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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 1, 2025 has been entered.
Claim Status
Claims 1, 3-4, 12-13, 15-17, and 24 are under consideration in this office action.
Withdrawn Objections/Rejections
Any objection or rejection of record pertaining to cancelled claims 2, 7-11, 14, and 19-23 is rendered moot by applicant’s cancellation of said claims.
The rejection of claims 1, 3-4, 12-13, 15-17, and 24 under 35 U.S.C. 112(b) is withdrawn in view of applicant’s amendment.
New Objections/Rejections Necessitated by Amendment
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, 3-4, 12-13, 15-17, and 24 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 and 13 are indefinite because it is unclear if the functional peptide comprises both SEQ ID NO: 7 and SEQ ID NO: 19 or only one. The “wherein” clause in line 8 may be misplaced. Applicant may consider amending the claim to, “wherein the functional peptide has a length of 20 or less amino acid residues and comprises of the following: (i) iRKLPDA (SEQ ID NO: 7); (ii) MHGKTQATSGTIQS (SEQ ID NO: 19); or (iii) a RGD-containing peptide.
Claims 3-4, 12, 15-17, and 24 are included in this rejection for failing to cure the indefiniteness of claims 1 and 13.
Modified Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112(a)
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.
Written Description
Claims 1, 3-4, 12-13, 15-17, and 24 are 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 claims contain subject matter that 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.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
Claims 1 and 13 are directed to a fusion protein comprised of a ferritin monomer or multimer and a functional peptide inserted at a flexible linker region between -helices in a B region and C region of ferritin monomer. The fusion protein of the claims comprise a functional peptide comprising a RGD-containing peptide. As such, claims 1, 3-4, and 12-23 are directed to a broad genus of RGD-containing peptides. As written, the functional peptide is not described sufficiently in the specification to show that applicant had possession of the claimed genus of fusion proteins comprised of ferritin and functional peptides of 3-20 amino acids comprising RGD.
Claims 3-4, 12, and 15-17 are included in the rejection under 35 U.S.C. 112(a), because even if one skilled in the art could envision the genus of claimed RGD-containing peptide, one skilled in the art would not be able to envision which of said inhibitors would also meet the limitations of these claims.
For claims drawn to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997).
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members. Agents described by function alone are not special and are not excluded from the written description requirement. As was held in University, Rochester v G.D. Searle Co., 358 F.3d 916 (Fed. Cir. 2004), a functional genus cannot be described by a method of obtaining or screening for the agent that meets the functional limitations of the claim.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.") Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Here, though the functional peptide comprises at least amino acids RGD, the claims lack written description because there is no disclosure of a correlation between function and structure of the fusion protein beyond those disclosed in the examples in the specification. Although the specification provides 16 species of RGD peptide (SEQ ID NOs: 14, 16, 37-42, 63, 113, 121-124, 140, and 142), lack sufficient variety to reflect the variance in the genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e. structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See MPEP 2163 II.A.3a.ii.
With respect to product claims, it is recognized that information which is well known in the art need not be described in detail in the specification (MPEP 2163 II.A.2). See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed.
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only 16 species within the genus of RGD-containing functional peptide.
The written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification’. Applicant has not described the fusion protein of the invention sufficiently to meet this requirement.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Therefore, claims 1, 3-4, 12-13, and 15-17 do not meet the written description requirement.
Response to Arguments
Applicant’s arguments filed July 1, 2025 with respect to the rejection of the claims under 35 U.S.C. 112(a) for failing to meet the written description for the functional peptide have been fully considered but they are moot because the new ground of rejection does not rely on any rationale applied in the prior rejection of record for any matter specifically challenged in the argument. The genus of RGD-containing functional peptide of amended claim 1 is not sufficiently described to meet the written description requirement, as only 16 species are provided in the specification. Applicant is encouraged to provide additional references that demonstrate that one of ordinary skill in the art would have been able to immediately envision the entire genus claimed with the requisite function. Otherwise, applicant may consider amending claims 1 and 13 to limit the RGD-containing functional peptide to only the sequences provided in the specification. If these sequences were added to claims 1 and 13, a scope of enablement rejection will not be applied, as it is the examiner’s position that determining the functionality of these fusion proteins would not require undue experimentation.
The rejection of claims 1, 3-4, 12-13, and 15-17 under 35 U.S.C 112(a) for failing to meet the written description requirement is maintained.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675