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 .
DETAILED ACTION
Application Status
This application is a CON of US patent application 18/473,416, filed on 7/22/2025.
The Examiner is acknowledging the filing of a Petition to make this patent application as a Track One under 37 CFR 1.102(e) filed on 09/08/2025, and the petition has been granted on 08/30/2021.
Claims 3-8, 10, 13-15 and 16 are currently pending in the instant patent application.
The preliminary claims amendment filed on 07/22/2025, amending claims 3-8, 10, 13 and 14, and canceling claims 1-2, 9, 11-12, and 17-20 is acknowledged.
Election/Restriction
Applicant's election with traverse of species (A) SEQ ID NO: 11 (KerS1) or a nucleic acid encoding KerS1 in the response filed on 02/03/2026 is acknowledged.
Arguments: Applicants argue that for restriction to be proper, there must be a patentable difference between the species as claimed, and the burden is on the Office to provide reasons and/or examples to support any conclusion in regard to patentable distinction. However, the Office has not provided any reasons or examples to support a conclusion that the species are indeed patentably distinct, and furthermore, Applicants argue that if the members of the Markush group are sufficiently few in number or so closely related that a search and examination of the entire claim can be made without serious burden, the Examiner must examine all claims on the merits...on the other hand, should no prior art be found that anticipates or renders obvious the elected species, the search of Markush-type claim will be extended. In addition Applicants argue that the election requirement of species is traversed on the basis that the Examiner has not shown a burden in a search and a search has not been extended.
Response: Applicant’s arguments have been fully considered but are not deemed persuasive because regarding species election, the examiner clearly indicated in the previous Office action that the proteins species of SEQ ID Nos: 11 (KerS1), 13 (KerS1ems), 15 (KerS13), 17 (KerS13uv), 19 (KerS13Uv+ems), 21 (KerS15), 23 (KerS15ems), 25 (KerS26), 27 (KerS26uv), 29 (KerS39), 31 (KerS39ems) are unrelated chemically and structurally. Inventions (species) are unrelated if it can be shown that they are not disclosed as capable of use together and they have different modes of operation, different functions, or different effects (MPEP § 806.04, MPEP § 808.01). In the instant case the different protein species represent structurally different polypeptides and polynucleotide encoding them. Therefore, where structural identity is required, such as for hybridization or expression or antibody binding, the different sequences have different effects.
The Examiner further pointed out that- There is an examination and search burden for these patentably distinct species due to their mutually exclusive characteristics. The species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search queries); and/or the prior art applicable to one species would not likely be applicable to another species; and/or the species are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Furthermore, the examiner only asked for electing a single species rather than election as invention of sequences recited in a Markush group style claim, and MPEP 803.02 clearly indicates that species election is valid (see, Copy of MPEP 803.02 as shown below).
803.02 Election of Species Requirements – Markush Claims [R-10.2019]
I. MARKUSH CLAIMS
A "Markush" claim recites a list of alternatively useable members. In re Harnisch, 631 F.2d 716, 719-20, 206 USPQ 300, 303 (CCPA 1980); Ex parte Markush, 1925 Dec. Comm'r Pat. 126, 127 (1924). The listing of specified alternatives within a Markush claim is referred to as a Markush group or a Markush grouping. Abbott Labs v. Baxter Pharmaceutical Products, Inc., 334 F.3d 1274, 1280-81, 67 USPQ2d 1191, 1196 (Fed. Cir. 2003)(citing to several sources that describe Markush groups).
When examining a Markush claim, the examiner may generally choose to require a provisional election of species from among patentably indistinct species or patentably indistinct groups of species. See subsection III, below. The applicant’s election serves as a starting point for the search and examination of the claim.
See MPEP § 2117 for a general discussion of Markush claims, guidance and examples regarding the determination of whether a Markush grouping is proper, and rejections on the basis that a claim contains an improper Markush grouping. A rejection based on an improper Markush grouping should be made in an Office action on the merits. In certain circumstances, both a provisional election of species requirement and an improper Markush grouping rejection may apply to the same claim.
