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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 8/12/2022, 11/03/2022, 12/12/2023, and 06/21/2024 before the mailing of a first office action. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1, 2, 7, and 17 are pending. Claims 1, 2, 7, and 17 are under examination.
Claim Objections
Response to Arguments
Applicant’s arguments, see Applicant Reply, page 4, para. 4, filed 12/22/2025, with respect to claim 1 have been fully considered and are persuasive. Amended claim 1 recites appropriate wherein clauses. The objection to claim 1 has been withdrawn.
Claim Rejections - 35 USC § 112
Response to Arguments
Applicant’s arguments, see Applicant Reply, page 5, para. 8, filed 12/22/2025, with respect to claims 1, 2, 7, and 17 have been fully considered and are persuasive. The amended claim set has removed references to “homology”. Claim 1 will be examined as a composition claim. The rejections of claims 1, 2, 7, and 17 have been withdrawn.
Response to Arguments
Applicant’s arguments, page 6, para. 7, filed 12/22/2025, with respect to the rejection of claims 1, 2, 7, and 17 under U.S.C. 112(a) have been fully considered and are persuasive. The sequence space issue created by the usage of percentage homology has been resolved. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of amended claim 1.
New Rejection
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, 2, 7, and 17 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.
Regarding claim 1, claim 1 now recites a material for endobronchial occlusion comprising: a protein (A),wherein the protein (A) comprises an amino acid sequence of SEQ ID NO: 16, an amino acid sequence of SEQ ID NO: 17, an amino acid sequence of SEQ ID NO: 20, an amino acid sequence of SEQ ID NO: 23, an amino acid sequence of SEQ ID NO: 26, an amino acid sequence of SEQ ID NO: 27, or an amino acid sequence at least one region corresponding to an amino acid sequence of SEQ ID NO: 4 within any said amino acid sequences replaced by any one of an amino acid sequence of SEQ ID NO: 7, an amino acid sequence of SEQ ID NO: 8, an amino acid sequence of SEQ ID NO: 9 or an amino acid sequence of SEQ ID NO: 10, wherein the material for endobronchial occlusion has a density of 90 to 300 mg/cm3, and wherein the material for endobronchial occlusion is spongy form, and wherein the material for endobronchial occlusion satisfies the following relational expression (2):0.01< Q/P (2) wherein in the relational expression (2), P is the weight of a dried product (DP) of the material for endobronchial occlusion subjected to drying at 100°C and 1 atm for three hours and then drying at 40°C and 1 atm for 15 hours; Q is the weight of a dried product (DQ) of the dried product (DP) subjected to immersion in water having a weight 1000 times the P at 25°C and 1 atm for 72 hours, taking out, drying at 100°C and at 1 atm for three hours, and then drying at 40°C and 1 atm for 15 hours.
Using SEQ ID NO: 16 as an example, SEQ ID NO: 16 contains 84 instances of SEQ ID NO: 4, GVGVP. There are four possible substitutions at each of the 84 instances. This gives a minimum of 84 * 4 = 336 combinations. However, anywhere from one to 84 substitutions may be made, yielding a minimum of 84! * 4 combinations, which is an extremely large number.
In this case, 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 inventor was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. (MPEP § 2163 (II.A.3.a.ii.))
According to MPEP § 2163 (II.A.3.a.ii.), a "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
Applicant discloses six examples of varying length from 310 residues to 2694 residues, none of which possess the claimed substitutions at “VGVGP”.
MPEP § 2163 (II.A.3.a.ii.) states that “for inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’ 45.
Even when several species are disclosed, these are not necessarily representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, as here, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species. Since each genus recited in the instant claims is large, it would be very challenging to describe sufficient species to cover the structures of the entire genus.
In the instant case, six species members have been disclosed. At the time the invention was made, the level of skill for preparing polypeptides and then selecting those polypeptides with desired functional properties was high. However, even if a selection procedure was, at the time of the invention, sufficient to enable the skilled artisan to identify polypeptides with the recited properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010); see also Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1876 (Fed. Cir. 2011) (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”) Absent the conserved structures provided by the six provided species, the skilled artisan generally would not be able to visualize or otherwise predict, a priori, what peptide with a particular set of properties would look like structurally beyond the provided repeats. However, subsequences of the disclosed members have been claimed as well as variations that necessarily modify the repeats in undisclosed ways.
