The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election of Group I, claims 1-6, 9-10, in the reply filed on February 12, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 7-8, 11-14, 17, 20, 29-30 are canceled. Claims 15-16, 18-19, 21-28 have been withdrawn from further consideration by the examiner because they are drawn to non-elected inventions. Claims 1-6, 9-10 are under consideration.
Priority: This application is a 371 of PCT/US2021/059427, filed November 15, 2021, which claims benefit of provisional application 63/113267, filed November 13, 2020.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code: see at least paragraph 0132 (of the application publication). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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.
Claims 1-6, 9-10 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. The instant claims are product claims reciting titin proteins that are not markedly different from naturally occurring titin proteins.
Claims 1-5 are directed to a microbially-synthesized titin protein comprising a plurality of folded immunoglobulin-like (Ig-like) domains and claims 6, 9-10 are directed to a titin fiber comprising the microbially-synthesized titin protein. The patentability of a product does not depend on its method of production, i.e. a product-by-process is not limited to manipulation of the recited steps, but instead is limited to the structure implied by the steps. MPEP 2113. The limitation “microbially-synthesized” is a process by which the titin protein is produced. The claims include titin proteins or polypeptides having amino acid structures that are the same as mammalian titin proteins. The claims are directed to a statutory category, i.e. a composition of matter (step 1: YES).
Since the claims recite a nature-based product, i.e. a titin protein and/or titin fiber, the claims are analyzed to determine whether it is directed to any judicial exception. The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. The recited titin proteins and/or titin fibers are compared to its closest naturally occurring counterpart(s) to determine if it has markedly different characteristics. Here, the closest natural counterpart is naturally occurring titin protein and/or titin fiber. When the claimed titin protein and/or titin fiber is compared to this counterpart, the comparison indicates that there are no differences in structure, function, or other characteristics. Human muscle tissue comprises titin protein and/or titin fiber having 112 Ig-like domain folds (Labeit et al. p. 293, 295). There is no indication that the claimed titin protein comprising a plurality of folded Ig-like domains is a titin protein having any structural and/or functional characteristics that are different from the naturally occurring titin protein and fiber in its natural state. Therefore, the claimed titin protein and fiber do not have markedly different characteristics from what occurs in nature and is a “product of nature” exception. Accordingly, the claim is directed to an exception (step 2A: YES). Next, the claims as a whole are analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception(s). The claims do not recite anything significantly different than the natural product, i.e. the claims do not recite elements or features that demonstrate that the claimed titin protein comprising a plurality of folded Ig-like domains is markedly different from what exists in nature. Therefore, the claims as a whole add nothing significantly more to the “product of nature” itself (Step 2B: NO), and thus, the claim does not qualify as eligible subject matter.
See also Funk Brothers Seed Co., V. Kalo Inoculant Co., 333 U.S. 127, (1948) and Association for Molecular Pathology v. Myriad Genetics, Inc. 569 U.S., 133 S. Ct. 2107, 2116, 106 USPQ 2d. 1972 (2013).
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 2-4 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.
Claim 2 recites the protein is an oligomer protein having “at least about” 4 Ig-like domains to “at least about” 20 Ig-like domains. Claim 2 recites the protein has to have “at least” 4 Ig-like domains or 20 Ig-like domains. However, the term “about” is a relative term which allows for amounts below the recited 4 Ig-like domains or 20 Ig-like domains. Additionally, it is not clear what the lower limit for the number of Ig-like domains would be since the claim recites “at least about 4” to “at least about 20.” Further clarification and/or correction is requested.
Claim 3 recites the oligomer protein has a molecular weight of “at least about” 40 kDa to “at least about” 150 kDa. As similarly noted above for claim 2, the term “about” is a relative term which allows for molecular weights below the recited 40 kDa or 150 kDa. Additionally, it is not clear what the lower limit for the molecular weight would be since the claim recites “at least about 40 kDa” to “at least about 150 kDa.” Further clarification and/or correction is requested.
Claim 4 recites the polymer protein comprises “more than about” 20 Ig-like domains. The term “about” is relative term which allows for amounts below the recited 20 Ig-like domains. Therefore, it is not clear how the claim can comprise “more than” 20 Ig-like domains while also allowing for less than 20 Ig-like domains. Further clarification and/or correction is requested.
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.
Claims 1-6, 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trinick et al. (1984 J Mol Biol 180: 331-356), and evidenced by Labeit et al. (1995 Science 270: 293-296). The instant claims are product-by-process claims. As noted above, the limitation “microbially-synthesized” is a process by which the titin protein is produced. The patentability of a product does not depend on its method of production, i.e. a product-by-process is not limited to manipulation of the recited steps, but instead is limited to the structure implied by the steps. MPEP 2113.
Trinick et al. teach a preparation comprising native titin protein or polypeptides, where the chain molecular weight of titin is ~106 Mr (at least p. 331-332, 350; instant claims 1-4), where the titin protein inherently comprises 112 Ig-like domains (evidenced by Labeit et al. p. 293). Regarding instant claim 5, Trinick et al. teach the longest titin strands contain several polypeptide chains of weight ~106 (p. 350); therefore, Trinick et al. can be deemed to teach the native titin protein has a mass average molecular weight of at least 2 MDa.
Regarding instant claim 6, Trinick et al. teach rabbit muscle comprising myofibrils and titin protein (at least p. 332). Therefore, Trinick et al. can be deemed to teach a fiber comprising a titin protein comprising a plurality of Ig-like domains. Regarding instant claims 9-10, since Trinick et al. teach a titin fiber comprising the same structural features recited, including the recited titin protein comprising a plurality of Ig-like domains, it would follow that the muscle fibers comprising titin protein of Trinick et al. have the same properties of toughness and ultimate tensile strength recited in the instant claims. MPEP 2112.01 notes that a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garcia et al. (2009 Proteins 75: 706-718; previously cited). Garcia teach a I27 is an Ig-like domain repeated ~40 times in the I-band of human cardiac N2-B titin (at least p. 707, also Fig. 1). Garcia et al. teach I27 polyproteins with multiple number of I27 domains, with up to 20 (at least p. 708; instant claims 1-3).
No claim is allowed.
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/Marsha Tsay/Primary Examiner, Art Unit 1656