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 .
DETAILED ACTION
Priority and Status of Claims
1. This application which claims benefit of the foreign applications KOREA, REPUBLIC OF KR 10-2023-0008002 01/19/2023, and KOREA, REPUBLIC OF KR10-2023-0181783 12/14/2023.
2. Applicant’s remarks filed on 04/29/2026 are acknowledged. Claims 1-11 are pending in the application.
Responses to Election/Restriction
3. Applicant’s election without traverse of Group II claims 6-11, in the reply filed on April 29, 2026 is acknowledged.
Claims 1-11 are pending in the application.
The scope of the invention of the elected subject matter is as follows.
Claims 6-11, are drawn to compositions, and are prosecuted in the case.
Claims 1-5, are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
The requirement is still deemed proper and therefore is made FINAL.
Claim Rejections - 35 USC § 112
4. 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.
Claims 6-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first
paragraph (pre-AIA ), because the specification does not reasonably provide
enablement of the instant “photosensitizers” without limitation (i.e., no named
compounds or moiety). The specification does not enable any person skilled in the art to
which it pertains, or with which it is most nearly connected, to make the invention
commensurate in scope with these claims.
ln In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining
whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first
paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or Iack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
In the instant case:
The nature of the invention
The nature of the invention is a composition comprising “photosensitizers” without limitation (i.e., no named compound), see claims 6-11.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Kascakova et al.US 2016/0271251 A1, it discloses a
number of compounds including Oxazine 170 and chlorin e6 (Ce6) as photosensitizer or photodynamic therapy agents for treating tumors or cancer, see column 5.
The amount of direction or guidance present and the presence or absence
of working examples
The only direction or guidance present in the instant specification is the description of a number of “photosensitizers” on pages 10-15 of the specification. There is no data present in the instant specification for the “photosensitizers” without limitation (i.e., no named compound).
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure,
specifically, the instant “photosensitizers” are without limitation (i.e., no named compound).
The quantity or experimentation needed and the Ievel of skill in the art
While the level of the skill in the chemical arts is high, it would require
undue experimentation of one of ordinary skill in the art to resolve any “photosensitizers” without limitation. There is no guidance or working examples present for constitutional any “photosensitizers” without limitation for the instant invention. Incorporation of the limitation of “photosensitizers” (i.e., TPP-Ce6 in claims 10-11) supported by specification into claims 6 would overcome this rejection.
5. 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 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.
Claim Rejections - 35 USC § 103
6. The following is a quotation of 35 U.S.C. 103(a) 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 6 and 11 are rejected under 35 U.S.C. 103(a) as being obvious over
Kascakova et al.US 2016/0271251 A1
Applicant claim a composition for treating brain tumors that includes photosensitizers loaded on extracellular vesicles (bEVs) derived from brain vascular endothelial cells as an active ingredient, and the photosensitizers is chlorin e6 (Ce6), see claims 6 and 11.
Determination of the scope and content of the prior art (MPEP §2141.01)
Kascakova et al. ‘251 discloses a composition comprising a number of compounds including Oxazine 170 and chlorin e6 (Ce6) as photosensitizer or photodynamic therapy agents for treating tumors or cancer, and lanthanide, see columns 5-6.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Kascakova et al. ‘251 is that the instant claim photosensitizer is chlorin e6, while Kascakova et al. ‘251 represents
Oxazine 170 and chlorin e6 (Ce6).
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 6 and 11 prima facie obvious because one would be motivated to employ the compositions of Kascakova et al. ‘251 to obtain instant invention.
The motivation to make the claimed compositions derived from the known compositions of Kascakova et al. ‘251 would possess similar activity to that which is claimed in the reference.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REI TSANG SHIAO whose telephone number is (571)272-0707. The examiner can normally be reached on 8:30 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
June 01, 2026
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