Since only a six species of polypeptides are taught within the claimed genus above, the instant claims above fail the written description requirement. A representative number of species has not been taught to describe this genus. A single point mutation can change the biophysical properties of a peptide: “In summary, we have shown that the structural changes in the fibrillar state of the Aβ42 peptide that are observed to occur upon introduction of single point mutations can be accompanied by changes in the dominance of the microscopic processes by which these aggregates are themselves formed.” (Bolognesi et al. ACS Chem Bio 9:2 (2013) page 381 col. 2 para. 3) and “In summary, while ovispirin-1 and novispirin G-10 both had solution structures that were helical and amphipathic in the presence of TFE, a relatively simple change in their primary structure (a single glycine–isoleucine exchange) had profound effects on their respective toxicities for human erythrocytes and epithelial cells.” (Sawai et al. Protein Eng. 15:3 (2002) page 232 col. 1 para. 3).
Furthermore, many sequences allowed by the current scope of the claims, result in non-functional aggregates. Wang (Wang, et al. MAbs. Vol. 1. No. 3. Taylor & Francis, (2009)) discloses a variety of aggregation prone motifs that occur in commercial antibodies (Wang, page 262, Table 2). The scope of the claims currently may incorporate such motifs and result in non-functional aggregates.
Given this unpredictability of polypeptide design, the skilled artisan would not have been in possession of the substantial repertoire of peptide species encompassed by the claimed invention; one of skill in the art would conclude that applicant was not in possession of the structural attributes of a representative number of species possessed by the members of the genus of every peptide molecule recited by claim 1. One of skill in the art would conclude that the specification fails to disclose a representative number of species to describe the claimed genus. Therefore, claim 1 is rejected.
Regarding claims 2, 7, and 17, claim 1 is rejected as described above. These claims do not significantly reduce the size the claimed genus because of how many possible proteins described by claim 1 possess a mass of 15kDa to 200kDa.
Consequently, claims 2, 7, and 17 are rejected.
Claim Rejections - 35 USC § 103
Response to Arguments
Applicant’s arguments, see Applicant’s arguments, page 7, para. 3, filed 12/22/2025, with respect to the rejections of claims 1, 2, 7, and 27 under U.S.C. 103 have been fully considered and are persuasive. The cited references do not include references to “spongy form”. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Kawabata et al. (Kawabata, et al. Journal of Biomaterials Science, Polymer Edition 28.18: 2143-2153 (2017)).
New Rejection
Claim Rejections - 35 USC § 102
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, 2, 7, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kawabata et al. (Kawabata, et al. Journal of Biomaterials Science, Polymer Edition 28.18: 2143-2153 (2017)).
Regarding claim 1, claim 1 recites a material for endobronchial occlusion comprising: a protein (A),wherein the protein (A) comprises an amino acid sequence of SEQ ID NO: 16, an amino acid sequence of SEQ ID NO: 17, an amino acid sequence of SEQ ID NO: 20, an amino acid sequence of SEQ ID NO: 23, an amino acid sequence of SEQ ID NO: 26, an amino acid sequence of SEQ ID NO: 27, or an amino acid sequence at least one region corresponding to an amino acid sequence of SEQ ID NO: 4 within any said amino acid sequences replaced by any one of an amino acid sequence of SEQ ID NO: 7, an amino acid sequence of SEQ ID NO: 8, an amino acid sequence of SEQ ID NO: 9 or an amino acid sequence of SEQ ID NO: 10, wherein the material for endobronchial occlusion has a density of 90 to 300 mg/cm3, and wherein the material for endobronchial occlusion is spongy form, and wherein the material for endobronchial occlusion satisfies the following relational expression (2):0.01< Q/P (2) wherein in the relational expression (2), P is the weight of a dried product (DP) of the material for endobronchial occlusion subjected to drying at 100°C and 1 atm for three hours and then drying at 40°C and 1 atm for 15 hours; Q is the weight of a dried product (DQ) of the dried product (DP) subjected to immersion in water having a weight 1000 times the P at 25°C and 1 atm for 72 hours, taking out, drying at 100°C and at 1 atm for three hours, and then drying at 40°C and 1 atm for 15 hours.
