Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of heavy chain in the reply filed on July 29, 2025 is acknowledged.
New claims are drawn to a new group which is examined.
IV. Claims 65-82, drawn to a composition comprising fibroin heavy chain protein fragments, fibroin light chain protein fragments and fibroheamerin protein fragments, classified in C07K 43586 for example.
Claims 65-82 are pending. Claims 1-64 are canceled. Claims 65-82 are examined.
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 65-69, 76, 80-82 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim(s) is/are directed to a naturally occurring product. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because claims do not recite something significantly different than a judicial exception. The rationale for this determination is explained below.
The rationale for this determination is explained below and is based on USPTO’s 2014 and 2016 Interim Guidance on Patent Subject Matter Eligibility, called ‘‘Interim Eligibility Guidance’’ (published in Federal Register /Vol. 79, No. 241 /Tuesday, December 16, 2014) for use by USPTO personnel in determining subject matter eligibility under 35 U.S.C. 101 in view of recent decisions by the U.S. Supreme Court (Supreme Court). In Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo) 101 USPQ2d 1961, 1965-1966 (SC 2012) it was stated:
“Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U. S. 63, 67 (1972). And monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it. (Emphasis added)
Still, as the Court has also made clear, to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words “apply it.”
Our conclusion rests upon an examination of the particular claims before us in light of the Court’s precedents. Those cases warn us against interpreting patent statutes in ways that make patent eligibility “depend simply on the draftsman’s art” without reference to the “principles underlying the prohibition against patents for [natural laws].” Flook, supra, at 593. They warn us against upholding patents that claim processes that too broadly preempt the use of a natural law. Morse, supra, at 112– 120; Benson, supra, at 71–72.
And they insist that a process that focuses upon the use of a natural law also contain other elements or a combination of elements, sometimes referred to as an “inventive concept,” sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself. Flook, supra, at 594; see also Bilski, supra, at ___ (slip op., at 14) (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment’ or adding ‘insignificant post solution activity’” (quoting Diehr, supra, at 191–192)). (Emphasis added)
We find that the process claims at issue here do not satisfy these conditions. In particular, the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries. (Emphasis added)
The claims are drawn to a composition comprising fibroin heavy chain protein fragments (elected restriction) which encompass naturally occurring products or non-naturally occurring products that are not markedly different from naturally occurring products. The same fragments are encompassed by fibroin light chain and fibroheaxmin protein. The product claimed encompass naturally occurring protein in animal because the claimed fragment encompasses 2 amino acids with species N70D elected which occurs in the natural heavy chain protein thus the protein only required KD or DH in the sequence. The claimed composition also encompass naturally occurring silk protein if the composition modification is not 100%. Under the holding of Myriad, isolated but otherwise unchanged nucleic acid is not eligible because it is not different enough from what exists in nature to avoid improperly tying up the future use and study of naturally occurring gene. In University of Utah Research v. Ambry Genetics Corporation, the courts held that the claims drawn to primers are natural product and ineligible under 35 USC 101. The claim limitation “composition” does not impart a significantly more than the judicial exception because the claim limitation is generic and does not provide significantly more structural change. Eligibility requires more than the “hand of man” but claimed product must be both non-naturally occurring and markedly different from naturally occurring products. The claim as a whole does not recite meaningful limitations that add something of significance to the judicial exception. The claims are recited at a high level of generality such that the products encompass naturally occurring products. The products must be used by others to apply the judicial exception. The products are drawn to well-known and routine claim limitations using the natural products and the product is drawn to nothing more than a mere field of use because the similar products were well known to one of skill in the art. The claim limitations are insignificant extra-solution activity because the claim limitations are generically drawn to other natural products or were well known to one of skill in the art in the ion channel art. The Association for Molecular Pathology v. Myriad Genetics, Inc. 569 U.S. __, 133 S. Ct. 2107 2116, 106 USPQ2d 1972 (2013) held that naturally occurring products or non-naturally occurring products that are not markedly different from naturally occurring products are not patentable.
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 65-82 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 66 recite “each modification is independently ranging in the composition between about 1% to about 99%” which is confusing because it is not clear how the modification is ranging.
Claim 67 recite or encompass “percent modification” which is ambiguous because it is not clear why the term is defined when the dependent claim 65 does not refer to the term.
Claims 68 recite the term “fractions” which is ambiguous because it is not clear how the compositions are in fractions.
Claim 80 recite “a percentage of amino acid modification in the fibroin heavy chain protein fragments at N70D (elected species) is from about 20% to 100%” which is ambiguous because claims encompass unmodified natural silk protein.
Claim 66-68 is dependent on claim 65 (claims 69-82 are dependent on claim 65) and encompass all the limitations of claim 66-68.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 65, 69, 76, 80-82 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Fei et al. (US 2022/0205165).
Fei disclose Bombyx silk fibroin protein fragments heavy chain, light chain and hexamerin with substitution in repetitive region with amino acids and fragments size of 5 -20 kD (paragraph 3, 29, 31, 41, 43, 304, 494). The product claimed encompass naturally occurring protein in animal because the claimed fragment encompasses 2 amino acids with species N70D elected which occurs in the natural heavy chain protein thus the protein only required KD or DH in the sequence.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 65-82 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-64 of copending Application No. 19/111,013 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims of reference application disclose the silk fibroin peptide comprising heavy chain, light chain and fibrohexamerin with identical substitutions and composition comprising and silk fibroin peptide of the same size thus anticipate the claims.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL D PAK whose telephone number is (571)272-0879. The examiner can normally be reached on flexible.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL D PAK/Primary Examiner, Art Unit 1674