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 .
Status of claims
The preliminary amendment filed 12/18/2023 is acknowledged. Claims 3, 6 and 7 are amended. Claims 1-8 are under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The effective filing date of the instant application is 06/18/2021.
Claim Rejections - 35 USC § 112(b)
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 1-8 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.
(i) Claim 1 is drawn to an affinity peptide comprising a leptin receptor affinity peptide and a short peptide with a collagen-specific binding ability. The claim recites a sequence of the leptin receptor affinity peptide is as shown in SEQ ID No.1” and “a sequence of the linker is as shown in SEQ ID No.4 or SEQ ID No.5”. The recitation of the indefinite article “a” preceding the description of the leptin receptor affinity peptide and the linker is indefinite because it is not clear whether the claim encompasses other unrecited leptin receptor affinity peptides or linkers. In other words, “a sequence” of the leptin receptor affinity peptide is SEQ ID NO: 1, but there may be other unrecited leptin receptor affinity peptide sequences. Similarly, “a sequence” of the linker is either SEQ ID NO: 4 or 5, but there may be other unrecited linker sequences. Note that this issue could be addressed by amending the claim to recite the definite article, for example, as is done in the clause referring to the short peptide with the collagen-specific binding ability.
(ii) Claim 4 recites “wherein a ratio of an amount of the affinity peptide with the collagen binding ability used to an amount of the collagen material used”, which is indefinite. The claim is drawn to a functional material or product, thus, the recitation of “used” in this context is confusing, as it suggests a method step. The claim should be amended to clarify the meaning of the claim, for instance:
The functional material according to claim 3, wherein ratio is 1x10-4-2x10-3 μmol : 60 mm3.
The proposed amendment makes clear that the claim describes the structural characteristic of the functional material and not a method of making.
(iii) Claim 6 is written as providing for the “[u]se of the functional material according to claim 3 to preparation of a product with a tissue injury repair function”. The claim is indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. See Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986) and MPEP 2173.05(q). For the purpose of applying prior art, the claim is interpreted as a method of making a functional material.
Claims 2-8 are also rejected for depending upon an indefinite claim without resolving the indefiniteness.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 6 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because it is written as providing for the “[u]se of the functional material according to claim 3 to preparation of a product with a tissue injury repair function”, but does not set forth any active steps involved in the method/process. The claimed recitation of a use, without setting forth any steps involved in the process results in an improper definition of a process, which does not comply with 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). The claims should be rewritten to comply with 35 U.S.C. 101.
Notice for all US Patent Applications filed on or after March 16, 2013: 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.
Claim Rejections - 35 USC § 103
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.
Claims 1-3 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Yamaoka et al. (US2019365944) in view of Panitch et al. (US20110020298), Shi et al. (CN102115495—on IDS filed 12/18/2023) and Federico et al. (Angew. Chem. Int. Ed. 2015, 54, 10980-10984). Note that claim 2 is a product-by-process claim. The MPEP 2113(I) instructs that even “‘though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process’”, citing In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
The first factor to consider when making a rejection under 35 U.S.C. 103(a) is to determine the scope and contents of the prior art. Yamaoka et al. teach a peptide, HGGVRLY (instant SEQ ID NO: 1), that binds vascular endothelial cells and is useful in the making of medical devices that contact blood (see paragraphs [0009]-[0011]). Yamaoka et al. contemplate collagen as a medical device material (see paragraph [0019]). The second factor to consider is to ascertain the differences between the prior art and the instant claims. Yamaoka et al. do not teach that a collagen binding domain (CBD), TKKTLRT (instant SEQ ID NO: 3), is bound to HGGVRLY at the N-terminus through a linker having the sequence “GGGS”, for example. Nevertheless, the CBD, TKKTLRT, and linker, GGGS, were well known and characterized in the prior art prior to the filing of the instant invention. For example, Panitch et al. teach collagen-binding synthetic peptides, including TKKTLRT, that bind a collagen matrix (i.e., a collagen sponge) for use “tissue engineering applications”, wherein the peptide is fused through a linker at the N-terminal of a glycan (see paragraph [0004]; claims 10-15). In addition, Shi et al. teach that TKKTLRT may be linked thorough the linker “GGGS” (see paragraph [0081] of the machine translation).
It would have been obvious to the person of ordinary skill in the art at the time of the filing of the invention to modify the teachings of Yamaoka et al. by attaching the CBD, TKKTLRT, to the N-terminus of the endothelial binding peptide, HGGVRLY, because attaching TKKTLRT to HGGVRLY on the collagen medical device taught by Yamaoka et al. would anchor HGGVRLY (the endothelial binding peptide) to the collagen sponge/matrix. See for instance, Federico et al., who teach “collagen-binding peptides...have relevance to biomaterial applications”, for instance in interacting with collagen proteins or controlling release of “bioactive substances” (see p. 10980, left column; p. 10983, left column and right column, last paragraph). Further, the GGGS linker is commonly used in the art, and the linking sequence can be conventionally selected by a person skilled in the art. The person of ordinary skill in the art would have been motivated to design a collagen material comprising the CBD TKKTLRT linked to the N-terminus of the endothelial cell binding peptide, HGGVRLY, because it would endow HGGVRLY with a collagen binding capability useful in the collagen containing medical device taught by Yamaoka et al.
The effects recited in claims 3, 7 and 8 with regard to binding, tissue injury repair and mesenchymal stem cell adsorbing functions would have been inherent to the combined teachings of Yamaoka et al., Panitch et al., Shi et al. and Federico et al. because they suggest the same functional material comprising the same affinity peptide with collagen binding ability as recited in the claims. The recitation of the characteristics and functions of the recited functional material are part of to the understandings and expectations disclosed in the applied prior art. Further, for the record, the express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983). See also MPEP 2112.
Thus, the claims do not contribute anything non-obvious over the prior art.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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 5712720911. 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.
/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675
Prosecution Insights