See MPEP § 2111.03, subsection II, and MPEP § 2173.05(h) for a discussion of Markush claims and compliance with the definiteness requirement of 35 U.S.C. 112(b).
II. PROPER MARKUSH GROUPING
Pursuant to the Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications ("Supplementary Guidelines"), 76 Fed. Reg. 7162 (February 9, 2011), a Markush grouping is proper if: (1) the members of the Markush group share a "single structural similarity," and (2) the members share a common use. Id. (citing In re Harnisch, 631 F.2d 716, 721-22, 206 USPQ 300, 305 (CCPA 1980)).
Where a Markush grouping describes part of a combination or process, the members following "selected from the group consisting of" (or a similar introductory phrase) must be substitutable, one for the other, with the expectation that the same intended result would be achieved. Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350, 1357, 119 USPQ2d 1773, 1779 (Fed. Cir. 2016)("It is generally understood that … the members of the Markush group … are alternatively usable for the purposes of the invention … .")(citations omitted). Where a Markush grouping describes part of a chemical compound, regardless of whether the claim is limited to a compound per se or the compound is recited as part of a combination or process, the members following "selected from the group consisting of" (or similar introductory phrase) need not share a community of properties themselves; the propriety of the grouping is determined by a consideration of the compound as a whole. See Harnisch, 631 F.2d at 722, 206 USPQ at 305 ("in determining the propriety of a Markush grouping the compounds must be considered as wholes and not broken down into elements or other components").
See MPEP § 2117 for guidance and examples regarding the determination of whether a Markush grouping is proper.
In accordance with the principles of compact prosecution, if the examiner determines that one or more claims appear to include an improper Markush grouping (see MPEP § 2117), the examiner should require the applicant to elect a species. Note that if a written provisional election of species requirement must be made separate from the first Office action on the merits, it should not include a rejection on the basis of an improper Markush grouping. Any appropriate improper Markush grouping rejection should be made in an Office action on the merits.
III. ELECTION OF SPECIES PRACTICE FOR MARKUSH CLAIMSA. Overview
Markush claims recite a plurality of alternatively usable substances or members. In most cases, a recitation by enumeration is used because there is no appropriate or true generic language. A Markush claim may include independent and distinct inventions. This is true where two or more of the members are so unrelated and diverse that a prior art reference anticipating the claim with respect to one of the members would not render the claim obvious under 35 U.S.C. 103 with respect to the other member(s). In applications containing a Markush claim that encompasses at least two independent or distinct inventions, the examiner may require a provisional election of a single species (or grouping of patentably indistinct species) prior to examination on the merits, with one exception. If the members of a proper Markush group are sufficiently few in number or so closely related that a search and examination of the entire claim can be made without serious burden, the examiner must examine all the members of the Markush group in the claim on the merits, even though they may be directed to independent and distinct inventions. In such a case, the examiner will not require provisional election of a single species. See MPEP § 808.02
An examiner should set forth a requirement for election of a single disclosed species (or a grouping of patentably indistinct species) in a Markush claim using form paragraph 8.01 when claims limited to species are present or using form paragraph 8.02 when no species claims are present. See MPEP § 808.01(a) and § 809.02(a). If a Markush claim depends from or otherwise requires all the limitations of another generic or linking claim, see MPEP § 809.
Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. Note that where a claim reads on multiple species, only one species needs to be taught or suggested by the prior art in order for the claim to be anticipated or rendered obvious. See, e.g., Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298, 92 USPQ2d 1163, 1171 (Fed. Cir. 2009)(the entire element is disclosed by the prior art if one alternative in the Markush group is in the prior art).
If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration. As an example, in the case of an application with a Markush claim drawn to the compound X-R, wherein R is a radical selected from the group consisting of A, B, C, D, and E, the examiner may require a provisional election of a single species, XA, XB, XC, XD, or XE. The Markush claim would then be examined fully with respect to the elected species and any species considered to be clearly unpatentable over the elected species.
