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.
Claim 1 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. The claim recites “(a) contracting biological tissue of a human or animal subject with a compound… (b) allowing time for the compound to distribute within the biological tissue; (c) guiding a flexible probe to the biological tissue… (d) illuminating the tissue with an excitation light… . It’s unclear if what is intended in the claim is contracting biological tissue of a human with a compound, or contacting biological tissue of a human with a compound. Contracting biological tissue means causing the muscle fibers inside the tissue to tighten, shorten, or squeeze together. Contacting biological tissue means touching or applying a compound to the surface or cells of the tissue. As the following steps don’t seem to be related to a contracted biological tissue, and as the disclosure in the application recites contacting biological tissue (paragraph 190), it’s unclear if what is intended is contracting biological tissue of a human or animal subject with a compound” or “contacting biological tissue of a human or animal subject with a compound. ” Further regarding claim 1, step (b) recites “allowing time for the compound to distribute within the biological tissue. It’s unclear if the claim requires complete, uniform distribution of the compound within the biological tissue, or only partial distribution. The term “the composition” in step (d) has insufficient antecedent basis as there is no composition previously recited in the claim. Further regarding the recitation “thereby including cell death and necrosis of diseased cells and destroying the biological tissue,” it’s unclear what it means to “destroy” the biological tissue. What feature or features of the biological tissue need to change in order to be considered “destroyed” within the meaning of the invention.
Claim 1 is 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: performing an interventional procedure.
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.
Claim 1 is 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. Claim 1 recites “L’ is a linker to improve pharmacokinetic properties.” There is no description of what “improved” pharmacokinetic properties are or what compounds are under the genus of “a linker to improve pharmacokinetic properties” within the meaning of applicant’s claims. Therefore, the genus of “a linker to improve pharmacokinetic properties” and what species are encompassed by this genus are not described. Further, claim 1 recites “L’’ is a linker which may be configured to release an organelle-targeted photodynamic therapeutic (PDT) agent.” There is no description of how a linker may be configured according to the claim, and what species of linkers are encompassed by the claimed invention.
Claim Rejections - 35 USC § 101
Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 on the ground of statutory double patenting as claiming the same invention as claim 47 of copending application No. 16874270. Both the present claim and the copending claim teach the same method.
Notes and Comments
No prior art against the invention was found.
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
September 1, 2026
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