims 2, 30, 35, 36, 39, 41 and 68, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 4, 36, 39 and 41, the phrase "for example" or “e.g.” 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).
Regarding claims 10 and 68, where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Here, the claims reference “Example 10,” which renders the claims indefinite.
Regarding claim 14, where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Here, the claim references “treatments provided herein,” which renders the claim indefinite.
Regarding claims 69, 71, 74 and 76, recite both a compound and method of using the compound. It is unclear whether the claim is directed to a product or process. Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) (claim directed to an automatic transmission workstand and the method of using it held ambiguous and properly rejected under 35 U.S.C. 112, second paragraph).
Claim Rejections - 35 U.S.C. § 101
35 U.S.C. § 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 77 is rejected pursuant to 35 U.S.C. § 101 because the claimed invention is directed to non-statutory subject matter. As claimed (i.e., recited as a “use” only), the invention does not fall within at least one of the four categories of patent eligible subject matter recited in 35 U.S.C. § 101 (process, machine, manufacture, or composition of matter). The claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., it results in a claim which is not a proper process claim pursuant to this statutory section. See, for example, Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967), and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
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.
Claim(s) 1-4, 12, 14, 30, 35, 36, 39, 41, 46, 50, 64, 68, 69, 71, 74, 76 and 77 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipted by Mena et al., J. Nucl. Med. 2020;61:881-889 (Published Online Nov. 1, 2019).
Regarding claim 1, Mena et al. studied the use of 18F-DCFPyL PET/CT for detection and localization of recurrent disease in patients with biochemically recurrent prostate cancer. See page 882, col. 1. According to Mena et a., “accurate identification of the site and extent of tumor recurrence is important for further treatment planning” (current claim 3). Page 881, col. 2. Mena et al. concluded that “18F-DCFPyL PET/CT imaging offers high detection rates in biochemically recurrent prostate cancer patients and is positive in about 50% of patients with a PSA level of less than 0.5 ng/mL, which could substantially impact clinical management.” Abstract.
Regarding claim 2, Mena et al. specifically aimed to investigate tumor detection rate. See page 882, col. 1.
Regarding claim 12, Mena et al. teaches performing a PET/CT scan approximately 2 hours after injection. See page 882, col. 2.
Regarding claim 30, Mena et al. teaches obtaining vital signs after imaging. See page 882, col. 2.
Regarding claim 35, Mena et al. teaches that the subjects were monitored via telephone query. See page 882, col. 2.
Regarding claims 36, 39 and 41, the wherein clauses are not considered limitations because they merely express the intended results of a process step positively recited. MPEP 2111.04 (“Claim scope is not limited by claim language that . . . does not limit a claim to a particular structure.”) Nonetheless, Mena et al. teaches that “18F-DCFPyL PET/CT successfully identifies PSMA-positive lesions compatible with prostate cancer in patients with BCR after primary local therapy when conventional-imaging results are negative.” Page 888, col. 1.
Regarding claims 46 and 50, Mena et al. explains that “[t]his was part of a prospective study assessing the performance of 18F-DCFPyL PET/CT in BCR prostate cancer patients after primary curative therapy. The patients had negative conventional imaging results and a relatively low median PSA of 2.5 ng/mL (range, 0.21–35.5 ng/mL). This patient population is particularly difficult to assess because disease recurrence can vary from local recurrence to metastatic disease and the therapies for each disease category differ significantly. In this population, 18F-DCFPyL PET/ CT had an overall lesion detection rate of about 78%.” Page 885, col. 2 – page 886, col. 1.
Regarding claims 4, 14 and 64, Mena et al. describes the various follow-up treatment for 66 patients, See page 885, col. 2. Some of which were local, nodal or bone. Id.
Regarding claim 68, Mena et al. teaches that the subjects were monitored via telephone query. See page 882, col. 2.
Regarding claims 69, 71, 74, 76 and 77, A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the claims are meet because Mena et al. teaches 18F-DCFPyL PET/ CT.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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/ROBERT S CABRAL/ Primary Examiner, Art Unit 1614