If on examination the elected species is found to be anticipated or rendered obvious by prior art, the Markush claim and claims to the elected species will be rejected, and claims to the nonelected species will be held withdrawn from further consideration.
If the examiner determines that the elected species is allowable over the prior art, the examination of the Markush claim will be extended. If prior art is then found that anticipates or renders obvious the Markush claim with respect to a nonelected species, the Markush claim shall be rejected; claims to the nonelected species would still be held withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species, and need not be extended beyond a proper Markush grouping. See subsection III.C.2, below, for additional guidance.
Should applicant, in response to a rejection of a Markush claim, overcome the rejection by amending the Markush claim to exclude the species anticipated or rendered obvious by the prior art, the amended Markush claim will be examined again. The examination will be extended to the extent necessary to determine patentability of the Markush claim. In the event prior art is found during this examination that anticipates or renders obvious the amended Markush claim, the claim will be rejected and the action can be made final unless the examiner introduces a new ground of rejection that is neither necessitated by applicant’s amendment of the claims nor based on information submitted in an information disclosure statement filed during the period set forth in 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p). See MPEP § 706.07(a). Amendments submitted after the final rejection further restricting the scope of the claim may be denied entry if they do not comply with the requirements of 37 CFR 1.116. See MPEP § 714.13.
B. Provisional Election of Species
If a claim that includes a Markush grouping reads on two or more patentably distinct inventions, a provisional election of species requirement may be made at the examiner’s discretion. When making such a requirement, the examiner will require the applicant to elect a species or group of patentably indistinct species for initial search and examination. The examiner should not require provisional election between species that are not patentably distinct, or when the Markush group is proper and there would be no serious burden if the species were examined together. The examiner should not invite the applicant to elect any group of species that would clearly be rejectable either as an improper Markush grouping or under 35 U.S.C. 112(a) if presented in a separate claim.
In accordance with current practice, when an examiner chooses to require a provisional election of species, in most cases the examiner should call the applicant to request a telephonic election. See MPEP § 812.01. If the applicant elects by telephone, form paragraph 8.23 should be used in the next Office action on the merits. The examiner should note whether the election was made with or without traverse. If a rejection on the basis of an improper Markush grouping is to be made, it should be done in the first Office action on the merits with the written provisional election of species requirement.
If a written provisional election of species requirement is made prior to the first Office action on the merits, it should not include a rejection on the basis of an improper Markush grouping. Any appropriate improper Markush grouping rejection should be made in an Office action on the merits. If during prosecution a new claim is added that includes an improper Markush grouping, or an existing claim is amended to include an improper Markush grouping, the examiner may require provisional election of species at that time, in the same action as any appropriate rejections . Include form paragraph 8.23.01 if the applicant declined to elect by telephone.
C. Initial Examination of Elected Species1. Rejection of Claims to Elected Species
Examination on the merits begins after the applicant’s election. If the elected species or group of patentably indistinct species is anticipated by or obvious over the prior art, an appropriate art-based rejection of any claim that reads on the elected species or group of patentably indistinct species should be made. Non-prior art rejections that apply to the elected species or group of patentably indistinct species should also be made. If the election was made with traverse, it should be treated in accordance with MPEP § 821.01.
If the Markush grouping was improper, a rejection on the basis of there being an improper Markush grouping should be made as described in MPEP § 2117. The examiner should use form paragraph 8.40 to make the improper Markush grouping rejection and to advise the applicant of the species that do not belong to a proper Markush grouping that includes the elected species. The form paragraph also serves to advise the applicant that a rejection on the basis of there being an improper Markush grouping is an appealable rather than a petitionable matter.
Example 1.
