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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/20/2026 has been entered.
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 1,11 and 12 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.
With regard to claim 1, there is no formula ii or iii as recited in lines 2-3 as these formulae have been deleted from the claim.
Also in claim 1, X23-X25 are confusingly not included in the groups for R1, thus their presence is unclear. Note R1 includes only groups X1-X22. Claims 11 and 12 incorporate this indefiniteness by dependency.
Claim Rejections - 35 USC § 102
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 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) 1,11 and 12 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Scherz et al. (CN 102036684 A), English translation provided by examiner. The following rejection is based upon art which was found incidental to the search for the elected species. This is not indicative that the entire scope of the claims has been examined; however, the following art is being applied in an effort to promote compact prosecution of the case.
Scherz discloses methods of targeting tumors and imaging with RGD chlorophyll and bacteriochlorophyll conjugates with imaging agents including metal containing biliverdin, the peptide and chelate were bound through amide bonds. See entire disclosure, especially abstract, [0003], [0086]-[0087],[0095]-[0096],[0227]-[0235] and claims. RGD peptides are considered to read on the claimed active peptide with the function of immunoregulation.
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 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 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.
Claim(s) 1 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arumugham et al. (WO 2005/058940) in view of Scherz et al. (CN 102036684 A) in view of Arumugham et al. (WO 2005/058940).
Arumugham teaches immunogenic peptide carrier conjugates featuring immunologically active peptides including SEQ ID 3. See entire disclosure, especially abstract, [0074],[0102] and claims. Arumugham is silent with respect to use of biliverdin.
Scherz teaches methods of targeting tumors and imaging with RGD chlorophyll and bacteriochlorophyll conjugates with imaging agents including metal containing biliverdin, the peptide and chelate were bound through amide bonds. See entire disclosure, especially abstract, [0003], [0086]-[0087],[0095]-[0096],[0227]-[0235] and claims.
Since the secondary reference Scherz teaches how to attach biliverdin to peptides via amide linkages, one of ordinary skill in the art would have a high expectation of success in attaching the imagining agent to Arumugam. Reason to make such a modification would be to image the immunogenic peptide carrier in use. Thus the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Response to Arguments
Applicant's arguments filed 8/20/2026 have been fully considered but they are not persuasive.
Applicants assert CN fails to disclose bilverdin-biomolecule complex formed via covalent amide 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 assert the secondary reference Giuntini is too different from CN as it is concerned with PDT while CN is drawn to PTT and a person skilled in the art would not combine these different references which are said to be incompatible.
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). The examiner considers these references generally related to the general field of peptide tetrapyrrole macrocycles. Yan teaches the complex was used as a photothermal composition to treat diseases such as tumors while Giuntini teaches HSA showed greater photoactivity compared to other conjugates and BSA tetrapyrrole conjugate was successfully taken into ovarian cancer cells and upon irradiation killed the tumorous cells. Since Yan teaches use of the tetrapyrrole macrocycle biliverdin with carboxylic functional groups and Giuntini teaches how to modify carboxylic containing tetrapyrrole macrocycles one of ordinary skill in the art would have a very high expectation of success in substituting biliverdin with immune modifying peptides such as HSA or BSA leading advantageously to greater photoactivity.
Applicants assert their claims require short sequences as opposed to the long sequences of HAS and BSA of Giuntini. Applicants state there could be steric hinderance and other difficulties in producing a conjugate between HAS and BSA with biliverdin.
Simply because one of ordinary skill in the art may have to apply a modified synthetic strategy would not necessarily dissuade the solution claimed. Obviousness does not require absolute predictability of success. In re 0 'Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988).
Applicants pick on the secondary reference Arumugam for not teaching how to couple peptides to biliverdin.
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 Arumugam was not used for its disclosure of bilverdin which is covered by the primary reference. The reference was used for its teaching of SEQ 3 elected by applicants.
Conclusion
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 on 9:30-6:00 PM.
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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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/JAMES W ROGERS/Primary Examiner, Art Unit 1618
