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 .
Election/Restrictions
Claims 4-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse to prosecute group I, claims 1-3 and 11-12, and the species of SEQ ID 3 in the reply filed on 12/29/2025.
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 1-3 and 11-12 are rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention.
Claims 1,3 recite the limitation, “derivative” in reference to a specific sequences used in the conjugate. Applicant has not described the claimed genus of "derivative" in a manner that would indicate they were in possession of the full scope of this genus, or even to describe what this genus is comprised of. The instant specification does not describe these derivatives or their methods of preparation. Applicant has not described the claimed genus "derivative" in a manner that would indicate they were in possession of the full scope of this genus.
Regarding the requirement for adequate written description of chemical entities, Applicant's attention is directed to the MPEP §2163. In particular, Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish or plain for obtaining the claimed chemical invention." Eli Lilly, 119 F.3d at 1566. The Federal Circuit has adopted the standard set forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent Applications under the 35 U.S.C. 112.1 "Written Description" Requirement ("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5, 2001), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including, inter aria, "functional characteristics when coupled with a known or disclosed correlation between function and structure..." Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. at 1106 (emphasis added)). Moreover, although Eli Lilly and Enzo were decided within the factual context of DNA sequences, this does not preclude extending the reasoning of those cases to chemical structures in general. Univ. of Rochester v. G.D. Searle & Co., 249 Supp. 2d 216, 225 (W.D.N.Y. 2003).
In the instant case, the claimed "derivative" encompasses any amino acid sequence, protein or peptide that are theoretically derivable from the sequences listed. Applicants describe no "derivative" in the specification. Therefore, it is not described adequately enough to allow one skilled in the art to ascertain that Applicant is in possession of the entire scope of that genus. Applicants have not described this genus in a manner that would allow one skilled in the art to immediately envisage the amino acids, peptides or proteins contemplated for use. As such, the claims lack adequate written description for the claimed " derivative." Claims 2 and 11-12 incorporate the written description formality by dependency.
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 1-3 and 11-12 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.
Claims 1-3 and 11-12 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
The recitation of "derivatives " found throughout the claim when referring to the type of sequence renders the claim indefinite. The term “derivatives” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what is encompassed and excluded by the limitation "derivative”. The Merriam-Webster' s Dictionary defines “derivative” as “a chemical substance related structurally to another substance and theoretically derivable from it” ([online], retrieved on 12/9/2015, at: http://www.merriamwebster.com /dictionary/derivative. Hence, one of ordinary skill would clearly recognize that derivatives or analogues of the conjugates claimed in claim 1 and 3 would read on any of those sequences having any widely varying groups that possibly substitute the sequences claimed. One of ordinary skill could not ascertain and interpret the metes and bounds of the patent protection desired as to these terms. Thus, it is unclear and indefinite as to how the “derivatives” herein are encompassed thereby.
Claims 1 and 12 recite the limitation "amino acids peptides or protein with similar functional of the above". There is insufficient antecedent basis for this limitation in the claim. Note that the claim does not disclose any functional ability of the amino acid, peptide or protein. Therefore, there is no antecedent basis for “similar functions of the above”.
Claims 2-3 and 11-12 incorporate the indefiniteness by dependency.
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) 1-3 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.
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.
Yan teaches biliverdin-biomolecule-metal complex formed, the metal includes Fe, Co, Ga and others and the biomolecule includes peptides, the complex was used as a photothermal composition to treat diseases such as tumors. See entire disclosure, especially abstract and claims of English translation.
Yan does not teach conjugating the peptides claimed, or peptides with similar function, to biliverdin.
Giuntini reviews synthetic approaches for conjugation of porphyrins and related tetrapyrrole macrocycles (which biliverdin is considered to be within the genus) to peptides which includes reacting carboxy containing macrocycles to either amine or carboxy units of the peptide. See entire disclosure, especially abstract and Fig 1. The types of peptides introduced to the pyrrolic macrocycles include human serum albumin (HSA) and bovine serum albumin (BSA), two peptides that are immunologically active. See page 782 rt col-page 784 rt col 1st ¶. Applicants’ specification and claims note that the peptides of sequence 1-36 are immunologically active, therefore BSA and HSA are considered to meet the claimed peptides with similar function to the sequences claimed. The claims only require the peptides to have similar function to the sequences claimed. 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. See page 782 rt col.-page 783 1st ¶.
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. Reason to make such a substitution stems from the teaching that BSA and HSA conjugates of tetrapyrrole macrocycles leads to greater photoactivity to kill cancer cells. 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.
Claim(s) 1-3 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, as applied to claims 1-2 and 11-12 above, in view of Arumugham et al. (WO 2005/058940).
The combination of Yan and Giuntini is disclosed above. The combination is silent with respect to the elected species of SEQ ID 3.
Arumugham is used for its teaching on immunogenic peptide carrier conjugates featuring immunologically active peptides including SEQ ID 3. See entire disclosure, especially abstract, [0074],[0102] and claims.
Since the combination of Yan and Giuntini renders obvious a biliverdin immunoactive peptide conjugate one of ordinary skill in the art would have a very high expectation of success in adding other immunoactive peptides such as SEQ ID 3. The artisan would recognize that, based on their close structural similarity, SEQ ID 3 could be substituted for immune active peptides with similar results. Obviousness also stems from the notion that the combination of art known elements that, when combined, do no more than serve their art-recognized functions is obvious. An “obvious to try” rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. “ [A] person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. KSRInternational Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1397 (2007).
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 9:30-6:00 PM.
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/JAMES W ROGERS/Primary Examiner, Art Unit 1618