A claim is drawn to a proper Markush grouping of species A, B, or C. The three species are patentably distinct, and the examiner requires a provisional election. Species A is elected. The examiner rejects species A over prior art, and indicates that species B and C have not been searched and examined. Use form paragraph 8.01 or 8.02 as appropriate to set forth the election requirement.
Example 2.
A claim is drawn to a Markush grouping of species A, B, C, D, or E. The five species are patentably distinct, and the examiner requires a provisional election. The grouping of species A, B, or C is a proper Markush grouping. However, the grouping of species A, B, C, D, or E is not a proper Markush grouping. Species A is elected. The examiner rejects species A over prior art, and indicates that species B, C, D, and E have not been searched and examined. Use form paragraph 8.01 or 8.02 as appropriate to set forth the election requirement. The examiner should also reject the claim on the basis of there being an improper Markush grouping using form paragraph 8.40. The improper Markush grouping rejection should indicate that species D and E do not belong to the proper Markush grouping of species A, B, or C.
2. Elected Species in Proper Markush Grouping Allowable over the Prior Art
If the elected species or group of patentably indistinct species is not anticipated by or obvious over the prior art, the examiner should extend the search and examination to a non-elected species or group of species that falls within the scope of a proper Markush grouping that includes the elected species. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The examiner need not extend the search beyond a proper Markush grouping. In other words, the examiner need not extend the search to any additional species that do not share a single structural similarity and a common use with the elected species (i.e., do not belong to the same recognized physical or chemical class or to the same art-recognized class and/or do not have a common use and/or do not share a substantial structural feature of a chemical compound and a use that flows from the substantial structural feature). The examiner should continue examination of the Markush claim to determine whether it meets all other requirements of patentability (e.g., 35 U.S.C. 101 and 112, nonstatutory double patenting, and proper Markush grouping).
In the interest of compact prosecution, the examiner should ensure that the record is clear as to which species have been searched and have been found allowable over the prior art. The examiner should indicate that the provisional election of species requirement has been modified if additional species beyond the elected species have been searched and determined to be allowable over the prior art. The examiner should indicate that the provisional election of species requirement has been withdrawn if the full scope of the Markush grouping has been searched and been determined to be allowable over the prior art. Note that the examiner can only make or maintain any restriction requirement if there would be serious burden. Clarity of the record with regard to the provisional election of species requirement is critical to proper application of 35 U.S.C. 121 in later divisional applications.
If a Markush grouping as set forth in a claim is proper and election of species has been required, the examiner must continue to search the species of the claim unless the claim has been found to be unpatentable over prior art. An examiner may not (such as by way of an Ex parte Quayle action or a Notice of Non-Responsive Amendment) seek to require an applicant to limit the scope of a claim that is directed to a proper Markush group to a subset of species that falls within the scope of the claim in the absence of a rejection of the claim for not complying with the requirements for patentability (e.g., 35 U.S.C. 101, 102, 103, and 112, and nonstatutory double patenting).
The MPEP 803.02 further stated that “2. Elected Species is Proper in Markush Grouping Allowable over the Prior Art: If the elected species or group of patentably indistinct species is not anticipated by or obvious over the prior art, the examiner should extend the search and examination to a non-elected species or group of species that falls within the scope of a proper Markush grouping that includes the elected species. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The examiner need not extend the search beyond a proper Markush grouping. In other words, the examiner need not extend the search to any additional species that do not share a single structural similarity and a common use with the elected species (i.e., do not belong to the same recognized physical or chemical class or to the same art-recognized class and/or do not have a common use and/or do not share a substantial structural feature of a chemical compound and a use that flows from the substantial structural feature). The examiner should continue examination of the Markush claim to determine whether it meets all other requirements of patentability (e.g., 35 U.S.C. 101 and 112, nonstatutory double patenting, and proper Markush grouping)”.
