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 .
Amendments
Applicants’ amendments to the claims filed 4/27/2026 have been entered. Any objection\rejections from the previous office action filed 1/28/2026 not addressed below has been withdrawn.
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 1-2 and 11-12 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement, for the reasons set forth in the previous office action filed 1/28/2026. 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(s), at the time the application was filed, had possession of the claimed invention. Applicants have not deleted the recitation of derivatives on page 2 of claim 1.
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 1-2 and 11-12are 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, for the reasons set forth in the previous office action filed 1/28/2026. Applicants have not deleted the recitation of derivatives on page 2 of claim 1.
Additionally the new formula for I,II and III in claim 1 are blurry and unreadable rendering them unclear and indefinite. This new rejection was necessitated by amendment.
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.
Claim(s) 1-2 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yan et al. (CN 109224073 A, cited by applicants, English translation provided by examiner) in view of Giuntini et al. “Synthetic approaches for the conjugation of porphyrins and related macrocycles to peptides and protein”, Photochem. Photobiol. Sci., 2011, 10, 759–791, for the reasons set forth in the previous office action filed 1/28/2026.
Claim(s) 1-2 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yan et al. (CN 109224073 A) in view of Giuntini, cited above, in view of Arumugham et al. (WO 2005/058940), for the reasons set forth in the previous office action filed 1/28/2026.
Response to Arguments
Applicant's arguments filed 4/27/2026 have been fully considered but they are not persuasive. Applicants argue they amended the claims such that the use of “derivatives” is no longer an issue. As noted above applicants have not deleted the recitation of derivatives on page 2 of claim 1.
Applicants assert CN fails to disclose bilverdin-biomolecule complex formed via covalent bonding.
The relevance of this assertion is unclear as CN clearly teaches in claim 2, “the biliverdin-biomolecule complex, biliverdin and the biomolecule to form a conjugate, formed by amidation reaction between the two, or formed based on of the weak interaction between molecules”, clearly amidation reaction will form a covalent bond. The weaker interaction between molecules is presented in alternative and is not limiting as amidation is clearly disclosed.
Applicants pick on the secondary reference Giuntini for not teaching the specific structure of biliverdin and use of a peptide as a carrier rather than an immunologically active agent.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Clearly Giuntini was not used for its disclosure of bilverdin which is covered by the primary reference. The reference was used for its teaching of attaching peptides to tetrapyrrole macromolecules. The use of the peptide as a carrier makes no difference as the carrier proteins BSA and HAS also have the property of being immunologically active. Once combined with bilverdin the immunologically active property is naturally met by the combination.
Applicants assert Arumgham is directed to an entirely different therapeutic field then the present application and thus one of ordinary skill would not consider it.
In response to applicant's argument that Arumgham is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Arymgham is considered related in its general teachings of peptide conjugates which Giuntini is also concerned along with applicants’ invention.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 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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/JAMES W ROGERS/Primary Examiner, Art Unit 1618
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