Kawabata discloses a silk-elastin with the following sequence: “Silk-elastin is composed of four silk fibroin-like blocks, seven elastin-like blocks, and one modified elastin block containing a lysine (K) substitution (MDPVVLQRRDWENPGVTQLNRLAAHPPFASDPMGAGSGAGAGS [ (GVGVP)4 GKGVP (GVGVP)3 (GAGAGS)4 ]12 (GVGVP)4 GKGVP (GVGVP)3 (GAGAGS)2 GAGAMDPGRYQDLRSHHHHHH) [1]. The silk-elastin was supplied by Sanyo Chemical Co., Ltd., Kyoto, Japan.” (Kawabata et al., page 2144, para. 4).
When expanded, this formula yields:
MDPVVLQRRDWENPGVTQLNRLAAHPPFASDPM
GAGSGAGAGS
GVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGS
GVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGS
GVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGS
GVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGS
GVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGS
GVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGS
GVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGS
GVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGS
GVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGS
GVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGS
GVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGS
GVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGS
GVGVPGVGVPGVGVPGVGVP
GKGVP
GVGVPGVGVPGVGVP
GAGAGSGAGAGS
GAGAMDPGRYQDLRSHHHHHH, which is aligned against Applicant SEQ ID NO: 16 below:
########################################
#=======================================
#
# Aligned_sequences: 2
# 1: EMBOSS_001
# 2: EMBOSS_001
# Matrix: EBLOSUM62
# Gap_penalty: 10.0
# Extend_penalty: 0.5
#
# Length: 884
# Identity: 884/884 (100.0%)
# Similarity: 884/884 (100.0%)
# Gaps: 0/884 ( 0.0%)
# Score: 4680.0
#
#
#=======================================
EMBOSS_001 1 MDPVVLQRRDWENPGVTQLNRLAAHPPFASDPMGAGSGAGAGSGVGVPGV 50
||||||||||||||||||||||||||||||||||||||||||||||||||
EMBOSS_001 1 MDPVVLQRRDWENPGVTQLNRLAAHPPFASDPMGAGSGAGAGSGVGVPGV 50
EMBOSS_001 51 GVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAG 100
||||||||||||||||||||||||||||||||||||||||||||||||||
EMBOSS_001 51 GVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAG 100
EMBOSS_001 101 SGAGAGSGVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAG 150
||||||||||||||||||||||||||||||||||||||||||||||||||
EMBOSS_001 101 SGAGAGSGVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAG 150
EMBOSS_001 151 AGSGAGAGSGAGAGSGAGAGSGVGVPGVGVPGVGVPGVGVPGKGVPGVGV 200
||||||||||||||||||||||||||||||||||||||||||||||||||
EMBOSS_001 151 AGSGAGAGSGAGAGSGAGAGSGVGVPGVGVPGVGVPGVGVPGKGVPGVGV 200
EMBOSS_001 201 PGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGSGVGVPGVGVPGVGVP 250
||||||||||||||||||||||||||||||||||||||||||||||||||
EMBOSS_001 201 PGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGSGVGVPGVGVPGVGVP 250
EMBOSS_001 251 GVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGSG 300
||||||||||||||||||||||||||||||||||||||||||||||||||
EMBOSS_001 251 GVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGSG 300
EMBOSS_001 301 VGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAG 350
||||||||||||||||||||||||||||||||||||||||||||||||||
EMBOSS_001 301 VGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAG 350
EMBOSS_001 351 SGAGAGSGAGAGSGVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGV 400
||||||||||||||||||||||||||||||||||||||||||||||||||
EMBOSS_001 351 SGAGAGSGAGAGSGVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGV 400
EMBOSS_001 401 GVPGAGAGSGAGAGSGAGAGSGAGAGSGVGVPGVGVPGVGVPGVGVPGKG 450
||||||||||||||||||||||||||||||||||||||||||||||||||
EMBOSS_001 401 GVPGAGAGSGAGAGSGAGAGSGAGAGSGVGVPGVGVPGVGVPGVGVPGKG 450
EMBOSS_001 451 VPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGSGVGVPGVGV 500
||||||||||||||||||||||||||||||||||||||||||||||||||
EMBOSS_001 451 VPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGSGVGVPGVGV 500
EMBOSS_001 501 PGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSG 550
||||||||||||||||||||||||||||||||||||||||||||||||||
EMBOSS_001 501 PGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSG 550