Furthermore, the proteins species of SEQ ID Nos: 11 (KerS1), 13 (KerS1ems), 15 (KerS13), 17 (KerS13uv), 19 (KerS13Uv+ems), 21 (KerS15), 23 (KerS15ems), 25 (KerS26), 27 (KerS26uv), 29 (KerS39), 31 (KerS39ems) are amino acid sequences and are different among each other chemically and structurally, and the eleven (11) polypeptide sequences and corresponding eleven (11) polynucleotides sequences needed to be searched to examine accurately of the claimed invention, i.e., total 22 sequences and each of the sequences requires 8 databases search (.rag, .rup, .rpr, .rai, ..rapm, .rapn, .rapbm and .rapbn for polypeptide sequence), and thus, total 88 databases search for only polypeptides and 80 databases search for only polynucleotides of total 88+ 88 = 176 databases search, and each of the sequences in each of the databases has to analyze by manually by looking through the eyes with special attention to relevancy to the subject matter of the claimed invention with priority date, as well as if there is any variant claimed, which would create a serious search burden to the Office and as well as to the examiner.
Furthermore, applicants are reminded that species election is just for beginning of the examination, but not for sequence elimination. Attorney Docket No.: SG0136-US-CON Inventor: Conradie et al. Serial No.: 16/947,598
The requirement is still deemed proper and is therefore made FINAL.
Claims 6-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 3-5, 10, 13, 14-15 and 16 are present for examination.
Priority
Acknowledgement is made of applicants claim for priority of US patent applications 18/473,416, filed on 09/25/2023, now US patent 12410421, and 17/822,823, filed on 08/29/2022, now US patent 12146172, and claim for priority of US Provisional application 63/332,472, filed on 04/019/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/22/2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are considered by the examiner. The signed copy of 1449 is enclosed herewith.
Specification Objections
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see, pg 37, para 4, pg 38, para 1). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01.
Drawings objections-Non-Compliance of Sequence Rule
The disclosure is objected to because of the following informalities:
MPEP 2417-2422.01-.04 The Requirement for Exclusive Conformance; Sequences Presented
in the Drawing Figures (see, Fig. 8 A, B, C, D, E, F, G, H, I, and J; Figs. 16 A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U, V, W, X, and Y). 37 CFR 1.821(b) requires….Any sequence more than 10 nucleotides or more than 3 amino acids, regardless of the format or the manner of presentation of that sequence in the Claims, Specification or Drawings the sequence must still be included in the Sequence Listing and the sequence identifier (“SEQ ID NO:X”) must be used. It should be noted, though, that when a sequence is presented in a drawing, regardless of the format or the manner of presentation of that sequence in the drawing, more than 10 nucleotides or more than 3 amino acids, regardless of the format or the manner of presentation of that sequence in the Claims, Specification or Drawing the sequence must still be included in the Sequence Listing and the sequence identifier (“SEQ ID NO:X”) must be used. See particularly 37 CFR 1.821(d).Appropriate correction is required.
Drawings
Drawings submitted on 08/11/2025 are Not accepted by the Examiner because Drawing Figures (see, Fig. 8 A, B, C, D, E, F, G, H, I, and J; Figs. 16 A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U, V, W, X, and Y) are non-compliant for Sequence Rule.
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 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.
(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.
Claims 14, 3-5, 10, 13, and 15-16 are rejected under 35 U.S.C. 102(a1)(a2) based upon a public use or sale or other public availability of the invention as anticipated by Gurunathan et al. (Novel recombinant keratin degrading subtilisin like serine alkaline protease from Bacillus cereus isolated from marine hydrothermal vent crabs. Scientific Reports (2021), Volume 11, 12007, pg 1-24).
The Broadest Reasonable Interpretation (BRI) of claim 14, which is drawn to a composition chicken feathers, a surfactant, an aqueous medium and a keratinase comprising the amino acid sequence of SEQ ID NO: 11 (KerS1) (elected species) or an amino acid sequence that is at least 95% identical to SEQ ID NO: 11 (elected species).
