DETAILED ACTION
Notice of 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
Applicant’s election without traverse of Group I, claims 1-10 and 14-15 in the reply filed on 12 November 2025 is acknowledged. The requirement is deemed proper and therefore made Final.
Status of Application
Claims 1-15 are pending; Claims 11-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Thus, claims 1-10 and 14-15 are subject to examination on the merits.
Priority
The instant application claims benefit of foreign priority document KR 10-2022-0059486 filed 16 May 2022 is acknowledged. Said document has been received.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07 December 2022 and 24 June 2025 have been considered by the examiner. See initialed and signed PTO/SB/08’s.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in paragraph 0136 (p. 29). 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 Objections
Claim 10 is objected to because of the following informalities: Claim 9 recites “a non-human transformant”; claim 10, which depends on claim 9, recites only “the transformant”. For consistency purposes, it is suggested to change claim 10 to also recite “non-human transformant” (e.g. The non-human transformant of claim 9, wherein the non-human transformant is Komagataella phaffii”. Appropriate correction is required.
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.
Claim 2 is 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.
The claim recites “inserting arginine into an amino acid at position 2 of the N-terminus….”. The claim is deemed indefinite because it is unclear whether the claim intends to substitute an arginine at position 2. Or rather, if the claim is meant to insert an arginine between amino acids 1 and 2, thus making the arginine the 2nd amino acid from the N-terminus; or inserting an arginine between amino acids 2 and 3, thus making it the third amino acid from the N-terminus of hydrophobin Srh1.
The specification suggests an insertion is the correct choice (rather than substitution) but is also confusing and contradictory. For example, paragraph 0083 states inserting Arg between amino acids 2 and 3 of hydrophobin Srh1, which would result in the Arg being the third amino acid from the N-terminus. However, paragraph 0059 seems to suggest that it is inserted between amino acids 1 and 2, making it the second amino acid from the N-terminus. In addition, in viewing the respective hydrophobin Srh1 signal sequences in the sequence listing, it appears that the arginine is actually inserted between amino acids 1 and 2 (See for example, SEQ ID NO: 53 (MQFSIVALFATGALA) and SEQ ID NO: 54 (MRQFSIVALFATGALA).
Clarification and amendments to the claim are requested.
Claim 3 is 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.
The claim states that the alpha-mating factor is derived from yeast (Saccharomyces cerevisiae). It is unclear if the species Saccharomyces cerevisiae found within the parenthesis is meant to be a claim limitation or if it is a preferred embodiment. This ambiguity renders the claim indefinite. The claim will be examined with the broadest interpretation that the alpha-mating factor is from any yeast.
Claim 3 is 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 3 is further rejected as indefinite because the claim recites the hydrophobin Srh1 sequence is derived from Trichoderma harzianum. However, the specification does not define what this signal sequence is, rather, the specification recites a Srh1 hydrophobin signal sequence from Trichoderma viride, which is SEQ ID NO: 53 (with Arg inserted, SEQ ID NO: 54) and also defined in Table 1 as the entire srh1 gene from T. viride (SEQ ID NO: 16) and which includes the signal sequence. It is thus unclear whether the Srh1 hydrophobin signal sequence is derived from T. viride or T. harzianum.
Claims 5-10 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 5 and 8 recite “wherein the polynucleotide consists of a base sequence of SEQ ID NO: 5” (claim 5); or “wherein the expression vector consists of a base sequence of SEQ ID NO: 6” (claim 8). It is unclear whether the breadth of the claims are intended to encompass the full length sequences or fragments of said sequences. Accordingly, the metes and bounds of the phrase cannot be ascertained from the claims.
Claims 6-7 and 9-10 are included in the instant rejection as they do not remedy the noted ambiguities.
The rejection can be overcome by substitution of “a” with “the”.
Claim 7 is 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 7 recites “wherein the polynucleotides are tandemly repeated 2 to 6 times.” Claim 7 is dependent upon claim 6, which recites “the polynucleotide of claim 4 and a polynucleotide encoding a human insulin-like growth factor-1 (hIGF1).”
Given claim 6 recites two different polynucleotides, it is unclear in claim 7 which ones are tandemly repeated in the expression vector.
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.
Claims 1-4, 6-7, 9-10, 14-15 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 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 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.
The MPEP in section 2163(I) states that the purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made/filed, of the specific subject matter claimed:
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonable conclude the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings.
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An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997)"
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"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 (Fed. Circ. 1997).
MPEP § 2163 further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." Furthermore, the courts have also held that possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895.
The claims in their broadest are drawn ultimately to a fusion signal peptide comprising hydrophobin Srh1 at the N-terminus and an alpha-mating factor at the C-terminus of the Srh1, wherein the hydrophobin Srh1 comprises “one or two or more amino acid mutations.”. The specification at paragraph 0059 stipulates: “The amino acid mutation may mean, but is not limited to, substitution, addition, deletion, and the like of an amino acid.” Thus, the claims are drawn to a large and extensive genus of Srh1 signal sequences that can have an unlimited number of substitutions, deletions, insertions and combinations thereof. In addition, the alpha-mating factor is known to comprise two parts, e.g. is comprises a 19 amino acid pre-pro-signal sequence and a 67 amino acid pro-signal sequence and thus, said alpha-mating factor could be either pre-pro-signal (19aa); pro-signal (67aa) or the entire pre-pro-signal sequence (86aa), not to mention any potential variants thereof of any of the three. Thus, the combination makes for a very large and diverse genus hybrid signal sequences. However, the specification only discloses the hydrophobin Srh1 of SEQ ID NO: 53 which has an Arginine inserted in between amino acids 1 and 2 (resulting in SEQ ID NO: 54), which is fused to the S. cerevisiae alpha-mating factor pro-signal sequence, wherein the resulting hybrid signal sequence is encoded by SEQ ID NO: 5 (See Example 3.2, paragraph 0089; Example 4.4). This single example, however, is not deemed representative of the entire diverse and very large genus in terms of structure and function of hybrid signal sequences comprising Srh1 at the N-terminus and having an unlimited number of mutations (e.g. insertions, substitutions, deletions, etc.) and fused to an α-MF signal sequence which could be one three different forms, and variants thereof.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 31 December 2025