EMBOSS_001 551 AGAGSGVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAG 600
||||||||||||||||||||||||||||||||||||||||||||||||||
EMBOSS_001 551 AGAGSGVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAG 600
EMBOSS_001 601 SGAGAGSGAGAGSGAGAGSGVGVPGVGVPGVGVPGVGVPGKGVPGVGVPG 650
||||||||||||||||||||||||||||||||||||||||||||||||||
EMBOSS_001 601 SGAGAGSGAGAGSGAGAGSGVGVPGVGVPGVGVPGVGVPGKGVPGVGVPG 650
EMBOSS_001 651 VGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGSGVGVPGVGVPGVGVPGV 700
||||||||||||||||||||||||||||||||||||||||||||||||||
EMBOSS_001 651 VGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGSGVGVPGVGVPGVGVPGV 700
EMBOSS_001 701 GVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGSGVG 750
||||||||||||||||||||||||||||||||||||||||||||||||||
EMBOSS_001 701 GVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSGAGAGSGAGAGSGVG 750
EMBOSS_001 751 VPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSG 800
||||||||||||||||||||||||||||||||||||||||||||||||||
EMBOSS_001 751 VPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGVPGAGAGSGAGAGSG 800
EMBOSS_001 801 AGAGSGAGAGSGVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGV 850
||||||||||||||||||||||||||||||||||||||||||||||||||
EMBOSS_001 801 AGAGSGAGAGSGVGVPGVGVPGVGVPGVGVPGKGVPGVGVPGVGVPGVGV 850
EMBOSS_001 851 PGAGAGSGAGAGSGAGAMDPGRYQDLRSHHHHHH 884
||||||||||||||||||||||||||||||||||
EMBOSS_001 851 PGAGAGSGAGAGSGAGAMDPGRYQDLRSHHHHHH 884
#---------------------------------------
#---------------------------------------
Furthermore, Kawabata discloses that this composition may be sponge-like in form and may have a density of 100 mg/cm3: “We prepared ultrapure water and ultrapure water solutions containing silk-elastin at concentrations of 12.5, 25, 50, and 100 mg/cm3 and casted each solution to each formwork to obtain silk-elastin sponges with a final thickness of 5, 1.25, and 2.5 mm. We then subjected the casted formworks to freezing, primary drying, and secondary drying using a freeze dryer (Nihon Techno Service Co., Ltd.) and thereby obtained six types of silk-elastin sponges (A–F in Table 1). The sponge structures were visualized using a scanning electron microscope (Quanta 250 FEG; FEI company [please describe the company location]) (Figure 1).” (Kawabata et al., page 2144, para. 5).
Regarding the relational expression, the material disclosed by Kawabata has the same sequence and the same density and the same spongy form. Therefore, the relational expression for this material will necessarily also be the same. MPEP 2112.01 states: “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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.”
Consequently, claim 1 is anticipated by Kawabata et al. and rejected.
Regarding claim 2, claim 1 is anticipated as described above. Regarding the relational expression, the material disclosed by Kawabata has the same sequence and the same density and the same spongy form. Therefore, the relational expression for this material will necessarily also be the same. MPEP 2112.01 states: “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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.”
Consequently, claim 2 is anticipated by Kawabata et al. and rejected.
Regarding claim 7, claim 1 is anticipated as described above. The sequence disclosed by Kawabata has a molecular mass of 69814.12 Da, or 69.8 kDa.
Consequently, claim 7 is anticipated by Kawabata et al. and rejected.
Regarding claim 17, claim 2 is anticipated as described above. The sequence disclosed by Kawabata has a molecular mass of 69814.12 Da, or 69.8 kDa.
Consequently, claim 17 is anticipated by Kawabata et al. and rejected.
Conclusion
No claim is allowed.
Claims 1, 2, 7, and 17 are rejected.
Applicant's amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Paul Bowles whose telephone number is (571)272-0919. The examiner can normally be reached Monday-Friday 8:30-5:00.
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/DAVID PAUL BOWLES/ Examiner, Art Unit 1654
/LIANKO G GARYU/ Supervisory Patent Examiner, Art Unit 1654