Regarding claims 14, 3-5, 10, 13, and 15-16, Gurunathan et al. teach a novel recombinant keratin degrading subtilisin like serine alkaline protease from Bacillus cereus isolated from marine hydrothermal vent crabs, which is about 97% identity to SEQ ID NO: 11 of the instant application (see, the sequence alignments as shown below) and further teach the protease gene from Bacillus cereus obtained from shallow marine hydrothermal vents and was cloned in an expression vector pET32B(+), expressed in E. coli, culturing and purified from cellular components after centrifugation, wherein the protein sequence of 38 kDa protease SLSP-k was retrieved from mass spectrometry and identified as a subtilisin serine proteinase, wherein the novel SLSP-k is a monomeric protein with 38 amino acid signal peptides being active over wide pH (7–11) of total 501 amino acids, and temperature (40–80 °C) ranges, with maximal hydrolytic activities at pH 10 and at 50 °C temperature, and the hydrolytic activity is stimulated by Ca2+, Co2+, Mn2+, and DTT, and is inhibited by Fe2+, Cd2+, Cu2+, EDTA, and PMSF, wherein the SLSP-k is stable in anionic, non-anionic detergents, which are surfactants and solvents, wherein the ability to degrade keratin in chicken feather, wool, and hair indicates that this enzyme is suitable for the degradation of poultry waste without the loss of nutritionally essential amino acids which otherwise are lost in hydrothermal processing, and the proteinase is efficient in environmentally friendly bioconversion of animal waste into fertilizers or value-added products such as secondary animal feedstuffs (see, whole document, in particular Title, abstract, pg 2, para 3-6, pg 3, para 1-5, pg 5, para 1-3, Fig. 1-2, 5, and Table 1).
Query Match 99.6%; Score 1221; Length 397;
Best Local Similarity 99.6%;
Matches 234; Conservative 1; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MKNKIIVFLSVLSFIIGGFFFNTNTSSAETSSTDYVPNQLIVKFKQNASLSNVQSFHKSV 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MKNKIIVFLSVLSFIIGGFFFNTNTSSAETSSTDYVPNQLIVKFKQNASLSNVQSFHKSV 60
Qy 61 GANVLSKDDKLGFEVVQFSKGTVKEKIKSYKNNPDVEYAEPNYYVHAFWTPNDPYFKNQY 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GANVLSKDDKLGFEVVQFSKGTVKEKIKSYKNNPDVEYAEPNYYVHAFWTPNDPYFKNQY 120
Qy 121 GLQKIQAPQAWDSQRSDPGVKVAIIDTGVQGSHPDLASKVIYGHDYVDNDNTSDDGNGHG 180
||||||||||||||||:|||||||||||||||||||||||||||||||||||||||||||
Db 121 GLQKIQAPQAWDSQRSNPGVKVAIIDTGVQGSHPDLASKVIYGHDYVDNDNTSDDGNGHG 180
Qy 181 THCAGITGALTNNSVGIAGVAPQTSIYAVRVLDNQGSGTLDAVAQGIREAADSGA 235
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 THCAGITGALTNNSVGIAGVAPQTSIYAVRVLDNQGSGTLDAVAQGIREAADSGA 235
Therefore, Gurunathan et al. anticipate claims 14, 3-5, 10, 13, and 15-16 of the instant application as written.
Double Patenting Rejection
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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 14 (independent claim), 3-5, 10, 13, and 15-16 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over at least claims 1-5, 9, 10, 11-12, and 13 of U. S. Patent 12410421 B2, granted on 09/09/2025. Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1-5, 9, 10, 11-12, and 13 of the instant application disclose a compositions comprising; chicken feathers, a surfactant, an aqueous medium, and a keratinase comprising the an amino acid sequence of SEQ ID NO: 11 (KerS1), 13 (KerS1ems), 15 (KerS13), 17 (KerS13uv), 19 (KerS13Uv+ems), 21 (KerS15), 23 (KerS15ems), 25 (KerS26), 27 (KerS26uv), 29 (KerS39), 31 (KerS39ems) or an amino acid sequence that is at least 95% identical to SEQ ID NO: 11, 13, 15, 17, 19, 21, 23, 25, 27, 29 or 31, wherein the microorganism expressing the keratinase is Bacillus, wherein the microorganism expressing the keratinase is Bacillus cereus, wherein the keratinase comprises comprising at least one of the amino acid sequences comprising sequence-of SEQ ID NO: 11, 13, 15, 17, 19, 21, 23, 25, 27, 29 or 31, wherein the composition further comprising hair or wool and animal feed, wherein the keratinase is isolated from cellular components, wherein the composition comprises a microorganism expressing the keratinase.
Claims 1-5, 9-12 and 13 of US patent 12410421 B2 disclose a composition comprising a keratinase comprising the amino acid sequence of SEQ ID NO: 11 (KerS1), 13 (KerS1ems), 15 (KerS13), 17 (KerS13uv), 19 (KerS13Uv+ems), 21 (KerS15), 23 (KerS15ems), 25 (KerS26), 27 (KerS26uv), 29 (KerS39), 31 (KerS39ems) or an amino acid sequence that is at least 95% identical to SEQ ID NO: 11, 13, 15, 17, 19, 21, 23, 25, 27, 29 or 31, wherein the keratinase is isolated from cellular components, wherein the comprises a microorganism expressing the keratinase, wherein the composition further comprising a keratin-containing material, which is feather, wherein the microorganism expressing the keratinase is Bacillus, wherein the microorganism expressing the keratinase is Bacillus cereus, wherein the keratinase comprising at least one of the amino acid sequences comprising SEQ ID NO: 11, 13, 15, 17, 19, 21, 23, 25, 27, 29 or 31, wherein the keratin-containing material is hair or wool, wherein the keratin-containing material is an animal feed
The above indicated claims of the reference patents while not totally identical to the instant claims, are indeed a product claim of a composition comprising a keratinase comprising the amino acid sequence of SEQ ID NO: 11 (KerS1), 13 (KerS1ems), 15 (KerS13), 17 (KerS13uv), 19 (KerS13Uv+ems), 21 (KerS15), 23 (KerS15ems), 25 (KerS26), 27 (KerS26uv), 29 (KerS39), 31 (KerS39ems) or an amino acid sequence that is at least 95% identical to SEQ ID NO: 11, 13, 15, 17, 19, 21, 23, 25, 27, 29 or 31, as claimed in the instant claims. The portion of the claims and the specification in the reference patent US 12410421 B2, while drawn to the actual product as claims in claims 14, 3-5, 10, and 13-15 in the instant application, includes several embodiments that would anticipate the invention claimed in the instant application. Claims of the instant application listed above cannot be considered patentably distinct over claims of the reference patents when there are specifically recited embodiments that would either anticipate to claims 14, 3-5, 10, and 13-15 of the instant application or alternatively render them obvious. Alternatively, claims 14, 3-5, 10, and 13-15 cannot be considered patentably distinct over claims 1-5, 9-12 and 13 of the reference patent US 12410421 B2, when there is specifically disclosed embodiment in the reference patent that falls within the scope of claims 14, 3-5, 10, 13-15 of the instant application, i.e. there is substantially overlapping scope between the claimed invention and the teachings of the reference. One having ordinary skill in the art would have been motivated to do this because that embodiment is disclosed as being a preferred embodiment within the claims 1-5, 9-12 and 13 of US patent 12410421 B2.
Conclusion
Status of the claims:
Claims 14, 3-5, 10, 13, and 15-16 are rejected.
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Iqbal H. Chowdhury, Primary Examiner
Art Unit 1656 (Recombinant Enzymes and Protein Crystallography)
US Patent and Trademark Office
Ph. (571)-272-8137 and Fax (571)-273-8137
/IQBAL H CHOWDHURY/
Primary Examiner, Art Unit 1656